With his voice almost breaking, Mr. Jeff Hitchcock (Founder, Children with Diabetes, West Chester, OH) showed a photo of his beautiful new baby grandson and proclaimed, “We do diabetes care so that our kids can grow up to be happy and healthy, to fulfill their dreams, to have a baby. That’s why we’re here and that’s why we work so hard.” His inspiring and emotional opening address shared the story of his daughter’s type 1 diabetes diagnosis at age 2, which kicked off the organization’s founding and brought one of our very favorite conferences into being. The 15th (!) Annual Friends for Life Conference was filled with positive energy at every turn, with over 800 families in attendance and some of the most renowned experts in diabetes sharing wisdom, positivity, and hope with parents and families. Indeed, this meeting has become a “mini-ADA” and though traditionally has been very focused on children with type 1, there is now an incredibly valuable adult type 1 track and given the crossover between type 1 and type 2, we understand that next year there will be badges for type 2 patients as well (a number were at early advocacy sessions not aimed only at type 1). This is a terrific direction to see CWD moving, particularly the focus on so many volunteers in diabetes, broadly speaking, working together. Children with Diabetes has always had a major focus on the psychosocial aspects of diabetes care as well, and this year was absolutely no exception – perhaps most notably, psychologist Dr. Jill Weissberg-Benchell received this year’s Jeff Hitchcock Distinguished Service Award, a truly well deserved recognition.
In this report, we bring you our top ten highlights, followed by detailed discussion and commentary on select talks.
1. Dr. Ed. Damiano (BU, Boston, MA) shared the latest on the bionic pancreas, including results from the first two patients in the ongoing 11-day multicenter study. It was terrific to see this new data and to hear of ongoing funding by NIH and other top organizations. His presentation had a clear bit of urgency, as the team is currently in need of ~$5 million in the next 60 days to fund development of the Bionic Pancreas device for pivotal trials.
2. Diabetes Hands Foundation organized and led Masterlab, an outstanding all-day workshop on diabetes advocacy, with talks from Mr. Mike Mangianello (HIV/AIDS activist, HCM Strategists), FDA EMDAC patient rep (and type 1) Ms. Rebecca Killion, FDA’s Dr. Stayce Beck, and more.
3. Dr. Anne Peters (USC, Los Angeles, CA) and Ms. Kelly Close (Close Concerns/the diaTribe Foundation, San Francisco, CA) discussed “Everything But Insulin” for type 1 diabetes – metformin, Symlin (pramlintide), GLP-1 agonists, DPP-4 inhibitors, SGLT-2 inhibitors, and glucagon.
4. dQ&A’s Mr. Richard Wood and Close Concerns’ Mr. Adam Brown followed up their ADA 2014 poster with a presentation entitled, “Reducing Social Stigma from Diabetes: A Patient Perspective.”
5. Mr. Gary Scheiner (Integrated Diabetes Services, Wynnewood, PA) shared his encyclopedic knowledge on strategies for preventing and treating hypoglycemia.
6. Ms. Kerri Sparling (SixUntilMe.com) and Mr. Adam Brown (Close Concerns, San Francisco, CA) held an open parent discussion panel, where attendees focused on the psychosocial, emotional, and family dynamics of living with type 1 diabetes.
7. Dr. Anne Peters’ (USC, Los Angeles, CA) motivating presentation discussed “why diabetes is a good thing,” highlighting her care of successful athletes with type 1.
8. Mr. Jeff Hitchcock and Ms. Moira McCarthy delivered a heartfelt opening keynote, sharing recent CWD/FFL milestones and honoring all attendees as the “2014 CWD/FFL Super Hero.”
9. Motivational speaker and type 1 athlete Mr. Sebastien Sasseville delivered a moving and inspiring closing keynote via Skype, discussing his ongoing run across Canada – a marathon every other day for nine months!
10. The Friends for Life Exhibit Hall was bustling, in contrast to the floor at ADA; companies aren’t limited from sharing tools and toys to help with diabetes. Represented on the floor were large booths from Lilly, Novo Nordisk, Animas, Tandem, and Dexcom, with smaller booths from Medtronic, Sanofi, Insulet, and Abbott.
- Executive Highlights
- Top 10 Highlights
- Detailed Discussion and Commentary
- The Bionic Pancreas
- Diabetes Advocates Masterlab
- Effective Patient Advocacy
- The Role of FDA in Regulating Diabetes Devices and Advancing Safe Innovation in the Management of Diabetes
- Getting the Attention of Decision Makers
- How Diabetes Can Do It Too: A Roadmap for Diabetes Advocacy
- Making A Successful Ask
- Everything But Insulin
- Managing Hypoglycemia
- Parent Panel
Top 10 Highlights
1. Dr. Ed. Damiano’s research update is always a can’t-miss highlight at Friends for Life, and this year’s edition was the most hopeful and exciting yet – from the visionary title of his presentation, to the five-minute compelling Helmsley Charitable Trust video, to the Summer Camp and Beacon Hill results. However, it also had a clear bit of urgency, as the team is currently in need of ~$5 million in the next 60 days to fund development of the Bionic Pancreas final pivotal device. Brochures labeled “Go Bionic” asked Friends for Life attendees to take “The $5,000 Bionic Challenge,” each raising $100 a day for the next two months. The fundraising time crunch to build the pivotal device stems from an NIH grant due in about nine months – this could support all of the clinical costs of the pivotal study, but for the reviewers to take it seriously, the final pivotal study device will need to be completely built by then. Dr. Damiano’s talk made it fairly clear that the final pivotal study device is currently being built in collaboration with his “industrial collaborators” (although he didn’t specify who those collaborators were) and will be a fully integrated device with CGM input, a dual-chambered pump, and algorithms all contained within a single handheld unit (not an iPhone and a separate G4 Platinum receiver like the current study device). Notably, his ambitious timing remains the same (commercial launch in 2H17), which we describe in detail below. Hot off the press, Dr. Damiano showed results from the first two participants in the team’s recently started 11-day multicenter home study of the Bionic Pancreas (n=40 total, ten each at MGH, UMass, UNC, and Stanford). The first patient had an average glucose level (over 11 days) of 133 mg/dl with <1% of the time <60 mg/dl. The second patient had similar results – an 11-day average of 132 mg/dl and 0% of the time spent <60 mg/dl. The results were highly consistent with those of the Beacon Hill and Summer Camp studies. More detailed coverage is below.
2. Diabetes Hands Foundation’s Masterlab provided an outstanding all-day workshop on diabetes advocacy. All the slides are posted at http://diabetesadvocates.org/masterlab/ and video footage is coming soon. The day featured an incredible slew of speakers intended to get the entire community of diabetes advocates on the same page: the fiery and charismatic Mr. Mike Mangianello (HIV/AIDS activist, HCM Strategists), FDA EMDAC patient rep (and type 1) Ms. Rebecca Killion, FDA’s Dr. Stayce Beck, renowned blogger Ms. Kerri Sparling, several industry representatives (Dexcom, Roche, Sanofi, Medtronic), long-time advocate Mr. Paul Madden, StripSafely’s Mr. Bennet Dunlap, Close Concerns/the diaTribe Foundation’s own Ms. Kelly Close and Mr. Adam Brown, and inspiring DHF head Mr. Manny Hernandez. A major message of the day was that in diabetes, Congress is “checking our box” and that there is a great deal more to do – effectively, that advocates aren’t even close on reaching the number of people needed to drive change, particularly on the policy front. An ask for the day was to support the National Diabetes Clinical Care Commission Act (House Resolution 1074/Senate bill 539) – both bills call for a commission of health professionals, agencies, and patients to coordinate disparate federal actions to help people living with diabetes. More details are posted at DHF’s “Diabetes Action Hub,” a central portal intended to inform stakeholders about diabetes advocacy opportunities. The page includes a Diabetes Advocacy Survey and resources to speak up for coordinated diabetes policy (the first of many issues to be included in the hub). Overall, the goal of the Diabetes Action Hub is very needed and highly laudable: to strengthen the community’s collective force in support of diabetes advocacy. Our detailed coverage from the day is below.
3. Dr. Anne Peters (USC, Los Angeles, CA) and Ms. Kelly Close (Close Concerns/the diaTribe Foundation, San Francisco, CA) discussed “Everything But Insulin” for type 1 diabetes – metformin, Symlin (pramlintide), GLP-1 agonists, and SGLT-2 inhibitors. In an open discussion format with attendees seated in an intimate circle, Dr. Peters highlighted that treatment options very much depend on “where patients are and what they want” and Kelly spoke on various patient perspectives gained from patients on the off-label compounds. Dr. Peters strongly supported the use of metformin in type 1 diabetes (titrated correctly) and stated her hope that Symlin would ultimately be co-formulated with insulin. She also spoke of the very important need to individualize therapy; she was wary of prescribing GLP-1 agonists for all type 1 patients off-label, citing the possible need to stay on this drug long-term (a concern in pediatric patients) and stressed it worked well for some type 1 patients and less so for others. She also shared her experiences with SLGT-2 inhibitors, mentioning that insulin requirements go down remarkably quickly in the first three weeks of use, and that the drug seems to lose efficacy over time for certain patients – again, individualizing therapy was a major theme. More detailed coverage is below.
4. dQ&A’s Mr. Richard Wood and Close Concerns’ Mr. Adam Brown followed up their ADA 2014 poster with a presentation entitled, “Reducing Social Stigma from Diabetes: A Patient Perspective” – as a reminder, the data stems from a survey of 5,410 patients in the US. Right out of the gate, Mr. Wood made it clear that parents of children with diabetes feel the most stigma out of any population surveyed – a striking 83% reported that diabetes comes with social stigma, compared to 74% of adults with type 1, 61% of type 2s on intensive insulin therapy, and 51% of type 2s not on insulin. Respondents reported that this stigma takes many forms, including failure of personal responsibility (72% of all patients), being a burden on the healthcare system (65%), and having a character flaw or fault (52%) – interestingly, those percentages were consistent across groups, except for fewer parents that felt like their kids were a burden on the healthcare system. Mr. Wood highlighted the overarching theme that stigma tends to increase as insulin therapy becomes more intensive, regardless of the type of diabetes – indeed, a very similar percentage of type 2s on MDI/pump (35%) vs. type 1s (39%) reported strong agreement with experiencing either guilt, shame, embarrassment, isolation, or blame. In terms of solutions, public awareness/education about diabetes was the dominant proposal, though many type 1s strongly advocated for changing the name (i.e., they felt that the societal stigma associated with type 2 unfairly spills over into type 1). In an interesting twist, however, Mr. Wood showed open-ended answers to the question, “What do you wish society knew about your diabetes?” – the comments appeared like they could have come from any type 1 patient (e.g., “That a cure could be found”; “That people knew how dangerous it can be”; “That I did not have to hide when I take insulin outside the house”), though Mr. Wood dramatically revealed that all of the comments came from type 2s. This led to the presentation’s final concluding point: there are many commonalities between type 1 and type 2 diabetes, and if we can remove the stigma associated with type 2, we can likely erase the stigma associated with type 1. To download the slide deck, click here, and those interested in getting more information can write to Richard.Wood@d-qa.com. The team is currently working on publishing the data.
5. Mr. Gary Scheiner (Integrated Diabetes Services, Wynnewood, PA) talked about all things hypoglycemia, focusing on strategies for treatment and prevention. He defined hypoglycemia as “more things taking stuff out of the blood stream compared to what’s putting it in” and called it the “greatest limiting factor in diabetes management.” Mr. Scheiner highlighted that “our job is to keep the five grams of sugar in the blood,” as lows can result in a variety of negative outcomes, such as lasting brain damage and hypoglycemic awareness. He recommended a plethora of prevention strategies, discussing insulin program setup, the timing of meals and snacks, as well as using “floating glycemic targets.” Regarding treatment, Mr. Scheiner pointed out that “one size does not fit all” and everyone’s needs and situations are different. More detailed coverage is below.
6. Ms. Kerri Sparling (Blogger, SixUntilMe.com) and Mr. Adam Brown (Close Concerns, San Francisco, CA) discussed with parents a range of psychosocial, emotional, and family concerns of living with type 1 diabetes. This session served as a good reminder that diabetes care is about much more than the clinical aspects of managing insulin, diet and devices – parents eagerly asked about transitions to college, teenage rebellion, dealing with siblings who do not have diabetes, diabetes burnout, and more. Our detailed coverage below highlights some of the most notable quotes.
7. Dr. Anne Peters’ (USC, Los Angeles, CA) motivating presentation discussed “why diabetes is a good thing,” highlighting her care of successful athletes with type 1. She opened the talk with a video about Gary Hall Jr., an Olympic swimmer with type 1 diabetes. He served as an example of the dietary challenges faced by top athletes with type 1, who must typically consume huge quantities of carbohydrates; interestingly, Mr. Hall has addressed the issue by turning what was originally Platinum Performance’s “horse food” into a line of consumer nutrition products for athletes. Dr. Peters also mentioned type 1 skier Kris Freeman’s hypoglycemic event in the 2010 Winter Olympics, a clear example of the consequences of out of range blood sugars. Dr. Peters also serves as an endocrinologist to racecar drivers Charlie Kimball and Ryan Reed, who she mentioned might not be racing if it weren’t for type 1 diabetes – in both cases, their diagnoses were essential in sponsorships from Novo Nordisk and Lilly, respectively. Dr. Peters concluded that “having diabetes can be an advantage that should be used,” another reminder of FFL’s amazing pride and optimism around diabetes.
8. Mr. Jeff Hitchcock (Founder, Children with Diabetes, West Chester, OH) and Moira McCarthy (Despite Diabetes) together delivered a heartfelt opening keynote, sharing recent CWD/FFL milestones and honoring everyone as this year’s CWD/FFL Super Hero. Mr. Hitchcock opened by encouraging families to participate in clinical trials, proclaiming that, “the world’s best scientists, with all the world’s money, cannot cure type 1 diabetes without you participating in clinical trials.” He highlighted that Children with Diabetes parted ways with Johnson & Johnson, becoming its own independent community as of December 6, 2013. Stating that “it’s the everyday accomplishments we savor,” Mr. Hitchcock also teared up telling the story of the first CWD/FFL to marry after meeting at a Friends for Life Conference. He also shared news of his daughter Marissa’s birth to a healthy baby boy named Connor. Ms. McCarthy then energetically took the stage, sharing the story of her daughter’s journey with type 1 diabetes and presenting the toolbox of a CWD/FFL “Super Hero,” which included “nerves of steel, sidekicks (medical team, friends, siblings), capes and other cool tools (technology, inspiration, knowledge).” Highlighting that all of these tools can be gained throughout the conference, Ms. McCarthy ended by naming all attendees as the 2014 CWD/FFL Super Hero, starting the conference off with a bang and a sense of pride and confidence in everyone.
9. Mr. Sebastien Sasseville Skyped in from his ongoing run across Canada to deliver an inspiring closing keynote with an emphasis on optimism and positivity: “Diabetes is the best thing that’s ever happened to me – it’s a gift”; “Diabetes doesn’t cause complications –poor management of diabetes does”; and “There’s no limit to where we can go with the right diet and attitude – diabetes can be managed.” A cardboard cutout of Sebastien stood at the podium, while Sebastien himself showed up on the projector screen, speaking to the packed ballroom from his RV. The keynote was engaging and packed with lighthearted fun as a 19-year-old FFL conference attendee played out a day in the life of Sebastien, running a lap around the ballroom, sitting in a kiddie pool ice bath, and giving his own motivational speech to the crowd. We were thoroughly inspired by Sebastien’s journey across Canada as he runs a marathon every other day for nine months, in order to make it to the finish line in Vancouver on World Diabetes Day, November 14 – visit www.outrundiabetes.ca to support and follow him until then.
10. The Friends for Life Exhibit Hall included large booths from Lilly, Novo Nordisk, Animas, Tandem, and Dexcom, with smaller booths from Medtronic, Sanofi, Insulet, and Abbott. Lilly was front and center, with a focus on type 1 NASCAR driver Ryan Reed (who just finished fourth in the Subway Firecracker 250 at Daytona). Meanwhile, Novo Nordisk drew eager attendees with four celebrities with diabetes: cyclist and Team Novo Nordisk owner Phil Southerland, INDYCAR driver Charlie Kimball, and triathlete Jay Hewitt. We heard lots of buzz for Dexcom’s G4 Platinum, which could finally be marketed to conference attendees (including on-site trials) following February’s FDA approval of a pediatric indication for the device. In insulin pumps, Animas and Tandem offered free trials as well. The latter has always been a supporter of FFL’s Adult Type 1 Casino Night, which seemed bigger than ever this year and gathered some of our absolute favorite people in diabetes. For those interested in sponsoring next year, Friends for Life 2015 will take place at Disney's Coronado Springs Resort in Lake Buena Vista, Florida from July 6-12.
Detailed Discussion and Commentary
The Bionic Pancreas
Making Diabetes Management Disappear: A Bionic Pancreas for One and All
Ed Damiano, PhD (Boston University, Boston, MA)
Dr. Ed. Damiano’s research update is always a can’t-miss highlight at Friends for Life, and this year’s edition was the most hopeful and exciting yet – from the visionary title of his presentation, to the five-minute compelling Helmsley Charitable Trust video, to the Summer Camp and Beacon Hill results. His talk also had some urgency, as the team is currently raising ~$5 million in the next 60 days to fund development of the Bionic Pancreas final pivotal device. Brochures labeled “Go Bionic” asked Friends for Life attendees to take “The $5,000 Bionic Challenge,” each raising $100 a day for the next two months. The fundraising time crunch to build the pivotal device stems from federal funding opportunities over the next nine months – this could support all of the clinical costs of the pivotal study, but for the reviewers to take it seriously, the final pivotal study device will need to be completely built by then. Dr. Damiano’s talk made it fairly clear that the final pivotal study device is currently being built in collaboration with his “industrial collaborators” (although he didn’t specify who those collaborators were) and will be a fully integrated device with CGM input, a dual-chambered pump, and algorithms all contained within a single handheld unit; as we have reported before, it will not run on an iPhone like the current research device does. Dr. Damiano’s ambitious timing remains the same: a multicenter study is ongoing and expected to wrap up in 2Q15, another summer camp study in patients 6-11 years will occur this month (we think it’s very notable that the team is not delaying testing in children as was the complaint of some researchers at ADA – that children are tested last and often after quite significant delays). The timeline calls for the final pivotal study to happen throughout 2016 (n=100s, several months) assuming the device is ready (lots still has to happen on this front), and the team would, if all goes right, submit the PMA to the FDA in 1H17. Commercial launch would begin after approval and obviously there would be lots of questions to address on this front. The timing is certainly tight, but ever since the vision was shared at FFL 2012, Dr. Damiano and the team have hit all their milestones. Hot off the press, Dr. Damiano showed results from the first two participants in the team’s recently started 11-day multicenter home study of the Bionic Pancreas (n=40 total, ten each at MGH, UMass, UNC, and Stanford). The first patient had an average glucose level (over 11 days) of 133 mg/dl with <1% of the time <60 mg/dl. The second patient had similar results – an 11-day average of 132 mg/dl and 0% of the time spent <60 mg/dl. These continue to be exceptional results – significant reductions in effective A1cs with major reductions in hypoglcyemia. The results were highly consistent with those of the Beacon Hill and Summer Camp studies that were published in the renowned NEJM earlier this summer.
- A brochure labeled “Go Bionic” asked Friends for Life attendees to take “The $5,000 Bionic Challenge” – the goal is to raise the funds needed to build the final integrated bi-hormonal bionic pancreas platform that will be used in the team’s final pivotal study of 2016. The Go Bionic campaign asks each of the ~800 families at Friends for Life to raise $5,000 in 60 days by September 1 (i.e., ~$4,000,000). If the target is met, the team can resume development in September and keep on schedule for the final pivotal study in 2016. While the mobile bionic pancreas platform used in Beacon Hill, Summer Camp, and the current multicenter study cost about $100,000 to develop (iPhone hardwired to Dexcom G4 Platinum receiver with the help of SweetSpot Diabetes Care), Dr. Damiano estimated the final pivotal device will cost at least $5 million to develop.
- The fundraising time crunch to build the pivotal device stems from a “limited major federal funding opportunity” due in about nine months – these funding opportunities could support all of the clinical costs of the pivotal study, but for the reviewers to take it seriously, the final pivotal study device will need to be completely built by then. “We have to get this device built in the next 15 months if we’re going to do this – I have no sand in this timeline,” emphasized Dr. Damiano.
- The team is working with its “industrial collaborators” to build the Bionic Pancreas device for the final pivotal study – the fully integrated device, which will consist of a CGM, a dual-chamber insulin/glucagon pump, and all of the mathematical glucose control algorithms in a single handheld unit, will connect to their own custom infusion set. He presented a generic schematic showing a dual chamber pump with an embedded control algorithm and input from a CGM. Bluetooth radios embedded in the device would send the data to a nearby mobile device and up to the cloud. Incorporated in the submission would be an NDA for glucagon (presumably Xeris’ G-Pump formulation). We’d note that Tandem has not updated progress on its dual-chamber pump since it went public last fall – see our Tandem 1Q14 report – we certainly assume it will be part of the bionic pancreas, though likely not the first generation.
- Said Dr. Damiano, “The medical device companies are not going to do it alone. They’re going to help, but they’re not going to do it by themselves. We need to step it up another level. If you want to go bionic, we need some help from you. The money is tax deductible and 100% of it goes directly to this project.” Dr. Damiano has a fundraising webpage posted at https://www.bu.edu/alumni-forms/forms/eng/damiano/ to solicit donations
- As a reminder, Dr. Damiano’s goal continues to be to conduct the final pivotal study throughout 2016 (n=100s, several months), submit the PMA to the FDA in 1H17, and commercial launch thereafter. Dr. Damiano’s son David goes to college; the ambitious goal continues to be for him to be able to use the bionic pancreas when he begins college. Notably, the team has stuck to this timeline since it was presented at FFL in 2012. The current ongoing multicenter outpatient study will run until 2Q15 and include 40 adults wearing the device for 11 days and 11 nights. In addition, a camp study this summer will include pediatric patients 6-11 years old (12 boys, 12 girls). He noted that the FDA was confident enough in the Beacon Hill and 2013 Summer Camp results to allow the team to back off on much of the remote monitoring. Only safety metrics are being tracked in real time for hypoglycemia – they will no longer need to watch all the insulin and glucagon and CGM data, and blood glucose will not be corrected in the usual care or bionic pancreas groups unless the CGM is <50 mg/dl for 15 minutes or more in the multicenter study (or <60 mg/dl for 15 minutes or more in the 2014 Summer Camp study). These are important changes in our view that move the team closer to the Pivotal Trials. Summary results from the 2014 summer camp study are expected in 60 days. Importantly, both the multicenter and 2014 Summer Camp studies are fully funded, with resources from the NIH in the case of the former and NIH and the Helmsley Charitable Trust in the case of the latter. Funding for pivotal trials is ongoing.
- Dr. Damiano shared that at the last FDA meeting, the Agency said, “Ed, we want to see you in pivotal studies in 2016, and we want to do everything in our power to help you get there.” Though Dr. Damiano’s timeline builds in a short six-month FDA review, he expressed optimism in the new FDA guidance for breakthrough class III medical devices that address unmet medical needs (read our coverage here). He also noted that their team has been in front of the FDA so much, the data would by no means be new to them. “We’ve met with the FDA early and often,” he emphasized. We also note the IRB approvals seem to have been unusually fast, which has contributed to the rate of progress.
- Hot off the press, Dr. Damiano showed remarkable results from the first two participants in the team’s recently started 11-day multicenter home study of the Bionic Pancreas (n=40 total, ten each at MGH, UMass, UNC, and Stanford). This trial is different in that the patients are doing everything on their own – at home – quite different from last year’s trials when they were with nurses 24/7 and every move was watched remotely. The first patient in the multi-center home trail had an average glucose level (over 11 days) of 133 mg/dl with <1% of the time <60 mg/dl. Presumably the standard deviation was very low. The second patient had similar results – an 11-day average of 132 mg/dl and 0% of the time spent <60 mg/dl. Dr. Damiano emphasized that the team merely “typed in the patients’ weight and sent them home;” meal announcement continues to be optional. He added, “It would look like a cure if we knew that it wasn’t. The results are totally consistent with the Beacon Hill study in a true home use study that is twice as long.” We note that the device is clunky and not yet “ready for prime time” ~ we anticipate those using the first generation device will be very willing to put up with some hassle factor surrounding the device in exchange for the improvements in overall control and absence of mild, moderate, and severe hypoglycemia and extended hyperglycemia, but also the worry associated with mild, moderate, and severe hypoglycemia and extended hyperglycemia.
- “What is happening at these camps is an outpatient trial of an innovative technology in the early stages of development that could really change the game for people with type 1 diabetes.” Dr. Damiano started off his talk with a compelling Helmsley Charitable Trust video summarizing the 2013 Summer Camp study of the Bionic Pancreas – the five-minute video was captivating, engaging, and provided a most valauble overview of the study and how transformational the technology could be.
- Dr. Damiano highlighted the results from the Bionic Pancreas Summer Camp and Beacon Hill studies, covered in detail in our ADA 2014 report and published on June 15, 2014 in NEJM. Notably, it remains the most viewed NEJM article of the past month by a very wide margin (212,844+ views vs. 57,512+ views for the second place article).
- Below, we’ve included some quotes from Dr. Damiano’s presentation:
- “This is not a cure. It’s a device. A contraption. Something to wear. It’s not without its burdens. Infusion sets, sensors, calibrations, reservoirs and set change-outs. But it is so much better than what we’re doing today. It’s so much safer and so much more effective, that we’ll bear that burden until a cure becomes available.
- “I distinguish between diabetes management and maintenance. Diabetes maintenance – we can do it. That’s changing reservoirs, infusion sets, batteries. Diabetes management – that’s overwhelming.”
- “CGM is a fantastic tool, but it requires more of your time, not less. It’s extremely important, because it keeps us safe. But it also requires that people think about their diabetes a lot more.”
- “The bionic pancreas does not need to know anything about your insulin therapy. It should never need to know what your basal rates or your carb or correction factors are. And neither should you. The system should be able to figure that out.”
- “People are afraid to go to bed at night with type 1 diabetes. They are running high to avoid hypoglycemia. The bionic pancreas blows them away, especially at nighttime. And they’re not even thinking about their diabetes, let alone managing it. “
- “You cannot talk about mean blood sugars without talking about hypoglycemia. They go together.”
- “No person with diabetes left behind. Every adult got a mean on the bionic pancreas under the ADA goal.” – regarding the ball and stick plot to jointly summarize the hypoglycemia and mean glucose results from Beacon Hill study.
- “We’re dramatically reducing hypoglycemia. Perhaps eradicating severe hypoglycemia. We’re reducing average glucose below the ADA goal. And we’re doing all that with a fully automated system, without the patient having to think about it.”
- “We’ve been very successful in raising money from philanthropy and federal agencies – it’s taken $12 million in six years to do this. That’s an incredibly tiny budget for what we’ve accomplished. It is to JDRF’s credit that we have access to much of the NIH money we have received – year in and year out, they have managed to get Capitol Hill to focus huge federal resources on type 1 diabetes [i.e., the Special Diabetes Program]. It’s the NIH and HCT that have poured millions of dollars into the bionic pancreas to make all of this happen.”
Diabetes Advocates Masterlab
Effective Patient Advocacy
Michael Mangianello (HIV/AIDS activist; Founding Partner, HCM Strategists)
The fiery, charismatic, forthright, and most compelling HIV/AIDS activist Mr. Michael Mangianello shared learnings from Back to Basics, a distillation of the five principles that were key to the highly successful HIV/AIDS advocacy movement (attention; knowledge and solutions; community; accountability; and leadership). He highlighted the HIV/AIDS movement’s impressive accomplishments in a very short period of time (e.g., $0 spent on research in 1981 to a combined $30 billion today!) and shared frank views on the potential for major coordinated advocacy in diabetes – the latter alternated between frustration (29 million patients is a huge voice, and yet there have been few tangible wins) and hope for the future (e.g., citing successes of the Cystic Fibrosis Foundation and Duchenne Muscular Dystrophy). Regarding the current state of diabetes advocacy, Mr. Mangianello said, “I wouldn’t call what you have a movement, yet. You have energy.” He urged the audience to put together the Back to Basics model together for diabetes, especially “to get members of Congress to rise above the din.” Despite the frustration in diabetes advocacy, he believes the community has “the absolute building blocks to have a movement.”
- Mr. Mangianello shared learnings from Back to Basics, a distillation of the five principles that were key to the highly successful HIV/AIDS advocacy movement: attention; knowledge and solutions; community; accountability; and leadership. He noted, “Once you have all five things in place, you really can change the world.”
- Attention – “Occupy Wall Street got attention. But they didn’t have a leader and a movement.” In reference to a panel comment about getting “five people” to coordinate and call legislators, Mr. Mangianello advocated for “masses and masses of people. You need 500,000 people calling in to change the system.”
- Knowledge and Solutions – “You have to be smart enough to sit down with NIH.” Mr. Mangianello noted that getting smart “was critical” to the HIV/AIDS movement. After HIV/AIDS activists took over the NIH campus, they left flyers all over the place. In these flyers, activists made scientific suggestions (e.g., “The research should go in this direction”). The flyers lent credibility to the movement (e.g., “These guys have something to say”) instead of skepticism (e.g., “This is just a bunch of insurrectionists”).
- Community – Mr. Mangianello noted that diabetes advocacy is currently siloed, a theme also mentioned in Mr. Manny Hernandez’s subsequent presentation. He joked that the HIV/AIDS movement “used fax machines,” a far cry from today’s technology that enables a much greater sense of community.
- Accountability – “If you’re not holding their feet to the fire [e.g., politicians], then what’s the point?”
- Leadership – “You have leaders in this room. Leadership is built and grown and nurtured and taught.”
- Mr. Mangianello summarized some of the impressive accomplishments of the HIV/AIDS movement. In 1981, thousands of people were dead, hundreds of thousands were infected, and not a single dollar from the federal government, industry, or philanthropy was dedicated to cure/research. Today, combined HIV/AIDS investment from industry, NIH, and the federal government is $30 billion. The HIV/AIDS movement also pioneered the parallel track to accelerated FDA approval – promising drugs continued on their defined clinical trial path, but desperate patients were separately allowed to take them in order to stay alive.
- The Back to Basics model has also proven effective in Cystic Fibrosis and Duchenne Muscular Dystrophy. These conditions affect 30,000 and 15,000 kids in the US, respectively.
- Example 1: Cystic Fibrosis Foundation. Kalydeco, a drug in development, led to a 10% improvement in lung function in just 4% of the Cystic Fibrosis population (i.e., 1,200 kids). Originally, the efficacy data was not strong enough for the FDA, but the CF Foundation, along with patients and clinicians, got the FDA to recognize the clinical importance of this data. Notably, the FDA approved Kalydeco just three months after it was submitted for review. Said Mr. Mangianello, “The FDA eventually understood what patients knew from the start” – he highlighted the inspiring story of a patient with CF who did not need to be awakened at night to be percussed.
- Example 2: Duchenne Muscular Dystrophy. A disease that affects 15,000 kids, those with Duchenne Muscular Dystrophy are usually dead by 30 and require a wheelchair by 12 years old. Sarepta Therapeutics had a drug that showed positive results in 12 boys. The FDA expressed skepticism, but parents and families mounted an aggressive campaign. Videos of the 12 boys went viral, and 100,000 signatures were eventually obtained and sent to the White House. The campaign put pressure on the FDA and NIH (“If you get the Hill supporting you, they fund the FDA and NIH!”), and five months after obtaining the signatures, the Agency detailed a potential path forward for the drug and indicated a willingness to consider it for accelerated approval. “This is disruption as far as I’m concerned,” said Mr. Mangianello.
- Below, we’ve included some of our favorite quotes from Mr. Mangianello’s presentation:
- “What you don’t want to have happen – the worst thing – is that you make all this progress, and what’s happened is that you’ve been a box check. Checking your box sucks. It’s not acceptable. You want something to happen.”
- “Patient driven change is possible. How many of you were told you would need insulin to live? I was told something similar. I was diagnosed with HIV/AIDs and told I had 18 months to live.”
- “I talked to an FDA guy. He would say, ‘But there’s not enough data.’ Well, there’s never ultimately going to be enough. At some point, there’s enough for us as the patients. It’s up to us to make the decision about benefit-risk.”
Stayce Beck, PhD, MPH (Office of In Vitro Diagnostic Device Evaluation and Safety, CDRH, FDA, Silver Spring, MD)
FDA’s Dr. Stayce Beck gave an overview of the Agency’s activities in diabetes devices, highlighting patients needs, the recent glucose meter draft guidance, post-market evaluation of BGMs and strips, and CGM/artificial pancreas. Her comments emphasized the need for simple devices that improve lives without adding complexity, the Agency’s commitment to the artificial pancreas (“Big developments are happening rapidly,” despite remaining challenges), and the successful advocacy on the BGM draft guidance. “If there’s one message I want you to take away,” she said, “it’s that we do want to hear from you. We really enjoy getting to talk to patients.” It was great to hear this emphasized so strongly in her presentation, and we salute Dr. Beck for making public appearances at many recent meetings (e.g., the JDRF/NIH closed-loop night at ADA 2014; the DiabetesMine D-Data Exchange). We continue to hear positive perspective on the FDA from key opinion leaders, and at this point, there seem to be very few calling out the FDA’s device division as a roadblock to new technology.
- To start, Dr. Beck’s presentation had a very refreshing patient perspective: “People with diabetes face many challenges.” The slide highlighted both the immediate risks faced everyday (severe hypo and hyperglycemia) and “long-term health risks due to glycemic variability” (the slide actually mentioned this word for word!) and hyperglycemia. In addition, she noted the many quality of life challenges patients face – the need to carry multiple devices, pain at lancing and injection sites, complicated drug dosing and nutrition decision, and frustrating data overload (“many of you have to do a lot of math, which a lot of people don’t like to do...it can be a lot of data and you can feel like an Olympic athlete at times”).
- Said Dr. Beck, “What we’re trying to do is work with companies to get devices that improve quality of life without adding complexity...I have one of those GPS watches that tracks my heart rate. But the number of times I upload to my computer is minimal – maybe once per month.” This honesty and frankness definitely reflected the patient experience, and illuminated some of the key areas to improve on in diabetes. Indeed, her slide very specifically noted three patient needs: 1) devices that improve lives without adding complexity; 2) simple, easy to interpret device data outputs; and 3) easy to use, safe, and effective medical products.
- “We believe very strongly that an artificial pancreas will be helpful for people, both to improve short-term and long-term outcomes.” Dr. Beck emphasized that many patients “still struggle to maintain good glycemic control,” that “better quality of life is needed,” and hypoglycemia unaware patients remain at risk (especially at night). She noted three current challenges to get to an approved device: 1) device limitations (pump imprecision, sensor inaccuracy/unreliability); 2) biology – “complicated”; and 3) inter-individual variability – “one-size fits all possible? Smart algorithms?” Even still, her slide had a clearly optimistic final bullet point: “Big developments are happening rapidly.”
- Dr. Beck’s comments were careful to note that Medtronic’s MiniMed 530G is a “first step,” but “is not a true artificial pancreas.” This terminology was a point of controversy following the device’s September 2013 approval, since low glucose suspend falls under the single Artificial Pancreas guidance document.
- The FDA received over 600 comments on the two glucose meter draft guidances (released in January), with over 200 coming from people with diabetes or their family members. She deemed these draft guidances
“a success” due to the very high number of comments received (more than for any diabetes device guidance). The agency is currently reworking the guidances based on the comments. Dr. Beck specifically mentioned that the draft guidance “can be modified significantly” – for example, the original artificial pancreas draft guidance was two separate documents (low glucose suspend and fully closed-loop), but after receiving lots of feedback, they were combined into one final document. An additional piece of feedback was the need for additional primary endpoints beyond A1c. We would note that the final Artificial Pancreas guidance was widely considered a success, in large part due to a collaborative dialogue between the FDA and JDRF.
- Regarding the post-market BGM surveillance program (spearheaded by the Diabetes Technology Society), things are “moving forward very quickly.” A steering committee with the FDA and experts will begin meetings in July. We’d note that the slide was careful and hesitant in the language – “Potential new surveillance program?” – implying that this is far from a done deal.
- On the CGM front, Dr. Beck highlighted the February approval of a pediatric indication for Dexcom’s G4 Platinum (“down to two years of age!”) and last September’s approval of Medtronic’s Enlite. Dr. Beck addressed four remaining challenges in CGM: 1) sensor accuracy needs improvement; 2) new materials/technologies are needed to reduce sensor biofouling; 3) improved reliability is needed (e.g., signal dropout); and 4) better standards to help advance the technology. On the latter, she said the agency is “hoping to develop” such standards – we assume this would come in the form of FDA guidance on study design and product development , but cannot be sure.
- Dr. Beck’s commentary on mobile apps was balanced, highlighting both the key challenges and the promise of greater convenience for patients. She specifically pointed to three obstacles: 1) security and hacking (“specialized communication protocols essential”; 2) Android vs. Apple OS; and 3) mechanisms for verification of software/OS updates and upgrades. She reminded the audience that the Agency has already cleared several apps for use with diabetes devices and plans to include several more. At this time, the FDA is working with industry on requirements/process for market entry, upgrades, etc. – the major need is to “reach the right regulatory touch,” which we assume means balancing the need for submissions/approvals with the pace at which consumer technology moves.
- What can you do? Dr. Beck had three recommendations: 1) report adverse events to manufacturers and the FDA; 2) comment on draft guidances (“the recent feedback on the glucose meter guidance was a success because of feedback from the community”); and 3) become informed on the facts (from all perspectives).
Getting the Attention of Decision Makers
Rebecca Killion (Patient Representative, FDA Endocrinologic and Metabolic Drugs Advisory Committee)
The engaging Ms. Rebecca Killion shared her perspective as the patient representative on the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee. As an adult onset type 1 patient (originally misdiagnosed as a type 2, but correctly diagnosed following a near fatal DKA in 2001) she brings a critical perspective to this influential committee, most recently at the FDA Advisory Committee meeting for MannKind’s Afrezza. Her presentation shared her personal experiences on the panel (going all the way back to the withdrawal of troglitazone) up to the present day. She concluded her talk with a list of five tips for making an impact: membership has its privileges; stand in your own truth; cut to the chase; use visual aids; and own your space. Referring to Mr. Mangianello’s talk from earlier in the day, she was quite frank, “I think the message to all of us is we need to get off our butts. We’re mad as hell and we’re not going to take it anymore.”
- “Afrezza was approved on Friday, in large part because of the testimony in the open public hearing. That was the power of advocacy.” Ms. Killion put Afrezza’s approval in perspective, given the lead-up to the Advisory Committee, “The FDA sent out their Briefing Document the day before the Ad Comm. The zeitgeist on Afrezza was DOA – dead on arrival. ‘This drug wasn’t going to happen.’ Trading on MannKind shares was halted because the price was dropping so low.”
- Ms. Killion truthfully shared her initial experience at an FDA Advisory Committee – the withdrawal of troglitazone. She emphasized how clueless and intimidated she felt walking in: “I had no idea what I was doing in there. I’m not usually quiet, but I was pretty quiet and felt like a lamb that day. But then someone said, ‘The mortality and comorbidities from diabetes are so significant, that it doesn’t matter what patients die from.’ I went from a lamb to a lion.” At that point, she realized just how powerful and valuable her voice could be as a patient representative.
- Ms. Killion shared her five tips for making an impact with decision makers:
- Membership has its privileges. “We’re all part of a club we didn’t really want to join. This includes a secret handshake – we cannot fault people for not knowing about diabetes. However, we must also hold people accountable. During the day, I’m the not so mild-mannered Director of Professional Development at a law firm. During the FDA Advisory Committee, I’m a patient rep – I think, ‘This is an incredibly important position and you need to listen to me.’”
- Stand in your own truth. Ms. Killion reminded the audience to be authentic and speak in one’s own voice. “I get quoted a lot in these advisory committees. You know why? Because I speak English. Be deeply truthful about what is important to you.”
- Cut to the chase. “People are really busy – hit them with something powerful right from the start. If you heard, ‘Please help my mom,’ how does that not choke you up? Those people sitting on the panel are not heartless.”
- Visual aids. “Manny Hernandez was a big visual aid at the Afrezza advisory committee – it was very, very effective seeing him on video during the Open Public Hearing. You need to have your voice. But if you can back it up with something that is really visual, that really helps. We’re looking at a lot of boring stuff all day long.”
- Own your space. “As a patient, you have a perspective that is hard fought. It is really, really valuable and it can really make a change. That is very empowering to me.”
- Below, we’ve included some of our favorite quotes from Ms. Killion’s presentation:
- “The FDA was considering whether diabetes drugs should have a CV risk assessment. I was completely against it. I thought that if a drug is not giving a risk signal, it would be an overly burdensome requirement. There was a broad range of panel members. When we took that vote, it was 14-2 – 14 yes votes and 2 no votes. We were blown out of the water. When we vote, first we vote yes or no and then we explain our vote. I was in the early round and explained why I voted the way I did. When they got midway around, one of cardiologists said, ‘I voted yes, but after listening to Rebecca, I think I voted incorrectly.’ What I learned from that was something important – sometimes even when you think you’ve lost, you’ve won. Don’t be afraid to lose; you don’t know what kind of change you could be promoting.
- “Steve Nissen and I have a very interesting relationship. I think he is absolutely 100% wrong in the way he thinks.”
- “When you’ve talked to one diabetic, you’ve talked to one diabetic. Our experiences are very heterogeneous.”
- “When I bought that 7.2% A1c at the cost of a lot of lows, that’s not quality. That’s risk.”
Questions and Answers
Q: You said you would turn it up to an 11 at the Afrezza Advisory Committee meeting on a scale of 1-10 – what did you mean by that?
A: One of things I try to talk about when I’m on the panel is, ‘What could this drug do for me?’ When I wear my patient rep hat – I try to be as close as possible to all people with diabetes. When asked, ‘What does this drug have to offer people with diabetes?’ one of panelists said, “I’d rate it about a 5.’ I said, ‘On a scale of 1-10, this one goes up to 11 for me.’ The doctors have a different perspective; if it’s not superior to insulin, why should we use it? Because not everybody wants to take insulin! The panelists can understand we have enthusiasm – we have different needs and we have different goals.
How Diabetes Can Do It Too: A Roadmap for Diabetes Advocacy
Manny Hernandez (Diabetes Hands Foundation, Berkeley, CA); Bennet Dunlap (StripSafely and Your Diabetes May Vary, Philadelphia, PA)
To begin, Mr. Hernandez summarized the state of diabetes advocacy with a picture of two disconnected islands – “Diabetes advocacy today, perhaps more than ever, is exemplified by this picture of two islands. We are not compelled to speak to each other – it could be patients, it could be advocacy groups working in siloes, it could be diabetes companies not collaborating enough, or it could be the policy landscape – we encountered all of the above, with different groups focusing on different things.” To counteract the status quo, Mr. Manny Hernandez and Bennet Dunlap provided a “roadmap for diabetes advocacy,” starting with DHF’s new online Diabetes Action Hub. The initial release of the hub asks individuals to do three things: 1) take a short diabetes advocacy survey; 2) speak up for coordinated diabetes policy (the National Diabetes Clinical Care Commission Act; HR1074 or the S539); and 3) follow the leaders (ADA, JDRF, and AADE). Both speakers emphasized the importance of doing something, no matter how small – one tweet makes a difference, as does one letter to a legislator. The hub is intended to provide an avenue for everyone to contribute – however they can – in a more coordinated fashion.
Making A Successful Ask
David Lee Strasberg (CEO/Creative Director, The Lee Strasberg Theater and Film Institute, West Hollywood, CA)
Mr. David Lee Strasberg of the prestigious Lee Strasberg Theater and Film Institute charismatically discussed the four steps to making a successful ask (e.g., from getting a ride to the airport, to asking for a raise, to getting a major grant, to dealing with a policymaker):
- 1. Relationship. “Any request you make, whether it’s for a $10 million grant, an expedited FDA approval process, or $18 to buy a Starbucks coffee, is governed by the relationship. It’s your bandwidth. Are you on 56k dialup, or on broadband with high-speed access? You can ask for anything from anybody based on the relationship.” Mr. Strasberg noted three primary and fast ways to build relationship:
- A) Shared mission. How can you build relationship in a room you don’t know? (e.g., 15 seconds with a congressperson). Find commonality and a shared mission. This could be as simple as, “To reduce the burden of diabetes” or “I’d like to sleep through the night as a parent with diabetes.”
- B) Acknowledgement. “You must acknowledge the person you’re talking to.” Mr. Strasberg explained that this is tricky, since “we think we acknowledge people all the time” (e.g., “this is a great conference”). However, these generic statements could be delivered whether or not the person we’re talking to is in the room. Presence is key, he emphasized, “You must say something that could only be delivered in person; it’s not about compliments and praise. It’s about seeing something in the other person and speaking it out.” This step can take as little as 5-10 seconds.
- C) Tell your story. “Really, really important.”
- 2. Vision. “Where is this train going to? You must communicate something that is possible. If your vision has more than one sentence, pull back. A good way to start is, “I want to see a world where...”
- 3. Opportunity. Any ask has to be an opportunity for the person you are asking. “People at the FDA want to save lives! Doctors want to help people! They get to be a hero. Articulate an opportunity so they can gain something.”
- 4. Make a really clear ask. If the ask doesn’t have an action item, it’s off the mark – make it easy for this person to know what to do (e.g., “push this button,” “sign this,” “authorize that,” “send an email,” etc.). If this step is messed up, a request will flounder.
Everything But Insulin
Everything But Insulin
Anne Peters, MD (University of Southern California, Los Angeles, CA) and Kelly Close, MBA (Close Concerns/the diaTribe Foundation, San Francisco, CA)
In an open discussion format with attendees seated in an intimate circle, Dr. Peters highlighted that treatment options very much depend on “where patients are and what they want,” and Kelly spoke on various patient perspectives gained from patients on the off-label compounds. Dr. Peters commented that as people age and gain weight, they look for more adjunctive therapy – she strongly supported the use of metformin in type 1 diabetes (titrated correctly) and stated her hope that Symlin would ultimately be co-formulated with insulin. Dr. Peters spoke of the very important need to individualize therapy; she was wary of prescribing GLP-1 agonists for all type 1 patients off-label, citing the possible need to stay on this drug long-term (a concern in pediatric patients) and stressed it worked well for some type 1 patients and less so for others. She also shared her experiences with SLGT-2 inhibitors, mentioning that insulin requirements go down remarkably quickly in the first three weeks of use, and that the drug seems to lose efficacy over time for certain patients – again, individualizing therapy was a major theme. Certainly, the theme of type 2 therapies for type 1 diabetes has emerged in a big way in the last couple of years, and the next couple of years will see many large trials reporting data for both GLP-1s and SGLT-2s. While use of these medications is off label in type 1 right now, the most forward thinking endocrinologists are already trying them out, and many more will do so once if they are approved. Our key question relates to reimbursement for GLP-1s and SGLT-2s in type 1, though we imagine the potential for reduced hypo and less insulin use will make a compelling case and that advocacy can make a real difference.
- Dr. Peters highlighted that metformin is associated with many favorable outcomes that can help people with type 1 diabetes. She mentioned that those with type 1 diabetes can get metabolic syndrome later on, which metformin can help alleviate. Similarly, metformin can also treat polycystic ovarian syndrome. Dr. Peters also mentioned metformin’s potential to reduce the risk of cardiovascular disease, dementia, and cancer, although she expressed some doubt about these associations. She added that metformin has been shown to have good outcomes in hepatitis C, but that the drug overall can be hard to take due to gastrointestinal side effects.
- Regarding Symlin (pramlintide), Dr. Peters said that “it’s something that should be in the insulin, but isn’t.” She called Symlin the “antidote to insulin” and lamented at how Symlin was never highly developed in the drug marketplace. She shared how she would love to see it in pumps, stating, “Unless it’s actually easy, people won’t take it.” This was greeted with affirming nods from attendees. There was disappointment expressed that this hasn’t been a major focus of AZ’s (or of AZ/BMS) following the Amylin acquisition in 2012.
- Dr. Peters stressed that the effects of GLP-1 agonists depend on the patient with type 1, and she stressed the importance of individualizing therapy in patients. With some patients, she would be wary of prescribing this drug class. She explained that if the patient continues to make some insulin, GLP-1 agonists can have meaningful benefits; however, she felt most patients who have no C-peptide (like many in the type 1 population) would not be likely to benefit meaningfully from the drug over a long period of time. Dr. Peters warned about the lack of knowledge of the class’s side effects and the risk for pancreatitis in type 1 diabetes – she believes that more high quality data is needed to determine whether GLP-1 agonists do increase the risk of pancreatitis. If so, the question then centers on whether that risk is worth taking in people who already need to take insulin. She also expressed concern over the possible need to stay on this drug for long-term use, which is of particular concern with younger patients given that not much is known about long-term use of the drug.
- Regarding SGLT-2 inhibitors, Dr. Peters said that she “loves them in type 2 and loves them in type 1 for the first three months,” and that she is “more willing to play with this drug class because it seems to work.” She commented that SGLT-2 inhibitors help significantly with postprandial blood glucose excursions and dramatically reduce insulin requirements. However, in her experience, insulin requirements seem to re-equilibrate back up after three months and the drug becomes “not so magical” in many patients. Dr. Peters noted that she is currently playing around with staggering or alternating doses to see if this can alleviate the loss of efficacy; she also emphasized the importance of individualization.
- Dr. Peters shared some tips and tricks on preventing urogenital infections with SGLT-2 inhibitors. She recommended having people apply antifungal cream and start with lower doses and then slowly increase the dose. She emphasized to “gently treat early” and to “always think lower doses means lower side effects.”
Questions and Answers
Q: Use of glucagon has been proposed in different ways. Do you have any comments on the daily use of glucagon?
A: I spend a lot of time helping people deal with low blood sugar and I really like idea of using glucagon. It’s incredibly helpful because it gives that buffer. So much of the highs are related to over-treating the lows. We need type 1 drugs, and glucagon to me is a type 1 drug. I want a world of things that are specific. I have no concerns about glucagon for long-term use at low doses. People with type 2 have elevated glucagon levels anyways. So if I’m more concerned about lows, I would give glucagon. I’m a purist – the purer the drugs, the better.
Q: You spoke about making risk assessments and we know that this room is full of patients who are highly motivated to learn. What do you think is the best way to show people, who may be less motivated, the potential of these different drugs?
A: The best way is to show data. If everybody can monitor, they can give their physicians data. Patients looking at data can make better decisions.
Q: I’ve heard that Invokana is a drug that’s developed to mimic what naturally happens in a small subset of people – is that true?
A: No, they think that people with type 2 diabetes pee out more sugar. The drug shifts the threshold of peeing out sugar. It uncouples sugar in blood with sugar in urine, so overall blood sugar goes down. The natural mechanism is to reabsorb sugar, but the drug is shifting that threshold point.
Gary Scheiner, CDE (Integrated Diabetes Services, Wynnewood, PA)
Mr. Gary Scheiner talked about all things hypoglycemia, focusing on strategies for treatment and prevention. He defined hypoglycemia as “more things taking stuff out of the blood stream compared to what’s putting it in” and called it the “greatest limiting factor in diabetes management.” Mr. Scheiner highlighted that “our job is to keep the five grams of sugar in the blood,” as lows can result in a variety of negative outcomes, such as lasting brain damage and hypoglycemic awareness. He recommended a plethora of prevention strategies, discussing insulin program setup, the timing of meals and snacks, as well as using “floating glycemic targets.” Regarding treatment, Mr. Scheiner pointed out that “one size does not fit all” and everyone’s needs and situations are different.
- Mr. Scheiner emphasized that hypoglycemic events can impair performance, put people at risk of accidents, lead to lasting brain damage, hyperglycemic rebounds, accelerated gastric emptying, weight gain, and hypoglycemia unawareness. He stressed the importance of preventing severe hypoglycemia in young people, as such events can reduce spatial memory and performance in those under age five. Almost all lows are also followed by highs or so-called rebounds, he said. Hypoglycemia also requires calories that would not otherwise be consumed, leading to weight gain. The more lows one has, he cautioned, the more transporter cells the body creates and the more brain cells learn to tolerate low blood sugar – both lead to the disappearance of physical symptoms and corresponding loss of hypoglycemia awareness. The degree of such unawareness positively correlates with how long one has had diabetes. Mr. Scheiner pointed out that fortunately, this can be reversed by preventing hypoglycemia for an extended period of time (several weeks) and raising target blood sugars.
- Mr. Scheiner’s presentation recommended a number of helpful hypoglycemia prevention strategies:
- Insulin program setup: Mr. Scheiner emphasized the importance of proper correction factors and setting basal rates properly. He pointed out that most people need different correction factors at different times of the day (e.g., most people are more insulin resistant in the morning) and that the basal insulin should hold the blood glucose levels steady in the absence of food, exercise, and bolus insulin.
- Use “floating” targets: Mr. Scheiner mentioned that severe lows are more common the day after erratic blood glucose levels, hypoglycemia, and intense exercise, and thus targets need to be flexible. He recommended adjusting “today’s targets based on yesterday’s events.”
- Accurate carb counting: Since fiber does not raise blood glucose, he advocated for subtracting 100% of fiber if it’s over five grams. However, patients should only subtract 50% of sugar alcohols. He recommended looking up unknown and restaurant foods and only counting the carbs that were consumed.
- Awareness of delayed onset hypoglycemia: Following high intensity exercise or extended duration activity, delayed onset hypoglycemia may occur up to 24 hours later. Mr. Scheiner suggested reducing basal insulin for 8-12 hours, eating low GI snacks, and using lower mealtime boluses and watching to see if corrections are needed.
- Adjustment for alcohol: Alcohol reduces the liver’s output of glucose and masks hypoglycemia symptoms. He reminded the audience that it is the liver’s output of glucose that provides the reason to take basal insulin in the first place. Thus, he recommended drinking in moderation, decreasing basal insulin (or overnight long-acting insulin) after drinking, and having a low-GI snack at bedtime.
- Frequent monitoring: Mr. Scheiner stressed that “the longer you go between blood glucose checks, the greater the risk of hypoglycemia.” He suggested monitoring before all meals and snacks, pre- and post- exercise, at bedtime, and occasionally at around 3:00am.
- Recording and analysis: To help prevent lows in the first place, it’s important to understand what’s causing them. Mr. Scheiner recommended keeping track of carbs, insulin, activity, and emotional levels. The key is to review every 7-10 days and look for patterns. He mentioned that using an organized form or smartphone app can be very useful.
- Continuous glucose monitoring: Mr. Scheiner compared CGM alerts to blood sugar bumpers and emphasized their utility in alerting users and family members to pending lows. Mr. Scheiner recommended setting a low alarm at 80-90 mg/dl – this way, the alarm will go off before a low is reached, accounting for lag time.
- Mr. Scheiner stressed the heterogeneity of hypoglycemia treatment, stating that treatment strategies depend very much on the patient and situation. He pointed out that “the bigger you are, the more carbs you’ll need” and highlighted idiosyncrasies such as raising the quantity of treatment glucose based on insulin on board and for recent exercise. Mr. Scheiner also suggested reducing treatment amount for previous low-GI foods. He commented that apple and orange juice are not as effective as glucose tabs and proclaimed that “dextrose rules,” as it is the form of carbohydrate that raises blood sugar the fastest. It can be found in glucose tabs, gels, drinks and in many candies (Sweet Tarts, Smarties, Spree, Nerds, Runts, etc.).
Ms. Kerri Sparling (Blogger, SixUntilMe.com) and Mr. Adam Brown (Close Concerns, San Francisco, CA) host a discussion with parents – notably, all concerns centered around the psychosocial, emotional, and family impact of living with type 1 diabetes. Parents asked about transitions to college, teenage rebellion, dealing with siblings who do not have diabetes, diabetes burnout, and more. Below, we have highlighted some notable quotes.
- “What do I do if my teen is using diabetes to get what she wants? The other day, she took a large bolus, and the only option was to go get her ice cream since we were far from home.” – Parent of a child with type 1 diabetes
- “My son is very on top of his diabetes management right now, but I’m worried about diabetes burnout down the line.” – Parent of a child with type 1 diabetes
- “My daughter and I have type 1 diabetes, but my husband does not. He always wants to help, but he has absolutely no clue what to do. What do you recommend I do?” – Parent of a child with type 1 diabetes
- “My younger child has diabetes, while the older child does not. The older child resents it and is not supportive. We want to get the child with diabetes a smartphone to communicate with us – how do we position this to the child without diabetes?” – Parent of a child with type 1 diabetes
- “Tell them it’s not what makes them different. It’s what makes them special. Remind them that they’re not the only ones. They may be the only ones in the family with diabetes, but they’re not the only ones in the world. Remind them to think of this conference.” – Kerri Sparling, on children who feel excluded due to type 1 diabetes
- “It’s amazing the number of factors that affect blood glucose besides the obvious things like food, insulin, and exercise. For instance, I tend to be around 30% more insulin resistant when I get less than seven hours of sleep. Studies find that most people, with or without diabetes, are more insulin resistant when they don’t get enough sleep. It’s important to remember that a bad number on your meter may not be because you messed up – there’s a lot to take into account!” – Adam Brown, on factors influencing blood sugar
- “When your kid is at college, have him or her put his Dexcom in a glass – it will vibrate against the glass and wake you up pretty quickly … They can also try the Earthquake app on his phone. Put a Dexcom on top of that and you will think the world is ending – it wakes up everyone you know.” –Kerri Sparling, on waking up to CGM alarms
- “Make sure your son or daughter understands alcohol and blood sugar. Glucagon doesn’t work when you’re drunk. You have to sugar and fluids, or in extreme cases, use IV glucose.” – Kerri Sparling, on transitioning to college
- “Parents, as it turns out, feel the most stigma associated with diabetes, in the study that dQ&A presented at ADA. It gets better over time – many adults with type 1 feel less stigma. Your child is probably better off than you think they are in terms of stigma. And as we think about automating insulin delivery, I feel like the future of type 1 is going to have even less stigma.” – Adam Brown, on the stigma associated with diabetes.
- “Don’t use the language of “good” or “bad” when talking about blood sugars. Don’t make these numbers judgments of your skills as a parent or your child’s ability to manage his or her diabetes.” – Adam Brown, on the psychology of blood sugars
- “My mom always made it a thing that you shouldn’t hide your diabetes. You should disclose it to people so they know why you do what you do. It makes you safer and it becomes part of their normal.” – Kerri Sparling, on the decision to disclose a diabetes diagnosis
- “Lows are scary, they aren’t just clinical values… Emergencies don’t happen every single day. It’s just that when they do, they suck so much that they leave a lasting impression. You might change your diabetes management and end up running higher blood sugars than you should.” – Kerri Sparling, on the impact of severe hypoglycemia
-- by Melissa An, Adam Brown, and Kelly Close