August 6-9, 2014; Orlando, FL; Full Report - Draft

Executive Highlights

In this report, we provide our full coverage of the 41st Annual Meeting of the American Association of Diabetes Educators (AADE), held at the Orange County Convention Center in Orlando, Florida from August 6-9, 2014. This year’s conference saw a slight drop in attendance - ~2,500 attendees vs. ~3,000 who attended in 2013 (Philadelphia) and 2012 (Indianapolis). All 50 US states were represented, as were 25 countries, a testament to the conference’s continuing international appeal. This year’s 199 exhibitors represented a 15% decline from the 233 companies and organizations in 2013; however, we did see booths from 33 first-time exhibitors, including Regeneron Pharmaceuticals, GSK, and iHealth Lab. Our team was thrilled to have the opportunity to learn from so many intelligent, hardworking diabetes educators, who make an incredible difference in patients’ lives and too often do not receive the full recognition they deserve.

The four-day agenda included over 71 breakout sessions, four corporate symposia, and six product theaters, not to mention a host of other workshops. Organizers experimented with four new education formats – Meet the Experts Debates, Snap Learning Sessions, Master Classes, and Critical Conversations – that were designed to offer more interactive discussions and deeper learning opportunities. Public policy emerged as a major theme of the conference, as multiple speakers stressed the need for greater provider and payer appreciation of the value of diabetes education. We also heard many perspectives on the emergence of telehealth, as speakers eagerly encouraged educators to incorporate it into their practices – diabetes care and education certainly needs to move in this more scalable direction to keep pace with the increasing number of patients. After all of the enthusiasm and dedication we saw in Orlando, we are already looking forward to next year’s meeting in New Orleans, LA on August 5-8, 2015.

Below, we begin our report with a high-level overview of the conference’s major themes. For ease of navigation, we have divided our coverage into six categories: (i) Diabetes Technology; (ii) Diabetes Drugs; (iii) Mobile Health and Social Media; (iv) Health Policy, Reimbursement, and Healthcare Models; (v) Additional Topics; and (vi) Exhibit Hall. Talks included in this report that were not covered in our daily highlights reports are highlighted in blue, while those in yellow represent some of the most memorable presentation we attended.

Themes

Diabetes Technology

• AADE included new product launches and announcements from BD, Roche, and Asante. BD launched its newest pen needle product, the AutoShield Duo, which features front and back-ended shields for safety. For young kids, anyone newly diagnosed with diabetes, people who “inject on the go,” or those who generally have a strong aversion to needles, the new BD needle may provide a more comforting and safer method for handling injections. During a company-sponsored product theater, we also got an up close look at Roche’s Accu-Chek Aviva Expert, a standalone meter with a built-in bolus calculator. Given that the majority of people taking insulin do not have access to an insulin pump’s bolus calculator, this should be a welcome tool for reducing the hassle and uncertainty of calculating insulin doses. Last, Asante’s late-night corporate event highlighted the launch of the new MySnap color-customizable insulin pump program, as well as plans for a next-generation Bluetooth-enabled pump and an accompanying mobile app (launch scheduled for next year) – notably, the new mobile platform is expected to allow users to bolus from their smartphones. Dexcom and Asante also announced that Dexcom’s Gen 5 mobile platform will integrate and display insulin data from the Snap insulin pump. We see the move to mobile bolusing and smartphone CGM integration as a huge convenience win for patients – the major question is how long the regulatory process will take. Asante CEO Mr. David Thrower also hinted that the company has plans to become involved in closed-loop technology, stating, “We’ll have much more to say about an artificial pancreas later this year.”
• Corporate events from Medtronic, Dexcom, and Bayer focused on marketing CGM; this was a significant change from last year’s program that offered limited content on this technology. Dexcom’s product theater provided a broad outline of the advantages of CGM and positioned the G4 Platinum as an effective tool for improving outcomes. The company’s presence was not as substantial as at Keystone 2014, where we heard a comprehensive overview of Dexcom’s robust pipeline and had the opportunity to test-drive a CGM for a day. Still, educators were buzzing about the technology, and it was clear that they appreciated the strides in accuracy that Dexcom has made from the Seven Plus. Medtronic’s AADE presence included two events – a product theater and a dinner (co-sponsored by Bayer) – that portrayed the MiniMed 530G/Enlite as the solution to the challenges of an increasingly diverse type 1 patient population. Educators seemed impressed with the benefits of the product’s threshold suspend feature – a slide depicting a CGM trace following threshold suspend activation drew excited murmurs from the audience. Overall, we noticed a great deal of interest in CGM among diabetes educators, and at future AADE annual meetings, we would appreciate seeing more focus on the technology in breakout sessions and symposia. The majority of attendees seemed familiar with the technology, but could likely benefit from guidance on optimizing therapy and interpreting data (which can be tough even for the most knowledgeable providers).
• Speakers and attendees called for more convenient software that integrates CGM, insulin pump, and SMBG data. In particular, we heard lots of frustration stemming from electronic health record (EHR) options. Notably, Dr. Irl Hirsch’s (University of Washington, Seattle, WA) informal poll at a Medtronic/Bayer co-sponsored dinner revealed that only 5% of the event’s ~400 attendees worked with providers who routinely download CGM and insulin pump data. We see this figure as a testament to how busy most providers are, but more importantly, as an illustration of the need for more convenient data download and interpretation solutions. Along the same lines, Ms. Virginia Valentine (Northside Family Medicine, Albuquerque, NM) and Ms. Deborah Hinnen (University of Colorado Health, Colorado Springs, CO) stressed the overwhelming, unstructured nature of current CGM outputs in their presentation on the Ambulatory Glucose Profile (AGP) – as a reminder, this single-page report (developed through an expert panel coordinated by the International Diabetes Center) hones CGM data into the most critical statistics and a modal day plot. The audience was noticeably awed at the simplicity and utility of the approach – indeed, we heard loud groans from educators when they were informed that the software is not yet available (EU studies are presently ongoing).
  
  • Multiple presentations promoted Medtronic’s CareLink software as a convenient, easy-to-use EHR system that can improve diabetes management and inform therapy adjustments; unlike many other options out there, CareLink can conveniently integrate data from a variety of meters and Medtronic pumps. There are certainly many reasons why Medtronic is the market leader in insulin pumps (e.g., installed base retention, longstanding market experience, etc.), though one important one is the value that providers continually place on CareLink. What will be interesting to see is how providers like cloud-based data platform options from Tidepool and Dexcom, once they launch in the next couple of years.

Diabetes Drugs

• Diabetes educators seemed very interested in “wrapping their head[s] around this new idea” of SGLT-2 inhibitors, as Ms. Davida Kruger (Henry Ford Health Systems, Detroit, MI) put it during J&J’s product theater on Invokana (canagliflozin), which emphasized the drug’s usefulness in a variety of treatment regimens as well as its beneficial effects on A1c, body weight, and blood pressure. Invokana was prominently featured in the exhibit hall as well, with over half of J&J’s booth devoted to touchscreens explaining its mechanism of action and efficacy data. Meanwhile, at an AstraZeneca corporate symposium, Dr. Anne Peters (University of Southern California, Los Angeles, CA) admitted that she started out “determined not to like the class,” as its mechanism didn’t initially make intuitive sense to her; however, she now feels confident using SGLT-2 inhibitors at nearly any point in the spectrum of type 2 diabetes. Dr. Charles Schaefer (Medical College of Georgia, Augusta, GA) expressed similar enthusiasm for the drug class at AstraZeneca’s product theater on Farxiga (dapagliflozin), largely because of the drug’s favorable impact on cardiovascular risk factors. Most diabetes educators seemed to be aware of, if not fully familiar with, this relatively new class and intrigued by its potential, though some did have concerns about the risk of adverse events like genitourinary infections and long-term effects on renal function.
• GLP-1 agonists also received plenty of positive press at this year’s AADE, with several speakers highlighting the class’ favorable impact on weight and hypoglycemia as well as the class’ potential in combination therapy with basal insulin. Dr. James Gavin (Emory University, Atlanta, GA) and Mr. Joe Largay (University of North Carolina, Chapel Hill, NC) explicitly contrasted GLP-1 agonists with sulfonylureas regarding their effects on body weight and hypoglycemia. Both argued that the risks of sulfonylureas are often overlooked or underestimated because the class is so familiar and inexpensive, but that GLP-1 agonists offer a much more appealing profile in terms of efficacy, safety, and adherence. Looking ahead, the promise of GLP-1 agonist/basal insulin combination therapy came up in multiple talks; Ms. Geralyn Spollett (Yale Diabetes Center, New Haven, CT) claimed that “most of the literature now says that is the ideal combination,” and Dr. Curtis Triplett (University of Texas Health Science Center, San Antonio, TX) expressed enthusiasm for the early data. GLP-1/basal insulin combinations could indeed be a transformative drug class, especially given the data thus far from the DUAL phase 3 program for Novo Nordisk’s Xultophy (insulin degludec/liraglutide). As a reminder, Xultophy recently received a positive CHMP opinion in the EU; a final EMA decision is likely within the next two to three months, and a launch could come in 1H15.
• Given that AADE typically focuses on strategies for the best use of already-available drugs, it was notable to see an entire session dedicated to drugs not yet marketed in the US. The session, entitled “Medications Update: New and Emerging Therapies,” focused on emerging insulins, SGLT-2 inhibitors, and GLP-1 agonists; MannKind’s inhaled insulin Afrezza (approved by the FDA in June and to be commercialized in partnership with Sanofi, starting in the US in early 2015) was a major focus of Q&A. Additionally, lingering concerns regarding last year’s incretins/pancreatitis controversy came up at this and several other sessions – speakers seemed to agree that there is no solid evidence to support an increased risk, but they acknowledged that there is still plenty of anxiety around the issue.

Mobile Health and Social Media

• Multiple presentations espoused the benefits of telemedicine and provided educators with guidelines for initiating their own telehealth practices. It was excellent to see this topic raised so frequently at AADE, as telemedicine will likely play a critical role in improved, more cost-effective diabetes care delivery in the coming years. Dr. Paul Wadwa (University of Colorado, Aurora, CO) discussed the success of his team’s telemedicine practices across Colorado and Wyoming, which has enhanced patient satisfaction, decreased time missed from work/school, and achieved the same glycemic control relative to in-person care. Later in the conference, Ms. Rynn Geier (Olmsted Medical Center, Rochester, MN) presented a protocol for establishing a diabetes education telehealth practice. Notably, an informal poll during her presentation indicated that only 5% of the audience (~150 providers) currently used telemedicine in their practice, though 25% said they had plans to incorporate telehealth in the coming 12 months. Educators cited questions surrounding the utility of telemedicine and concerns over reimbursement as the most formidable barriers to wider adoption of telehealth. We heard similar sentiments echoed by Ms. Joanne Rinker (The Center for Healthy North Carolina, Greensboro/Winston-Salem, NC), who promoted telehealth as a solution to the time and resource limitations of in-clinic practices. She noted that 45 out of 50 states have Medicaid reimbursement for telehealth services, suggesting that reimbursement challenges are certainly surmountable. On the whole, we were impressed with the amount of interest these sessions generated and hope to see this focus replicated in next year’s agenda, but with more of an emphasis on the reimbursement challenges.
• Several speakers encouraged educators to become more conscious of social media’s potential as a tool for improving patient outcomes. Some educators are clearly quite savvy on this front already, as many revealed that they have active Facebook and Twitter profiles that they use to communicate with patients. This was especially evident during a packed, at times emotional Breakout Session that addressed the positive role social media can play in enhancing diabetes management. Moderated by the highly respected Mr. Jeff Hitchcock (Children with Diabetes, West Chester, OH), the star-studded panel featured well-known figures from the diabetes community: Ms. Kerri Sparling (SixUntilMe.com), Mr. Bennett Dunlap  (StripSafely and Your Diabetes May Vary, Philadelphia, PA), Ms. Jennifer Block (Stanford University, Palo Alto, CA) and Dr. Jill Weissberg-Benchell (Northwestern University, Chicago, IL). Despite concerns regarding the potential for misinformation and harassment in online forums, speakers urged providers to engage in online dialogue to learn from the rich community and enhance their understanding of the psychosocial burden of diabetes.
  
  • Along similar lines, Dr. Shelagh Mulvaney (Vanderbilt University, Nashville, TN) discussed leveraging online resources to support adolescent self-management. She noted that few social learning opportunities exist for diabetes; in response to this need, her team developed YourWay, an online and mobile self-management program for adolescent type 1 patients that features to-do checklists, customizable backgrounds and avatars, and interactive digital stories.

Health Policy, Reimbursement, and Healthcare Models

• Many presentations pointed to the need for greater provider and payer appreciation of the value of diabetes education. AADE President Ms. Joan Bardsley (MedStar Health Research Institute, Hyattsville, MD) opened the conference with a call for diabetes educators to more effectively communicate their impact to key healthcare decision makers, stressing that diabetes education has been proven to improve outcomes and reduce costs, but still does not receive adequate reimbursement. Such sentiments were also brought up repeatedly during a pre-conference session on “Building Your Diabetes Education Program,” as educators lamented the lack of referrals from primary care physicians and payers’ perception that diabetes education is not worth the investment. The importance of adequate reimbursement was evident during Ms. Joanna Craver’s (AADE, Chicago, IL) update on the AADE Diabetes Prevention Program – the program has produced very promising results thus far (~6% weight loss after 12 months among participants who attended at least four sessions) – but will only be sustainable if AADE can convince payers that investing in the DPP will prove to be cost-effective over time. We agree that diabetes educators often do not receive the full recognition they deserve, though the path to improved reimbursement and recognition seems both long and uncertain (i.e., What are the actionable steps individual educators can take?). We also wonder if payers would ask for randomized controlled trials demonstrating the value of diabetes education.
• On a more hopeful note, several speakers indicated that current trends toward a more patient-centered, evidence-based approach to healthcare delivery should produce incentives that are more in line with diabetes educators’ goals. Ms. Patty Telgener (Emerson Consultants, Excelsior, MN) argued that diabetes educators will be essential for the success of accountable care organizations (ACOs), which will place a greater emphasis on prevention and care coordination. Similarly, keynote speaker Dr. Angela McBride (Indiana University School of Nursing, Indianapolis, IN) asserted that “diabetes educators have the defining expertise for where the world is going” as care becomes more integrated and outcomes-oriented. As an example of its potential, Ms. Lovely Varghese and Ms. Yesenia Cabral (New York Presbyterian Hospital, New York, NY) discussed the successful implementation of a patient centered medical home (PCMH) at New York Presbyterian Hospital – the program led to A1c reductions in 67% of 1,263 participants from an underserved, largely immigrant community. We agree that the broad healthcare delivery paradigms encouraged by the Affordable Care Act are a net positive for diabetes educators, though as Dr. Jonathan Oberlander (University of North Carolina, Chapel Hill, NC) cautioned, the verdict is still out on how effective ACOs and other similar models will be in practice.  

Diabetes Technology

Breakout Session

Expanding Patient and Professional Engagement with CGM Data: The Ambulatory Glucose Profile (AGP)

Deborah Hinnen, APRN, BC-ADM, CDE (University of Colorado Health System, Colorado Springs, CO); Virginia Valentine, APRN, CNS, RN, BC-ADM, CDE (Northside Family Medicine, Albuquerque, NM)

Ms. Virginia Valentine and Ms. Deborah Hinnen impressed a packed auditorium of ~350 attendees with a wide-ranging overview of how CGM data can be synthesized into an Ambulatory Glucose Profile (AGP) – as a reminder, this one-page CGM output was developed at the International Diabetes Center and refined following an expert panel in 2012 (Bergenstal et al., DT&T 2013). The two presenters stressed the overwhelming, unstructured nature of current CGM outputs and the need for software that integrates this data, making analysis simpler and less time-consuming for providers. The audience was noticeably awed at the simplicity of the AGP, the ease of vital data extraction (e.g., likelihood of low glucose at a particular time of day) and the user-friendly interface. Indeed, there were groans from the audience lamenting the fact that the software is not yet available (EU studies are presently ongoing) – Abbott has been the quickest in industry to jump on AGP, as the software will be a centerpiece of its Flash Glucose Monitoring products. We are not sure whether Medtronic and Dexcom will incorporate AGP into their data management platforms. As a reminder, the original vision was that AGP could be a single standardized CGM download report, no matter the manufacturer.

• “Are you overwhelmed by data?” This question framed the presentation as both Ms. Valentine and Hinnen emphasized the overwhelming, unstructured nature of current CGM outputs. While they applauded the usefulness of real-time CGM features (e.g., detection of nocturnal hypoglycemia and postprandial excursions, trend arrows showing rate and direction of glucose change, high and low alarms, etc.), they lamented the inconvenience of most electronic health records (EHR), pointing out that there is no standardized format for visually displaying this data.
  
  • In discussing the biggest barriers to CGM use in clinical practice, one educator cut straight to the chase: “It’s time consuming.” This statement received many affirming nods from the audience, suggesting that CGM still has strides to make in terms of saving providers time.
• The Ambulatory Glucose Profile (AGP) consolidates CGM data into a simple one-page graphic (see an example here from the 2013 DT&T paper), which summarizes glucose data with time-in-range statistics and a shaded modal day plot (median, interquartile range, and 10/90% bounds).  Ms. Valentine stressed that we have a natural tendency to be drawn toward outliers in CGM data analysis outputs, whereas the AGP “puts things in perspective,” helping providers to focus on patterns as opposed to individual data points.
• Judging from the audience’s palpable excitement, the on-screen dashboard is the highlight of the software. This consists of a simple 3 × 5 modal day plot that summarizes a patient’s CGM data over the course of the day. Rather than representing this information with numbers, a series of algorithms simplified the data into a red-yellow-green color scheme. For example, if a patient was consistently experiencing lows in the morning, the corresponding spot in the matrix would be marked red; that same spot could also be marked yellow (mediocre control) or green (great control), allowing providers to efficiently and easily identify trouble spots and patterns.
  
  • Case studies provided the most impressive testament to the AGP’s ease of use. Educators were asked to assess CGM outputs during the presentation and reached consensus on trouble spots within a few seconds of looking at downloads. Indeed, there were groans from the audience lamenting the fact that the software is not yet available; we did hear that EU studies are presently ongoing to refine the algorithm and software, though no timeline was provided.
• During an informal discussion with the audience regarding the real-world utility of this software, Ms. Valentine noted that the AGP “might just provide the rationale you need to work with an insurance company to justify getting [patients] off [sulfonylureas].” Noting that sulfonylureas are a “killer,” she highlighted the ease with which even an insurance provider would be able to understand that data, forcing them to acknowledge the very real risk of hypoglycemia.

Questions and Answers

Q: How many days are included in a profile?

A: It could be anything from one week to three weeks.

Q: How do the meal icons work if you have a weekend meal vs. weekday meal?

A: Currently nothing distinguishes them. However, work is being done on that. I think that’s one of the things we need to tease out.

Corporate Symposium: Diabetes Technology Comes of Age: Practical Strategies for Optimizing Integrated Insulin Pump Therapy and Continuous Glucose Monitoring (Supported by an Unrestricted Educational Grant from Medtronic-Bayer Alliance)

State-of-the-Art Diabetes Technology in 2014

Irl Hirsch, MD (University of Washington, Seattle, WA)

Dr. Irl Hirsch’s presentation focused on current SMBG accuracy standards and CGM/pump use in the T1D Exchange. He stated that the 2013 ISO and 2014 FDA proposed accuracy standards for home use of meters are “doable,” though the FDA proposed point-of-care (POC) accuracy standards are unrealistic – indeed, he emphasized that the latter leaves “zero tolerance for statistical outliers” and even YSI cannot meet them. He predicted that changes will be made to the guidance before final publication. Dr. Hirsch also shared unpublished data from the T1D Exchange on insulin pump and CGM penetration (used by 59% and 9% of type 1 patients, respectively) – despite the disparity, Dr. Hirsch reiterated his prediction from ENDO 2014 that “in the next three to five years CGM is going to out-enroll pumps.” In particular, he pointed to what he considers the unjustifiably high frequency of severe hypoglycemia in the current US population (as high as ~20%/year in patients with a duration of diabetes >40 years), noting that hypoglycemia “is the reason we fight for CGM.”

• Dr. Hirsch characterized current 2013 ISO and 2014 FDA proposed accuracy standards for home use of meters as “doable,” noting that Roche’s Accu-Chek Aviva Plus and Bayer’s Contour Next Link currently meet these guidelines. However, he was critical of offshore strip brands, none of which meet either the 2013 ISO or 2014 FDA proposed standards – this is of course cause for concern, as patients and payers frequently turn to offshore brands in order to cut costs.
  
  • Dr. Hirsch was incensed over the FDA proposed point-of-care (POC) accuracy standards. As a reminder, these guidelines call for 99% of measured values to be within ±10% of reference for >70 mg/dl and within ±7 mg/dl for <70 mg/dl. Additionally, 100% of individual results are expected to fall within ±20% of the reference method for samples >70 mg/dl or ±15 mg/dl for <70 mg/dl. Echoing sentiments we have heard since the January publication of the document, Dr. Hirsch noted that there is “zero tolerance for statistical outliers” and that even YSI cannot achieve these standards. That said, he did express confidence that “common sense will prevail” – he predicted that significant changes would be made to the FDA guidelines before final publication.

Table 1: Insulin Pump Use by Age in the T1D Exchange

	Age (years)
	<6	6-12	13-17	18-25	26-49	>50	Overall
At Enrollment*	31%	47%	50%	53%	63%	57%	54%
Current	51%	62%	55%	53%	65%	60%	59%

*Not defined in Dr. Hirsch’s presentation, though we assume this means over the last five years.

Table 2: CGM Use by Age in the T1D Exchange

	Age (years)
	<6	6-12	13-17	18-25	26-49	>50	Overall
At Enrollment*	3%	3%	2%	5%	18%	15%	6%
Current	9%	6%	4%	5%	19%	18%	9%

*Not defined in Dr. Hirsch’s presentation, though we assume this means over the last five years.

• Dr. Hirsch shared unpublished data from the T1D Exchange on insulin pump and CGM use by age. Though certainly not representative of the whole US type 1 population, the data reveal the gradually increasing penetration of CGM and insulin pumps in the type 1 population over the last several years (currently used by 9% and 59% of Exchange participants, up from 6% and 54% at the time patients were enrolled – the latter was not defined). Use of pumps in pediatric patients <12 years has increased quite substantially over time, rising from 31% to 51% in those <6 years and 47% to 62% in those 6-12 years. A similar pattern has been observed in CGM penetration; the prevalence of use in the youngest age groups has tripled (<6 years) and doubled (6-12 years), albeit from very small bases. It was disappointing to see the limited uptake of CGM (5%) in the young adult population (ages 18-25), a number that has not increased. One might expect comparable, if not greater, penetration relative to the other adult age groups, given the familiarity with new technology; we wonder if this stems from insurance and/or income constraints, as out of pocket costs of using CGM can sometimes be quite high.  
• Dr. Hirsch also shared T1D Exchange data on the relationship between mean A1c and insulin pump and CGM use. Unsurprisingly, pump users had a lower average A1c relative to those on MDI, and CGM users had a lower average A1c relative to non-CGM users (see below).

Table 3: Mean A1c – Insulin Pump Therapy vs. Injection in the T1D Exchange

	Age (years)
	<13	13-25	> 26
Injection	8.8%	9.2%	7.8%
Insulin Pump	8.2%	8.6%	7.6%

Table 4: Mean A1c – CGM Users vs. Non-CGM Users in the T1D Exchange

	Age (years)
	<13	13-25	> 26
Non-CGM Users	8.4%	8.9%	7.7%
CGM Users	8.0%	8.5%	7.3%

• Despite the disparity in CGM vs. pump penetration, Dr. Hirsch projected that “in the next three to five years CGM is going to out-enroll pumps” – a prediction we heard most recently at ENDO 2014. As evidence, he pointed to what he considers the unjustifiably high frequency of severe hypoglycemia in the US population; according to a recent study (Weinstock et al., Journal of Clinical Endocrinology and Metabolism 2013), the frequency of severe hypoglycemia is as high as 20% per year in patients who have had diabetes for over 40 years (regardless of age) and does not drop lower than ~7% for patients whose duration of diabetes is < 20 years (regardless of age). Dr. Hirsch emphasized that hypoglycemia “is the reason we fight for CGM,” noting that these devices can change “these horrible numbers.”

Practical Issues of Teaching and Using Sensor-Augmented Pump Therapy with Threshold Suspend

Elizabeth Nardacci, MS, RN, CDE (Albany Medical Center, Albany, NY)

In a clinically focused presentation, Ms. Elizabeth Nardacci provided attendees with guidelines to effectively educate patients on the use of sensor-augmented pump therapy (SAPT). Highlighting the MiniMed 530G/Enlite system, she stressed that patients are capable of surmounting the perceived intricacy of optimizing insulin pump, CGM, and software technology in a short period of time. Ms. Nardacci’s guidelines stemmed from the protocol used in the STAR-3 trial – she noted that the long-term adherence achieved in that study was facilitated by positive habits established in the first weeks of training. Her protocol encouraged providers to begin the process simply and deliberately, introducing patients to a pump alone in the first few weeks before incrementally presenting advanced features and incorporating the CGM into treatment (in Q&A, she acknowledged that the order could also be reversed, with patients being introduced to CGM prior to pump therapy – we see pros and cons to each approach). Ms. Nardacci highlighted the importance of familiarizing patients with the CareLink software early in this process to help facilitate self-management and reduce dependence on providers in the future. She also encouraged the use of personalized alarm settings to minimize nuisance. In her view, gradually familiarizing patients with the MiniMed 530G system in this manner makes it appear less overwhelming and reduces the likelihood that patients will stop using the device out of frustration.

Interactive Use of Downloaded Data in Adults with Type 1

Irl Hirsch, MD (University of Washington, Seattle, WA)

In his second trip to the podium, Dr. Irl Hirsch emphasized the importance of CGM and insulin pump downloads in contemporary diabetes care. An informal poll of the audience revealed that only 5% of the ~400 attendees worked with providers who routinely download CGM and pump data. Dr. Hirsch noted ruefully that this figure is significantly lower than that reported by physicians themselves. The low percentage – lower than we would have expected – illustrates limited provider time and the need for more convenient data download and interpretation solutions. [Of course, there are other factors that could explain the lower number as well – e.g.,  most patients are not on CGM and pumps, especially the type 2s that educators are more likely to be caring for; the educators in the audience may have been at the session because they are unfamiliar with pumps/CGM; etc.]. In particular, Dr. Hirsch highlighted the difficultly in rationalizing glycemic targets without referring to downloaded data. As was a theme throughout the evening, he pointed out that patient education on data downloads is even more preferable, as it enhances self-management and allows patients to begin to own their diabetes.

Interactive Use of Downloaded Data in Pediatric Patients with Type 1

Jennifer Block, RN, CDE (Stanford University, Stanford, CA)

Ms. Jennifer Block discussed the off-label use of the MiniMed 530G with Enlite in pediatric patients (the device is only indicated for patients >16 years of age), using case studies from her practice to highlight the benefits of the threshold suspend feature for children as young as 13 years old. In her view, unrealistic expectations often present the largest hurdle to earlier introduction of this technology, as young patients expect the device to “automatically” deal with lows for them rather than viewing it as a tool to enhance their self-management of the disease. Interestingly, Ms. Block encouraged providers to use the CareLink Personal software (which is available to patients) rather than the standard CareLink Professional software, so that lessons from the clinic translate more readily to the home. [As a reminder, patients cannot currently use the CareLink Pro software, despite its more powerful analytic capabilities.] Especially when integrated with threshold suspend data, Ms. Block believes this software is very useful for identifying trouble spots that are easily missed in more general CGM summaries, and that both the MiniMed 530G/Enlite and the CareLink software can be important components of pediatric diabetes management.

Panel Discussion

Q: Ms. Nardacci, have you ever tried teaching the CGM first and then adding the pump?

Ms. Elizabeth Nardacci (Albany Medical Center, Albany, NY): Yes, once. It’s very possible.

Q: Do you recommend using CGM data to replace basal testing?

Ms. Jennifer Block (Stanford University, Stanford, CA): I’ll be honest. I think CGM data – mind you, CGM is not approved for dosing – can really help. I don’t usually ask for finger stick data from my patients.

Q: Does it affect the accuracy of the sensor to calibrate more than four times a day?

Ms. Nardacci: Yes. More is not necessarily better.

Ms. Block: We talk about calibration when glucose is relatively stable. You need to be aware that these systems have algorithms and that they’re using more than one calibration point. It’s not just the last data point that matters. Patients should understand that everything they enter is really important.

Q: How long does it take you to interpret data? Do you do all your work during a visit (download + review + evaluation and discussion with patient)? How do you get your patient on board with the plan? How long do you get with your patient?

Ms. Block: As an NP, I get 45 minutes. And I have my medical students do my downloads, then I sit down with my patients. I find some positives to point out first. I typically look at two weeks of data and generally focus on the last week. And we go through that week, and I have blood glucose and CGM and insulin data in front of me. What I find is that I can identify what is causing which results much faster. I can avoid uncomfortable questions, such as: How many carbs did you really eat? And sometimes, depending on how talkative a family is, they can speed up the visit for me.

Ms. Nardacci: I get 30 minutes with my patients. I think a lot of times providers get hung up on looking at everything. Instead, I recommend focusing on the big picture things. That’s what’s important.

Ms. Block: I spend a lot of time teaching parents and families about how to interpret data themselves. That takes a lot of time. However, it’s worth the investment, because in the future, it saves me time on data analysis. In fact, they will come in with recommendations, and they tend to know more than me.

Dr. Irl Hirsch (University of Washington, Seattle, WA): I also get 30 minutes with patients. You were saying that you cannot just look at averages and standard deviations. I know my colleagues get 15-20 minutes, if that. How do we use this therapy if downloads keep giving us more information? Admittedly, the data is a good use of time, but it continues to take time. How will businesses go into this, if they know they’re going to lose money? It’s a big problem, and I don’t have solutions for it. And I don’t think our new healthcare system that focuses on type 2 diabetes is set up to deal with this.

Q: What steps need to be taken to get insurance companies to cover pumps and CGM? Why aren’t insurance companies at this conference?

Dr. Hirsch: What I’m told in the state of Washington is that we have the most difficult reimbursement policy for third-party insurance. I actually had a Mom with two kids with diabetes, and she asked how she can afford devices because reimbursement is so minuscule. I told her to leave Washington. This is a huge problem, and it’s only getting worse as it pertains to Medicare. The good news about the Medicare situation is that it’s on the radar again. At Congress, Dr. Anne Peters (University of Southern California, Los Angeles, CA) developed a great video. But even with non-Medicare patients, we have to fight, fight, fight to get what they need. To get threshold suspend, for example. I even had a pre-authorization I had to sign for insulin. For insulin! Because of what’s happening to the cost of insulin. I can tell you that getting pumps approved is not as difficult as it used to be. I shared that in an editorial. I had a patient who needed a pump renewal and insurance wouldn’t cover it. And I had to have a peer-to-peer evaluation and was asked what makes you qualified to prescribe pumps. And I said, “Google me.” It’s a fight. And it’s difficult.

[Comment]: The downloads are particularly great for patients with eating disorders. I love it when I have patient who puts everything into their pump. It’s great, and we have an average amount of insulin per day.

Dr. Hirsch: What we have with CareLink is that it allows me to see everything. I see them override and “underride.” I can see how they’re thinking. And that’s exactly where I want to be. I want to be in their mind.

Q: What is the greatest predictor of severe hypoglycemia?

Dr. Hirsch: The number one predictor of severe hypoglycemia is duration of diabetes followed by age. Everything else is low compared to duration of diabetes.

Ms. Block: There is type 1 data on this, not shown here. What is interesting is that there are higher rates of severe hypoglycemia in populations whose A1c’s are above target. I know that I used to have a bias on this front. I thought that when a patient’s A1c was higher, the lesser the patient’s risk for severe hypoglycemia. But that data showed me that patients whose A1cs are high are also at risk for severe hypoglycemia.

Dr. Hirsch: If you recall from the DCCT, A1c and hypoglycemia were strongly correlated. But from the T1D Exchange, what we’ve found is that severe hypoglycemia occurs at the same rate regardless of whether a patient’s A1c is greater than 11% or less than 6%. It is insane.

Product Theater: Meet The New Accu-Chek Aviva Expert Meter – The First And Only Stand-Alone Meter With A Built-In Insulin Calculator (Sponsored by Roche)

Benefits of Bolus Advice for MDI Patients

Bruce Bode, MD (Atlanta Diabetes Associates, Atlanta, GA)

A standing-room only audience packed the Roche product theater to hear Dr. Bruce Bode discuss the medical evidence and rationale for the “first and only” commercialized stand-alone blood glucose meter with a built-in insulin calculator: the Accu-Chek Aviva Expert. (We’d note that the language is highly misleading, as Abbott’s FreeStyle Insulinx in Europe also has a built-in bolus calculator. We assume the company meant to add, “In the US.”) In a review of multiple studies of manual bolus calculation, Dr. Bode highlighted both the complexity (“it’s hard to do even with proper education!”) and potential danger – one multicenter analysis suggested that 63% of manually calculated bolus insulin doses were incorrect (Sussman et al., Journal of Diabetes Science and Technology 2012). By contrast, Dr. Bode stressed that the Accu-Chek Aviva Expert provides a simple and safe alternative for MDI patients trying to calculate boluses. He cited data (Schmidt et al., Diabetes Care 2012) from a recent 16-week study (n=51) of the Aviva Expert indicating that patients using automated bolus calculations experienced an impressive drop in A1c (-0.7% vs. -0.1%, p=0.001; baseline: 8.8% and 9.1%, respectively) and increased satisfaction (p=0.008) in their treatment regimen relative to a control group that only received carbohydrate-counting education. Dr. Bode also highlighted the indications for such a device: (i) patients starting bolus insulin (i.e., new onset type 1 diabetes patients); (ii) patients failing basal insulin therapy and who are not at goal on MDI; and (iii) patients considering pump therapy (to verify that they can do multiple tests per day and calculate carbohydrate doses). We came away with the impression that meter meets a significant unmet need in the US marketplace and are curious to see whether and how quickly the device is embraced by patients and providers.

Meet The New ACCU-CHEK Aviva Expert Meter – The First And Only Stand-Alone Meter With A Built-In Insulin Calculator

Deborah Hinnen, ARNP, BC-ADM, CDE (University of Colorado Health, Colorado Springs, CO)

Ms. Deborah Hinnen provided a clinically focused how-to guide for optimizing the Accu-Chek Aviva Expert. Like Dr. Bode, Ms. Hinnen was quick to point out the simplicity of the meter, which requires only “three steps” for generating bolus advice: (i) testing and receiving blood glucose results; (ii) inputting carbohydrates and personal information (e.g., carb ratios, sensitivity factor, active insulin, and target); and (iii) injecting and confirming the dosage on the meter – i.e., similar to using an insulin pump bolus calculator. She highlighted that the meter’s personalized bolus advice settings include a unique feature called Customizable Health Events, which allow providers and patients to program the algorithm to adapt to a patient’s lifestyle; the setting has multiple presets that instruct the algorithm to reduce or increase the advised bolus by preset amounts (e.g., 10%, 20%) when a user indicates it is necessary (e.g., after exercise, during times of stress, or before menstrual periods) – this is terrific to see, given the variable context that comes with each bolus calculation. As expected, 90% of the educators revealed that they had more patients on MDI than on insulin pumps, a reminder that the majority of people on insulin do not use a pump (and thus don’t have access to a bolus calculator). In closing, Ms. Hinnen emphasized the accuracy of the meter – which meets the most recent ISO 2013 standards for SMBG – remarking that Roche’s high standards are driving innovation at the other Big Four blood glucose companies (J&J, Abbott, and Bayer).

Panel Discussion

Q: How do you decide on the numbers for the bolus modification on the Health Events setting? 

Ms. Deborah Hinnen (University of Colorado Health, Colorado Springs, CO): The example in the slide deck was just random numbers. I would not do very big numbers if I were starting a patient on it. If you have someone who’s a pro cyclist, you might make a big difference. So a 10% or 20% drop might be more applicable for many of our more sedentary patients.

Q: I have a patient who does extensive exercise and most of the time he’s having lows in the middle of night. What would you recommend I do with him?

Dr. Bruce Bode (Atlanta Diabetes Associates, Atlanta, GA): I recommend you reduce the basal overnight and go from there.

Ms. Hinnen: The ADA has recommended that a patient’s blood glucose be at least 100 mg/dl before going to bed. This is because if the body uses all its glucagon during the day, then it is going to replenish that store during the night. So you might reduce the basal and give a bigger snack before bed.

Q: Can this device be used for people who are using regular insulin? If so, how would you change the parameters?

Ms. Hinnen: Yes, you’d just have to change the offset time.

Dr. Bode: For regular insulin, you’d set the offset time for three hours. For Afrezza, on the other hand, the offset time would be 60 minutes.

Q: When you were speaking about the “three simple steps” to bolus advice, what happens if a patient doesn’t confirm the advice after injecting?

Ms. Hinnen: It doesn’t get recorded.

[Comment]: A patient can override the device. The advice they input and override with is the new information it uses. And it does tell them that it’s been overridden.

Product Theater: Different Patients, Different Challenges: One Customized Solution – Benefits Of MiniMed 530G with Enlite (Sponsored by Medtronic)

MiniMed 530G with Enlite – The Only System on the Market That Takes Action When Needed

Linda Burkett, MSN, RN, CDE (Medtronic Diabetes, Northridge, CA)

Ms. Linda Burkett opened the product theater by highlighting the MiniMed 530G/Enlite as the solution to the challenges of an increasingly diverse type 1 patient population. Her clinically focused talk began with an overview of Threshold Suspend automation, specifically detailing the opportunities for patient-provider collaboration; given the murmurs throughout the audience, it appeared that most educators were relatively new to the device – and were relatively impressed. Ms. Burkett went on to praise the accuracy of Bayer’s Contour Next Link BGM, noting that the device meets the most recent 2013 ISO accuracy standards for SMBG home and professional use. We heard interesting color regarding this meter during Q&A, when one educator complained about the difficulty of attaining prior authorization for the meter. In response, Bayer management highlighted a new reimbursement support program to help patients with the appeal process, which has apparently achieved a 100% success rate.

Management of Type 1 Diabetes Using Telemedicine

Paul Wadwa, MD (University of Colorado, Aurora, CO)

Dr. Paul Wadwa discussed how using the CareLink software with the MiniMed 530G/Enlite has aided his team’s telemedicine programs, which have enhanced patient satisfaction and decreased time missed from work/school while achieving the same glycemic control as in-person care. He reminded the audience that CareLink can integrate data from a variety of meters and Medtronic pumps. Dr. Wadwa explained that the CareLink software can also enhance the threshold suspend feature of the MiniMed 530G/Enlite by providing detailed insight into patterns of hypoglycemia (e.g., by indicating when the threshold suspend was activated and for how long, the software can improve awareness of hypoglycemia and help patients make dose adjustments accordingly). We believe that telemedicine will be an increasingly key component of healthcare delivery in the coming years, and we expect to see an abundance of software that facilitates improved care delivery, especially remotely.

Case Studies of the MiniMed 530G with Enlite

Jane Patterson (Medtronic Diabetes, Northridge, CA)

In an overview of several case studies, Ms. Jane Patterson provided a “how-to” guide to optimizing the MiniMed 530G with Enlite, including tricks and tips to help with sensor insertion and taping and guidelines for calibration (3-4 times a day, never during rapid changes of blood glucose – this is a limitation of the Enlite compared to Dexcom’s G4 Platinum, which needs twice-daily calibration at any time); she also stressed the importance and ease of using the CareLink software to identify patient behavior patterns.

Panel Discussion

Q: Dr. Wadwa, what billing code do you use to recoup the time you spend on the CareLink software?

Dr. Paul Wadwa (University of Colorado, Aurora, CO): For the sensor data, there are a couple of different codes for that. There’s a code for the insertion, and there’s another code for the interpretation of downloads. I don’t have it off the top of my head. Certainly one of the keys to reimbursement is documenting what you’ve done.

Ms. Linda Burkett (Medtronic Diabetes, Northridge, CA): The codes are 95250 for insertion data and 95251 for download data. This has to be signed off by a physician PA, DO, or NP. And the work has to be for a minimum of 72 hours of CGM data analysis. Payers will compensate for that work. Those are the codes I understand to be true.

[Comment]: My understanding is that Medicaid will cover for a meter or pump if a patient has a mental or dexterity issue. I have seen the appeal granted in those cases.

[Comment]: My clinic has had huge issues with the Bayer Contour meter in getting prior authorization [from a physician, NP, etc.]. There’s a $200 copay and patients are not willing to do that. It’s been a huge barrier for us.

Ms. Burkett: I would recommend you stop by the Bayer booth. There are options available to patients.

[Comment]: At Bayer, we have a new reimbursement support program in place for physicians, office staff, or patients. It is a free resource that will help the patients through prior authorization or appeals. They’re having a 100% success rate at this point. It’s live and free assistance for your patients.

Product Theater: Optimizing Therapy and Clinical Outcomes Using Real-Time Continuous Glucose Monitoring (Sponsored by Dexcom)

Optimizing Therapy and Clinical Outcomes Using Real-Time Continuous Glucose Monitoring

Gary Scheiner, MS, CDE (Integrated Diabetes Services, Wynnewood, PA); Patricia Gaye Knutsen, MSN, ACNS-BC (Washington University, St. Louis, MO)

At a Dexcom-sponsored product theater, Mr. Gary Scheiner and Ms. Patricia Gaye Knutsen  guided educators on how best to use real-time CGM in their practice. Mr. Scheiner explained his preference for real-time CGM over blinded CGM, as the former allows for cause/effect learning, better calibration, and safety. Educators seemed to share a similar preference, as an informal poll revealed that the majority preferred real-time CGM or a combination of real-time and blinded CGM over blinded CGM alone. Mr. Scheiner also advised attendees to employ an objectives-based approach in their CGM data analysis that focuses on mean blood glucose values (including standard deviation) and the percentage of time above/below/within target range. Ms. Knutsen followed by calling educators to action, stressing that they “are and will be the leaders in promoting CGMs.” She outlined several advantages of the technology, highlighting that CGM can warn of impending highs and lows, provide immediate feedback on lifestyle modifications, and effectively promote behavior change.

• Regarding reimbursement, Mr. Scheiner noted that Medicare and 90% of commercial plans cover professional CGM. This is notable given that Medicare does not cover for personal CGM use, though the pending Medicare CGM Access Act of 2014 could help change that. However, providers can bill for professional CGM startup and interpretation, which may even be done remotely. The latter was particularly encouraging to hear, given frequent complaints that remote care reimbursement is either absent or severely lacking.

Customer Appreciation Event

Snap to the Beat! Blue Man Group at Universal Orlando Resort

David Thrower, MBA (CEO, Asante, Sunnyvale, CA)

A series of pipeline updates headlined Asante CEO Mr. David Thrower’s presentation at the company’s late night even featuring the Blue Man Group. In front of an enthusiastic crowd at Universal Studios, Mr. Thrower opened his presentation by highlighting the recent launch of the MySnap program; this service will allow users to customize the color of the face, frame, and accent of Snap pumps in an effort to promote patient individualization. Mr. Thrower also detailed plans for a next-generation, wireless Snap pump (launch scheduled for “next year”) that will be cloud-enabled and will feed into an Asante smartphone app – creatively called the “SnapCoach.” According to Mr. Thrower, the app will allow users to bolus from the smartphone app itself – that would represent a major convenience advantage for patients, though we wonder how long the regulatory path would be. This mobile platform will also precede the integration of Asante Snap pump data into Dexcom’s Gen 5 mobile platform (also announced at AADE), as Asante seeks to provide new innovation “every year” in the foreseeable future. Mr. Thrower also highlighted Asante’s Simple Upgrade program, which allows patients to move to the newest product for $99 dollars. Intriguingly, Mr. Thrower also hinted that the company has plans to become involved in closed-loop technology, stating, “We’ll have much more to say about an artificial pancreas later this year.”

• Asante took the unusual approach of forgoing an exhibit hall booth in favor of a more extravagant, high-profile event. The decision appears to have paid off from a public relations perspective, as we overheard multiple attendees eagerly anticipating the event throughout the conference. Those who attended are unlikely to forget Asante soon – the impressive display (which took place at Universal Studios, a short bus ride away from the conference center) featured an open bar, a finger-food buffet, and, of course, an energetic performance by the Blue Man Group.
• Mr. Thrower opened his presentation by highlighting the national launch of the “world’s most person-friendly” insulin pump, Asante’s Snap. As a reminder, Asante began a controlled launch in the Northeastern US (New England, Philly, Pittsburgh, and Baltimore/Washington, DC) in April 2013. Mr. Thrower cited data indicating that patients trained on the Snap once can use the pump correctly on their second attempt 99.4% of the time. The pump is the only one on the market with a prefilled insulin cartridges (300 units of Humalog, up to seven days), which Asante claims will save the user roughly eight hours over the course of four years (or, as their clever – and touching – promotional video noted “59,500 warm fuzzy hugs”). Emotional appeals aside, we think the Snap’s focus on ease of use and prefilled cartridges could help expand the market for insulin pumps by appealing to patients on MDI therapy who are eager for a low-hassle alternative to injections. See diaTribe’s test drive of the Snap for more information.
  
  • Mr. Thrower highlighted Asante’s four-week risk-free trial program, something that is highly unique in the pump industry. We are big fans of this marketing strategy, as a permanent switch to pump therapy can be a very daunting decision for patients. Given that only ~30% type 1 patients are currently pump users, we hope – and Asante is certainly convinced – that more might be persuaded to make the leap if they could simply try pump therapy for just a few weeks.
• Mr. Thrower highlighted the recent launch of Asante’s MySnap program, which will allow users to choose custom colors for the face, frame, and accent of their pumps in an effort to promote individualization – Snap is currently the only insulin pump to offer this feature, similar to what Nike did with its NikeID program. According to Asante’s press release, the company will begin shipping MySnap pumps on November 24th of this year; anyone who purchases a Snap pump between now and then will also receive a free MySnap pump upgrade.
  
  • Mr. Thrower highlighted Asante’s $99 Simple Upgrade program, which will allow Snap users to upgrade to “every single innovation [Asante] introduce[s] for $99 dollars.” We believe this program will apply to most, if not all, of Asante’s upcoming innovations; we know for certain that it will apply to the MySnap program and the next-gen Bluetooth-enabled pump.
• Mr. Thrower detailed plans for a next-generation, wireless Snap pump (launch scheduled for “next year”) that will feed into a new Asante smartphone app. The pump will be cloud enabled, featuring a new screen and new look, while the app – creatively called the “SnapCoach” – will allow users to bolus from the app itself and will eventually integrate data from Dexcom’s Gen 5 CGM. Though Mr. Thrower provided little granularity on either front, the announcement offered our first concrete glimpse of the company’s robust pipeline. We are fans of Asante’s Silicon Valley approach to product development and willingness to try new things; in particular, we see the move to mobile-bolusing as a huge win for patients, though the regulatory path is a major unknown.
  
  • According to a timeline on the accompanying slide deck, the next-gen pump will precede the integration of Snap pump data into Dexcom’s Gen 5 mobile platform that was also announced during AADE. The relative timeline of platform development was previously unclear. As a reminder, FDA submission of Dexcom’s Gen 5 platform is expected by the end of 2014/1Q15. A formal timeline for the Gen 5 launch depends on how fast the regulatory process goes – we assume it will take at least 12 months.
• “We’ll have much more to say about an artificial pancreas later this year.” This announcement was certainly the highlight of Mr. Thrower’s pipeline updates, though he was otherwise coy on details. Given Asante’s new CGM integration partnership with Dexcom, we assume it would build its own predictive low glucose suspend or treat-to-range system.  Dexcom already has existing CGM integration partnerships with Animas and Tandem, though neither company has moved very quickly on automating insulin delivery.

Diabetes Drugs

Master Class Session: Medications Update – New and Emerging Therapies

Insulin

Curtis Triplitt, PharmD, CDE (University of Texas Health Science Center, San Antonio, TX)

Given that drug-related presentations at AADE often focus on how to best use already-available therapies, we were glad to see a session dedicated to drugs that are not yet approved in the US. Dr. Curtis Triplitt provided a comprehensive presentation on emerging insulins, giving the room a reason to be excited about the products on the horizon. He covered the complex ongoing regulatory journey of Novo Nordisk’s Tresiba (insulin degludec), attempted to pronounce Sanofi’s “Toujeo” (U300 insulin glargine), reviewed the clinical profile of Lilly’s peglispro, and concluded with an in-depth discussion of MannKind/Sanofi’s inhaled insulin Afrezza – the couple minutes of Q&A at the end of the session were dominated by questions about Afrezza.

• Novo Nordisk’s Tresiba (insulin degludec): Dr. Triplitt noted that Tresiba was the victim of a slightly “backhanded” move by the FDA, which applied its CV Guidance (originally not intended to apply to insulin) to the candidate. Examining the clinical data on Tresiba, Dr. Triplitt characterized it as a good basal insulin that (from most trials) appears to have a hypoglycemia advantage over Lantus (insulin glargine).
• Sanofi’s Toujeo (insulin glargine U300): Introducing the candidate’s name with a French accent, Dr. Triplitt highlighted that Toujeo appears to have a hypoglycemia benefit in type 2 diabetes patients but perhaps not in type 1 diabetes patients (at least not to the same extent). Concentrated insulins that are already available (such as Lilly’s Humulin U500 vials) require some tricky math, but Dr. Triplitt suggested that Toujeo will be available in a pen that will make dosing simpler for patients. 
• Lilly’s Peglispro: Dr. Triplitt focused on the flat PK/PD profile and long half-life (~36 hours) of Lilly’s novel basal insulin, characterizing it as a step up from currently available basal insulins.
• MannKind/Sanofi’s Afrezza: This was the only emerging prandial insulin Dr. Triplitt covered; he gave it a very thorough overview. He covered both the established benefits (a PK/PD profile comparable to IV insulin), safety concerns (pulmonary function, patients with lung disease), and the ideal patients for the product. In Dr. Triplitt’s view, the lack of dosing precision means that Afrezza is much more useful for type 2 diabetes patients than type 1 diabetes patients – in fact, during Q&A, Dr. Triplitt and his co-presenter Dr. Joshua Neumiller (see below) could not recall whether the drug had even been approved for type 1 diabetes. Dr. Triplitt believes that the dose conversion required for Afrezza is quite complex, especially considering that the product has demonstrated a non-linear dose response at higher doses.

SGLT-2 Inhibitors

Joshua Neumiller, PharmD, CDE (Washington State University, Spokane, WA)

Dr. Joshua Neumiller followed Dr. Triplitt with a review of the SGLT-2 inhibitor class. In his view, although the class is very new, manufacturers have done a fairly good job of educating providers on how it works. He shared that SGLT-2 inhibitors’ unique insulin-independent mechanism of action makes them ideal as an add-on to other agents when greater glucose-lowering efficacy is needed. Regarding the dose adjustments required in patients with chronic kidney disease, Dr. Neumiller displayed a table comparing the different eGFR thresholds included on the labels of J&J’s Invokana (canagliflozin), AZ’s Farxiga (dapagliflozin), and the very newly approved Jardiance (empagliflozin) from Lilly/BI. Jardiance has the most lenient renal safety contraindication in its class so far.

• Patients can use either dose of Jardiance (10 mg and 25 mg) down to an eGFR of 45 ml/min/1.73 m² without dose adjustment. In contrast, AZ's Farxiga (dapagliflozin) is completely contraindicated in patients with an eGFR less than 60 ml/min/1.73 m², while J&J's Invokana (canagliflozin) is capped at the lower 100 mg dose for patients with an eGFR between 45 and 60 ml/min/1.73 m². Patients with chronic kidney disease have relatively few options in terms of glucose lowering agents, and Jardiance's utility at its maximum dose through stage 3A chronic kidney disease (CKD) provides an edge with this part of the population. Additionally, even in patients with earlier-stage CKD, we believe providers will be more comfortable providing Jardiance knowing that a dose adjustment will not be needed if a patient's renal condition deteriorates further.

GLP-1 Agonists

Curtis Triplitt, PharmD, CDE (University of Texas Health Science Center, San Antonio, TX)

Dr. Triplitt took the stage again, this time to discuss new and emerging GLP-1 agonists. As compared to drug classes like DPP-4 inhibitors, Dr. Triplitt emphasized that there is a great deal of heterogeneity within the GLP-1 agonist class, meaning that providers (or payers) cannot simply switch patients from one GLP-1 agonist to another. [Indeed, this underscores why Express Scripts caused such a stir with its decision to solely cover AZ’s Byetta and Bydureon (exenatide) – and not Novo Nordisk’s Victoza (liraglutide) – in its 2014 formulary.] Dr. Triplitt discussed Victoza, Byetta/Bydureon, and GSK’s Tanzeum (albiglutide), all of which are on the market. Dr. Triplitt suggested that the new Bydureon pen is an improvement over the previous kit, but is still not optimal – in a show of hands, around 10-20% of the audience had seen the pen. Moving on to agents in development or under review, Dr. Triplitt covered Lilly’s Trulicity (dulaglutide), Novo Nordisk’s semaglutide, the possibility of oral GLP-1 agonists, and Intarcia’s implantable exenatide mini-pump ITCA-650, characterizing them all as positive potential additions to the type 2 diabetes treatment armamentarium. He also expressed enthusiasm for the early data on GLP-1 agonist/basal insulin combinations, although he did not discuss this topic in depth. 

Panel Discussion

Q: Can you comment about the risk of pancreatitis and pancreatic cancer with incretins?

Dr. Curtis Triplitt (University of Texas Health Science Center, San Antonio, TX): The models for pancreatitis do not show that these drugs increase pancreatitis. The best evidence showing an increase in pancreatitis is spontaneous pancreatitis in people who took the drugs. With these people, after you stop taking the drugs, the pancreatitis goes away. Large database trials show no increase in pancreatitis. Most of the research on pancreatitis is from one investigator at USC – if you take away the data from that particular person, there is only one database study by Blue Cross Blue Shield showing an association, and it was a poorly done study.

Dr. Joshua Neumiller (Washington State University, Spokane, WA): It comes down to a medical-legal issue, and so we will still need to talk to people about it. The data is not there; this is mostly from post-marketing reporting. I’m usually not concerned, although I would not start an incretin with a patient with pancreatitis.

Dr. Triplitt: Legally it is a big issue. For clinicians, there was also an article in the New England Journal of Medicine by the FDA and EMA people saying pretty much what I just said. It’s not just clinicians that do not see evidence of a risk – it’s those organizations.

Q: Can Afrezza be used in type 1 diabetes?

Dr. Triplitt: I know it was approved for type 2 diabetes, I don’t recall whether it was approved for type 1 diabetes.

Dr. Neumiller: I know they conducted studies in both type 1 and type 2 diabetes, but I would echo Curtis’ statement that I think the usage and applicability makes much more sense in type 2 diabetes given that you have those set doses and there is not as much fine-tuneability. It may be useful in early type 1 diabetes in patients that have injection issues. At least in my view, I don’t see it being a good option in the long term for type 1 diabetes. As I understand it, they are seeking that indication.

Comment: I asked the question because I had an eight-year-old patient ask me about it.

Q: With Afrezza, and the carrier FDKP, do you end up with the dry powder on the back of your throat?

A: Simply stated: yes. Not all the drug goes into the lungs. About 20% ends up in the pharynx, and about 20% you end up swallowing.

Q: On the Technosphere insulin, one of the slides said that it is excreted through the urine unchanged. Does that change the look of the urine in a way that might require patient education?

A: The molecule I was talking about is not the insulin, but the sphere part that surrounds the insulin. To my knowledge, there is no noticeable change in the urine, as it is a very small amount of material.

Q: If you take Afrezza before a meal, do you recommend doing a fingerstick before the meal?

A: Checking before the meal would help you understand what corrective dose you would have to take, but the dose should still hopefully be based on carbohydrate content. One of the things I didn’t talk about extensively was that you might need to mix and match different cartridges together. You may end up taking an eight-unit cartridge and a four-unit cartridge if you need 12 units.

Q: With SGLT-2 inhibitors and the lowering of eGFR, I get nervous when a patient starts at a baseline of 38 or 39 and you’re putting them on an SGLT-2 inhibitor, and it takes them down to 32.

Dr. Neumiller: For canagliflozin, they did studies down to an eGFR of 30, but if someone has an eGFR that is borderline and was at risk of lowering that further, that is not a good population to start the drug in.

Q: You mentioned the increased expression of SGLT-2 in type 2 diabetes. When does that happen in the progression of the disease?

A: I don’t know the answer to that. There is some discussion about whether that is the whole truth, or if there are other mechanisms at play.

Breakout Sessions

Hypoglycemia and Weight Gain: The “Achilles Heel” in the Treatment of Patients with Type 2 Diabetes

James Gavin, MD, PhD (Emory University, Atlanta, GA)

In front of a very receptive audience, Dr. James Gavin asked why, in an era with so many treatment options for type 2 diabetes, the field has not been more successful in improving patients’ long-term outcomes. He named several factors that have contributed to the problem, including clinical inertia and the failure to take advantage of combination therapies earlier in the disease progression. However, Dr. Gavin pointed to insufficient adherence to treatment as one of the most vexing obstacles, which he attributed to unacceptable rates of weight gain and hypoglycemia with many diabetes drugs. Given the well-documented link between improved glycemic control and a reduced risk of microvascular complications, Dr. Gavin argued that improving treatment adherence must be a top priority for providers, and therefore weight gain and hypoglycemia need to be more strongly considered when prescribing medications for type 2 diabetes. For him, the high hypoglycemia rates associated with sulfonylureas make the drug class much less cost-effective than many providers think, as reduced adherence, lower quality of life, and increased risk of complications and hospital visits all contribute to the real “cost” of the drug along with the price itself. Reviewing results from numerous clinical trials, Dr. Gavin demonstrated the more favorable profile of incretin-based therapies (which he called “21st century secretagogues”) and SGLT-2 inhibitors, and he repeatedly urged educators to prioritize these agents whenever possible in their type 2 diabetes treatment algorithms.

Questions and Answers

Q: Can you comment on hypoglycemia in the post-bariatric surgery patient?

A: Frankly, I don’t know. It’s a complex issue. We need to find out what is the frequency and what is the mechanism. When you’ve done that much rewiring and re-plumbing, changing hormonal profiles that profoundly, and depending on the type of surgery, changing emptying rates and the presentation of nutrients to beta cells, all bets are off in terms of understanding the nature of hypoglycemia by any models we have for drug-induced hypoglycemia or underutilization of calories. It’s a very different and complicated subject, and I wouldn’t presume to give an answer with real clarity.

Q: The data showed that more women had hypoglycemia. Do you think there was a correlation with menopause?

A: I don’t know if that’s the reason. I’m not aware of the data. On the face of it, women get pregnant, and that’s an insulin-resistant period, which lowers the likelihood of hypoglycemia. Women have more fat relative to muscle, which would also tend to confer more protection. I’m not sure if it’s the tissue distribution, hormonal profiles, or the demographics of treated diabetes. Men may be just as successful but they tend to be more trifling in terms of getting treated.

Type 2 Diabetes and Insulin Therapy: Can Diabetes Educators be More Effective in Meeting the Educational Needs of Their Patients?

Robert Powell, MS, CDE (University of Pittsburgh, Pittsburgh, PA)

Mr. Robert Powell presented results from patient focus groups run by the University of Pittsburgh and Pennsylvania State University that underscored the presence of “psychological insulin resistance” (this is the term that has been traditionally used in place of “needle-phobia”) in patients with type 2 diabetes. A qualitative analysis of patient responses found that the largest barriers to insulin use included misperceptions about the health effects of insulin (“the longer you’re on insulin, the more likely you are to have complications”), lack of knowledge about new advances like smaller needles and insulin pens, prohibitive costs, and inadequate one-on-one education about the mechanics of insulin administration. Mr. Powell urged diabetes educators to take the initiative in overcoming these obstacles and to proactively seek out patients in need of education, given that provider focus groups have suggested that other HCPs often do not have up-to-date knowledge about insulin or sufficient time to thoroughly educate their patients.

Diabetes Guideline Comparison: Understanding Key Differences & Applying the Evidence to Help Patients Reach Individualized Goals

Melissa Max, PharmD, CDE (Harding University, Searcy, AR)

Dr. Melissa Max presented a comparison of the ADA/EASD and AACE/ACE guidelines for the management of hyperglycemia in patients with type 2 diabetes; interestingly, an audience poll revealed that the majority of educators in attendance preferred the ADA/EASD algorithm. Dr. Max listed several advantages of each algorithm: she applauded both the “easy-to-read” design of the ADA/EASD guidelines and the green-yellow color-coding used to indicate preferences in the AACE/ACE algorithm. She also highlighted the looser A1c target of the ADA/EASD algorithm (< 7% vs. < 6.5% in the AACE/ACE algorithm) and its more conservative stances on dual and first-line insulin therapy: the ADA/EASD algorithm only advises dual therapy in patients with A1c >9% (vs. >7.5% in the AACE/ACE algorithm) and advises insulin as a first-line therapy in patients with A1c >10% (vs. >9% in the AACE/ACE guidelines). In closing, Dr. Max noted that it will be interesting to see how the guidelines adapt to emerging treatment options, such as MannKind’s recently approved ultra-rapid-acting inhaled insulin Afrezza (which is being commercialized in partnership with Sanofi). Our general impression is that both algorithms have pros and cons, and different providers may prefer one over the other; certainly, both are works in progress as they move into clinical practice.

Questions and Answers

Q: I’ve seen physicians many times remove metformin treatment after a severe hypoglycemic episode. Can you speak to that?

A: I think what may happen is that if a patient has a severe hypoglycemic emergency and has been hospitalized, then metformin can get appropriately taken away in the hospital, but then not restarted. I think frequently, because of the risk of lactic acidosis in a dehydrated patient, it’s good to get rid of metformin at first. But it’s unfounded to remove metformin when they get better.

Q: A lot of physicians max out metformin dosing before adding another medication. I believe in adding another medication before maxing the metformin dose. What is your take on this? I want to wait to have a second mode of action before maxing out on metformin. Does that make sense?

A: I would personally titrate up my metformin before adding another drug. I think your idea about the two mechanisms is spot on. I would want to do whatever can be done to maximize benefit. If you’re doing what you’re doing and A1c is 6.2%, then I would keep doing that.

Metformin: Beyond Diabetes Management

Oluwaranti Akiyode, PharmD, CDE (Howard University, Washington, DC)

Dr. Oluwaranti Akiyode began her hour-long presentation on metformin by noting that we don’t know exactly why metformin works, only that it does work. She began with metformin’s use in type 2 diabetes, expressing a strong preference for extended release (XR) formulations over metformin immediate release due to differences in GI side effects. She expressed excitement about Elcelyx’s NewMet, a delayed release formulation targeted to the distal intestine that minimizes systemic exposure. Dr. Akiyode suggested that the perceived risk of lactic acidosis with metformin is more a case of being guilty by association with other biguanides – she noted that the guilty by association problem also applied to liver safety monitoring with pioglitazone and rosiglitazone due to the issues associated with troglitazone and hepatic safety. The focus of Dr. Akiyode’s presentation was on metformin’s utility in a number of non-diabetes conditions, including heart failure, polycystic ovary syndrome (PCOS), cancer, and neurodegeneration. The key theme across these disease areas was that metformin shows early promise, but that more research is needed.

Questions and Answers

Q: In the existing research, is there any evidence to suggest that metformin might have a place in the treatment of type 1 diabetes, especially in patients that are insulin resistant or overweight?

A: There have been some studies showing that metformin was insulin sparing in type 1 diabetes.

Q: With some of my patients who are a little concerned about GI side effects, I just start them right out on the extended release formulation. Is there any reason not to do that?

A: No, there is no reason clinically. It might come down to money for some.

Q: I read somewhere that metformin immediate release is more effective than the extended release formulation. Have you heard of any data on that?

A: The evidence has shown that any difference in efficacy is minimal and not clinically meaningful.

Product Theater: Advancing Paradigm Changes in Type 2 Diabetes Management (Sponsored by Janssen)

Advancing Paradigm Changes in Type 2 Diabetes Management

Davida Kruger, MSN, APN-BC, BC, ADM (Henry Ford Health Systems, Detroit, MI)

In a product theater focused on J&J’s Invokana (canagliflozin), Ms. Davida Kruger called on diabetes educators to “wrap their heads around this new idea” of SGLT-2 inhibitors. She began her talk by providing a high-level overview of the role of the kidney in glucose homeostasis, walking educators through Invokana’s mechanism of action. Addressing concerns about the drug’s harmful effect on kidney function, Ms. Kruger pointed to data from a study comparing Invokana to Merck’s Januvia (sitagliptin) demonstrating no difference in eGFR changes between the two treatment groups. Ms. Kruger emphasized that “you can use Invokana again at any point in a patient’s therapy and can expect benefit,” as a variety of treatment regimens (including mono, dual, and triple therapy) have led to substantial A1c reductions. In discussing the drug’s safety profile, she acknowledged the increased risk of genital mycotic infections but downplayed them, stating that “patients usually only get one.” She also advised patients to stay hydrated, as increased urinary frequency is a common side effect in the first month of treatment.

• “This is the new idea we have to wrap our heads around after we grew up thinking, ‘No glucose in the urine,’” highlighted Ms. Kruger in her overview of Invokana’s mechanism of action. She explained that the drug lowers the renal threshold for glucose excretion, thus increasing the amount of glucose in the urine, which many older educators have been taught to avoid.
• Ms. Kruger cited female genital mycotic infections, urinary tract infections, and increased urination as the most common adverse reactions to treatment with SGLT-2 inhibitors. However, she suggested that such infections are not cause for too much concern given that “only 20%” of women experience a second infection. With respect to men, she noted that infections are more frequent in individuals who are uncircumcised. Such comments are similar to those of Dr. Anne Peters (University of Southern California, Los Angeles, CA) at CWD/FFL this past July, where she offered tips and tricks to avoid these infections.
• Ms. Kruger noted that treatment with Invokana leads to weight loss and cardiovascular benefit. Presenting the comparison between Invokana vs. sitagliptin, she pointed out that while sitagliptin is weight neutral, Invokana can lead to a five-pound weight loss. Similarly, she showed that Invokana had a greater systolic blood pressure reduction (-5.1 mm Hg) compared to sitagliptin (+0.9 mm Hg).

Questions and Answers

Q: How often do you see mycotic infections?

A: I’ve only seen them in the first couple weeks to a month. Twenty percent of women will have a second one. One lady I worked with said that she took a probiotic and hasn’t had a yeast infection since. But honestly, I’m not sure if probiotics make a difference. You can also prescribe diflucan.

Q: Why do you start at the 100 mg dose and not the 300 mg dose?

A: As with any medication, go low and slow and see how the medication responds. Keep the patient on the 100 mg for 4-8 weeks, recheck GFR, and then increase to 300 mg. You want to make sure that the drug is agreeable. This also helps prevent side effects.

Q: With increased sugar in the urine, does it change the odor?

A: I haven’t heard any reports of changed odor. And my patients would tell me if it did.

Q: I’ve heard that two-thirds of patients reported increased hunger.

A: I have not seen that at all. It may be due to a slight SGLT-2 blockage. But I don’t know of any other mechanisms otherwise. It’s possible that patients see the scales go down and are motivated to work on dieting, but this wasn’t reported in studies.

Q: Is there any UTI data in women older than 65 or 75?

A: There was no difference across all age groups. 

Product Theater: The Critical Role GLP-1 Receptor Agonists Play in Addressing the Treatment Goals of Adult Patients with Type 2 Diabetes (Sponsored by AstraZeneca)

The Critical Role GLP-1 Receptor Agonists Play in Addressing the Treatment Goals of Adult Patients with Type 2 Diabetes

AstraZeneca’s product theater (held in its massive booth) featured the first public demonstration we’ve seen of the new Bydureon (once weekly exenatide) pen. As a reminder, the dual-chambered pen, which encapsulates the entire reconstitution process within one device, was approved by the FDA in March and recently received a positive CHMP opinion in Europe, paving the way for a likely European approval within the next few months. The “twist, tap, twist” procedure demonstrated by the AZ representative looked significantly more user-friendly than the old vial-syringe reconstitution process, though it is of course not quite as convenient as a “ready-to-use” device like those for Novo Nordisk’s Victoza or Sanofi’s Lyxumia. Device and administration continues to be a significant point of differentiation between various once-weekly GLP-1 agonists, and AZ is certainly taking positive steps in a more patient-friendly direction. The company plans to submit a Bydureon ready-to-use suspension formulation device in both the US and EU in 2015.

Product Theater: Glucose Removal: An SGLT-2i Treatment Option for Adults with Type 2 Diabetes (Sponsored by AstraZeneca)

An SGLT-2i Treatment Option for Adults with Type 2 Diabetes

Charles Shaefer, Jr., MD (University Health, Augusta, GA)

Dr. Charles Shaefer’s product theater on AZ’s Farxiga (dapagliflozin) drew a crowd of approximately 200 attendees. He spent much of the hour explaining that Farxiga is far superior in a number of ways (including hypoglycemia and weight) than the “Walmart special” of metformin plus a sulfonylurea. The rest of the presentation revolved around a basic overview of the drug’s label and clinical data – there was no Q&A session. 

Corporate Symposium: Choosing Your Diabetes Treatment Adventure: Clinical Decision Points Using GLP-1 Receptor Agonists (Supported by an Unrestricted Educational Grant from Lilly)

State of the Science: Review of GLP-1 Receptor Agonists – Available and Emerging Agents, Current Recommendations, and Place in Therapy

Joe Largay, PA, CDE (University of North Carolina, Chapel Hill, NC)

Mr. Joe Largay characterized the GLP-1 agonist class as one of the more appealing therapeutic options for type 2 diabetes, offering robust, sustainable A1c reductions along with a fairly benign side effect profile and beneficial effects on weight and other cardiovascular risk factors. He reviewed clinical trial data comparing the various GLP-1 agonists currently on the market or in development and provided some commentary on their pros and cons relative to other diabetes drug classes. In his view – and we would agree – the combination of GLP-1 agonists and basal insulin offers great potential for synergistic effects on A1c with lower rates of adverse effects due to lower doses of each component. On the other end of the spectrum, he believes secretagogues have the “most red flags” of any drug class due to their risk of hypoglycemia, commenting that “providers don’t know how much hypoglycemia is going on and neither do patients.”

Clinical Decision Points Cases

Geralyn Spollett, MSN, ANP, CDE (Yale Diabetes Center, New Haven, CT); Lucia Novak, MSN, ANP-BC, BC-ADM, CDTC (Uniformed Services University of the Health Sciences, Bethesda, MD)

Ms. Geralyn Spollett and Ms. Lucia Novak presented two detailed case studies (complete with cartoon videos) to illustrate the role of GLP-1 agonists within a larger treatment plan for type 2 diabetes. Ms. Spollett echoed Mr. Largay’s endorsement of GLP-1/basal insulin combination therapy, highlighting that “most of the literature now says that is the ideal combination” because it provides basal coverage and effectively addresses postprandial excursions. Regarding cardiovascular risk, Ms. Novak commented that she believes GLP-1 agonists could potentially be cardioprotective, though that has not yet been conclusively demonstrated; she also mentioned that DPP-4 inhibitors “have a very concerning signal that hasn’t been ironed out yet,” presumably referring to several studies that have suggested a potential increase in heart failure risk with the drug class, though the data is far from conclusive [read our report on a recent retrospective study of Merck’s DPP-4 inhibitor Januvia (sitagliptin) for more background on this issue]. Ms. Novak also reminded the audience that A1c should not be the only consideration when evaluating a treatment program’s effectiveness – in her case study, the patient’s A1c increased from 7.6% to 7.8% when his treatment regimen was altered, but his health and quality of life were significantly improved thanks to the combination of weight loss, lower blood pressure, and reduced glucose variability. We hope to hear more speakers emphasize getting beyond A1c, since it is such important implications for patient adherence, long-term treatment durability, and satisfaction.

Questions and Answers

Q: If someone were on Byetta (twice daily exenatide) for five years with good results and no side effects, would you recommend switching to a once weekly option for convenience?

Ms. Spollett: If a patient is missing doses, I would move them to a once weekly or once daily. Exenatide has a better profile for post-meal glucose lowering than extended release or once daily agents. You have to ask, what does the patient need? What would the convenience get for them? Most patients on exenatide have opted to go to a once daily or once weekly option.

Q: In the case study, the patient’s compliance wasn’t great. Could you go to extended release metformin because it would be easier?

Ms. Spollett: Switching to extended release would’ve been about convenience and how to improve A1c. If she took it more consistently, it would have an impact, but just switching to extended release when there were no side effects with regular metformin would be more for her convenience than anything.

Q: What’s the latest thinking on a link between GLP-1 agonists and retention of beta cells?

Ms. Spollett: My latest reading is that the jury is still out. Some people thought that there was, but no one has been willing to say if there is a link and if so, how much.

Mr. Largay: That’s true. In humans, it’s all been computer modeling. There’s some evidence in rodents.

Q: Why didn’t the patient [in the case study] get insulin?

Ms. Spollett: We know insulin works. That’s its biggest claim to fame. If you give enough of it at the right time, you’ll get an improvement in glucose, though maybe not to goal because there are lots of other factors. This patient’s biggest fear was hypoglycemia because of her irregular schedule. Basal insulin can be added, and it doesn’t have untoward effects in terms of scheduling. Her fears were what led us down a different path. There are some cases where adding another oral medication is just prolonging the agony of moving on to insulin. For her, a GLP-1 agonist offered other positive things like weight loss that made it better for her than basal insulin. Adding insulin and a GLP-1 agonist and getting that added effect might be something to think about in the future. Most of the literature now says that is the ideal combination – you’re dealing with post-meal rises and basal coverage.

Corporate Symposium: The People’s Choice: Matching T2DM Therapy to Give Patients What They Want and What They Need (Supported by an Unrestricted Educational Grant from Novo Nordisk)

The People’s Choice: Matching T2DM Therapy to Give Patients What They Want and What They Need

Davida Kruger, MSN, APN-BC, BC, ADM (Henry Ford Health System, Detroit, MI); Thomas Repas, DO (University of South Dakota, Vermillion, SD); James Gavin, MD, PhD (Emory University School of Medicine, Atlanta, GA)

At a packed Novo Nordisk-sponsored dinner symposium, Ms. Davida Kruger, Dr. Thomas Repas, and Dr. James Gavin promoted the use of newer anti-hyperglycemic agents (AHAs) in type 2 diabetes patients. Ms. Kruger opened the symposium by pushing for individualized glycemic control therapy that takes into account all factors (motivation, risk factors, comorbidities) and pointed to the Elements of Diabetes Care Scale (EDCS) as a general guide to help tailor therapy. She emphasized that the “two things patients hate most are hyperglycemia and weight gain,” and that newer AHAs (including GLP-1 agonists, DPP-4 inhibitors, and SGLT-2 inhibitors) provide effective glycemic control while maintaining weight neutrality (or even weight loss, in some cases). Dr. Repas followed by supporting the use of AHAs early on in the progression of type 2 diabetes, reiterating that the drug class is weight neutral and shows slight blood pressure reductions (although he commented that “time will tell if this is clinically significant for cardiovascular events”). Rounding out the session, Dr. Gavin explained that combination AHA therapy with a supplementary agent in addition to insulin is common and can improve glycemic control compared to insulin alone. He noted that the order of administration doesn’t matter, but that educators should be aware that use in combination with sulfonylureas or insulin may increase hypoglycemia risk.  

Questions and Answers

Q: Is weight loss of SGLT-2 inhibitors from water loss or actual fat loss?

Dr. Gavin: Studies have shown that it’s actually body fat after looking at the body composition. Those studies will be published soon. 

Q: If you add a DPP-4 inhibitor to a treatment regimen of metformin and sulfonylureas, you would not expect further decrease in A1c?

Dr. Gavin: That’s not correct. With the mechanism by which incretin-based therapies – including DPP-4 inhibitors – work through GLP-1, you get some rehabilitation of the underlying beta cell function. If you add a DPP-4 inhibitor, you may get enough restoration of residual beta cell function to actually get additional A1c reduction.

Q: Are SGLT-2 inhibitors studied in type 1 diabetes?

Ms. Kruger: Yes, there are two trials that will start this fall.

Q: Do we know if using SGLT-2 inhibitors in prediabetes is beneficial for weight loss?

Dr. Repas: I’m not aware if this is being studied.

Dr. Gavin: It’s clearly off-label and so no clinical trials have been done. But anytime you get a drug and it’s approved and one of its secondary benefits is weight loss, people come out of closet. I do know that people use these agents off-label to achieve weight reduction even in people with prediabetes.

Q: What are your thoughts on switching from basal insulin to a GLP-1 agonist?

Dr. Gavin: The general tendency is that weight is a problem with insulin and so this does pose a reasonable alternative as long as you can ensure access and be clear that the patient is on board.

Mobile Health and Social Media

Breakout Sessions

The DOC Rx: The Role of Social Media in Managing Type 1 & 2 Diabetes

Jeff Hitchcock (Children with Diabetes, West Chester, OH); Ms. Kerri Sparling (SixUntilMe.com); Mr. Bennett Dunlap, BS (StripSafely and Your Diabetes May Vary, Philadelphia, PA); Ms. Jennifer Block, RN, CDE (Stanford University, Stanford, CA); Dr. Jill Weissberg-Benchell, PhD (Northwestern University Feinberg School of Medicine, Chicago, IL)

An intense and at times emotional panel discussion addressed the positive role that the diabetes online community (DOC) can have in enhancing diabetes management. Moderated by the well-respected Mr. Jeff Hitchcock, the star-studded panel featured Ms. Kerri Sparling, Mr. Bennett Dunlap, Ms. Jennifer Block, and Dr. Jill Weissberg-Benchell. The panel opened with a discussion of the guilt (“the worst complication of diabetes”) and fear associated with diabetes, including the burden of carrying stress 24/7 without a break and the impossible task of trying to explain that burden to family, friends, and providers. In particular, panelists found consensus in discussing the more sympathetic perspective educators and providers need to take when advising patients on diabetes management. The presenters also spoke very positively about the diabetes online community as a resource for patients, families, and providers; they all agreed that the benefits of sharing the burden of the disease with other patients outweigh the risks of misinformation and harassment and can provide an avenue for owning the disease more fully.

Panel Discussion

Mr. Jeff Hitchcock (Children with Diabetes, West Chester, OH): Let’s begin by talking about the shame, guilt, and fear associated with diabetes.

Ms. Kerri Sparling (SixUntilMe.com): I think one of the most challenging things about diabetes is that you don’t get time off for good behavior. You can spend a whole day doing all the things right, and what’s the reward: You have do it again. You have to go and do the same thing, and it wears you out. I think even my family has trouble understanding this sense of being burned out. I get burned out doing the right thing. It’s a psychosocial burden as much as a physical one. I have trouble having people understand that. Because at the same time, I don’t want to sound like a pity party – that isn’t fun.

Mr. Bennett Dunlap (StripSafely and Your Diabetes May Vary, Philadelphia, PA): The stress that Kerri just spoke about is different for a parent. We were just talking right before this session. The fear of hypoglycemia is a real psychological burden for parents. It’s not the hypoglycemia itself. It’s the fear of hypoglycemia. I think that’s a function of the 24/7 nature of diabetes. But that’s part of living with diabetes, and I hope it becomes recognized as part of the clinical visit.

Ms. Jennifer Block (Stanford University, Stanford, CA): As a provider, I used to approach diabetes differently than I approached it myself. I used to feel as if I had to put up a front that I could do this every day without being burdened. But it was the online community that I learned from. And what I learned is that I’m not perfect at this, and it’s OK to admit that this is hard to do. And by admitting that, as providers, we’re empowering people. As a provider, I can teach people about diabetes; that part of my job is easy and fun. The challenge is how to support others through this process. Many of my patients are adolescents who are overwhelmed by diabetes. There are few things better for them than when they meet someone else with diabetes. That said, I’m not going home with them. But their computer is at their fingertips 24 hours a day. And that community can support them in a really positive way.

Dr. Jill Weissberg-Benchell (Northwestern University Feinberg School of Medicine, Chicago, IL): For parents, I think the question is whether they’re doing enough for their child, enough for their child’s health and safety. As health care providers, it’s important to think about what contributions we might be making to the fear and guilt. Yesterday, I talked to a mom who shared a story about the stress of taking her child to the endocrinologist. They had had a bad day managing blood glucose values the day before the visit – because of a bad vial of insulin – and she was afraid to take her child to the endocrinologist. She felt he was likely going to hyper-focus on yesterday, despite it just being a bad vial of insulin, and ignore the previous weeks of success. As HCPs, we need to think about that. We need to partner with patients and families, so that we don’t promote these feelings of shame and guilt and fear. And to Jen’s point, for teenagers, the feeling of a shared experience through the online community is something so powerful and life changing. And for loved ones to see what other people are thinking and feeling, the online community is incredibly powerful too. And for people like Kerri, who are able to express on paper what others are unable to – that ability is an incredible gift.

Ms. Sparling: Thank you. And you’re right in speaking about this stress of visiting your provider. If my A1c is out of range, I hear ‘What did you do?’ Out of the gate, emotions are assigned. I find that stressful. I don’t want to be judged. That’s a sticking point. I want to be a good girl, and I’m trying. So there are emotions automatically assigned to values even though it’s just one statistic. I want my CDE to understand that diabetes is occurring within the context of my normal life. I’m trying and I don’t want to disappoint you. I want my CDE to know I’m a good girl. That’s what everyone wants. Do you want to be a good girl, Bennett?

Mr. Dunlap: Yes.

Ms. Block: To me, every single time that things work out, I want you to celebrate it. But when things don’t work out, accept that it is just diabetes. I think we need to be really humble in our approach with people. I think we’re all here because we want to help our patients. But I’m not sure how we help them when we’re making them feel guilty.

Mr. Hitchcock: There’s this overwhelming fear of the complications of diabetes. But what we’ve learned is that if you stay engaged in managing your diabetes, that’s a path you need not see. My guidance is to echo this: Do the best you can every day. What we really want every day are the coaches that teach us how to play the game well. Sometimes we’re going to drop the ball, run toward the wrong goal, but with you as our coaches, that gives us the strength to go back every day.

Mr. Dunlap: “Control” is a loaded word. Someone was talking about a few years ago, and I was seething. He talked about taking energy from something stressful, like diabetes, and moving it over to something else that isn’t a problem. I would encourage providers to understand that there are unique emotions and stress associated with diabetes. But where can we transfer it? You don’t get a get-well card for diabetes. And you don’t get the reward of feeling better. So it’s hard to move that anxiety to something else. But when I go on the online community, I can find inspiration. I have a friend who I get inspiration from. He’s a biker and whenever I’m down, I see pictures of him biking and get back on my own bike. So people should get online and help each other out.

Ms. Sparling: It struck me when you [Jeff Hitchcock] said you try your best every day. But I don’t try my best every day. I would be lying my face off if I said that. I need to be honest with my doctors about where I’m struggling. I don’t want to be judged for saying that I didn’t check my blood sugar in the morning or that I didn’t respond to a blood sugar over 200 mg/dl. I need to be honest with my health care professional, so that I feel comfortable to share that.

Mr. Hitchcock: Doing your best sometimes means saying, “I’m not going to check my blood sugar this morning,” and taking a break.

Ms. Block: I often don’t have the right answers to diabetes management as a provider, but sometimes the parents and families I work with do. And by having open conversations, we can make changes. Because if I’m the only one making a decision, it’s not going to be as effective. So as a patient, you’ve got to open the door. I’m not living with your diabetes. You are.

Mr. Dunlap: A week ago, I found that in giving a peer support for type 2, I owned mine much more. Someone came to me and said that I have diabetes. She said she doesn’t know how this works. I sat down, and we went through how to check her blood sugar, and she kept getting error 5. I kept laughing and she was getting frustrated. And I said, I have a friend whose license plate is Error 5. And we talked about the conversation she should have with her doctor. This person was my sister. And I was empowered by this interaction. And I get empowered by working with other people.

Dr. Weissberg-Benchell: Honestly, I think the online community is equally as powerful as going to camp or going to Children with Diabetes. I think sometimes, especially with the use of different technologies that give you better control over your diabetes, management can be isolating. After all, nobody in middle school wants other people to ask about it. I’ve had people tell me that substitute teachers have pulled a pump out of a kid’s hands, saying, “You’re not allowed to have a cell phone.” And the kid saying, “Uh no, that’s attached to me…” How do you have those conversations and deal with that? Those online conversations are important.

Ms. Block: Even as a provider, I openly go to the online community. When one of my patients was having trouble waking up to her alarms, I went to the Diabetes Online Community (DOC) and saw Kerri’s advice to put the CGM in a glass cup. I got that from the DOC. And I don’t know if you’ve heard about Glu. Glu has actually conducted clinical trials online. And in their first trial, in 48 hours, they got responses from over 200 patients. These online blogs can be very insightful. This is where we are going to learn about our diabetes in the future.

Q: I don’t want to mislead any of my patients. And there is a lot of misinformation out there. What kinds of regulation or oversight can there be?

Ms. Block: I actually think there is a role for educators with that. Insulin is a very dangerous drug, and who do we trust with it? Our patients. So I think we owe it to our patients to prepare them to sort through that information, especially because this information isn’t just online. It also comes from the people we meet who give us advice. So misinformation isn’t just on the Internet; it’s everywhere. I think patients need to be savvy consumers. As providers, you need to say, “I know you’re going to get information from the Internet and if it tells you to change something significant about your medical management, let’s have a conversation about it.” You should say that it is OK to learn and look around. But let’s just have a conversation about it.

Dr. Weissberg-Benchell: I think we should also trust the family and patients to be able to sift through that information as well. Like Jen said, they are savvy consumers. To an extent, they will be able to figure it out.

Mr. Hitchcock: Almost every human in the world who has a computer searches online for something related to healthcare. So people with diabetes naturally go online and search for diabetes and get millions of hits. And most of those are misinformation. So I would encourage you to encourage people to use the Internet, but to print information out and bring it with them into the clinic to have a conversation about it.

Ms. Sparling: That’s true. But let’s also remember that there is a lot of good information online, too. How many people in the room have blogs on diabetes or share your story online? [~10% of audience raises a hand]. See, these weirdos from the Internet are here, too. You can meet them here. Talk to one of these people to get a sense for the good content that is online. And also, when you’re online, feel free to speak up when you see something that’s incorrect.

Mr. Hitchcock: Speaking of going online, let’s talk about rules of engagement. You’ve got to remember the “Five Ws.”

(i) Who runs/funds the website? – If you can’t find that, don’t’ trust it;

(ii) What does the site say? Do they have citations for the science to back it up?;

(iii) When was the information posted or reviewed? Is it up-to-date?;

(iv) Where did the information come from? Do they have good science to back their claims?;

(v) Why does the site exist? Is it selling something?

Ms. Block: When you [providers] open that door and look online, you learn so much. You learn what your patients are looking at.

Q: Glu is looking to partner with all of you [providers]. We ask a question every day. I’m sure you have questions that you’d like answered by thousands of respondents. And we self-report and police ourselves, so if anyone sees something inappropriate, we remove it immediately. We’ve only had to remove two posts in two years.

Mr. Hitchcock: I would caution everyone though. Some adults resort to seventh grade behavior online. When people hide behind a screen name, immature behaviors come out. Remind families that they are going to meet bullies online. If you introduce yourself online, and someone gets mad at you for using the wrong language, don’t let it bother you. They’re not real. They’re just a screen name. You will hear about that. Don’t be surprised.

Ms. Block: These things happen because you’re hiding behind that wall. But because they are behind a wall, people also say things that they’re uncomfortable saying in person. So we have to take into account that there are some incredibly good things that come out of this anonymity in addition to the bad. We should appreciate that."

Dr. Weissberg-Benchell: You can offer families sites that you trust. They are going to look for you for advice.

Mr. Hitchcock: How many of you go online and look around? [80% of audience raises a hand]. How many of you are anxious and have reservations about it? [10% response]. I just want to remind you that if you’re uncomfortable putting your name out there, you can lie. You don’t have to give your real name if you want protection.

Q: When I go online, I have a different screen name, but list that I’m a diabetes educator. And sometimes, I correct things. I make people think about things twice if I think there’s bad advice out there.

Mr. Hitchcock: I think very few people are out there trying to cause problems or lead people astray.

Mr. Dunlap: My website is called Your Diabetes May Vary. I coined that because of the number of people I heard giving strict advice. I’ve often heard people comment that a particular treatment is bad or that something must be done a certain way. And I would always say, “your diabetes may vary.”

Mr. Hitchcock: Today there is literally an explosion of online opportunity for people with diabetes. Whether you run triathlons or snowboard…if you have a certain passion in your life, there will be someone out there who’s done it before and can chart out that path for you. The greatest fear we have is this feeling of being alone. And the online community is there to show you that you are not alone.

Q: For 20 years, I ran a support group for people with diabetes. But when I moved recently, I couldn’t get that started up again. Do you think that the online community is sapping that personal, face-to-face support and moving it online?

Ms. Block: I think that’s an incredibly challenging issue. There’s a huge benefit to face-to-face interaction. However, there are a lot of patients who are incredibly busy. Life has gotten incredibly busy. But I feel like the online community has broken down some of the barriers to that access. The truth is that we’re not doing as well as we wish we were in diabetes management. So everything we can do to improve management is a good thing.

Mr. Hitchcock: CWD has a chat room. And during the conference, you can see at one in the morning, moms who get up to check their child’s blood sugar, and it’s high but they are not sure whether to treat. And they would get online and receive reassurance from families in Hawaii and others who were awake. At that exact moment, the online community provided exactly what she needed. And we need that.

Q: In the community, we are in a tough spot when we have important, valid questions, such as how much do I need to bolus for this cake? These are real-time decisions, but we don’t want to bother HCPs, because that’s not fair, and it’s not an emergency. So the online community can provides this real-time feedback. What do you think about that?

Ms. Sparling: I personally feel uncomfortable telling people how much insulin to take. That’s something I step away from. However, if someone wants to talk about emotional or psychosocial issues, I’m comfortable talking about that. But not so much telling people how much to bolus.

Mr. Dunlap: I’m also not happy giving out my ratios. However, I’m happy to say how I figure out my ratios.

Ms. Block: One of the things I use the online community for is that I see what people are asking about and incorporate that into my practice. I can understand what questions they have, and it can help us adapt more efficiently.

Dr. Weissberg-Benchell: I just want to point out that if you don’t feel comfortable asking your diabetes educator or nurse a question at two in the morning, you need to switch to someone else. Because that’s what we’re here for. If you need to contact us, you need to feel comfortable doing that. We’re here to support you.

Q: I live by myself. And I don’t have CGM. And two months ago, I had a super high blood sugar before going to bed. And I was up until three in the morning because I didn’t feel safe going to bed. I went onto Twitter, because I wanted the support. Not for advice. But while I was waiting for my unexplained blood sugar to go down, I needed and wanted that support. That’s what Twitter was there for – it was the community.

[Ms. Block puts a green Children with Diabetes Friends for Life (FFL) bracelet on her wrist.]

Mr. Hitchcock: Just to explain that green bracelet, it’s something that started at FFL. Someone said they couldn’t distinguish between people with and without diabetes. So they decided to give everyone with diabetes green bracelets and those without diabetes orange bracelets. And it was originally intended to distinguish people, but it really came to mean so much more.

Ms. Block: It came to mean that you’re not alone.

Mr. Hitchcock: I remember my daughter had to leave FFL early one year and said, “I feel like I’m leaving my home.”

Ms. Block: Speaking about support, I have lots of thoughts about the words we use. Why does it have to be that the words we use often are taken to reflect our number? As a patient, we have personal wants. Maybe I don’t want to ever be low in front of my friends. I don’t want to go low on a date. I would rather be up around 200 and 300 than around 60. You have to take into account a patient’s preferences.

Mr. Dunlap: I love Jen.

Comment: Thank you so much! As a nurse, I always tell my patients, “You will teach me more than I will teach you.” I’ve started on Facebook, and I’ve got a Twitter account and I identify myself as a diabetes educator. I also run a radio show that was picked up by three new radio stations yesterday. What happened is that I’ve tied in Twitter and Facebook to the radio show. What I’ve heard on the show is that everyone is overwhelmed by diabetes. “How do I manage diabetes? Can you recommend a safe way to manage this? How do you stop it from consuming you?” Those are the questions I get.

Ms. Sparling: What is the name of your show?

Comment: The Health and Humor Show. I do corporate comedy. I was invited to speak at a fundraiser, and I was invited to speak to add some humor to these situations. Kerri, what you said was so true about doing well and the reward just being getting to do it again. I have so many people that are only told to go home, stick themselves a couple times a day, and come back in a week. So to hear this amazing feedback from all of you, my soul is happy.

Q: You talked about the guilt and shame and fear of diabetes. You talked about easing those emotions. Next month, I will celebrate my 50th year with diabetes. I’m applying for the Lilly and Joslin awards and when I walk around people are going to think I’m an Olympian [applause]. Earlier this conference, at the talk on erectile dysfunction, we heard that within 20-30 years of being diagnosed, you suffer from sexual dysfunction. I would encourage you to keep duration of disease in your mind. I think as providers we get way too caught up in what the numbers are. We forget that this person has neuropathy, etc. because this person has been carrying this disease for 40 years. The fact that this person still has some bowel function, some brain cells left, is reason to be celebrated!

Mr. Hitchcock: You’re right. What Benno Schmidt said was, “I suffered in silence.” And that’s unacceptable. What’s great about the online community is that people can feel comfortable to come out and share. And I just want to read this last bullet point. Many words are used in clinical practice because they are clinically appropriate. But that doesn’t mean that’s right. My personal pet peeve is the word “compliant.” It just doesn’t work.

Q: I have a Twitter account that’s in my name, and I enjoy it. And the online community appreciates my words as an educator. And I’ve learned so much from the community as well. I went in at my quarterly visit and my A1c was 5.8%, which is too high for me. My next one was 6.9%, and it was because of a lot of the challenges that we face. And I think as educators, it’s important to keep that in mind.

Ms. Sparling: I had a friend who was trying to get to an A1c of 6.1%. She got to 6.1%, but she was sobbing because she had been hypoglycemic all the time. And she was sobbing because that’s what it took for her to get there, and she would rather have been at 7% and not have all that hypoglycemia. And the doctor didn’t understand that.

Dr. Weissberg-Benchell: I celebrate any teenager whose A1c is not double digits [applause].

Q: Are there any online resources specifically for type 2 patients?

Mr. Dunlap: There is a website called The Type 2 Experience. It’s a wonderful place to start and branch out from. TuDiabetes is also a great resource. So is DiabetesSisters – they focus on all types of diabetes, including gestational.

Dr. Weissberg-Benchell: There’s so much guilt and shame for type 2s. There’s a stigma that you brought this on yourself. There is so much judgment that if only you hadn’t eaten all those Twinkies and Frosted Flakes, you wouldn’t have diabetes.

Ms. Sparling: As people with type 1, we need to get those with type 2 to bring their stories online and share them.

Q: I’m an educator and, in my third visit with a patient, he told me he’s a drug addict. He’s been in rehab. I got him on a pump and a meter, but I’m the only outside visit he’s allowed, and I want him to get on the online community. I think it would really help him as he’s by himself and trying to get rid of his other demons as well. I want him to see that diabetes can be empowering. Where should I start him?

Mr. Hitchcock: I would say TuDiabetes.org.

Mr. Hitchcock: Just to wrap up, I want to bring attention to a couple final points. A couple of years ago we were trying to think of something we could do as a group. We came up with Spare a Rose, Save a Child. The idea encourages people to buy 11 roses and donate the money for a 12th to diabetes. This year, we’ve raised $27,000. And it wasn’t one person dropping a lot of money. There was an average contribution of $30. That’s the power of social media to impact diabetes. It’s going to keep over 400 kids alive for a year. We’d love for you to take this back to your office. Please join us.

Ms. Sparling: Have you guys heard of CGM in the Cloud? Essentially, I’m a grown woman with a family and I travel a lot. My husband and mother want to see the CGM data from my pump off my Dexcom receiver. We’re waiting for that data to be available but regulatory regulations stop us from doing this. Given these regulations, CGM in the Cloud is a group of parents with kids with diabetes who hacked their CGMs and put this data in the cloud to allow them to follow CGM data from their loved ones. So my family can now see my blood sugars in real time because people with diabetes were tired of waiting for these regulatory hurdles to be cleared. So if you want to find these people, the CGM in the Cloud group is there for you. There’s a lot of focus on pediatrics, but this applies to everyone. Adults need the same support that kids need. Just because I’m a 35-year-old women doesn’t mean that my mother doesn’t care if I don’t wake up in the morning.

Delivering Personalized Diabetes Education via Telehealth: A Pragmatic Guide

Rynn Geier, MBA, RD, CDE (Olmsted Medical Center, Rochester, MN)

Ms. Rynn Geier presented guidelines for establishing a telehealth practice that successfully delivers diabetes education. This clinically focused talk provided educators with a step-by-step protocol for initiating a telehealth service, covering everything from her preferred Webcam ensemble (she endorsed the Logitech C930 because of its privacy shield) to the size of the monitor in the patient rooms (27” to facilitate as “real” an interaction as possible). Ms. Geier’s practice allows patients to schedule appointments at remote locations throughout Minnesota, while providers located at a centralized hub outside Rochester provide education services via Vidayo software. Ms. Geier reported that 90% of her patients have been satisfied with the program and said they would recommend it to a friend; 92% reported being new to education, suggesting that the program is also reaching patients who otherwise might not be receiving any instruction. We were certainly impressed with the effort to improve access to care, a sentiment that was echoed by many educators after the talk. Indeed, only 5% of the audience (~150 individuals) reported currently using telemedicine in their practice, although nearly 25% of them reported having plans to incorporate telehealth in the coming 12 months. This push toward telemedicine was a theme throughout AADE, and the movement appears to be gaining popularity quickly. That said, many reimbursement and logistical challenges remain, sentiments that came through loud and clear in Q&A.

Questions and Answers

Q: Is Skype HIPAA compliant?

A: No.

Q; Have you tried telehealth within the Spanish population?

A: Yes. We use interpreters on site [at the telehealth location]. That’s the majority of the time. You talked about Hispanics, but we also have a large Somali population as well. So in that case, we use a telephonic interpreter service.

Q: How do you keep your resources organized? How do you maintain copies of the boxes, for example, and ensure what you need at the telehealth location is available?

A: In terms of restocking, we have a system in place. Every quarter, we build new boxes and send them out to our locations. Admittedly, not everything gets used every time, so we don’t technically need new boxes. We’re looking at other options for staff on site to help. But for efficiency’s sake, building new boxes and replacing old ones is best.

Q: I have a question about working with insulin pumps and CGM using telehealth. Those techniques and the follow-up care are not reimbursable by CMS requirements, are they?

A: If you bill it under the G-codes, it would be.

Q: How are these appointments set up in terms of CMS then?

A: Well, you can arrange for a patient to see a provider the same day that you use a G-code. But you can’t see a dietician and nurse educator on the same day.

Q: So the draw is that the patient is already seeing a provider?

A: No. Most of the time, it’s not just, “Hey, let’s add this on.” The appointment is scheduled because of a referral they receive. Then they subsequently schedule a telehealth visit.

Q: How do you schedule appointments themselves?

A: Some clinics are very flexible as to when they offer telehealth. Others are only on Tuesday afternoons. It is really complicated. We also have a particular code we use for telehealth in our system. We also use a telephone “re-call” system, so that patients gets reminder about their telehealth visit. It does involve some consideration.

[Comment]: I can imagine that people in the office would not like to do the extra work.

A: No, no one does. But we ask, “Is this going to work for you?”

Q: What’s the draw for them to come to the telehealth clinic as opposed to the actual in-person clinic?

A: It’s the distance. The time commitment for going into the city would be three hours minimum. It may not seem that far, but driving and cost are the biggest barriers that our patients have identified.

Q: What was your initial budget? When do you expect return on investment?

A: I don’t have enough information on this. I know our budget ended up being double what we anticipated, because the telehealth program expanded and wasn’t just restricted to the diabetes clinic. We ended up having administrative support in other areas so it blossomed. But if you email us, we might be able to give you more information.

Q: When did your program start?

A: It started in May 2013. We have only seen 60 patients. We are not the biggest program within the hospital that is using telehealth.

Q: How long did it take from the start of your plan to the start of visits?

A: It was about three months. But we were very supported. If I was trying to do this on the fly, there was no way I could have done this in three months.

Q: I’m in a rural clinic in Ohio. Would we be considered rural?

A: There are websites where you can input your zip code and find out if your location is considered rural.

Q: Did you have any grant money?

A: Yes. Some, not a lot. Telehealth does not have to be expensive. Assuming you choose some of the same equipment we did, you can set up the webcam and speakers for $300 dollars.

Q: Can you talk about telehealth compensation for insulin consultations?

A: Insulin is the one thing CMS will not cover in telehealth. It says that needs to be given in person.

Q: Do you have issues with no-shows in the program?

A: There’s been no difference in no-shows in the telehealth clinic and what we see in person.

Engaging Patients Through Virtual Interactions—Best Practices in Utilizing New Technology to Expand Access to Diabetes Education

Joanne Rinker, MS, RD, CDE (The Center for Healthy North Carolina, Greensboro/Winston-Salem, NC)

In a wide-ranging discussion, Ms. Joanne Rinker reviewed the benefits of telehealth and provided guidance to educators on how to initiate their own telehealth programs. She opened by explaining how telehealth programs can address many concerns of healthcare delivery by circumventing insurance restrictions, demanding less time and fewer resources, and reducing the gaps between visits. In an interactive presentation (including a telehealth session simulation), Ms. Rinker walked educators through how to get started in telehealth, explaining the importance of IT support and what forms of equipment should be acquired. She pushed educators to recruit support from their organizations and to determine what outcome measures should be used to evaluate the program’s success. In addition, Ms. Rinker outlined the guidelines of reimbursement for telehealth and showed that reimbursement has been moving forward to make coverage of telehealth easier. Regarding best practices, she stressed that it is critical to test equipment and connections and to treat sessions as if they were face-to-face appointments (e.g., making eye contact, explaining privacy issues, and making introductions). Toward the end, Ms. Rinker also promoted the use of mobile health, noting that such tools make it easier for providers to monitor and check in with patients between sessions, leading to greater patient satisfaction. 

• Ms. Rinker pointed out that 45 out of 50 states have Medicaid reimbursement for telehealth services. This provides reimbursement for both the providers at the hub site and at the remote site. Costs must be linked to a covered Medicaid service and a technology code must be included.
• Changes in Medicare reimbursement over the past couple decades have made coverage of telehealth somewhat easier. For example, Ms. Rinker referred to the Balanced Budget Act of 1997, which expanded payments to include telehealth services and mandated that Medicare fund telehealth demonstration projects. Still, based on other talks throughout this conference, it seems that there is long way to go on this front.

Questions and Answers

Q: Do you get Medicaid reimbursement if your patients are rural?

A: The clinic they are being served at would have to be in that rural area in order to receive reimbursement.

Q: How can telehealth be incorporated in an urban area where people are at a higher risk of diagnosis? These patients need ambulance transportation and their families have to take work off to take them to hospitals, which are similar challenges to patients in rural areas.

A: This is a good point and it’s a good topic for us to work on policy change. There is a need for change in policy to allow telehealth to reduce cost and ambulatory care, etc. That is something urban communities will have to rally around in order to change policy.

Q: How do you assess patient and provider satisfaction?

A: We do this with providers through surveys by email or face-to-face. It doesn’t have to be intense. The same thing can be done with patients at the closure of consults.

Comment: For measuring satisfaction, we do it at the conclusion of every patient visit. One question we ask is how well the equipment worked today.

Q: Any tips on doing group sessions over telehealth?

A: This would be difficult because it may not be as interactive as face-to-face. You need to figure out ways to be interactive, such as doing short quizzes or having demonstrations. You’d also really have to think about ways to set up the room to enable visual interaction with everyone. As far as what they see on the screen, it can be something very simple like a PowerPoint, but seeing what’s in the room is what makes it enjoyable.  

Master Class Session

Leveraging Internet and Mobile Technologies to Support Adolescent Self-Management Problem Solving

Shelagh Mulvaney, PhD (Vanderbilt University, Nashville, TN)

Dr. Shelagh Mulvaney discussed her involvement in two mobile platforms that are being used to support adolescent diabetes self-management. Highlighting the psychosocial challenges (stress and burnout, social and autonomy support, embarrassment) faced by this population, Dr. Mulvaney stressed that the prevalence of smartphones offers a unique way to reach out and improve patient outcomes. However, in the absence of appropriate and effective platforms to date, Dr. Mulvaney’s practice has developed its own tools to engage this younger demographic. The first tool, YourWay, is an Internet and mobile social networking program that features to-do checklists, customizable backgrounds, and interactive digital stories. The second program, called “SuperEgo,” is a tailored text messaging service that sends personalized texts that address the psychosocial barriers of self-management. For example, the program can send specific texts during lunch, reminding an adolescent that her friends want her to be safe, making her feel more comfortable about checking her blood sugar. Given the preponderance of apps that are not designed by clinicians or those with diabetes management experience, we applaud Dr. Mulvaney’s efforts on this front.. The automated tailoring capability and interactive, real-time monitoring are promising, and we look forward to seeing data indicating that this platform is actually improving outcomes. Going forward, Dr. Mulvaney noted that her team is working to develop an actual mobile app, called YourDay, that will integrate blood glucose data into the software.

Questions and Answers

Q: Any there any HIPAA issues with texting and online messaging?

A: We don’t believe there are HIPAA issues, but it is a grey area.

Q: Did you notice ethnic/socioeconomic differences?

A: We collected socioeconomic data and there was no relationship with technology use and self-management because technology is so pervasive. Interestingly, lower socioeconomic classes have adopted smart phones faster than others perhaps because they are replacing laptops and desktops at home.

Q: Can you tell us more about the mobile phone reminder system?

A: So it’s called “SuperEgo” and it’s automated. The way it’s set up is that we have a template of communication times. We create a map of communication we want to have with somebody. Their responses to questions drive how content is generated. We manually tweak them regarding times of day. For teens, we’re really glad that we had it automated. Otherwise, it’s overwhelming and another thing to log into. That’s a real concern – too many tech avenues for their attention. The extent to which you can automate something and then give them choice is optimal.

Health Policy, Reimbursement, and Healthcare Models

Introduction

Opening Remarks

Joan Bardsley, MBA, BSN, RN, CDE (MedStar Health Research Institute, Hyattsville, MD)

AADE President Ms. Joan Bardsley opened the conference with a rousing call to action, advocating for diabetes educators to “effectively communicate our impact in order to get properly reimbursed.” Despite educators’ well-documented effectiveness in improving outcomes and reducing costs, many patients remain unaware of the importance of the educator’s role and reimbursement consistently falls short of what it should be. Ms. Bardsley cited a lack of primary care physicians’ referrals to educators as “one of the biggest obstacles” facing diabetes educators today. We wonder how this could change and if a direct-to-patient campaign from patients who have benefited from educators may help. Although educators focus on individual patients in their day-to-day work, Ms. Bardsley urged educators to also think at a macro level and strive to communicate with key healthcare decision makers – this was most valuable from our view since educators have significant expertise in direct patient care. Regarding efforts to increase reimbursement, Ms. Bardsley discussed recent state licensure initiatives that aim to expand educators’ legal scope of practice. In addition, she highlighted the AADE’s national promotional campaign, which encompasses both media relations efforts and collaborations with larger organizations like the American Academy of Family Physicians and the AARP.

Keynote Addresses

The Future of Healthcare Reform

Jonathan Oberlander, PhD (University of North Carolina – Chapel Hill, Chapel Hill, NC)

In a keynote address on US healthcare reform, political scientist Dr. Jonathan Oberlander stressed that “we can’t judge healthcare policy solely by cost control.” He reviewed the goals and challenges of the Affordable Care Act, emphasizing the fact that policy makers chose to build on an imperfect system rather than “wipe the slate clean” when crafting the law. He pointed out that although this was likely a smart approach politically, it has presented challenges for implementation. He also cited intense political opposition to “Obamacare” as a major obstacle to the law’s success, as analysts had not expected so many (mostly Republican-led) states to opt out of setting up their own insurance exchanges or expanding Medicaid. Dr. Oberlander highlighted several up-and-coming developments to watch including ongoing legal challenges, the debate over Medicaid expansion (“this is not an ideological issue, this is an issue of health”), and how the 2014 and 2016 election results could affect implementation. Regarding accountable care organizations (ACOs), he suggested that the verdict is still out on their effectiveness, commenting that although the model is sound in theory, “an ACO [alone] can’t provide compassionate, quality, effective care; it’s the people in it” who are crucial for success. He emphasized that despite the importance of bending the healthcare cost curve, improving health often requires investments that do not directly save costs, and that “allowing people with diabetes to live longer and better lives” is worth the investment. We wholeheartedly agree, and are sometimes frustrated by the expectation of cost savings with diabetes therapies while other disease areas do not face similar expectations.

A Decade of Progress Towards a New DAWN

Martha Funnell, MS, RN, CDE (University of Michigan, Ann Arbor, MI)

In front of a packed audience, Ms. Martha Funnell (University of Michigan, Ann Arbor, MI) shared data from the second iteration of the Diabetes Attitudes, Wishes, and Needs Study (DAWN2); the main take-home message from the study was the widespread need for greater appreciation of the psychosocial burden of diabetes. Ms. Funnell reported distressing data regarding the impact of diabetes on quality of life for both patients and family members (see below), illustrating the need for support systems that go beyond brief office visits and handing patients a prescription. The study also concluded that discrimination remains a significant issue for people with diabetes and provided a new breakdown of self-management behaviors by ethnicity. Specific results and analysis of the study are presented below.

• DAWN2 (n=15,438) revealed the detrimental effects of diabetes on quality of life for people with diabetes (PWD) and their family members (FM) – sizable percentages of both groups reported that diabetes had a negative impact on their physical health (62% PWD; 26.7% FM), emotional well being (46% PWD; 45% FM), finances (44% PWD; 35% FM), leisure activities (38% PWD; 31% FM), work/studies (35% PWD; 23% FM), and relationships with family, friends, and peers (20% PWD; 20% FM). Ms. Funnell criticized traditional treatment plans, which she said often devalue the psychosocial burden of diabetes (“the problem”) and focus only on suboptimal self-management (“the symptom”) of the disease.
• There is currently a great unmet need for care that effectively addresses the psychosocial and behavioral dimensions of diabetes. Only 24% of DAWN2 respondents said that their healthcare provider had asked them how diabetes affects their lives, which Ms. Funnell believes is the single most important question a provider can ask. The study also revealed that 38% of family members wanted to be more involved in diabetes care, while 27% said they did not know how best to help. Ms. Funnell urged providers to emphasize psychosocial education over unnecessarily technical lessons about disease mechanisms, saying that it is one of the best opportunities to help patients improve their disease management. 
  
  • 81% of patients and 72% of family members who participated in education programs reported fewer psychological problems and enhanced self-management. The data suggest that health care providers recognize this need as well – ~60% of HCPs surveyed felt that there is a need for greater access to diabetes self-management education and that this education will improve the burden of diabetes. We hope that the documented benefits of education for patients and the acknowledgement by HCPs that the status quo is unacceptable will help persuade payers of the need for greater reimbursement for diabetes education and enabling technologies.
• A substantial number of respondents with diabetes (~20%) reported experiencing diabetes-related discrimination – we were actually surprised that this number was not higher. According to market research by our colleagues at dQ&A, a recent survey of diabetes patients demonstrated that 76% of type 1 patients and a 52% of type 2 patients believe that diabetes comes with social stigma.
• Ms. Funnell also shared data from a smaller study (n=1,055) within DAWN2 evaluating diabetes management among minority groups. Patients in minority groups (African Americans, Hispanics, and Chinese Americans) reported experiencing more diabetes distress compared to non-Hispanic whites (p <0.05). Interestingly, this finding is inconsistent with other DAWN2 data indicating that African Americans with diabetes reported the highest psychological well-being, quality of life, and diabetes empowerment of all groups examined. Given this conflict, we await further details regarding the scoring system used to assess these variables. Regardless of the ambiguity, Ms. Funnell highlighted the findings as a reminder that providers must be cognizant of cultural considerations when treating patients from different demographics.
  
  • Data on ethnic differences in the resources used to manage diabetes were quite revealing. As summarized in the table below, non-Hispanic whites seek very little information to supplement in-clinic care. Though Ms. Funnell did not speculate on the reasons for this discrepancy, we wonder whether minority groups are, perhaps, less satisfied with their in-clinic care or do not have frequent access to in-clinic care. On the other hand, the discrepancy may reflect underlying cultural differences in the way patients receive information from a perceived authority figure. Regardless, the question speaks to the need for further research in this area.

Table 1: Whom do patients rely on to help manage their diabetes?

	Non-Hispanic White (n=472)	African American (n=221)	Hispanic (n=189)	Chinese American (n=173)
Support groups	1%	15%	23%	17%
Another PWD	2%	17%	23%	15%
Social Media	4%	15%	--	12%

• In closing, Ms. Funnell stressed that people with diabetes, not providers, are the foremost experts on themselves. She encouraged providers to help patients identify problems as opposed to focusing on superficial behaviors. The message of DAWN2 is not simply that patient-centered care has long been misunderstood but that patient, family, and provider education regarding psychological aspects of disease management can enhance treatment and lead to better outcomes.

Diabetes Education: The Demand for 21^st Century Leadership

Angela McBride, PhD, RN (Indiana University School of Nursing, Indianapolis, IN)

In her keynote address, Dr. Angela McBride underscored that, “diabetes educators have the defining expertise for where the world is going.” She pointed toward new paradigm shifts in healthcare, highlighting that we are moving from episodic and process-oriented care to integrated delivery systems and outcomes-oriented care. In addition, she addressed diabetes educators’ importance in the paradigm shifts in academia, where the focus has shifted from “learning facts” to “learning to learn.” She acknowledged the external demand for diabetes educators’ leadership, the need to incorporate well-defined, systems-based routine care into clinics, and the utility of effectively managed teams, pointing out that, “you’ve already been doing this and my point is that now the Institute of Medicine (IOM) is recognizing this.” Dr. McBride followed by providing guidance on the different stages of a career in leadership, highlighting relevant opportunities for educators in building and leading teams and developing information systems and partnerships.

•  Dr. McBride positioned educators as future leaders of healthcare reform. She noted that the IOM itself recognized educators as the embodiment of the ACA and population-based care in their most recent report titled, “Best Care at Lower Cost: The Path to Continuously Learning Health Care in America.” In particular, she cited that diabetes educators – with their ability to inspire and catalyze others – are ideally positioned to play a significant role as the healthcare system shifts toward integrated delivery systems and outcomes-oriented care that educators are already familiar with.
• Dr. McBride encouraged educators to impact the healthcare system in 10 ways:
  
  • Orchestrate system-level change, in order to build cultures of safety, learning, and health. Notably, Dr. McBride commented that diabetes educators “know not only about diabetes, but everything touched by chronic diseases,” making them especially qualified to work on system-level change.
  • Build, lead, and study 21^st-century teams: Dr. McBride highlighted that inter-professional development is becoming more critical and that “teamwork is linked to a greater emphasis on the wisdom of the whole.”
  • Take lead in delivering outcomes that affect the bottom line. In particular, Dr. McBride highlighted that this includes educators’ familiarity with standardized measurement tools and a focus on realizing “the values proposition,” (e.g., HCAHPS scores, core clinical measures, and mortality index).
  • Take lead in comparative effectiveness research: This work consists of testing the usefulness of assistive devices and technology, behavior change strategies, and alterations in organizational structure.
  • Develop information systems: This understanding can help facilitate patient care and requires clinical decision support, just-in-time learning, and self-care materials.
  • Facilitate various transitions as clinical facilities strive to become accountable care organizations managing the care continuum: Dr. McBride noted that diabetes educators are already accustomed to think in terms of healthcare stages and have experience in helping individuals move from the acute stage to lifestyle change to long-term outcomes.
  • Take lead in coaching an aging population: Educators have the skillset to facilitate activities of daily living and manage chronic conditions.
  • Develop new partnerships: These include partnerships between and among health schools, clinical agencies, and other institutions.
  • Promote the notion that all healthcare policy boards, particularly of clinical agencies, should consider a director who is a diabetes educator: Dr. McBride stressed that quality and safety are becoming more important than financial solvency.
  • Promote the notion of the 21^st-century diabetes educator: This idea pushes for the publication of work of diabetes educators in meeting system changes demanded by IOM reports and the American public.

Master Class Session

Current State of DSMT Reimbursement and Healthcare Reform

Patty Telgener, RN, MBA (VP of Reimbursement Services, Emerson Consultants, Excelsior, MN)

Ms. Patty Telgener discussed the impact of healthcare reform on diabetes education and reviewed reimbursement guidelines for educators. She highlighted the benefits of the Affordable Care Act (ACA) for diabetes patients, and applauded accountable care organizations (ACOs) for aligning incentives with the use of diabetes education. She pointed out that diabetes educators are necessary components of successful ACOs, as care coordination and health education all lie within their expertise. Ms. Telgener was critical of competitive bidding in SMBG, explaining that while out-of-pocket costs have been reduced, patients have been left with significantly fewer options. In reviewing reimbursement guidelines, she expressed frustration with Medicare’s “antiquated” definition of diabetes and how nurses and CDEs are not labeled as “DSMT Certified Providers.” However, Ms. Telgener ended on a positive note, concluding that with the current direction of healthcare, “you [diabetes educators] are all here at the right time and place.”

• Ms. Telgener shared a positive perspective regarding the ACA’s impact on diabetes. She highlighted the elimination of the pre-existing conditions exclusion and lifetime limits on benefits. She applauded the fact that some preventative services will now be free of co-pays and deductibles and that premiums can no longer be based on diabetes or other chronic disease. However, she also acknowledged that flaws, such as unaffordable premiums, remain.
• With respect to competitive bidding in SMBG, Ms. Telgener noted that “manufacturers have been hit hard and patients have fewer options.” She explained that competitive bidding has hit mail-order diabetes supplies and that the program is expanding to more Metropolitan Areas. While the program has reduced out-of-pocket expenses, she recounted stories of patients being forced to switch manufacturers and losing options.
• Ms. Telgener is “not real optimistic about the timing” of the current legislation efforts to recognize CDEs as Diabetes Self-Management Training (DSMT) certified providers under Medicare. Notably, DSMT services are only covered by Medicare in the case of a referral from a certified provider. As such, the lack of recognition for CDEs represents a real reimbursement challenge for patients.
• Ms. Telgener labeled Medicare’s definition of diabetes as “antiquated,” as its criteria do not include A1c level. The current criteria are: i) a fasting blood sugar greater than or equal to 126 mg/dl on two different occasions; ii) a two-hour post glucose challenge greater than or equal to 200 mg/dl on two different occasions; and iii) random glucose test over 200 mg/dl for a person with symptoms of uncontrolled diabetes. Ms. Telgener also pointed out that Medicare does not currently cover prediabetes, noting that expansion of coverage is an important initiative for AADE.

Questions and Answers

Q: I’m seeing a lot of outpatient diabetes education programs, yet no reimbursement on the inpatient side. It’s supposed to be more about prevention. Can you comment on these trends? Will they eventually pay for inpatient diabetes education?

A: I’m seeing financial restraints everywhere. As far as getting paid for inpatient care, most payers pay the hospital. I would expect inpatient to continue to be bundled.

Q: I do a lot of CGM training and I wanted to clarify the billing code, 95250. As an RD, can I use that billing code?

A: For Medicare, it will not necessarily allow an RD to. But some of the commercial plans may allow the RD to bill it. You need to make sure it’s part of your contract. The physician can bill it even though you’re doing the training.

Q: Do our patients need to use up their MNT hours before we can bill for DSMT?

A: No, those are two different benefits. Some patients may not even have referrals for both.

Meet the Experts

Affordable Care Act: Opportunities and Obstacles

Joan Bardsley, MBA, RN, CDE (MedStar Health Research Institute, Hyattsville, MD), Ardis Hoven, MD (American Medical Association, Lexington, KY), Pamela Cipriano, PhD (American Nurses Association, Silver Spring, MD), Lucille Beseler, MS, RDN, LDN, CDE (Family Nutrition Center of South Florida, Coconut Creek, FL), Jonathan Marquess, PharmD (American Pharmacy Cooperative, Atlanta, GA)

This Meet the Experts panel brought together diabetes educators, physicians, nurses, dieticians, and pharmacists to discuss their professions’ roles in the Affordable Care Act’s new healthcare delivery systems. The move toward a more integrated, team-based model of care that takes fuller advantage of non-physicians’ skills has emerged as a recurring theme of AADE. Panelists and attendees emphasized the need for diabetes educators, dieticians, and other non-physicians to be formally recognized as healthcare providers and to be tasked with greater responsibility in coordinating care. Increasing patient access to the best diabetes care was clearly an issue at the top of providers’ minds – said Dr. Jonathan Marquess recounted patients’ frustration with competitive bidding limiting access to testing supplies and formularies that place new diabetes drugs in the highest-priced tiers. However, the panelists expressed confidence that new incentive structures focused on prevention and outcomes will be an excellent fit for diabetes educators (“we’ve been focused on patient-centered care for a very long time”), but acknowledged that there is still a great deal of uncertainty about how new systems like accountable care organizations will work in practice.

Questions and Answers

Q: Given the new incentives, are CDEs going to be extinct?

Ms. Joan Bardsley: Absolutely not. The key indicators are pay for performance and quality. Educators improve outcomes. For payers, reimbursement is increased when outcomes are tracked and reported. We’re fine.

Q: Registered dietitians provide DSME (diabetes self-management education) and MNT (medical nutrition therapy). What will the impact of the ACA be on MNT?

Ms. Lucille Beseler: People have access to nutrition services, including MNT. They can access an RD for many conditions, not just diabetes. There’s even access for preventive care. Looking at some of the insurance plans on the exchanges, I’ve been pleasantly surprised to see that people get ten visits of nutrition counseling in a year for anything, with no copayments and no deductibles. There’s increased access in general.

Q: We know the ACA was supposed to improve access. How has it affected affordability and compliance with treatment?

Dr. Jonathan Marquess: It has improved access; there are more people in the system. The level of access depends on the insurance you have. It has been difficult – we all saw the accounts of Healthcare.gov. The out-of-pocket caps will help. We have some great medications that produce good outcomes, but they cost a little bit. Formularies will help; everything is positive.

Q: What are your thoughts on competitive bidding now that Medicare has expanded it beyond meters and strips. Has that affected access to testing supplies?

Dr. Marquess: That’s a tough one. I’ve had hundreds of complaints from patients about getting strips and lancets and meters from mail order. These companies do a good job, but many patients have called me and said they wanted to get supplies at pharmacy.

Q: What gets measured gets managed. The question is, are we managing to numbers, not the individual? Are reporting requirements helping or hurting?

Dr. Ardis Hoven: We have to weigh the risks and benefits of performance measurement, and whether it’s population-based or about individuals. We need measures that matter and to think about what matters to patients; it’s not just checking boxes on the EMR I love so much. Measures need to reflect patient outcomes – that’s the key issue. Community-based prevention programs should be focused on individuals. Measurements help us do assessments at the population level, but we need more at the specific patient level

Q: We’ve heard a lot of discussion about the endocrinologist shortage. Has the ACA had an effect on the balance between primary care providers and the number of people with diabetes?

Dr. Pamela Cipriano: Workforce issues have not been emphasized yet in this discussion. The great benefit of teamwork is in a case where there’s no endocrinologist, you need to look at the rest of the team. In rural areas, there isn’t that access except through telemedicine. Care models need to evolve, and we need a partner for the physician, whether it’s a nurse practitioner, a physician assistant, a dietician, or other members of the team. The ACA has created a groundswell of need for primary care providers, and part of the solution is filling the gap with physician assistants and nurse practitioners and some changes in terms of medical payments to favor primary care, though that would work against the endocrinologists. It’s all part of recognizing the increase in people with diabetes and comorbid conditions. Our models have to reflect that, and maturation of the chronic care model has to partner primary care for chronic management with specialty care on an episodic basis.

Q: You’ve outlined the role of nurse practitioners. What about the role of nurses who aren’t nurse practitioners, like advanced practice nurses or RN/CDEs?

Dr. Cipriano: Many nurses are CDEs, and they’re a really critical part of the workforce; they far eclipse the number of nurse practitioners. RN CDEs are the largest component of care teams interacting with patients with diabetes. Their role becomes the pivotal coordination point. They identify which provider or which discipline is necessary, and coordinate that with the nurse and the physician. Nurse practitioners provide a different role, a more comprehensive management role. There’s a lot of overlap. It’s about making sure we provide the right care based on patients’ needs. That will determine whether an RN CDE provides a broader range of services or whether a nurse practitioner will do more.

Q: The dietitian representative outlined specifics, about taking blood pressure, etc. Can you outline clearly what RN/CDEs can do over a dietitian or nurse practitioner?

Dr. Cipriano: Nurses play a well-rounded, holistic role. They provide education, coordinate nutrition needs, access the dietitian, address medication issues, compliance issues. The RN/CDE is coordinating care, which doesn’t stray from the higher level CDE role.

Q: Should an RN/CDE be giving dietary instruction?

Dr. Cipriano: That is part of their basic education, but some patients require more expertise from dieticians.

Comment: I think the most frustrating thing is that registered dieticians are not reimbursed and recognized as much as RNs [Applause]. It’s an implicitly valuable skill, as is a pharmacist who ought to be reimbursed as we are as nurses and doctors. We all need to step up and speak for each other.

Q: We’re a medical home model with a diabetes center. We’re mostly registered dietitians, and they’re providers who get reimbursed. We have them do DSME, but we’ve expanded their scope of practice to not prescribing, but recommending medication changes. Everything is co-signed by a physician, but we’ve expanded their roles. Are you ok with that? It’s working really well.

Dr. Hoven: We call it a collaborative teamwork agreement. We talk about who does what and what the end result is up front. I don’t need you to come to me and request test strips. As part of our agreement, we understand each other. That’s how it ought to be done [Applause].

Dr. Cipriano: I agree, those expectations and role clarification need to happen up front. You need to know what restrictions you’re under by law, but it’s these agreements and collaborations that allow us to expand our skills.

Q: You said more people are coming to doctors’ offices since the ACA. In our region in rural Ohio, we’re not seeing that. We’re a small hospital affiliated with other regional small hospitals, and we’re actually seeing fewer office visits. Are there differences between regions?

Dr. Hoven: There are regional variances in how healthcare is accessed. All healthcare is local. We need to get over that barrier so patients in communities understand the importance of prevention, wellness, and front-end healthcare, not back-end or what I call disaster care. We need to do a better job at the community level and engage schools, churches, etc. That part starts with us, teaching our community fellows. That may be part of the issue. People have to be taught how to use health insurance, and people don’t understand prevention and wellness. There’s a multicultural issue around the delivery of healthcare.

Q: A lot of patients say their deductible is way too high so they’ll just wait to come in. [Applause]

Dr. Hoven: There’s no question; this is regional, and we will see modulation of this going forward. The last thing we want is for people who bought insurance not to be able to afford it. That’s the dumbest statement in the world but it’s true. It’s about policy and payment models, and we need to do a better job at the national level.

Q: AADE was formed because we were concerned we didn’t have a way to determine who was knowledgeable. I’m ahead of my time – I’ve had a multidisciplinary clinic for years. I’ve been here for two days and I haven’t heard “CDE” mentioned until just now. That was the real accomplishment of AADE. Why, with all these things we’ve discussed, aren’t CDEs reimbursable by Medicare? [Applause] Are we going to eliminate the CDE exam? What purpose does it have?

Ms. Bardsley: The exam looks at quality measures. CDE is a voluntary credential but it is an indicator of quality, so I don’t think it’s going away. We’re talking licensure because that’s what’s recognized.

Q: CMS released a proposal in July about a new primary care billing code for chronic care management. If that’s real, it could lead to increased access and quality. With your disciplines, how will you use that chronic care management piece?

Dr. Hoven: My background is as an HIV specialist. I’ve been involved with the Ryan White program, which is a wonderful integrated chronic disease management program that utilizes everyone. There is lots to be learned from that model. There is a recognition that chronic disease is a huge problem. We need to figure out what are tools to do prevention and wellness, keep people out of the hospital, and get care? It will take more than just me. We need seamless care, collaborative care, planned care, and it’s about articulating what that means.

Ms. Bardsley: We need to look at the continuum of care over the lifespan. We spend too much time on episodic care. All of the needs from prevention to late stage complications can’t be addressed with episodic care.

Snap Learning Session

AADE Diabetes Prevention Program

Joanna Craver, BS, MNM (AADE, Chicago, IL)

Ms. Joanna Craver presented encouraging early data from the AADE Diabetes Prevention Program (DPP). The analysis encompassed 12-month results from the majority of AADE’s 30 DPP sites, where participants implemented intensive lifestyle changes while attending regular support sessions with trained facilitators (sessions took place once weekly for the first four months and once monthly for the remainder of the year). Results showed that participants who attended more than four sessions had an average weight loss of 5.9% in the “core” phase (16 weekly sessions) and 6.5% in the “post-core” phase (monthly sessions for the remainder of the year) – this is of course a best-case completer analysis, which would show stronger results than an intention-to-treat analysis. The average number of core sessions attended was 14, and as Ms. Craver put it, “if they’re coming more than four times, they’re coming, and they’re successful.” As promising as these numbers are, Ms. Craver cautioned that AADE will need to find more sustainable sources of reimbursement if the program is to continue beyond 2016 (when its CDC funding expires). AADE is working to convince third-party payers that investing in the DPP will prove to be cost-effective over time and that AADE’s infrastructure and clinical expertise makes it uniquely well-positioned to implement a high-quality program.

• Ms. Craver outlined several key goals for the AADE DPP in the coming year, most of which are focused on reimbursement. AADE aims to launch several DPP sites in partnership with employer groups, with the goal of demonstrating that the program can be a reimbursable model. The organization is also engaging with health department officials in the few states (Kentucky, Washington, and Colorado) where the DPP is a reimbursable benefit for state employees; AADE hopes to better understand which strategies were successful in those states and encourage other state health departments to follow suit.
• The AADE-run programs have cost $565/patient/year on average, only slightly above the CDC’s recommendation of $500/patient/year. As such, Ms. Craver pushed back against the claim that AADE’s use of CDEs and registered DSME sites will lead to unnecessary costs. There is tension with the YMCA and certain payers that have argued the DPP should be run by lay facilitators in order to keep costs down. Ms. Craver said, “We’re not that much more expensive and we offer that much more quality,” thanks to the greater clinical expertise of diabetes educators and the greater access to physicians and other healthcare services from the AADE’s existing DSME infrastructure.

Questions and Answers

Q: We’re running a weight loss program that started as a 12-month program and had considerable dropout. Now we’re running six-week sessions that just give people tools. How do you keep 82% of participants going?

A: The sites set it up as a yearlong program and people sign waivers. We ask people, “Are you ready for this commitment?” If not, we say “let’s talk about other programs.” A lot happens in between sessions – e-mailing, Facebook groups, lots of communication. Once people attend four sessions, they’re hooked in. These are the sorts of things we discuss in forums.

Q: As AADE members, do we have access to your forums?

A: We’re setting that up in the next year. They’re currently just for our grant sites.

Q: I work for a hospital with a DPP that’s based out of the NIH and the CDC, and the people are trained in Pittsburgh. If we want to partner with the AADE, should we talk to you?

A: Yes, the AADE accepts the University of Pittsburgh curriculum.

Q: Is there data on the participation of men vs. women? We have an ongoing program and it seems that the females are there and the males aren’t.

A: The DPP is generally female-dominated. We have about 200 males out of 1,000 participants. The CDC is troubleshooting that to see how to get more men in. Women tend to be the caretakers, so they care about health from a different perspective. There’s research being done and tools we can offer. We’re talking to other groups that have had men and seeing why they signed up, and getting answers from the men who are there.

Q: We have a DPP associated with our medical office group, and patients have been pulled into our practice from the program. I think some of the nutrition content in the curriculum is outdated – they’re counting fat grams but they’re drinking sugary beverages and not counting carbs.

A: Some things are counterintuitive. CDEs are working with the program, and there are some questions about whether it’s outdated, but the program was based on the national study.

Comment: There are more current evidence-based guidelines now.

A: We’re looking at the standards – the new standards are supposed to be out in September – and we’re looking at things like that raised by our educators during a comment period. We tell sites that this is the curriculum, but if you have knowledge exceeding that, you can add as much as you want. You could have a guest speaker come in and talk about sugar. That definitely enhances our programs.

Q: So as of October, the curriculum might be updated?

A: I don’t know what they’re doing with the comments; they don’t want to alter the evidence-based curriculum too much. But our CDEs have expertise that others don’t, and we encourage them to use it.

Q: I’m in a rural area. Does the program depend on having community resources for exercise and diet?

A: Existing sites have teamed up with local fitness centers and offered coupons or free months; some sites have personal trainers come in. We encourage groups to meet outside the classroom – some groups have walking groups that meet before our weekly meeting. It depends on the site. I would reach out to existing sites in a similar area to see what they do.

Comment: As a PSA for AADE members waiting to join forums, there’s a Diabetes Prevention Community of Interest that has resources online.

A: Great. If you ask a question, maybe we haven’t heard it, and now we know that’s an issue. Communication is key.

Q: Is the curriculum fixed? Is it the same group every week or is there rolling admission?

A: The curriculum is fixed, and there is a core group. It really becomes a support group, so it unsettles the dynamic if people come in and out. We discourage people from entering after the first session, though we can do makeup sessions. We want a group dynamic and a yearlong commitment.

Q: So you’re devoting that year to eight to ten people?

A: Yes.

Q: I work with uninsured patients in a free clinic. There are lots of high-risk patients in that setting, 30-40% of my patients are Hispanic – how can we implement the program in that setting?

A: We want to work where there’s reimbursement potential but also elsewhere. The CDC is working to get programs covered by Medicaid; it’s currently covered in Montana. We’re not tackling everything at once so we’re not spearheading that effort, but we’re having conversations. Go to the discussion group and pose those questions.

Q: I’m from Washington, and there’s no recognized program within 75-100 miles. What kinds of opportunities are there? Is there any collaboration with the YMCA?

A: There is collaboration – we realize there aren’t DSME sites everywhere. We’re looking at what we can do. There’s no solution yet, but if you want to help us find one, that’s what we need to do: reach out to members. There has been some collaboration with YMCAs helping them to implement the program.

Q: I’m from Florida, I’m a CDE and RN, and when I sought out information from local YMCAs, I got tremendous pushback against joining the team as a lifestyle coach. I was told that our knowledge level would “veer off the set guidelines.” In light of not being welcomed into the YMCA setting, are there other avenues or trainings? The community needs more prevention, but the YMCA is the only organization offering this. There’s nothing in the hospitals.

A: Florida Blue is covering the program for YMCAs but not in our DSME setting. We’re working with insurance groups to change that and working with the YMCA from the top. We want to know what’s going on, so write that in an email so we can troubleshoot. The YMCAs spearheaded the DPP, the CDC wants it to be available in a setting where it’s taught by lay professionals, and we don’t want to disrupt that by saying our educators are better. But if our costs are similar and we have good, if not better, results, it shows that collaboration is good. We’re trying to show that. It’s not that the YMCAs aren’t doing a good job. There’s room for everyone in the space – with 86 million people [with prediabetes], we don’t have to worry about stepping on each other’s toes. We want to create our own space, and if there’s room for collaboration, that’s great.

Q: We felt a pushback; it was quite obvious. They wanted their own YMCA lay staff. They even pushed back medical residents who wanted to start their own program and build a patient load.

A: I would love to talk more about this. If we can look more closely at the reasons why, we can find solutions for other groups.

Breakout Session

Implementing a Diabetes Self-Management Education Program in the Patient Centered Medical Home: An Evidence-Based Model of Care

Lovely Varghese, RN (New York Presbyterian Hospital, New York, NY) and Yesenia Cabral, RN (New York Presbyterian Hospital, New York, NY)

Ms. Lovely Varghese and Ms. Yesenia Cabral shared results from the implementation of a diabetes self-management education (DSME) program in New York Presbyterian Hospital’s patient centered medical home (PCMH) initiative. New York Presbyterian Hospital’s PCMH serves a population of primarily Spanish-speaking immigrants, many of whom live below the poverty level and almost half of whom have at least one chronic illness. In an analysis of 1,263 participants in New York Presbyterian’s DSME program (which took place between April 2010 and June 2013), 67% experienced a drop in A1c and that 53% saw a reduction in LDL cholesterol levels. Additionally, the results demonstrated a 7% increase in the number of participants with an A1c <7% and a 16% decrease in the number of patients with an A1c >9%. While these results seem to indicate at least modest trends in the right direction, it is difficult to evaluate them without knowing the mean magnitude of the improvements seen – we imagine that with more time with the system, the magnitude of the changes stands to grow. Ms. Cabral stressed the importance of communicating such results to providers, highlighting that that’s how “you get people to trust and believe in our work.”

• Ms. Cabral urged providers to explain “how medications actually work,” noting that patients are much more motivated to adhere to treatment regimens when they understand their medications’ mechanisms of action.
• For background information on PCMHs in diabetes, please see the ADA’s Dr. Robert Ratner’s talk at this year’s Keystone Conference.

The Role of Shared Decision Making in Diabetes: Considering the Patient’s Preferences

Anna Vannelli, MS, CDE (International Diabetes Center, Minneapolis, MN)

Speaking to a packed auditorium, Ms. Anne Vannelli highlighted the utility of the Mayo Clinic Diabetes Decision Aid tool in facilitating shared decision-making. Ms. Vannelli believes that traditional evidence-based, “directive” approaches to care drive patients to non-adherence by making assumptions about their personal preferences and values. In contrast, the Mayo Clinic tool invites patients to participate in the decision-making process by providing them with a convenient and simple interface that facilitates education and allows patients to make deliberate choices regarding treatment options. According to Ms. Vannelli, this process leads to cognitive investment in the decision, thereby enhancing ownership of the therapy and improving adherence, often the biggest factor limiting treatment efficacy in practice. She acknowledged that shared decision-making is not a tool that will “make money” or dramatically lower A1c, but she said it represents a commitment to a patient-centered approach, and “that is what’s important.”

• “When we want your opinion, we’ll give it to you” – according to Ms. Vannelli, this hierarchical, directive school of thought has traditionally defined the patient-provider relationship. She suggested that this lack of consultation with patients and families is a major factor behind the high rates of non-adherence that currently plague the US health care system: data from IMS Health indicates that only 53% of type 2 patients fill their prescriptions within three months of the written date, only 38% fill their prescriptions within 12 months of the written date, and ~25% do not fill their prescriptions at all.
  
  • Citing a recent study (Cutler and Everett, NEJM 2010), Ms. Vannelli noted that the lack of adherence to medication regimens leads to costs of ~$100 billion annually due to avoidable hospitalizations; we hope that such overwhelming figures will convince payers and policy makers of the need for a more collaborative approach to care that can hopefully encourage greater patient adherence. Certainly, improved medication that don’t cause hypoglycemia and improve weight also stand to improve adherence.
• Ms. Vannelli characterized shared decision-making as a method of incorporating a more patient-centered focus into the traditional, evidence-based approach to healthcare. Ms. Vannelli stressed that patients are the experts in their own lives; only they can weigh the financial tradeoffs or the cultural perceptions regarding medications that ultimately impact adherence. She cited multiple studies demonstrating that engaging and educating patients increases their confidence in treatment decisions, thereby improving adherence.
• Ms. Vannelli highlighted the utility of the Mayo Clinic Diabetes Decision Aid in facilitating shared decision-making. The tool consists of color-coded handouts that allow patients to evaluate common type 2 diabetes medications across seven categories: weight change, A1c reduction, daily routine, low blood sugar, cost, daily sugar testing, and other considerations. For example, a patient whose foremost concern regarding medications is weight gain can look at the corresponding card that summarizes the effects of various drug classes on weight (insulin: 4-6 lb gain; liraglutide/exenatide: 3-6 lb loss; sulfonylureas: 2-3 lb gain; metformin: neutral; SGLT-2 inhibitors: 3-4 lb loss; etc.). We found the Decision Aid interface to be quite intuitive and user-friendly, and we think it would be readily applicable to a real-world clinical setting.
  
  • Educators seemed impressed by the simplicity of the Decision Aid, and several asked where they could access the cards. The cards are available free of charge online, allowing patients to access them outside the clinic as well. diaTribe has also developed a similar, but more general download to help providers and patients share decision making – see www.diaTribe.org/patientguide for more information.
  • Ms. Vannelli shared preliminary data from the TRICEP (Translating Information on Comparative Effectiveness Into Practice) study (n=342), indicating that patients using the Mayo Clinic Decision Aid expressed greater satisfaction and understanding of their treatment relative to those not using the tool (94% vs. 86% and 52% vs. 45%, respectively). The question, of course, is to what extent the higher satisfaction and understanding results in better adherence and improved outcomes.
• Shared-decision making is “a manifestation of your commitment to your patient.” Ms. Vannelli acknowledged that it is not a tool that will “make money” or dramatically lower A1c but said it represents a commitment to a patient-centered approach, and that “that is what’s important” – we imagine that in certain patients, A1c could be dramatically lowered given a significant bump in adherence.

Questions and Answers

Q: Is the Decision Aid available in Spanish?

A: Yes. And they’re working on a couple other languages as well. On the main page, you should be able to select Spanish.

[Comment]: I just want to point out that similar decision aids are available at a variety of clinics (Isenberg, etc.) across the country.

A: Thank you.

Q: Can you talk about the literacy level requirements for using the cards? What happens when we see patients whose level of understanding is at a third or fourth grade level?

A: I can’t fully answer the question about what reading level is necessary for use, because I wasn’t involve in making the cards, but I know it was considered. You could certainly contact someone on the website.

Q: And can you address cultural barriers? How would we work with these cards?

A: In the TRICEP study, we only took people who were English-speaking, but everyone was able to use the cards. In terms of cultural decision-making, some people actually want physicians to make decisions. Others want to be really involved. Maybe the cards are the way to do that, but in some cases, it may be better to ask them outright: What is most important to you? In other cases, the key may be having a conversation and to figure out what’s important to them. And so, my point is that this tool may not be perfect, and you may have to figure out something different that’s appropriate for the cultural groups you work with. However, we are working on it. For example, with the Native American population, we are involved in discussions about how to develop shared decision-making tools that are appropriate for them.

[Comment]: This website has really transformed the discussions I have with patients. If they speak Spanish, I use the Spanish version of the instructions. Patients actually get more engaged and are not as fearful of therapy. And with the [Mayo Clinic] statin decision-aid tool, you put in their personal information – If they are a smoker, etc. – and it gives you data on the likelihood of a heart attack. Patients are used to getting a pill thrown at them, but with this tool, they feel like they have a choice. Just a note: It would be great if we could order them instead of having to print them out online. I just wanted to thank you, because it’s made a big difference in my clinic.

A: Thank you.

Q: Is access to the Decision Aid free?

A: Yes.

Q: How do I get a physician to agree to sign a decision that agrees with a patient? What if the physician doesn’t agree with the treatment?

A: This has happened to me. Whether it’s because the chosen medication is new or because the physician doesn’t agree, sometimes you’ll have trouble getting everyone on board. You can talk to physician in person about the fact that it’s a patient’s decision, not theirs. Of course, you have to back it up with reasoning and feeling. One other solution is coming up with two options when you talk with a patient. Tell them that their first choice is a new medication and that the doctor may not agree to prescribe it. Ask them what their second option would be? We’ll often make that decision early, so that we have a backup option. But you’re right, sometimes the doctor may just not agree.

Q: If the clear decision is insulin, how do you use shared decision-making?

A: During the study that we did [TRICEP], we actually had some people who were on three oral medications and who probably needed to go onto insulin. So that’s kind of where your expertise meets patients’ values. Maybe still involve the patient in choosing what insulin regimen to go for. That’s a way to develop another shared decision-making conversation. That’s where patient shared decision-making values meet your knowledge. It’s all about having a conversation. Some organizations have a pamphlet on insulin that can help with that decision.

Pre-Conference Event

Building Your Diabetes Education Program – Everything You Need to Know and More

Leslie Kolb, MBA, RN (American Association of Diabetes Educators, Chicago, IL); Jody Jardine, CDE (Physicians Plus Health Insurance, Madison, WI)

This half-day workshop focused on the successful design and implementation of diabetes education practices. One key theme that emerged was that diabetes educators are not being utilized to their full potential. Educators often have difficulty getting patient referrals from physicians (this continues to be very surprising to us even though we have heard it for years), and they do not always receive the full support of healthcare systems because of the perceived low revenue potential of diabetes education (another systemic problem that needs to be addressed, perhaps with bonuses for sustained patient improvement). Session faculty also noted that educators must do a better job of reaching patients where they are, out in the community and on social media (we are not sure there are that many type 2 patients on social media but it’s definitely growing from a low base). In the session’s conclusion, CDE Ms. Jody Jardine suggested that the transition from fee-for-service to pay-for-performance will provide an excellent opportunity for educators to demonstrate their value to the rest of the healthcare system.

Additional Topics

Critical Conversation Session

Addressing Challenges of Weight Loss in the Obese Person

Stacy Smith, RD, CDE (Cleveland Clinic Florida, Fort Lauderdale, FL); Josh Neumiller, PharmD (Washington State University, Spokane, WA); Amanda Kirpitch, MA, RD/LDN, CDE (Joslin Diabetes Center, Boston, MA)

Ms. Smith, Dr. Neumiller, and Ms. Kirpitch discussed different challenges and approaches to treating obesity. Ms. Smith opened the session by discussing how bariatric surgery can provide significant metabolic benefits (glycemic improvements, benefits in blood pressure, higher insulin sensitivity) and can “reverse many of the core defects of diabetes.” On the other hand, she emphasized that while bariatric surgery is an effective treatment option for type 2 diabetes and obesity, it is “not for everyone” as remission rates vary. She also noted that it’s “hard to predict who’s a good candidate and who will go into remission” with the procedure. Dr. Josh Neumiller followed by discussing FDA-approved weight loss medications and the weight loss benefits of anti-hyperglycemic agents. He pointed to metformin, GLP-1 agonists, SGLT-2 inhibitors, and pramlintide as drugs associated with effective weight loss. Ms. Kirpitch closed the session by discussing the Joslin Diabetes Center’s upcoming Why WAIT group therapy program. This 12-week program is intended to help both type 1 and type 2 patients with weight control and diabetes management. She promoted this use of group therapy in weight management, stressing that a team-focused approach with consistent messaging and structured protocols is effective.

• Regarding bariatric surgery, Ms. Smith stressed that pre-operative education and post-operative follow-up care is essential. She commented that adherence is typically poor during follow-up, as it is difficult to have patients come back. During these follow-up visits, it is important to ensure that patients’ diets incorporate plenty of vitamins and minerals and to monitor patients’ bone health for the long term (as there is little long-term data on this). Ms. Smith also noted that psychological support is critical, as concerns regarding body image stigma can greatly impact this population.

Questions and Answers

Q: How much time is needed to prep for bariatric surgery?

Ms. Smith: It can be anywhere from three months to 12 months.

Q: What is the effect of adding agents like lorcaserin [Arena/Eisai’s Belviq] along with GLP-1 agonists?

Dr. Neumiller: I’m not aware of any data on what the true effect of this combination is, but we can speculate that we would have added weight loss with that combination.

Q: Why does the Why WAIT program use meal replacements?

Ms. Kirpitch: Research has shown that they’re effective. They’re quick and easy and require minimal thinking. At the beginning of the program, when patients have to think about all the changes, meal replacement isn’t complicated. At six weeks, they can move over to solid food. People like easy. And for patients who never ate breakfast, it’s an easy thing to get down.

Q: Has there been any research on the follow-up of these group therapy programs?

Ms. Kirpitch: Face-to-face works better and more frequent follow-up is better.

Master Class Session

What’s New in Diabetes and Nutrition

Marion Franz, MS, RD, LD, CDE (Nutrition Concepts, Minneapolis, MN)

Ms. Marion Franz argued that despite widespread confusion and frustration about competing guidelines, nutrition therapy can be an effective tool to help patients manage their diabetes. She reviewed evidence from a wide body of scientific literature to explain how different organizations have developed varied and sometimes contradictory nutritional recommendations. Based on the available evidence, she concluded that there is no single “best” approach to nutrition and diabetes and that a variety of interventions (she prefers “intervention” over the term “diet”) can lead to improved outcomes. However, she stressed that continuous support from a dietitian or other healthcare professional is often essential for successful implementation. In addition, Ms. Franz emphasized the benefits of modest (~5%) weight loss for preventing or delaying type 2 diabetes, pointing out that even if “we’re not going to solve the obesity epidemic,” patients can still derive real health benefits from losing modest amounts of weight.

Questions and Answers

Q: I didn’t hear anything super new – this is all kind of boring. I think the people we’re arguing with are the patients who took the raspberry enzyme Dr. Oz recommended. There are people who still insist that what they read on the Internet yesterday is the answer.

A: That’s what’s hard. People pick up the newspaper or turn on the TV and hear all this different advice. I would hope that one take-home message is that there is a variety of interventions and eating patterns that can be effective. You have to select what’s appropriate for patients. I say, “I can’t go home and cook for you, so you have to tell me what you can do and what’s reasonable for you.” We can all look at the evidence. If you look at low-carb studies, most of them are short-term, and when you do a review, most have such high dropout rates that they don’t get included.

Q: I saw a great article in the Daily News where you commented that for some patients, it’s painful to eat. Can you elaborate on that?

A: There’s so much in the news that’s conflicting that it becomes painful for people to decide what to do. The confusion contributes to the pain in their lives about making eating decisions. The simpler any of us can make it for people, the better. The ADA’s 2013 recommendations talk about people with type 1 diabetes on pumps and MDI and the importance of ratios and consistency. Their statement about type 2 diabetes is that people need simple guidelines. Sometimes we make it so complex for them. What some people need is just a simple outline of what to eat at breakfast, lunch, and dinner. We know all about this and we want to share it, and sometimes we make it too complex.

Q: Are you recommending three meals a day evenly spaced?

A: Three meals a day vs. six is an interesting question. Old research showed it didn’t matter. Logically, it makes sense to have three meals, though eating smaller amounts would help. I can’t find much research on doing six meals a day. It’s an issue of how people eat and the effect on their weight. When people go on a diet, they skip breakfast, and once they start eating, there’s no end. There’s very limited research on the frequency of meals and the effect on appetite. Intuitively, you see that once they start eating, there’s no end. It makes sense that they should start with a better breakfast. People say when they eat breakfast, they’re still hungry at lunch, but they’re not quite as hungry at dinner.

Q: Can you comment on the folks who are saying to avoid all animal products and eat all the carbs you want?

A: That’s a good example of how reputable people write books without any evidence. There’s no research on preventing diabetes and avoiding animal products that shows that. If anyone knows about any, let me know. We know that reduced energy intake helps, and we can find some evidence supporting the Mediterranean diet and exercise; we know that vitamin D supplements, for example, didn’t prevent diabetes. It goes back to the fact that books are often written because the author gets a great deal of money. They come up with theories, and you have to have a new theory to write a book. If they consider themselves reputable scientists, I wish they’d have the support of evidence. That’s why it’s confusing, and it becomes a challenge for all of us.

Snap Learning Session

What Have Gut Bugs Got to Do With Diabetes and Obesity?

Meghan Jardine, MBA, CDE (Physicians Committee for Responsible Medicine, Washington, DC)

In front of a standing-room-only audience of over 500 attendees, Ms. Meghan Jardine provided an introduction and overview of the human gut microbiome and the role it plays in metabolism and health. The presentation was filled with many exclamations as Ms. Jardine shared some striking facts about the microbiome, including the fact that most of the cells within our bodies are bacteria in our gut. Although much of the research on the microbiome is relatively early-stage (notably, the ADA and JDRF will hold a symposium on this hot topic from October 27-29 in Chicago), a unifying finding in the work that has been done to date is that microbial diversity is inversely correlated with obesity. Many of the positive influences on gut microbial diversity (vaginal delivery vs. C-section, breastfeeding, less sterile environments) are on a decline, which could conceivably be connected (via gut flora) to the obesity and diabetes epidemics.

• Ms. Jardine listed potential mechanistic connections between changes in the gut microbiome and metabolic disorders. These included more efficient digestion and energy harvest from food, indirect regulation of eating behavior, or low-level chronic inflammation from bacterial cell wall components that enter the bloodstream (the latter effect is targeted by Zealand’s preclinical GLP-1/GLP-2 agonist ZP-GG-23). Regarding changes in energy yield, Ms. Jardine pointed out that some types of bacteria allow humans to digest and absorb plant-derived polysaccharides that the body would otherwise not be able to absorb.

Breakout Sessions

Diabetes Education in a Commercial world: How Do We Protect Patient Interests?

Caroline Trapp, MSN, ANP-BC, CDE, FAANP (Physicians Committee for Responsible Medicine, Washington, DC)

Ms. Caroline Trapp began her talk on the “love-hate relationship” between providers and industry by saying “this is a topic I haven’t seen discussed at this meeting or others.” For her, the lack of attention to this issue is a serious oversight that leaves providers without a clear roadmap for negotiating their inevitable interactions with members of industry. Though most professional organizations (including AADE) have developed ethics codes and disclosure requirements in an attempt to minimize problematic conflicts of interest, Ms. Trapp believes these efforts are insufficient; at a typical corporate symposium, for example, a speaker’s disclosure of relationships with industry at the beginning of a talk does not cause the audience to question the validity of the information presented. Ms. Trapp said common themes that emerged from her qualitative research on nurses’ day-to-day interactions with industry are moral ambivalence – many nurses mentioned a “guilt factor” or a sense of “moral residue” – and a lack of clear guidance on what is appropriate and strategies for avoiding bias. She believes that the inherent inequality between pharmaceutical companies and providers can lead to unhealthy dependence, as companies can provide services like drug samples or funding for educational programs that are inconsequential for them but essential for underfunded clinics. A collaborative, transparent approach to provider-industry interaction strikes us as most productive – providers and industry have plenty to offer each other, and ultimately, both can help improve patient outcomes.

Questions and Answers

Q: I’ve noticed with endocrinologists and other doctors, when they prescribe insulin for the first time, there’s not a lot of discussion about the fact that insulin is great for preventing microvascular complications but it won’t cure the disease, whereas underlying lifestyle factors can turn back the clock on the metabolic problem. Have you seen that?

A: You said it beautifully. A really important part of our role is to not rely on one type of treatment and to take into account the potential risks of medications. I always joke with patients that I’m the waitress; there are a lot of ways to treat diabetes, so here are your options. Some people want to do medications, some want to do diet and exercise – I say, this is your choice, you have to live with it, but let me help you make the decision. I always say, “Would you like to know more about patients who’ve done very well with lifestyle changes and the evidence supporting that?” In defense of physicians, they have limited office time (or they think they do), and it’s very hard to make a living running a practice. I spend 30 minutes in follow-up, 45 minutes for new patients, which is more than many of them get from my colleagues. My practice has decided they won’t make money on me, but patients benefit. I can give them choices; that’s why diabetes education is valuable – they learn about the spectrum. We can empower the patient to go back and say, I learned about the benefits of diet and how if I eat differently, I can take less medication, so I’d like to give that a try. I have yet to run into a doctor who would say don’t do that. I appreciate the point. As educators we provide a great service. We’re a well-kept secret in many places, but we can help patients learn about lifestyle and support. In primary care, I’ve worked with some patients for many years. We really need to be lobbying for that; with ten hours of education and a couple of visits a year, how do you maintain those relationships? It could be much less expensive in a group setting.

Q: I am personally an example of someone who was in a medical experiment and I suffered health consequences that may end up killing me. I found myself at a session where they mentioned cancer was a potential side effect of a drug but it wasn’t proven. They just threw that out there. I didn’t want to be impolite and question it, but I wanted to rant.

A: Thank you so much for sharing and validating that concern. There’s no risk when patients eat more beans and fruits and vegetables, and it’s a lot more cost-effective. I wrote prescriptions for medications that are now off the market for safety concerns. A lot of doctors won’t prescribe anything until it’s been on the market for a year. After digging into studies, I’ve decided three years. Food is better, but sometimes a patient is a candidate for medication. I share that three-year rule with patients and I’ve never had anyone say, “I want that now, you’re being overly cautious.” If they want that medication, they’ll get it from someone else.

Q: We have doctors who don’t work in our office that do lots of prescribing, like Dr. Oz. We spend so much time dispelling misinformation from TV, the Internet, etc. It takes up time working that in.

A: You need the sign we’ve posted in our office saying, “Please refrain from mentioning Dr. Oz.”

What PWD Wish Their HCP/CDE Knew About Diabetes

Connie Chitwood-Vu, MS, RD, LD, CDE, BC-ADM and Lyndsay Wright, MA, RD, LD, CDE (Insulet Corporation, Bedford, MA)

Ms. Connie Chitwood-Vu and Ms. Lyndsay Wright presented results from an online survey sponsored by Insulet on patient preferences regarding their educators and other HCPs. The survey asked people with diabetes to name the most important lessons they had learned from their providers as well as a “wish list” of items they wished their providers understood more fully. The population that completed the survey (n=317) was split fairly evenly in terms of gender (57% female) and type of diabetes (53% type 1); the average age was ~40 years and the average duration of diabetes was ~18 years. The survey found that the specific messages patients valued the most related to the ability to live a normal life with diabetes, practical advice for blood sugar control, information about pump therapy benefits, and the assurance that difficulty managing their diabetes did not constitute a personal failure. Only 20% of participants said there was something they wished their provider knew more fully about diabetes; among that group, common responses included the sheer number of variables that can affect blood sugar, the emotional impact of diabetes on patients’ loved ones, and what it is truly like to live with diabetes 24/7/365. In addition, survey results showed that many participants preferred to learn about diabetes through one-on-one meetings with providers (67%) and online support groups.

Questions and Answers

Q: When patients answered how they want to learn about diabetes, one-on-one sessions were at the top and groups were at the bottom. We’ve been hearing so much about how great group education is, so how do we balance that?

Ms. Chitwood-Vu: We’ve gotten feedback elsewhere about learning more from others in a group setting. The majority of the survey population had type 1 diabetes, and I’m just speculating, but many people may already be participating in other support groups. The question was specifically “How do you like to learn from a healthcare provider or CDE?” Many people haven’t done group visits with a provider. But we could definitely explore this more.

Q: What’s your opinion on educators who have diabetes sharing that information with the group?

Ms. Chitwood-Vu: I don’t know how many educators have diabetes. I do, and I share it the majority of the time because no matter what the patient is experiencing, chances are I probably have too – not being perfect, having blood sugars that aren’t perfect. I absolutely share that. Especially when people are really struggling, I say that I understand it’s hard, that not every day is a great diabetes day. The vast majority of us that have diabetes went into diabetes to help other people. I’m impressed with all the CDEs who don’t have diabetes that put up with us.

Ms. Wright: I don’t have diabetes, and I’ve had patients say to me, “do you live with diabetes every day?” I lose a little credibility with them. So if you’re comfortable, I say, let patients know; you guys can really relate.

Diabetic Neuropathies: Pain and Beyond

Pat Rafferty, PharmD (St. Louis College of Pharmacy, St. Louis, MO)

After opening with the story of her mother’s struggle with longstanding painful neuropathy due to decades of undiagnosed type 2 diabetes, Dr. Pat Rafferty delved into the complexities of diagnosing and treating one of the most frustrating complications of diabetes. The term “diabetic neuropathy” encompasses a heterogeneous and often poorly understood collection of defects, as illustrated by the conflicting guidelines from the ADA, the American Academy of Neurology, and other organizations. These guidelines diverge on diagnostic criteria and the numerous pathways and proposed mechanisms, from changes in ion channel distribution to excess limbic system input. Since there are currently no disease-modifying treatments for diabetic neuropathy, Dr. Rafferty emphasized the need for realistic expectations even when pain relief is the only therapeutic goal, reminding attendees that drugs in this area are considered efficacious if they reduce pain intensity by 50%. Given the lack of effective treatment options for neuropathy, Dr. Rafferty stressed the importance of prevention, reviewing data from DCCT/EDIC and other trials that demonstrate the link between enhanced glycemic control and reduced neuropathy risk. She also reminded providers that diabetic neuropathy is “more than just a pain condition,” and is often accompanied by serious depression and anxiety, which must be treated as aggressively as physical pain.

Treatment of Mild DKA in the Emergency Department Setting

Maria Koen, NP, CDE and Marianne Chojnicki, MHA, RN, CDE (Joslin Diabetes Center, Boston, MA)

Ms. Maria Koen and Ms. Marianne Chojnicki shared a new protocol for the in-hospital treatment of mild diabetic ketoacidosis (DKA) that has significantly reduced admission rates at Joslin. Developed through a collaboration with the Beth Israel Deaconess Medical Center, this protocol – the Emergency Valuable Approach and Diabetes Education (EVADE) program – was designed to facilitate a team approach to care that focuses on identifying the triggering factor in the event, stabilizing glucose and electrolyte imbalances, patient education, and detailed follow-up plans. A preliminary analysis of seven-month data found that enrollment in EVADE reduced hospital admission by 23% (meaning 23% of patients who entered the ED were discharged without being admitted to the ICU) – this difference was statistically significant and well above the hospital’s original goal of a ~10% increase in the discharge rate. Notably, only one patient admitted to the EVADE program subsequently returned to the ED (due to unrelated alcohol abuse), a testament to the program’s effective patient education and follow-up care. While the lower admission rate resulted primarily from faster discharge of the least sick patients, the protocol has also reduced the length of stay for patients who are admitted: average length of stay (LOS) for non-ICU patients (n=20) was 133 hours, while the average LOS for ICU admissions was 34 hours in the ICU plus 79 hours in the hospital after ICU discharge. Regarding ICU stays specifically, Ms. Koen was quick to note that the protocol has “shaved off 16.2 hours in the most expensive part of the hospital” – an excellent example of how cost reduction can be achieved without compromising quality of care.

Questions and Answers

Q: Is this treatment appropriate for type 1 patients only where insulin is required?

A: No. It applies to type 2 patients also. That’s why we use an IV drip to begin to address the dehydration.

Q: Can you guys share this protocol with other inpatient CDEs who aren’t here?

A: Yes, they are in the slides.

Q: Can you discuss the age breakdown for patients who have been admitted to EVADE?

A: Sorry, I don’t know that we’ve looked at it.

Q: Have there been any pediatric patients?

A: No. Since Boston Children’s Hospital is right around the corner, most pediatric patients head there. So the patients we’re dealing with are all over 18.

Q: Were any of the patients admitted to EVADE frequent visitors to the ED? Have they returned since?

A: Yes, we did have some frequent visitors that were admitted once. But they’ve haven’t been back in since.

[Comment]: Wow. I’m so envious.

Implementing the AADE Practice Advisory for Diabetic Kidney Disease

Andrew Narva, MD (NIDDK, Bethesda, MD); Theresa Kuracina, RD (Albuquerque Indian Hospital, Albuquerque, NM); Eileen Newman, MS, RD (NIDDK, Bethesda, MD)

Dr. Andrew Narva discussed the important role diabetes educators play in chronic kidney disease (CKD), while Ms. Theresa Kuracina and Ms. Eileen Newman advised educators on how to best treat the complication. Dr. Narva began by stressing the importance of increasing patient awareness of CKD and how diabetes educators may be better positioned than physicians to discuss the issue with patients early on. This communication is essential, as CKD is a progressive disease that can remain asymptomatic for years; according to NHANES data, only 20% of patients who have lost half their kidney function know they have kidney disease. Though it is not currently possible to arrest or reverse CKD, interventions can slow its progression, improving quality of life and reducing costs (“that money hopefully becomes available to raise reimbursement for diabetes education,” Dr. Narva commented). Ms. Kuracina and Ms. Newman offered valuable nuts-and-bolts advice for educators on CKD management, in which the dietary considerations alone illustrated the complexity of the disease. During Q&A, Dr. Narva more provocatively asserted that “endocrinologists are not that key” in diabetes management and that “the most important interventions are more effectively implemented by non-physicians.” Given the current shortage of endocrinologists, allied healthcare professionals will become increasingly important with an expanding patient population, and we hope to see a continued shift toward delivery and reimbursement models that emphasize team-based, coordinated care.

• CKD is one of the areas of greatest unmet need in diabetes, and we hope that some of the novel compounds now in development will prove to be disease-modifying. The latest CDC statistics estimated that the number of patients on dialysis or with a kidney transplant due to diabetes rose 13% from 2008 (202,290) to 2011 (228,924). Promising recent developments in the area include the resumed development of bardoxolone methyl by Kyowa Hakko Kirin and J&J’s initiation of the CREDENCE study that investigates the potential renal benefits of the SGLT-2 inhibitor Invokana (canagliflozin). See our AbbVie 2Q14 report for a more complete update on the CKD competitive landscape.

Questions and Answers

Q: Do you think SGLT-2 inhibitors could have a harmful effect on kidney function?

Dr. Narva: There’s not a lot of data on that. It could be worrisome – there’s an increased risk of infection and in general, when you mess with physiology, there’s usually a price. The question is whether enhanced control of glucose outweighs the potential downside of increased glycosuria in the progression of CKD.

Q: What do you think is the role of specialists in treating CKD?

Dr. Narva: Kidney disease is where diabetes was 30 years ago, when you wanted to see the most famous endocrinologist. Then we realized diabetes is a primary care disease. Now we want the best team. The endocrinologists are not that key. The most important interventions are more effectively implemented by non-physicians. The best model is the Indian Health Service. If you look at incidence rates of kidney failure in diabetes, there has been a 30% drop over the last 15 years in American Indians with diabetes developing end stage renal disease, which is different from every other population. We think that’s associated with more access to CDEs, dieticians, etc. than many better-funded healthcare systems have.

Q: Can you comment on the validity of A1c as a measurement for patients who are anemic and on erythropoietin?

Dr. Narva: It’s less useful because the lifespan of red blood cells is different for dialysis patients. The data we use to convert A1c to average glucose is not anywhere near as valid. At a recent consensus meeting with eminent endocrinologists, there was a discussion about the uncertainty of A1c. I didn’t realize the spread on A1c is much greater than what most people realize. That points to the importance of assessing people beyond one single test.

Q: And to the importance of monitoring blood glucose numbers?

Dr. Narva: As one person at the meeting said, if you really want to know what the blood sugar is, you have to measure it.

Customer Appreciation Event

Your Travel Guide to the World: Lilly Diabetes and Becton, Dickinson and Company

BD and Lilly co-sponsored a customer appreciation dinner that featured a wide variety of international foods and drinks (from Mexico, India, China, and Italy!). The upbeat event was a celebration of educator’s hard work, which too often goes unnoticed. Attendees were welcomed to the event by a crowd of cheering employees, a testament to the positive vibe that belied the three-hour event. The dinner also featured brief remarks from AADE President Joan Bardsley, who extended her appreciation to BD and Lilly for their commitment to educators and patients and for acknowledging the worldwide impact of diabetes. Taken together, we were pleased to see the return of this event – co-hosted by Medtronic and Bayer last year – and certainly feel that educators deserve every bit of recognition they received, and more!

Exhibit Hall

Abbott

Abbott returned to the exhibit hall after choosing not to put forth a booth at ADA 2014. Located at the hall entrance, Abbott’s enormous booth featured its signature yellow panels and large, bright yellow circular banners reaching toward the ceiling. It was hard to miss their sales representatives, too, who were very approachable for educators in their bright yellow shirts. The center of the booth was taken up by a large bar, allowing attendees to refresh themselves with a drink (non-alcoholic!) and rest their legs. The exterior of the exhibit featured multiple booths with impressive outward-facing touchscreen monitors highlighting the entire line of FreeStyle products. Perhaps given the challenging economic climate in the US, representatives were highlighting for attendees of Abbott’s existing FreeStyle Promise program that provides patients with a free meter and “instant savings” on tests strips (as low as a $15 test strip co-pay per month) – we have heard excellent patient feedback from those who use this program. Educators not as familiar with Abbott’s “ZipWik” strip technology received cool demos showing the extent to which the technology minimized the amount of blood needed to make a reading (only 0.3 μl).

AstraZeneca

AZ fielded the largest booth in the hall. For a booth of its size, there was relatively little in the way of static displays, with just a few displays and desks at the corners of the booth. The major feature was a central product theater stage with comfy white seats where speakers gave scheduled presentations on the SGLT-2 inhibitor Farxiga (dapagliflozin) and the new Bydureon pen. AADE is the coming-out party for the Bydureon pen, which was approved in March but has not yet launched – the device encapsulates the entire reconstitution process within the device, representing a significant step up from the Bydureon kit. Overall, AZ’s booth emphasized the breadth of its portfolio more than any single product, with some displays encouraging educators to take a stand against high A1cs while individualizing therapy for their patients.  

Bayer

We were pleased to see Bayer’s presence at the exhibit hall after the company’s absence at ADA’s exhibit hall. The booth underwent a major stylistic redesign since last year’s AADE, as the brown and black shades were replaced by a much brighter and striking blue and white motif. A small bar at the rear of the exhibit offered attendees beverages, while stations set against shimmering white curtains advertised the Contour Next meter. A walk around the booth revealed a demo stage at the rear, where representatives stressed the convenience of the meter with two language features, audible test reminders, and “second chance testing” (applying more blood without wasting test strips). Adjacent to the coffee bar was a lounge space, equipped with a long couch, a few chairs, and a coffee table, providing fatigued attendees a location to relax, check their email, or hold a conversation.

BD

BD’s booth was prominently located at the front of the exhibit hall and was particularly busy with foot traffic. During AADE, the company announced the launch of the AutoShield Duo pen needle, and this product was the clear focus of the exhibit. A large-scale replica of the pen needle marked the entrance to the booth, while two-story panels surrounding the exterior proclaimed that, “The future of pen needles is here.” BD’s representatives were eager to demo the device at multiple stations, speaking enthusiastically about the first and only patented dual front and back-end shielded pen needle (“the first true innovation in a pen needle in a long, long time”); the design ensures the needle is never exposed in order to provide greater safety both before and after injection. Representatives also highlighted the convenience of the device (5 mm, 30 gauge) – the tactile feedback, the “audible click,” and the red indicator – that mark a successful injection (which attendees got to confirm for themselves). Prominent blue signage also noted that the device is covered by “virtually all insurance plans at the preferred co-pay” and fits all leading insulin pens. Meanwhile, just as at BD’s ADA booth, the center of the exhibit was devoted to an elevated stage that featured a lipohypertrophy demo, where “Lipo Larry” was spread out on an examination table. This dummy invited attendees to feel the lipohypertrophy on Larry as reps emphasized the importance of rotating injection location; accompanying monitors highlighted that appropriate rotation can allow patients to use up to 15 fewer units of insulin/day. We felt this was really valuable to share with educators and hope patients have a chance to learn more on this front as well. More notably, although we missed it on day #1, panels also announced a daily live demo – similar to that at EASD 2013 – that we are sure attracted a significant number of attendees.

Boehringer Ingelheim

BI’s fairly modest-sized booth featured the same sleek white appearance we saw at ADA (in contrast to the signature exuberant purple theme of previous years). Rectangular screens provided safety and efficacy data on Tradjenta and Jentadueto, and two banners highlighted the recent approval of Jardiance (empagliflozin), the third SGLT-2 inhibitor to gain approval in the US behind J&J’s Invokana (canagliflozin) and AZ’s Farxiga (dapagliflozin).

Dexcom

After a relatively more expansive display at ADA, Dexcom reverted to a more familiar design for AADE: the small yet stylish exhibit was nestled toward the side of the hall, offering an open floor plan with plenty of room for seating. Attendees could grab a beverage at a small coffee bar, while a monitor behind the counter displayed a video of what appeared to be testimonials of athletes – a golfer and BMX rider – showcasing Dexcom’s G4 Platinum CGM. Signage above the booth announced the company’s slogan, “One Step Ahead,” while three colorful ground-level panels highlighted the accuracy of the Dexcom G4 Platinum (“lowest Mean ARD in the industry”) and the device’s pediatric approval; the latter seemed to successfully tug at attendee heartstrings with a picture of a young girl holding a G4 in one hand and a teddy bear in the other. In speaking with representatives, the exhibit’s main news was the approval of the Professional version of the G4 Platinum and the even more recently announced integration partnership with Asante. 

Genteel

Though Genteel’s small booth was nestled toward the side of the exhibit hall, that did not stop a sizable crowd from eagerly gathering to test the company’s flagship product, a “100% pain-free” blood glucose test. Large signage advertising the slogan – “No More Ouch!” – framed the front of the exhibit while a display table at the rear presented the device. The “painless” technology works by controlling blood draw with six interchangeable “Contact Tips” of varying thickness that block the travel of the lancet into the skin; by choosing the appropriate tip for their skin – a learning curve of five minutes, according to representatives – patients can eliminate contact between the lancet and pain nerves. The device also features a vibration mechanism intended to block pain signals while generating lancing speeds up to “four times faster” (0.018 seconds) than conventional spring-loaded mechanisms; after lancing, the device applies a vacuum to the skin intended to “soothe” pain nerves and facilitate blood draw through a shallower, smaller lance site. The device is approved for alternate site testing and works with the majority of FDA-approved square lancets. The marketing campaign was clearly directed toward children, featuring multi-colored lancers – along with a variety of stickers – in an attempt to give the device a benign look, reducing the “trauma” associated with testing. While we love the ingenuity of the product and the unmet need it seeks to fulfill, the significant size (about four times bigger than a conventional lancing device) will deter many patients that perceive it as particularly indiscrete. In testing a demonstration device at home, we also found it incredibly hard to learn and setup; it most certainly did not pass the “no-instruction manual test” we apply to every new diabetes device (admittedly a hard test for some). Further details on the product can be accessed here.

GSK

The fairly low-key booth belied the company’s exciting recent news: the launch of the once-weekly GLP-1 agonist Tanzeum (albiglutide) (in line with the company’s 2Q14 update in late July. Four sets of static displays on the side of the booth displayed the product insert, while a set of information desks at the corner of the booth allowed representatives to catch passerby to tell them about the new drug and demo the device and administration protocol. Tanzeum was approved in the US in April, and at GSK’s medical affairs booth at ADA we got to see a demo of the 30 mg pen, which encapsulates the reconstitution process within one device (although the process takes slightly upwards of 15 minutes for the 30 mg pen and slightly upwards of half an hour for the 50 mg pen, most of that time being wait time during which patients can do other things). The FDA label for Tanzeum has a pictorial of the administration process. The booth layout appeared to be fairly conserved from ADA, featuring a few chairs and couches, a rich purple carpet, and granola for attendees. 

Insulet

Insulet’s modest exhibit was stationed toward one side of the exhibit hall, though that did not stop a host of educators from stopping by to inquire about the company’s second-gen OmniPod. The booth’s message was clear, as a poster proclaimed the benefits of the device: “Easy to use, wearable, and waterproof.” In particular, representatives highlighted the latter, distributing handouts with data illustrating the elevation in blood glucose that comes with disconnecting from a durable pump during a shower (or other water activities). Images of patients on surrounding panels displayed the OmniPod on the triceps, putting a clear emphasis on the product’s small size and high wearability. Eager attendees could step up to one of three podiums and receive a demo of the OmniPod. As in the past, the booth even featured a poster for solid chocolate OmniPods and provided attendees with copies of a Sam Talbot-authored cookbook (“The Sweet Life”) as a free giveaway. There was no mention of the company’s recent announcement that the integration partnership with Dexcom is back on.

J&J

J&J’s booth was hard to miss thanks to the enormous ring with its logo suspended from the ceiling and the artistic chandelier-like structure lighting up the center of the exhibit. The success of the SGLT-2 inhibitor Invokana (we estimated sales to be $84-93 million in 2Q14) was in line with how J&J used their booth space, as about two-thirds of the exhibit real estate was devoted to touchscreens explaining the drug’s mechanism of action and favorable efficacy profile. Sales representatives handing out pamphlets asking “What Have the Kidneys Ever Done for Type 2 Diabetes?” were eager to discuss the unique benefits of SGLT-2 inhibitors with providers; one representative said that most diabetes educators she had spoken with were very familiar with Invokana. While Invokana was clearly the focus of the exhibit, LifeScan/Animas still had a substantial presence. Educators who stopped by the booth could receive stuffed foxes intended to aid in infusion set insertion demonstrations for the OneTouch Ping insulin pump. As in previous years, Animas pumps floated in water to demonstrate the water resistance feature. Representatives also highlighted Janssen’s Care4Today Mobile Health Manager, a mobile app that reminds patients when to take their medications, complete with pictures of the pills. As in the past, the booth also featured some artistic touches, including kidney-shaped easels dedicated to “advocate art” and a stand with large “post-it note” cubes asking attendees, “What challenges will the next breakthrough in diabetes help solve?” [In our view, adherence, clinical inertia, and ongoing patient support.]

Lilly

Lilly’s booth had a lot going on, with its characteristic house theme in full force. We were drawn to an interactive wall of tablet screens on the far side of the booth, which allowed attendees to explore Lilly R&D highlights. A number of other Lilly programs and partnerships were highlighted as well, including joint efforts with Disney and NASCAR as well as its Diabetes Emergency Plan and Diabetes Journeys Awards programs. On the product front, small portions of the booth were allocated to Lilly/BI’s Tradjenta (linagliptin) and Lilly’s insulin and insulin pen portfolio. We noticed that Humulin U500 (Lilly’s highly concentrated human insulin formulation) received a wall of its own – during Lilly’s recent 2Q14 update management noted that Humulin U500 was a major driver of Humulin franchise growth.

Medtronic

Medtronic’s typically expansive booth was located at the entrance of the exhibit hall and featured floating circular panels reaching toward the ceiling. Representatives walked us through the Threshold Suspend feature of the MiniMed 530G with Enlite, which was displayed prominently at a kiosk toward the side of the booth. Located centrally within the exhibit was also a line of experimental Medtronic clothing and accessories, including colorful and stylish travelling cases alongside athletic wear with pump-sized pockets sewn directly into the fabric. Other pipeline items mentioned during the company’s Analyst Day – the MiniMed Flex “hybrid pump,” the Enlite 3 sensor, and the type 2 diabetes business – were not present in the booth.

Merck

Positioned close to the exhibit hall entrance, we quickly spotted Merck’s booth from the logo on a large hanging ring suspended from the ceiling. The expansive, light-hearted exhibit featured a frozen yogurt machine – quite popular among attendees – and many illuminated monitors, showcasing images of various smiling patients. The exhibit also highlighted safety and efficacy data of its market-leading Januvia (sitagliptin) franchise, with separate walls focused on Januvia and Janumet (combination sitagliptin and metformin) – we heard the latest on these drugs during Merck’s 2Q14 update; these walls featured slogans such as, “helping your patients on their lifelong journey” (similar to the company’s booth at ADA). Meanwhile, other screens throughout the booth offered support resources to patients and providers, while representatives provided attendees with diabetes recipe booklets.

Novo Nordisk

The sleek white booth occupied a relatively modestly sized footprint for the company, but it still seemed plenty spacious given the focus on three of its offerings: the GLP-1 agonist Victoza (liraglutide) and its major insulins Novolog (insulin aspart) and Levemir (insulin detemir). Sleek white structures with purple accent lighting and plentiful large displays set a high-tech theme. Much of the messaging was conserved from the company’s ADA booth, including the now characteristic tree root motif for Victoza. A portion of the booth was also dedicated to Novo Nordisk’s signature conference 5K, something the company does an amazing job spearheading at the major diabetes conferences.

Roche

Roche was back on the exhibit hall floor after its absence from the ADA 2014 hall. The company’s signature navy blue paneling arched over the booth, held up by what appeared to be blue, stick-figure-esque people. The open floor plan featured multiple white tables furnished with chairs and baskets of oranges. Roche heavily featured its new slogan, “Now patients can enjoy the meal without worrying about the math,” as the booth focused on the company’s new Accu-Chek Aviva Expert BGM – the meter was launched earlier this year and Roche is promoting it was the “first and only” meter with a built-in bolus calculator. [Though this is true “in the US,” the version of the Abbott FreeStyle Insulinx available outside the US does include a built-in bolus calculator, which makes Roche’s language somewhat misleading.] The booth featured multiple posters of the Aviva Expert against a background of alphabet soup imagery that emphasized the difficulties of bolus calculation – this was quite apt from a patient perspective. Representatives were quick to point us toward a demo of the Aviva Expert located at a white counter at the center of the booth that allowed attendees themselves to interact with the bolus calculator. To the right of this counter, attendees could also spin a large trundle in order to win a variety of prizes ranging from imitation food props to measuring cups; the eye-catching promotion seemed to attract a host of foot traffic throughout the conference.

Tandem

Tandem’s impressively high paneling was front and center at the entrance to the exhibit hall, reprising its signature modern, wood-floored look. Glassy paneling surrounding the booth displayed cases showcasing the t:slim insulin pump and accessories. Meanwhile, touchscreen monitors allowed attendees to experiment with the device’s user-friendly interface and to walk through the process of initiating a bolus. As expected, representatives highlighted the recent PMA submitted to the FDA seeking approval of its t:slim insulin pump integrated with the Dexcom G4 Platinum CGM (learn more in our coverage of Tandem’s 2Q14 update). A dedicated kiosk also displayed the t:connect diabetes management software, allowing attendees to mouse through the application at a small computer station. Alternative kiosks featured seating for attendees to rest and look through handouts detailing high scores for the t:slim in pump satisfaction research from San Francisco-based market research company, dQ&A (Contact richard.wood@d-qa.com for more details).

 

-- by Melissa An, Adam Brown, Varun Iyengar, Emily Regier, Manu Venkat, and Kelly Close