International Diabetes Federation: World Diabetes Congress 2013

December 2-6, 2013; Melbourne, Australia; Day #3 Highlights – Draft

Executive Highlights

Hello from a rainy Melbourne, Australia and Day #3 of IDF 2013. Today’s report contains our top five most notable happenings from the day, along with an appendix of additional valuable commentary.

To kick off our top five, Dr. Hertzel Gerstein’s presentation on incretins and CVOTs during Sanofi’s corporate symposium was incredibly valuable – his sharp criticism of releasing interim results (and the compelling example from the DCCT to back up his argument) had our jaws dropped on the floor. The same Sanofi corporate symposium shared new data on timing of lixisenatide dosing, along with Dr. Satish Garg (University of Colorado, Denver, CO) stating that he “heard” Roche’s CGM sensor will launch “next year”, at least in some locations (the first launch timeline we’ve heard). Meanwhile, the always captivatingalways-captivating Dr. James Gavin III (Emory University, Atlanta, GA) wowed everyone in the audience with a compelling presentation on the Partnership for a Healthier America’s efforts to tackle childhood obesity in the US. To close the day, we witnessed one of the most unique corporate events at any conference in recent memory (actually, ever) – Novo Nordisk’s symposium entitled, “Getting Straight to the Point: A Theatrical Play Exposing the Misconceptions Around Injections and Tackling the Barriers They Create.”

Our appendix includes several detailed write-ups from several other notable sessions: (i) an insightful Sanofi panel discussion featuring Drs. Richard Bergenstal (International Diabetes Center, Minneapolis, MN), Satish Garg, and Hertzel Gerstein (McMaster University, Hamilton, Canada) – comments discussed sulfonylureas, ORIGIN interpretation, and CGM/pumps in type 2 diabetes; (ii) a survey on why physicians prefer use of metformin over initial combination therapy; (iii) IDF Program Chair extraordinaire Dr. Paul Zimmet (Baker IDI, Melbourne, Australia) on the ability of famine to predict diabetes hotspots; and (iv) a social media workshop from this morning co-led by Kelly and attendees brainstormed thoughts to three provocative questions (even the overflow room was filled, she was told!).

Top Five Highlights

1) “If we had looked at the one-year interim results for the DCCT, we would not be promoting intensive diabetes care today – we would be saying that it causes retinopathy.” Commenting on the impact of releasing interim outcomes trial results, Dr. Hertzel Gerstein (McMaster University, Hamilton, Ontario, Canada) presented a “thought experiment” – he asked the audience what they would say upon seeing interim data where participants in the treatment group had a 13.1% chance of having a certain an adverse event while those in the control group only had 7.6% chance (odds ratio: 2.06; p<0.001). After remarking that such a study would be terminated immediately, Dr. Gerstein revealed that these data were the real retinopathy rates that would have been seen from a one-year interim analysis of the DCCT. Speaking over the shocked and surprised murmurs (including ours!), Dr. Gerstein emphasized that publicly releasing interim data based on only a small proportion of the expected outcomes can therefore produce misleading analyses that often do not reflect the final results, as was clearly the case with DCCT (where ultimately, retinopathy was reduced by over 50% with intensive therapy). Additionally, the behaviors of HCPs or patients may change in response to the results of the interim data (Cedars Sinai cardiologist Dr. Sanjay Kaul also spoke on this topic during the FDA advisory committee for J&J’s canagliflozin). Dr. Gerstein emphasized that “if reliable conclusions could be drawn from the interim data, there would be no need to do the longer trial in the first place.” A diabetes world without the DCCT is unimaginable – Dr. Gerstein’s point is well taken, and we think reinforced for many, even further, the detrimental effects of releasing interim trial results.

  • It was for precisely these reasons that Sanofi chose not to release interim results from CVOT ELIXA for Lyxumia (lixisenatide). As a reminder, Sanofi withdrew its lixisenatide submission from the FDA in order to wait for the full CVOT results in 2015. In light of the above, this decision seems very understandable – it also clearly learned from Novo Nordisk’s time with FDA that a negative decision has major downstream effects (in Novo Nordisk’s case, on GLP-1/insulin product in development iDegLira). It will be interesting to see if other companies follow suit and choose not to release interim results – certainly, IP and patent expiration are big considerations, so we imagine this will vary from company to company. Of course, FDA said back in the day that the delays wouldn’t be so long, because they could learn from interim data – wow we wonder what FDA would do today if they could hit replay. At least they would have made no judgments on interim data.

2) During his talk on new technology in the Sanofi symposium, Dr. Satish Garg (University of Colorado, Denver, CO) casually mentioned that he “heard” that Roche is going to launch its new CGM sensor “next year.This is the first time we can recall hearing a launch timeline on the Roche sensor – we last saw accuracy data on Day #3 of the 2013 Diabetes Technology Meeting – see page two here. Presumably this would not be a wide scale launch but at least in one geography. At the time, Dr. Matthias Axel Schweitzer showed accuracy data that continued to look strong, with the sub-10% MARD in line with data previously presented at ADA. At DTM, Dr. Schweitzer also presented new data from an admittedly small head-to-head study against the Dexcom G4 Platinum. Ten type 1 patients wore two Dexcom G4 sensors and two Roche sensors simultaneously. The Roche sensor slightly edged out the Dexcom G4 on MARD: 8.6% for Roche vs. 10.9% for Dexcom. Specifics were very light on study methodology, so we continue to look forward to more detail in the future. There were also complaints at that time about what was used for calibration etc. – we aren’t entering into a discussion at this point about which sensors are most accurate, merely reporting on the data shown. The patient reception, of course, to the Dexcom G4 Platinum has been particularly strong (see our Dexcom 3Q13 report)– there is undoubtedly plenty of room to expand this market, particularly if more health economics studies are done. We also think demand will increase the more that patients and HCPs hear about and get used to looking for “time in zone” data.

3) During Sanofi’s evening symposium, we got a sneak peek at data comparing Lyxumia (lixisenatide) administration before breakfast with administration before the main meal of the day. Full study results will be presented by Dr. Bo Ahrén (Lund University, Lund, Sweden) on IDF Day #4. Dr. Lawrence Leiter (University of Toronto, Toronto, Canada) revealed that the A1c reduction for pre-breakfast administration was 0.74% compared to 0.64% with pre-main meal administration, which met the criteria for non-inferiority (p=0.2664). That makes sense to us that breakfast is better, since patients come off better “nights” in general than “days” – less “disturbance” at night. The two administration schedules were associated with comparable GI tolerability and a low incidence of symptomatic hypoglycemia. As background, the 24-week study enrolled 451 type 2 diabetes patients who were on background metformin and had baseline A1cs between 7% and 10%. Dr. Leiter commented that the study results are important because they indicate that the drug can be administered at the time that is most convenient for the patient without compromising safety or efficacy. Given that GLP-1 agonists, as injectables, are not perceived as the most patient-friendly of the major diabetes drug classes, solid data supporting a convenience advantage for patients will be a plus. While Lyxumia has the advantage over the one other short-acting GLP-1 agonist (Byetta) in that Lyxumia is a once/day injection and Byetta is a twice/day injection, Lyxumia’s dose timing is still more constrained compared to the one other once/daily GLP-1 agonist on the market (Victoza) – Victoza may be taken at any time of the day, irrespective of meal timing.

4) Dr. James Gavin (Emory University School of Medicine, Atlanta, GA) walked attendees through the impressive success that the Partnership for a Healthier America (PHA) has had over its nearly four-year tenure. Working in conjunction with, but separate from Let’s Move!, PHA is striving to solve the childhood obesity crisis within a generation by (i) obtaining commitments from the private sector that “make the easy choice the healthy choice”; (ii) convening the Building a Healthier Future Summit; (iii) bringing ideas to scale (i.e., translating successful pilot programs to the national level); and (iv) “being a catalyst for change” (via the former three activities). In particular, Dr. Gavin expounded upon the broad and diverse commitments the private sector has made, and the benefits these partnerships have for both the public and for the companies themselves (full details in the Appendix). We were struck by the broad array of companies PHA is working with and hope to see work begin with companies and organizations in diabetes . Dr. Gavin concluded that while childhood obesity rates are beginning to decrease in many states and territories, much work remains to be done (e.g., the prevalence of severe obesity continues to rise) and PHA will continue to seek partners in the fight to end childhood obesity. We were glad to hear that – we think the plateau is good but also believe within the obese stats, there are more children moving to morbid and severe obesity – bad news. We know PHA will continue to deliver – the world class leadership of Larry Soler (previous #2 at JDRF) alone has made a massive difference and with Dr. Gavin on board, the team is doing an incredibly impressive job. We would love to hear more on continued achievements of companies like Wal-Mart; we also thought Sanofi and Novo Nordisk’s leadership at the PHA meeting last year was terrific to see and look forward to more.

5) Novo Nordisk presented the world premier of Getting Straight to The Point, a three-act theatrical production on the misconceptions surrounding injections. The play included five (incredible!) professional actors and presented the perspectives of patients, HCPs, and family members on initiation of injections. In between each act, Drs. Luc Martinez (Marie Curie University, Paris, France), Andreas Liebl (Fachklinik Bad Heilbrunn, Germany), Moshe Mishali (University of Haifa, Israel), and Natalia Piana (University of Perugia, Italy) reflected on the themes conveyed and elucidated take-home lessons for practitioners. Sometimes funny, other times deeply emotional, we thoroughly enjoyed this very fresh format for a corporate symposium. We felt it powerfully conveyed the need for HCPs to seek out and rectify any communication barriers and misconceptions around injections that might exist with their patients. Notably, Novo Nordisk capitalized on the inspiration the play generated by offering attendees the chance to inject themselves with a demonstration pen and sign a call to action on improving communication in diabetes care.

Some of our favorite lines from the play included:

  • “Now, you look like someone with diabetes; [….] you have got the look, […] the air of defeat” – Patient with type 2 diabetes speaking to another person with type 2 diabetes
  • “I do not cope with diabetes; diabetes copes with me.” – Patient with type 2 diabetes
  • “I am not sure if my last appointment was a patient or a hurricane with legs.” – Physician
  • “I manage a team of 20, you would think I could control my own damn blood sugar.” – Person with type 2 diabetes
  • “[The nurse] lost me when she said ‘GLP-1s.’ I have not heard of that kind of insulin before.” – Person with type 2 diabetes
  • “I know my basal from my bolus” – Patient 1
    • “She is a blogger” – Patient 2
  • “There is a difference between a last choice and the best choice.” – Physician
  • “You can sit back, relax, and watch me take my many, many medications.” – Person with type 2 diabetes speaking to his wife
  • “I have let things get on top of me. My heath is suffering and my sanity is not too far behind.” – Person with type 2 diabetes

Appendix

Oral Presentations: Diabetes Management

Why Physicians Do Not Follow AACE/ACE Guidelines in Treating Qualified Patients with T2DM: A Survey Study in the United States

Ying Qiu, PhD (Merck, Whitehouse Station, NJ)

Dr. Ying Qiu discussed the results of a study investigating the reasons why providers do not initiate combination therapy in patients with initial A1c levels of at least 7.6%, as recommended by the 2009 AACE/ACE guidelines. It is unrealistic to expect all providers to adhere to one specific guideline, especially given the multiplicity of guidelines available (such as the ADA/EASD position statement, which does not recommend initial combination therapy). However, we were certainly interested to learn more about providers’ opinions on initial combination therapy, especially given the well known issue of clinical inertia, the overly slow escalation of therapy. The study, conducted in the US, involved web-based physician surveys and patient chart reviews, and included 1,525 providers and 5,995 patient records. The most common reasons why providers did not proceed directly to combination therapy were a preference for initial metformin monotherapy before progression to combination therapy, a belief that metformin monotherapy was sufficient for the patient, and a preference for the simplicity of metformin monotherapy. Primary care providers tended to rate the reasons as more relevant than specialists did. Notably, fears over hypoglycemia were absent from the list of the top five most common justifications for metformin monotherapy versus initial combination therapy — that notable absence was addressed during Q&A.

  • The study, conducted in the US, involved web-based physician surveys based on patient chart reviews (four per physician). The charts were drawn from patients with an initial A1c between 7.6% and 9.0% who were started with metformin monotherapy. For each review, providers had to rate 22 different possible reasons why they initiated monotherapy instead of the initial combination therapy recommended by the 2009 AACE/ACE guidelines for patients in the specified A1c range. The study ultimately enrolled 1,525 providers (1,235 primary care providers and 290 specialists) and covered 5,995 patient chart reviews.
  • The top five most relevant reasons why physicians chose to initiate patients on metformin monotherapy and not combination therapy were: (i) “I recommend monotherapy before considering dual therapy;” (ii) “Metformin monotherapy is sufficient to improve glycemic control”; (iii) “Monotherapy is easier to handle than dual therapy”; (iv) “I believe that monotherapy and changes in lifestyle are enough for hyperglycemia control”; and (v) “Patient has mild hyperglycemia.” Each of these factors was rated as relevant by at least half of the responder pool.
  • Notably, primary care physicians tended to view the first four reasons as more relevant than specialists did (p<0.001), while the relevance of the fifth point was similar in the minds of primary care providers and specialists. We did not find this result particularly surprising, as we would imagine specialists (especially endocrinologists) might be more comfortable recommending slightly more aggressive initial therapy than primary care physicians. 
  • Dr. Qiu’s group also segmented the responses by the age of the patient. Reasons 1,3, and 4 were rated as significantly more relevant for younger patients, while reason 5 was rated as more relevant for older patients. This finding was somewhat surprising, as we would have hypothesized that providers would be less cautious about initial combination therapy in younger patients compared to older (and likely more frail) patients.
  • We were very surprised that fears over hypoglycemia did not make it into the top five most relevant concerns regarding initial combination therapy. This point was shared by others in the audience, and was brought up during Q&A (see below).

Questions and Answers

Comment: We are conducting a similar study in Europe, but our results were rather different. In the EU, the most common physician concerns were about hypoglycemia and about compliance.

A: Our study did include questions about hypoglycemia. As I mentioned, this was a study conducted in the US only, so the results may not be generalizable to other countries.

Q: I find it interesting that you picked what is perhaps the most controversial point of the algorithm, which is initial combination therapy. I think that many agree that initial combination therapy is appropriate for some groups of patients, but that there might be some disagreement about the specific A1c threshold for initial combination therapy. Perhaps in the future, instead of assessing a single aspect of the guidelines, we could assess opinions on multiple aspects.

A: True, but we felt there was value in focusing on the most controversial point.

Moderator: I want to have some audience participation: if all of you were presented with a patient with an A1c between 7.6% and 9.0%, how many of you would initiate dual therapy?

[Approximately 5-10 hands]

Moderator: How many would recommend initial metformin monotherapy?

[Approximately 10-15 hands]

Moderator: To me, that indicates that there is considerable discrepancy between our opinions on which guideline to go with.

Q: Did you ask to see if all the prescribers you interviewed were aware of the AACE/ACE guidelines?

A: All the providers did know about the guidelines, yes.

Q: How did you come up with the list of 22 questions?

A: We began with 50 questions, and then did initial focus group testing and boiled it down to the 22 top reasons. We wanted to keep the list relatively short. If a survey takes more than 30 minutes, the accuracy tends to be lower.

Corporate Symposium: A Comprehensive Approach to Type 2 Diabetes: Combining Clinical Experience with Technological Advances (Sponsored by Sanofi)

Panel discussion

Q: I want to ask about your suggestion that using basal insulin with metformin is better than metformin plus a basal insulin plus a sulfonylurea. That was based on pooled data. Physiologically speaking, it’s hard to appreciate how a basal insulin would take care of the postprandial peaks. Early in the course of diabetes, it might make sense to add in a sulfonylurea. Yes, if someone can afford a DPP-4 or a GLP-1, use that, but I think a sulfonylurea should remain in early diabetes to address the postprandial effect.

Dr. Richard Bergenstal (International Diabetes Center, Minneapolis, MN): Let me just say, I’m not opposed to the use of sulfonylureas. Some are saying we should never use them. That’s not what UKPDS showed. My point was a little bit different. The example was about using metformin and for whatever reason picking up a sulfonylurea, and then adding on a basal insulin because the patient was still not at goal. In that case, do you continue the sulfonylurea or drop it and use the basal and metformin only? What I’m saying is that the sulfonylurea just appears to get in the way of the ability to titrate the basal insulin to get to goal. Those on a sulfonylurea and metformin and a basal insulin didn’t get a better A1c and had twice as much hypoglycemia. 

Q: But in the early stages of diabetes, when they have an insulin reserve, it makes sense to use the sulfonylurea. Later in diabetes, there is no reason to add it.

Dr. Satish Garg (University of Colorado, Denver, CO): Part of the question is related to the duration of diabetes. I wonder if you looked at duration of diabetes?

Dr. Bergenstal: We’re sorting that out. But even so, at our initial look, it didn’t seem to matter. I know the populations are a little different. Your point is that a sulfonylurea may help – we all say that it “may.” But I would just challenge whether it is really helping or not. You can try it, but my advice is try some patients without it and adjust the basal insulin. You may need a few more units of insulin, but that’s a good thing. You won’t need to mix it up with the sulfonylurea.

Q:  There was a paper published in JCM on the risk of insulin from Cardiff. Insulin increased cardiovascular disease and cancer. Though it was not randomized, it was a huge database from England with around 90,000 patients followed for 10 years. That’s a more diversified population than ORIGIN or a controlled trial.

Dr. Lars Ryden (Karolinska Institute, Stockholm, Sweden): I’m not much in favor of registry trials. With glargine, it was a major mistake with cancer. Registry trials indicate things, but you need a randomized controlled trial to show whether the finding is true or not. But if we stay with registries for a while, as in Denmark, rather large registry trials show that sulfonylureas have drawbacks. I would like to see a sulfonylurea tested against another drug that has been proven safe. It’s rather difficult for me to understand why every new drug has to be cardiovascular neutral to be accepted, when sulfonylureas, for which we have suspicion of side effects, are not tested. Obviously no company will fund that, but society needs to do something about it. We cannot continue with an old and potentially dangerous drug.

Q: There is growing momentum for pump use in type 2 diabetes. Do you have thoughts on efficacy and whether this will happen?

Dr. Garg: Most of the trials are in a very small number of patients with type 2 diabetes. Almost all of the clinical trials using pump therapy in type 2 diabetes showed no difference vs. MDI. But most of the data also shows that quality of life and glycemic variability are definitely better with pump therapy. A much larger study needs to be done. The same is true of using sensors in type 2 diabetes. Larger studies of CGM are still not there for type 2 diabetes.

Q: Is CGM helpful for initiating insulin, or if you’re already on insulin, for adjusting the dose? And is CGM only for pumps?

Dr. Garg: Both ways – just like the beta cells, which sense glucose all the time, it makes sense to use CGM to see the glucose values in real time. There is a huge behavioral and therapeutic modification with using a continuous glucose monitor. The question on how often to use it in patients with type 2 diabetes still remains to be answered.

Q: Coming back to ORIGIN, the study found that glargine was safe for 6.5 years. But the data also showed no bad effect from use of a sulfonylurea and metformin and other drugs in the conventional arm. How do we see this data as positive for glargine? And you said we should finish off the glargine and cancer debate with ORIGIN. But cancer was not the primary or secondary purpose of the trial, and the follow-up was only 6.5 years. And patients were using doses less than 30 units.

Dr. Hertzel Gerstein (McMaster University, Hamilton, Canada): The absolute number of deaths in the glargine group was lower. You’re right, the hazard ratio was 0.98, so with respect to choosing an agent, the ORIGIN trial showed a clear neutral effect of glargine vs. standard care. There was no evidence of harm or benefit. Obviously, ORIGIN participants had lower glucose levels. In a presentation at ADA 2012, there was an exploratory analysis in patients who had an A1c above the median; those on glargine had a reduction in microvascular complications. That data will eventually be published. With cancer, it was prospectively measured and adjudicated in all participants. The cancer question was inserted when this scare came out. Remember that ORIGIN showed no clear effect after 6.5 years. You might say 6.5 years is only 6.5 years, but the whole scare was based on one year of data. Lack of evidence is not evidence of lack. There is not evidence anywhere that glargine causes cancer. That’s been shown extensively and globally. That’s the way that the status is.

Q: Regarding barriers to insulin therapy, can we better characterize patients to select the right ones who need it?

Dr. Bergenstal: That’s a challenge for all of us. Everyone would agree that insulin therapy is one of the most, if not the most effective therapy. Regarding barriers, some are real (injections), but we all want the outcomes of good glycemic control. We are developing new insulins to achieve goals. Perhaps through better phenotyping and genotyping we can select patients, but those are yet to come. CGM may be useful to identify patients’ glycemic profiles that suggest insulin is an excellent option.

Dr. Ryden: Talking about inertia introducing insulin. There are relatively few studies on insulin and quality of life. However, one of the few studies that did look at this found that those randomized to insulin did not see an impact on quality of life in a negative sense. Patients felt well cared for. From the evidence available, which is little, there is a myth that insulin should lower quality of life. If a patient gets the message of “Poor you, you have to take injections,” it makes a total difference. We should be cautious about how we talk about this.  

Symposium: Tackling Obesity: Innovative Health Promotion Programs in the Community

Partnership for a Healthier America: Urgency for Private Sector Engagement to Reduce Childhood Obesity

James Gavin III MD, PhD (Emory University School of Medicine, Atlanta, GA)

Dr. James Gavin walked attendees through the impressive success Partnership for a Healthier America (PHA) has had over its nearly four-year tenure. Working in conjunction with, but separate from Let’s Move! PHA is striving to solve the childhood obesity crisis within a generation by 1) obtaining commitments from the private sector that make the easy choice the healthy choice, 2) convening the Building a Healthier Future Summit, 3) bringing ideas to scale (i.e., translating successful pilot programs to the national level), and 4) “being a catalyst for change” (via the former three activities). In particular, Dr. Gavin expounded upon the broad and diverse commitments the private sector has made and the benefits these partnerships have for both the public and for the companies themselves. Dr. Gavin concluded that while childhood obesity rates are beginning to decrease in many states and territories (though the prevalence of severe obesity continues to rise), much work remains to be done and PHA will continue to seek partners in the fight to end childhood obesity.  

  • During its nearly four-year existence, PHA has announced close to 100 company commitments that help make the healthy choice the easy choice throughout an American family’s day. Dr. Gavin painted a picture of how these commitments work by using an animation of a family going about its average day, and being impacted by PHA commitments. We think the below examples demonstrate the penetration PHA has had in many areas impacting wellness and note that these do not even represent the full span of PHA’s influence.
    • Grocery shopping: Walmart (where >100 million customers shop each week) is reformulating its food products to make its offerings healthier and is conducting a campaign to help people identify healthier products. Importantly, Walmart has also agreed to offer healthy foods at a price comparable to unhealthy options. Additionally, the Healthy Weight Commitment Foundation (a CEO-led partnership to reduce obesity) is to cut at least 1.5 trillion calories from its members’ products over the course of three years. Furthermore, several grocery store chains have committed to have 1,500 stores provide fresh, affordable produce to 10 million Americans.
    • Eating at a restaurant: Darden (a family of restaurant brands including Red Lobster, Oliver Garden, LongHorn Steakhouse, and The Capital Grille) serves 400 million meals in 1,900 restaurants each year. Darden has reformulated its kid’s menu to reduce the meals caloric content by 20%. One way it is doing this is by making skim milk or water the default drink (instead of soda or juice) and vegetables the default side (instead of French fries, etc.). Hyatt, which serves food to three million kids annually, is similarly modifying its kid’s menu.
    • Visiting (or being treated in) the hospital: The more than 150 hospital systems (representing over 600 hospitals) participating in PHA’s Hospital Healthy Food Initiative serve 60 million meals each year. These hospitals have agreed to meet new standards in their cafeterias (specifics not defined). Dr. Gavin noted that if the new standards result in just 100 fewer calories being consumed in one out of every three meals participating hospitals serve, it will reduce caloric intake by eight trillion calories each year. Outside of the cafeteria, GE Healthcare, Cerner, and Physician’s Computer Company have each committed to develop and provide the Healthy Weight Plan (which provides tools to identify, manage, and track childhood obesity within the companies’ electronic medical records) to hundreds of thousands of patients and families during millions of doctors visits each year. Additionally, in 2012, over 77,000 new babies and mothers were reached by PHA partner hospitals with policies or programs that support breastfeeding.
    • In the neighborhood: Through the Play Streets initiative, PHA has helped organize over 40 events nationwide in which urban streets are closed to traffic, providing play space to the community. The US Olympic Committee and its member teams also worked with PHA to get 2.9 million kids moving in 2012.
    • At school: Reebok quintupled the number of sites offering BOKS (see page ten), a before-school physical activity program, to 1,000 schools. Nike has also provided $10 million to Let’s Move! Active Schools in order to help ensure limited resources do not prevent physical activity programs from being offered through schools.
    • At daycare: PHA’s private childcare commitments for wellness standards (i.e., caps on screen time, improved nutritional requirements, and floors on physical activity) have impacted 700,000 kids across the country. Dr. Gavin noted that the Department of Defense has followed suit, implementing similar standards in its childcare program that serves another 700,000 children for a total of about 1.5 million kids.
  • PHA also has partnerships with organizations that have an indirect impact on the community’s wellness. For example, PHA has a number of media partners who ensure that the public is aware of efforts to fight childhood obesity and the challenge the epidemic poses. Notably, Time Inc. will be the 2014 Building a Healthier Future Summit’s media sponsor. Additionally, several companies (i.e., Share Our Strength, The Links Incorporate, and All-Clad) work with PHA to verify the progress of PHA’s other commitments.  
  • Dr. Gavin underscored that companies benefit from partnering with PHA. As evidence he highlighted the positive impact Birds Eye (a frozen food company) commitment to offer and market-frozen vegetable to children had on the company’s bottom line. As background, Birds Eye conducted a consumer marketing campaign, which included having its vegetable products highlighted on the Nickelodeon’s TV show iCarly ­– the first time kids marketed vegetables to kids, according to Dr. Gavin. During the promotional period, the Birds Eye brand was responsible for more than one-third of the growth in the frozen vegetable market. Additionally, the campaign contributed to a 20% increase in brand unit sales year over year.
  • PHA is currently working on a campaign to get people to drink more water called Drink Up. For this initiative, PHA brought together a number of stakeholders including the American Beverage Association, Aquafina, Evian, Dasani, and Poland Spring. Participants are to prominently place the Drink Up logo on beverage containers, and the overall message is “You are what you drink – and when you drink water, you drink up.” Dr. Gavin explained that PHA is very explicitly working to ensure Drink Up does not sound like a public health campaign and only uses positive messages (i.e., does not include comparative messaging or discussion on what not to drink). The campaign has received substantial media attention: 46 stories have covered Drink Up conferring almost 80 million broadcast impressions. More specifically, Drink Up has been featured on Late Show with David Letterman, The Doctors, Good Morning America, and Late Night with Jimmy Fallon.
  • The 2014 Building a Healthier Future Summit is being held in Washington D.C. from March 12 to 14. We attended the Summit in 2013 (Day #1 and Day #2) and 2011 (Day #1 and Day #2), and found both Summits to be inspiring and informative.
  • Dr. Gavin explained how PHA and Let’s Move! are working together to solve the childhood obesity crisis within a generation. As background, Let’s Move! is the campaign stated by First Lady Michelle Obama in conjunction with but spate from PHA. PHA supports the First Lady’s cause by encouraging, tracking, and communicating commitments to healthier lifestyles from partner organizations.

Questions and Answers

Q: Are you getting any resistance from the schools when pushing the exercise commitment?

A: We are trying to negotiate that, because the schools say that they do not have time in their current curricular structure. We are trying to find workarounds. For example, we try to find partners to donate resources so that the costs for maintaining programs that are sometimes prohibitive are covered by partnership arrangementsus. We are now piloting about a dozen school districts to see if we can get such arrangements implemented.over those.

Workshop: Patient Empowerment Through Social Media

Patient Empowerment Through Social Media

Kelly Close, MBA (diaTribe/Close Concerns, San Francisco, CA)

Along with powerhouse Young Leader A. Overbeeke, Mrs. Kelly Close presented to a standing-room only audience on empowering patients through social media – the complete slide deck is posted here. Her presentation gave a focused overview of social media and why patients use it, with specific examples in four main areas: 1) peer-to-peer support (personal blogs and communities); 2) conversation (#DSMA twitter chat); 3) news and tips (e.g., dLife); and 4) advocacy (e.g., StripSafely, a diaTribe petition in support of an FDA patient meeting on diabetes). She emphasized that social media is not just for patients – it’s part of an ecosystem that also includes healthcare providers, industry, and organizations. Through presenting data from dQ&A diabetes market research, Mrs. Close emphasized that despite the increasing power and promise of social media, patients still turn to their HCPs for advice. She suggested that social media should be thought of as a supplement – not a replacement – for traditional patient-physician interactions (“Social media is one tool in a toolbox, but an increasingly important one”). And, Mrs. Close also stressed that HCPs should strive to be well acquainted with social media and recommend good resources to their patients – her dream is that every patient could get a prescription. Following her presentation, she facilitated a workshop discussion focused on three HCP-directed questions – see below for some of the highlights.

  • If healthcare providers were to prescribe social media, what would a such a prescription look like? Overall, audience members felt that HCPs are generally uncomfortable with information they cannot moderate. To overcome that issue, many suggested getting the basics of social media out there for HCPs (e.g., a “Twitter 101”) – this would help provide a baseline for people to get comfortable with social media, with potential for “advanced” classes for those who have the elementary aspects down. Many mentioned the need for doctors to be encouraging and direct patients to social media resources. While there are liability concerns, doctors can specifically tell patients to seek peer-to-peer support online, not medical advice (and if they do seek medical advice, come back to their provider and confirm its accuracy). Last, many suggested making flyers for HCPs to pass out to their patients containing high quality online resources.
  • What are the biggest risks and concerns over patients using social media? How could these be mitigated? The two major concerns brought up by attendees were misinformation (e.g., cinnamon will cure your diabetes!) and bullying/stigmatization (a type 1 patient telling a type 2 patient that type 2 diabetes is his or her fault). To overcome both worries, many suggested using designated moderators and/or encouraging HCPs to join in the conversation. Some brought up privacy concerns with social media, though these could partially be mitigated through closed groups and clear policies (e.g., don’t post your home address and phone number online).
  • What is needed to validate social media in the minds of healthcare providers and diabetes organizations? What would studies look like? Attendees seemed to struggle the most with this question. Certainly, professional organizations like the ADA, Endocrine Society, and AACE could help a lot in this respect – clinicians respect and listen to their guidelines. Social media could gain a lot more recognition and validation through a rigorous study, though many acknowledged it would be difficult to conduct such a study. Some of the biggest benefits of social media are psychosocial support, connection to other patients, and improved quality of life, aspects that are hard to capture and not as highly respected vis-à-vis harder clinical outcomes. Still given the number of patients on social media, simple observational studies could be done, perhaps through existing resources like the T1D Exchange. Moreover, the buy-in from a renowned principal investigator, perhaps someone like Dr. Bill Polonsky or Dr. Satish Garg, might go a long way towards giving social media more credibility.
    • “On the issue of social media and guidelines, we didn’t need RCTs when the telephone was invented. This is a communications platform. It isn’t good or evil. It’s how you use it. You don’t need guidelines to tell people what to do.” – Mr. Paul Buchanan, Founder, Great Britain Diabetes Online Community (#GBDOC). Notably, this tweet chat has grown to a staggering 500 people per week.
  • dQ&A data suggests that patients still overwhelmingly look to their HCPs for advice and information. In dQ&A’s quarterly patient survey, 1,050 type 1s and 2,985 type 2s responded to the questions, “Where do you get information about managing and living with diabetes?” The one number answer for both type 1 and type 2 diabetes was a “doctor or educator,” with a notable 52% of type 1s and 71% of type 2s reporting this resource. This was followed distantly by online communities/chat (14% of type 1s; 7% of type 2s), company websites (7% of type 1s and type 2s), and blogs (11% of type 1s; 2% of type 2s). [For more information, contact Richard Wood at richard.wood@d-qa.com]. Mrs. Close emphasized that online relationships are not a replacement for face-to-face interactions between patients and HCPs; however, given the authority HCPs have in patients’ eyes, providers can certainly help direct patients to high quality social media resources.

Lancet and Lancet Diabetes & Endocrinology Symposium: Managing Diabetes in the 21st Century

Diabetes: A 21st Century Challenge

Paul Zimmet, MD, PhD (Baker IDI Heart and Diabetes Institute, Melbourne, Australia)

Dr. Paul Zimmet’s forward-looking presentation covered a range of subjects, including the scale (and cost) of the diabetes epidemic, epigenetics, and strategies for anticipating and preventing diabetes on a population level. To emphasize the severity of the epidemic, he noted that the worldwide diabetes population is large enough to be the world’s third biggest country. He warned that the enormous predicted rise in diabetes prevalence in the developing world threatens to cripple entire economies through the direct costs of treatment as well as the cost of lost productivity. He noted, based on historical examples in Europe, China, and Cambodia, that spikes in diabetes prevalence tend to follow a few decades after periods of famine. Dr. Zimmet theorized that malnutrition during pregnancy induces epigenetic changes that condition the fetus to expect malnutrition after birth — when such a child develops in an obesogenic environment, he or she is at a greater risk for developing type 2 diabetes. This model, if correct, would allow for the prediction of future diabetes “hotspots” based on past and present droughts and famines; Dr. Zimmet expects Eastern Africa to see a spike in diabetes in future decades. We found this theory very interesting, as the ability to isolate future hotspots and target cost-effective preventative care towards them could save immense resources (not to mention patient suffering) in the future.

-- by Adam Brown, Hannah Deming, Hannah Martin, Manu Venkat, and Kelly Close