American Diabetes Association 76th Scientific Sessions

June 10-14, 2016; New Orleans, LA; Full Report – 10th Annual TCOYD/The diaTribe Foundation Forum

Executive Highlights

The annual TCOYD/The diaTribe Foundation forum celebrated its 10th anniversary by welcoming ~300 attendees to a night of delicious appetizers, refreshing drinks, and engaging discussion at the elegant Ritz-Carlton New Orleans. As is tradition, the night opened with a short video from the famed TCOYD team – this year’s hilarious rendition envisioned a world in which the artificial pancreas has improved diabetes care to the point where endocrinologists are out of their jobs. The star-studded panel of diabetes experts included Drs. Anne Peters (USC, Los Angeles, CA), Jeremy Pettus (UCSD, CA), John Anderson (Frist Clinic, Nashville, TN), and Professor Rury Holman (University of Oxford, UK). TCOYD founder and director Dr. Steve Edelman and our very own Ms. Kelly Close co-moderated the illuminating panel discussion.

The wide-ranging hour of insights shared enthusiasm for CGM and closed loop systems coming out of ADA (Dexcom’s DIaMonD study, 670G pivotal), but major concerns about access, adherence in type 2, and the continued lack of studies to inform real-world prescribing. Dr. Peters gave the entire room a reality check when she described some of the access challenges she still faces in East LA, where underserved patients often can’t get insulin analogs, and where sulfonylureas are still widely used. “Someone needs to do the study to make sure I don’t have to prescribe sulfonylureas because they’re cheap.” Dr. Holman further lamented that the regulatory focus of most drug trials excludes answering more important clinical questions: what therapy should this type of patient get at this time?

There was lots of debate about where new innovation is most needed: do we need more focus on new therapies or better using what we already have? Obviously both are critical, though panelists leaned towards the latter – despite so many new tools, outcomes have not improved, and adherence remains a significant problem in type 2 diabetes. Noted Dr. Edelman, “Type 2 diabetes is asymptomatic. The lack of urgency is not because they don’t care, but they don’t feel any symptoms and don’t feel any different whether they take their meds or not.”

Many expressed sincere hope that wider use of CGM will be a gamechanger, whether for intermittent diagnostic purposes, documenting drugs in clinical trials, or changing type 1 diabetes (even in MDIs). Dr. Edelman was particularly excited about the future of the GLP-1 class, while Dr. Holman hoped that digital health might help solve type 2. Clearly, lots is in the pipeline that is going to improve care, though the panel was very clear: the toolbox we have is quite good already, and more work needs to be done on better using it.

Below, we’ve included a handful of our favorite quotes from the panel discussion, followed by detailed coverage. This forum would not be possible with the support of our generous sponsors who envision a better future for diabetes. In particular, we’d like to thank the best-in-class sponsors Abbott, AstraZeneca, Intarcia, Merck, and the Fenix Group; our first-in-class sponsors Janssen and NuSirt; our forum sponsors Adocia, Ascensia, Bigfoot, Dexcom, Lilly, Sanofi, and Tandem, and our supporting sponsors BD, CeQur, Glysens, Insulet, Medtronic, Profil, and Zealand.  

Quotable Quotes

The Most Exciting Areas in Diabetes?

  • “What’s coming with the artificial pancreas...this is here and now and by the time we do the panel next year, Steve, Kelly, and I could all be on a closed-loop system. Most patients and even doctors don’t realize that and it could change the conversation around diabetes.” – Dr. Pettus
  • “My high point of this meeting by far was the DIaMonD trial. With one simple tool, CGM, given to people on MDI, you can get the same reduction in everything that’s as wonderful as what you get with closed loop systems. It makes me wonder why we need the loop when humans are just as good.” – Dr. Peters
  • “In type 2 diabetes, it would have to be the GLP-1 space. We have new approved fixed combinations, implantable micro pumps that deliver exenatide for a year, we have once weekly agents, and all kinds of new options. If I had to pick one class with the biggest effect, I would have to pick that.” – Dr. Edelman
  • “In the type 2 space, which is where I work, it will be digital or eHealth. For patients with long-term chronic conditions, they visit multiple practitioners, pharmacists, hospitalists, and others. There’s a wealth of data being collected, but it remains separate, in silos. We should integrate the data...[to] help with compliance and treatment, and help people providing care to see the whole picture” – Dr. Holman
  • “I love the idea of CGM as a human right” – Ms. Close

Biggest Concerns and Needs?

  • “My [East LA] folks don’t have insulin pens, they often don’t have analogs, and they’re dying in their 20s and 30s of a disease we treat with high level technology that may not trickle down.” –Dr. Peters
  • “I love CGM, I love being able to use it in my patients, but it’s a tiny fraction of my patients. I wish I could have 60% of my patients on it.” – Ms. Virginia Valentine from the audience
  • “...what did LEADER show? Is this another trial showing that a lot of insulin is bad or is it showing that GLP-1 is better? Someone needs to do the study to make sure I don’t have to prescribe sulfonylureas because they’re cheap...All I can think is give me a GLP-1 and take away sulfonylureas. That’s the data I need to get payers to pay for it, otherwise I have to keep using sulfonylureas and that kind of pisses me off.” – Dr. Peters
  • “The use of tech in primary care is woefully inadequate...there needs to be a big push...We need to get the technology into hands of patients who currently don’t even know it’s available because their providers don’t know about it.” – Dr. Anderson
  • “As the risk of DKA with SGLT-2 inhibitors in type 1 diabetes comes up with the FDA, its important to have patient there – what’s  lost in the data is the patient experience. As an anecdote, when I have type 1 diabetes patient who takes the drug, they say, “My life is better. Maybe I should’ve bolus four units and only bolused for three, and the SGLT-2 inhibitors picks up the slack. It takes away some of the chaos.” – Dr. Pettus
  • “One of the greatest things we could do is to move to running clinical trials that are informative for the clinician and patient. At the moment, it’s all built around regulatory licensing, which of course is needed to sell the drug. But there is a disconnect between regulatory studies and what we need to know how to best use the medication. If I have a particular patient in front of me, how do I know what is best for that patient at that time? – Dr. Holman
  • “I think the paradigm we use to treat type 2 diabetes is all wrong. We’re making adjustments in medications for individuals, not populations but individuals, based on A1c....We have to get the message that an A1c of 8% could be a glucose of 120 or 210. Deciding whether to add or subtract a drug by A1c is bad medicine.” – Dr. Irl Hirsch from the audience

What about Adherence?

  • “I would say that right now, with type 2, we have enough tools. It’s about getting people to adhere to them. If we had the same conversation ten years ago, and you told me that we would have multiple medications like we do now that would cause drops in A1c with weight loss, I would have said that we would be done. But it’s not. We’ve had multiple medications come out, and average A1cs in the population have stayed the same. It’s about adherence.” –Dr. Pettus
  • “There is a disconnect. We don’t have all the tools, not even for type 2 diabetes. But we could do better with what we have. Diabetes should be managed, it shouldn’t manage you.” – Dr. Holman
  •  “There has to be something to engage the patient. Type 2 diabetes is asymptomatic. The lack of urgency is not because they don’t care, but they don’t feel any symptoms and don’t feel any different whether they take their meds or not.” –Dr. Edelman
  •  “...we already have tools to make life better for millions underserved across world, and we don’t actually do it. We’re not pulling along those people who could benefit already. We could do a lot more with tools we have while waiting for a final answer.”–Dr. Holman

Advice for the FDA?

  • “...get the drug side to talk to the device side. We need to use CGM in trials and have it be an outcome.” – Dr. Peters
  • “I would tell the FDA to let patients have some say on the risk-benefit ratio they’re willing to accept.” –Dr. Edelman
  • “I was the first person to sound the alarm on euglycemic DKA in type 1 diabetes patients on SGLT-2 inhibitors. When I found that out and started to make noise to let people know, I spoke with Irl Hirsch and John Buse and they were seeing the same thing. We became a trio interested in informing the world of a risk, but we didn’t want to damn the drug. It turns out that’s harder to do than you’d think, because the second you say that you see a side effect, everyone flees.” –Dr. Peters

Panel Discussion

Ms. Kelly Close (Founder, The diaTribe Foundation, San Francisco, CA): Thank you SO much again everyone for being here. The first question we’re going to ask is – in 90 seconds or less – what is your overall impression of ADA and what has been the biggest highlight for you?

Dr. Jeremy Pettus: On a personal note, what really hit me in face was dealing with my own blood glucose. Since coming here and eating delicious food, staying up too late, and drinking too much, I’ve had multiple blood glucose readings over 300 mg/dl or less than 50 mg/dl. I actually turned off my Bluetooth because Steve follows me on Dexcom Share – I was getting texts from family asking what the hell I was doing. The point is, life with type 1 diabetes in 2016 is hard. I know a lot about the disease and it still gets better of me. Something that stuck out to me from the conference is what’s coming with the artificial pancreas. That was a funny video we watched, but there’s truth in it. This is here and now and by the time we do the panel next year, Steve, Kelly, and I could all be on a closed loop system. Most patients and even doctors don’t realize that and it could change the conversation around diabetes. I went to a session on calculating the pre-prandial bolus for fat and protein. The integrated calculus we require patients with type 1 diabetes to do is ridiculous. I hope that was the last time I sit in a session on that. If we can have system that really makes life easier, that’s a big deal to me.

Dr. Anne Peters: I don’t mean to be negative, but I spend half my time in the most underserved part of Los Angeles and the other half in the most well served. I see the most heartbreaking things in the less well-served population, especially people with type 1 diabetes. All I could think of when I watched that video was that it’s nice you rich white folks are out of a job because of the artificial pancreas. My folks don’t have insulin pens, they often don’t have analogs, and they’re dying in their 20s and 30s of a disease we treat with high level technology that may not trickle down. My high point of this meeting by far was the DIaMonD trial. With one simple tool, CGM, given to people on MDI, you can get the same reduction in everything that’s as wonderful as what you get with closed loop systems. It makes me wonder why we need the loop when humans are just as good. The study confirmed what I think. I tried to do a study five or six years ago in my population but the sensors were not good enough, so it was too much of a leap. Now we know we have to get them to the point where they can use them. Because of Helmsley we’re creating lower literacy treatment tools in English and Spanish to make technology available to low SES patients to get to where you are so we can all be equal.

Ms. Close: I love the idea of CGM as a human right.

Dr. Steven Edelman (UCSD, CA): I think the onset of CGM helping people on MDI is not a novel thought. Even the thought of doing a study didn’t make sense to me, but we have to prove it to the world. I’m glad we have and that we realize anyone with type 1 diabetes can benefit from CGM. Several companies are working to make cheap, accurate, disposable, durable glucose sensors for type 2 diabetes. I think it will really be a gamechanger.

Dr. John Anderson: There were lots of great sessions. There were new novel ultra-rapid-acting insulin analogs, the LEADER data was great, and there was interesting data on economics. I also found the Banting Lecture this year particularly impressive. Dr. Kahn did not refer to herself even once; everything was about her postdocs and fellows and their scientific brilliance. I’m struck by how one person’s brilliance can affect the careers of many researchers. It was an amazing moment for the Association.

Dr. Rury Holman: There are all these people desperate to do better. Barbara Kahn is phenomenal, she’s risen to the top and her novel lipid could be transformational. Everyone thinks we’ll cure diabetes tomorrow with some trick, some sensor, the computing cloud. But the presidential lecture highlighted that we already have tools to make life better for millions underserved across world, and we don’t actually do it. We’re not pulling along those people who could benefit already. We could do a lot more with tools we have while waiting for final answer.

Ms. Close: I would love to see all of science do much better and focus more on the prevention and systems problems that all of you work through. There is so much happening on behavior change that Steve and Jeremy are a major part of. If we look at how much is being spent on prevention, it is so cheap compared to what we’re spending on complications. It’s all about individualizing and personalizing. Do you have views on challenges outside the science?

Dr. Edelman: I agree that in type 1 diabetes it’s CGM, and think about it: the artificial pancreas is so close, it’s unbelievable after all these years. In type 2 diabetes, it would have to be the GLP-1 space. We have new approved fixed combinations, implantable micro pumps that deliver exenatide for a year, we have once weekly agents, and all kinds of new options. If I had to pick one class with the biggest effect, I would have to pick that. Thank god for all the oral agents, but that would be the single most important thing I’ve seen. We have a fantastic toolbox. We have lots of incredible insulins, GLP-1s, combinations, but A1c hasn’t changed in the past 10 years in this country with 40 new medications. It’s so hard to fathom. One of the biggest challenges is getting the right drug to the right person. The second big part is getting people to be adherent and persistent and make diabetes higher on their priority list. I’ve heard Bill Polonsky say that medications don’t seem to work unless you take them. [Laughter] I really think we need to address both issues head on.

Ms. Close: I also see a lot of you working on tools that would make things easier not just for patients, but also for healthcare providers. It’s great to see that focus since clinician positions need to be easier and better. Speaking of that, I’d like to have you all think about the biggest piece of advice that you would give to the manufacturers in this room – what would this be?

Dr. Holman: One of the greatest things we could do is to move to running clinical trials that are informative for the clinician and patient. At the moment, it’s all built around regulatory licensing, which of course is needed to sell the drug. But there is a disconnect between regulatory studies and what we need to know how to best use the medication. If I have a particular patient in front of me, how do I know what is best for that patient at that time? Obama copied David Cameron’s speech when he talked about precision medicine, or the right therapy for the right person at the right time. We have a huge group of therapies for diabetes, but we don’t know which one to give to which person. If would be helpful if we took registration trials and made them richer, delivering to clinicians and patients the information they need to make personalized choices. That might be wrapped up in some computerized system, but the complexity of such a system should not stop us. Instead of trying a drug, failing, and moving to the next one, why don’t we do the intelligent thing: use data and give the patient a drug that’s best for them.

Dr. Anderson: I’ll be honest, I’m not a big manufacturing guy, but I will say this: if you look at the vast majority of people taking care of diabetes, it’s primary care physicians. The use of tech in primary care is woefully inadequate, but companies are starting to understand that, beyond endocrinologist outreach, there needs to be a big push for the education of primary care and need primary care physicians need to be a target. We need to get the technology into hands of patients who currently don’t even know it’s available because their providers don’t know about it.

Dr. Peters: I think real world experience with medications is what we need. When I was watching the LEADER trial today, I was looking at it and thinking this is pretty cool, another drug that reduces cardiovascular risk, and then I looked at the placebo group and how much insulin they were suddenly using at the end of the trial. Then I raced back to my room and pulled up the NEJM article, and lo and behold there was a 30% increase in the rate of severe hypoglycemia in the placebo group and a significant increase in all hypoglycemia because they were on so much insulin, mixtures, and sulfonylureas. Then I looked at the EMPA-REG trial to see if there was a difference in hypoglycemia and there wasn’t. Then I said to myself in a slightly cynical tone, what did LEADER show? Is this another trial showing that a lot of insulin is bad or is it showing that GLP-1 is better? Someone needs to do the study to make sure I don’t have to prescribe sulfonylureas because they’re cheap. They took people whose A1cs were higher than in other trials and they needed to try really hard, so what did they do? They gave lots of insulin and sulfonylureas and it wasn’t very good for them. Actually the main flaw as far as I can tell in the LEADER trial is what happened in the placebo group. We need a sub-analysis of this. All I can think is give me a GLP-1 and take away sulfonylureas. That’s the data I need to get payers to pay for it, otherwise I have to keep using sulfonylureas and that kind of pisses me off.

Dr. Pettus: Keeping my type 1 hat on, I’d say more adjunct therapies, specifically SGLT-2 inhibitors in type 1. There’s no question that these drugs work in type 1 – they lower A1c, improve time in range, and improve quality of life, but there’s the risk of DKA. In 2016 we may be able to accept and mitigate the risk, but as technologies like CGM and the artificial pancreas improve or become more available, it will change the risk-benefit ratio. I actually think that is going to happen pretty quickly. I think the artificial pancreas is going to be here sooner than we realize, but the rollout will be slower. Things are going to be very different even two years in the future.

Dr. Edelman: My advice would be to talk with your patients. Bring them in when you are actually designing the study, before you lock in the protocol. At TCOYD we put together patient advisory committees for pharma, and it’s shocking how much they changed the way they thought about and designed studies. Like Rury said, listen to the patient from the beginning, not only when things are too late to be changed.

Ms. Close: Thank you! And along the same lines … what’s the single biggest piece of advice you have for FDA?

Dr. Edelman: I would tell the FDA to let patients have some say on the risk-benefit ratio they’re willing to accept.

Dr. Holman: I spent 15 years training FDA commissioner Dr. Robert Califf to be an endocrinologist and helped launch his new career. Three years ago, we wrote a joint paper on how to run cardiovascular outcomes trials, so we’ve got a roadmap there. We should look at trials that move away from pure non-inferiority and just looking at A1c and instead address the whole patient’s needs – that’s what I’d like to see. The issue is we have the FDA guidance, which was transformational, but it was also a major imposition. It’s a good thing in that it launched a thousand trials, and some were helpful, but I suspect we could do much more. I would like to see sequential licensing. In a trial, the drug first must do no harm – the FDA needs to make sure the patient is safe and make sure trials don’t kill people with a bad drug, but should also address potential benefits. We could have a system where the early part of a trial confirms safety and the drug is licensed based on an interim report for safety data. The trial could then continue to yield not only data on potential benefits in the longer term but also provide data on large sets of patients to inform precision medicine strategies. Thus, we’d have a rich data set and have information not only about the safety but also the true benefits of the drug and its clinical applicability for individuals. For LEADER, we saw a 13% risk reduction overall; I want to know for the patient in front of me whether he or she will get 5%, 13%, or 25%? We need to see much more intelligent trials.

Dr. Anderson: Pay them. Pay them really, really well and recruit the absolute best and brightest people. Secondly, remove them from the annual budgetary process and put them under HHS where they’re not subject to the whims of Congressional peccadillos. Make them a scientific, well-paid organization that’s not subject to political influence.

Dr. Peters: In full disclosure, I’m actually a special agent to the FDA. They vetted me, and said for some reason that I’m someone who is unpolluted enough to be a part of them. They don’t ask my advice very often, but if I was to tell them anything, the first thing would be to get the drug side to talk to the device side. We need to use CGM in trials and have it be an outcome. The FDA doesn’t let it be an outcome currently, but it’s really important to measure and something that the drug side doesn’t see. Also, I was the first person to sound the alarm on euglycemic DKA in type 1 diabetes patients on SGLT-2 inhibitors. When I found that out and started to make noise to let people know, I spoke with Irl Hirsch and John Buse and they were seeing the same thing. We became a trio interested in informing the world of a risk, but we didn’t want to damn the drug. It turns out that’s harder to do than you’d think, because the second you say that you see a side effect, everyone flees. Within 24 hours, there were 1-800-lawyer ads asking if people were on SGLT-2 inhibitors. Dr. Buse recommended that I speak to someone in the FDA drug division. I got to speak to a remarkable woman who listened. Previously, who knows who was working at the FDA, but nowadays it’s a darn good job – who wants to go into medicine anymore, when you get fixed benefits at the FDA? People at the FDA not only talked to me, but respected what I had to say, asked my opinion, and we had an amazing dialogue. They asked me to get my colleagues to report side effects, even if we were using the drug off-label. I realized that there is a role for us as physicians, who understand patients and understand the risks involved. No drug is without side effects, but diseases have side effects that are worse. Patients need to really understand the risks and benefits. And providers are afraid of lawsuits. We all need to work together to get drugs to market. Like I said, the dialogue I had with FDA pleased me, and there’s progress being made. It will need help from patient advocates, physicians like me, patients, and other voices that are not in it for the money, but are just interested in doing things right. 

Dr. Pettus: I’ll make mine short and I’m outmatched here. As the risk of DKA with SGLT-2 inhibitors in type 1 diabetes comes up with the FDA, its important to have patient there – what’s  lost in the data is the patient experience. As an anecdote, when I have type 1 diabetes patient who takes the drug, they say, “My life is better. Maybe I should’ve bolus four units and only bolused for three, and the SGLT-2 inhibitors picks up the slack. It takes away some of the chaos.” That’s the real value of some of these medications and needs to be considered, however you want to put that there.

Dr. Peters: I had a wonderful experience. I was asked at Rachmiel Levine to debate David Nathan about whether we were at a point where we could use non-insulin drugs for type 1 diabetes. He’s a little sure of himself. He was the captain of the Harvard debate team and I’m just from Wesleyan. I say, “I’ll do this,” then I thought “This was the stupidest thing. I’m bad at debate; I’m good at saying what I think, but debate is different.” I thought, “I’m never going to win; I will only win if I bring a patient.” So I brought a patient with type 1 diabetes on an SGLT-2 inhibitor who was the captain of her college debate team. So he speaks first and he doesn’t know I have a stealth weapon. I go and give a few slides and then say I have secret weapon, and she completely trumps him. I didn’t win because of me; I won because of my patient.

Ms. Close: Let’s pretend we get to a supreme world where access is improved and people can all get the technologies and drugs that they need. What therapies or technologies will be the biggest gamechangers in the next five years?

Dr. Holman: In the type 2 space, which is where I work, it will be digital or eHealth. For patients with long-term chronic conditions, they visit multiple practitioners, pharmacists, hospitalists, and others. There’s a wealth of data being collected, but it remains in separate silos. We should integrate the data on a platform that patients can access. It could help with compliance, treatment, and help people providing care to see the whole picture.

Dr. Anderson: I completely agree, because with all of the tech we’ve got and all of the new great medications, it’s an adherence and access issue that continues to plague lots of patients. If you look at nanotechnology, smart insulin, and even just recently, things like PCSK9 inhibitors have the potential to be gamechangers in how we deliver the right medication to the right person in the right way.

Dr. Peters: We have a lot of really good therapies now. I’m not sure I need more therapies, I just need more people to use them in the right way. That needs two kinds of people. We need lots more cognitive behavioral therapists. I want help from people who can help me figure out how to help my patients. I hate the word denial, it’s about people making choices, but I want people to make the right choice. I think mHealth can help but I’m not sure it’s enough. I helped develop Omada Health, and after they started it, the next two people they hired were a cognitive behavioral therapist and an expert in gamification. These guys who made the video games that addict our children could addict us to something positive. I see it as making tools. I’m not sure what the vision for the tools is, but online communities and ways to connect to each other and use the data, the information, and the tools we have. It’s not me telling someone to take a medication; it’s getting them to believe it’s the right medication for them. We need a lot more help to understand how to integrate that.

Dr. Pettus: I would say that right now, with type 2, we have enough tools. It’s about getting people to adhere to them. If we had the same conversation ten years ago, and you told me that we would have multiple medications like we do now that would cause drops in Aa1c with weight loss, I would have said that we would be done. But it’s not. We’ve had multiple medications come out, and average A1cs in the population have stayed the same. It’s about adherence. I think the things you do at TCOYD are important, in terms of getting the message out to people and educating them. This may be controversial, but in type 2 I don’t think we need more therapies.

Dr. Edelman: As a side note, I knew Jeremy when he was a fellow, and back then, he didn’t want to see people with type 2 diabetes. He would say, “I think they’re type 1.” He wanted to do antibody testing on a Pacific Islander whose parents both have type 2 and who has central obesity. But yes, Jeremy, there is type 2 out there. [Laughter]

I don’t have all the answers either, but my comment is a combination of what’s said before. I look to pharma and the device industry to come up with safe, easy-to-use products, whether it’s disposable CGM or a once-yearly GLP-1, but if you don’t have the patient part, it’s not going to work. There has to be something to engage the patient. Type 2 diabetes is asymptomatic. The lack of urgency is not because they don’t care, but they don’t feel any symptoms and don’t feel any different whether they take their meds or not. That’s the challenge, it’s not new drugs.

Dr. Anderson: Whether you’re a fan or not of the Affordable Care Act, there are all sorts of performance measurements in there for providers, but there’s not one patient component. There’s no stake in the game, no positive incentives, no way to engage patients in terms of participation in care. We give them 15 minutes 5 times a year. We need a systematic way to engage patients where they’re incentivized just like we are to have a stake in the game.

Dr. Edelman: For a patient to wake up and say, “I need to take this medication because it will help me live a long healthy life,” that’s what we want. That’s what we don’t have in type 2 diabetes.

Ms. Close: It’s really very disappointing to think about how many providers, patients, and advocates out there are so exhausted. It may be helpful as we look toward improvements to see how other therapeutic areas have engaged patients, like cancer has.

Dr. Aaron Kowalski (JDRF, New York, NY): First, can I please break the myth that we’re there with treatments for diabetes? I understand that there are access issues, but one of the most powerful studies over the past few years is the data from Drs. Buckingham and Maahs, focused on type 1, and showing that in patients on a pump and CGM testing eight times a day, in a clinical trial in two of the best centers in the world, still spent nearly one in ten nights with at least two hours below 60 mg/dl. Right now we don’t have all the tools we need. In the type 1 community, words like “compliance” and “adherence” are touchy. The real question is about the return on investment for a therapy, and for all the investment patients make in these new therapies they are still getting low almost every single week – sometimes profoundly low. The question I have is how we will drive towards better therapies, and how we can take big data and info from CGM, like Rury said, to do a better job of getting the right therapy to the right person.

Dr. Pettus: I always agree with you. My comment is that we have enough tools applies to type 2. Since I’ve been here, my blood sugars have been all over place. I’m intelligent, I have insurance, I have the right tools, and I still can’t get it right. In the type 1 space, we don’t have enough tools. There’s a need there. It’s not as simple as take more insulin, etc. When I do trials with patients with type 1 diabetes, they say to titrate the basal insulin to a fasting plasma glucose of less than 100 mg/dl. It’s not that easy, type 1 diabetes is so nuanced. We need more therapies and more solutions. We’re not there yet.

Dr. Holman: There is a disconnect. We don’t have all the tools, not even for type 2 diabetes. But we could do better with what we have. Diabetes should be managed, it shouldn’t manage you. People can’t be living 24/7 worrying about the next carbohydrate they’ll ingest. We need to harness technology. It’s difficult but we’ve got the scientists, the mathematicians, the big data experts, and they’ll develop the tools and the predictive algorithms. That will come and it will take over until we can prevent the disease or put in place a complete pancreas replacement. We have to manage it here and now. The theme is we could do so much better with what we have and not put so much of it on the person. It’s not their fault, not even in type 2 diabetes. They have bad genes; they might have a lifestyle that made it happen earlier, but they wouldn’t have it if they didn’t have the bad genes..

Dr. Peters: Since we’ve had Tresiba on the market, I’ve started using it in type 1 patients, and I think the conversations are quite different between type 1 and type 2. In type 2, I’d certainly like some therapies that could delay beta cell failure. It’s also frustrating that some people only have access to metformin and sulfonylureas. In the type 1 space, I push sensors and want everyone on a sensor. I put a bunch of people on Tresiba and they said they liked it – that it was a more stable basal for them. In my own little clinic, if I had a way to collect CGM data from everyone, I could take it to insurers and use it to argue with them for coverage. It’s tough for me to have to write all these prior authorizations. We need data that we can use to our benefit.

Tamar Sofer-Geri (CARB DM, Palo Alto, CA): Thank you all for wonderful remarks. My daughter been on the 670G as part of the pivotal trial and it hasn’t been easy. Jeremy mentioned that next year you three could be on the artificial pancreas. One of the most important things is to manage expectations – you’re still going to be doing a lot with your diabetes. Certainly for the first gen and the Medtronic pump, you will still have to count carbs, you’ll still be going high, though you won’t be going low as much. It’s important to manage patients’ and physicians’ expectations on what it’s going to be like. The wrong expectations are going to lead to failure of adoption.

Dr. Pettus: I totally agree. If you could take people with type 1 diabetes and get them to a reasonable A1c reduction, that’s a big deal. It’s not perfect, but it’s a first step in getting people on board, especially those who haven’t heard of it before. A lot of the general public think the artificial pancreas is a surgically implanted thing. Lots of people have different ideas of what this is. The whole community coming around to understand what does this actually mean. Education will be important. It’s good we’ll have multiple systems so people can have a conversation about the pluses and minuses of each system. It’s all going to change.

Ms. Geri: You’ll still even have to check your blood glucose. The main thing is the systems are still going to be a lot of work.

Ms. Close: I also know how amazing it is not to be scared of hypoglycemia. I want to commend the field. I’m so happy to see so much focus on reducing hypoglycemia here at the Scientific Sessions – it is absolutely unparalleled. Whether it’s the closed loop, FreeStyle Libre IMPACT study, DIaMonD, or other studies, we’d love to see much more focus on hypoglycemia and acknowledgement of its danger.  

Dr. Irl Hirsch (University of Washington, Seattle, WA): The reason I like listening to Anne is she gives a reality check. I’m going to give you a reality check now. I had a nice walk over here, and then I looked at my phone and saw that I have a patient who died this afternoon. I’ve been following him since 1991, he got his life in order and took good care of himself, and then he ended up with sepsis and had an MI as they were getting ready to amputate his toe and he never recovered. When you look at the three big trials in type 1 diabetes published in the last 18 months, you see that consistently around the world, 5-10% of the mortality is from hypoglycemia and about as much from DKA. To me that’s not acceptable. The next time we see big epidemiological studies from the UK or Scotland or the US, that number needs to be close to zero. As we improve the technology, we’re still seeing deaths for the same reason as before the discovery of insulin. And that’s just the adjudicated deaths.

I made the point yesterday that I think the paradigm we use to treat type 2 diabetes is all wrong. We’re making adjustments in medications for individuals, not populations but individuals, based on A1c. I didn’t know about the FDA meeting in August on Outcomes Beyond A1c, but I want everyone to realize what Richard Bergenstal taught us about the range of estimated glucose for a given A1c. We’ve seen it in three trials now. We have to get the message that an A1c of 8% could be a glucose of 120 or 210. Deciding whether to add or subtract a drug by A1c is bad medicine. We need glucose data. What we saw with CGM is the best way even if it’s intermittent, and even for someone with type 2 diabetes not on insulin.

Q: With all this data, I’m worried about all the attorneys in this world and liability as patients stream data to us. In California, we’re supposed to report severe hypoglycemia, which gets the patient’s license yanked. If I get a CGM trace and a patient has lots of hypo, do I report it? And if I get data and don’t look at it, am I responsible if I don’t intervene and something goes wrong?

Dr. Anderson: In Pennsylvania there was a similar requirement that physicians were to report hypoglycemia, which would immediately get the patient’s license revoked. That was even if the hypoglycemia didn’t occur when the patient was driving. They changed that law, because they found that patients just weren’t reporting their lows. When that happened, we were just missing opportunities to alter therapies for those individuals because of a law that was arbitrary and ridiculous. I’d encourage you to get your advocates together and fix laws like that.

Dr. Holman: We had a change to UK law that said any hypo, day or night, could put one’s license at risk. This inclusion of nocturnal hypoglycemia was punitive as you’re not usually driving when you’re sleeping. Fortunately this has been rectified so now there is much less emphasis on nocturnal hypos.

Dr. Anderson: At the heart of that is a arbitrary assessment that everyone with diabetes is the same. Treating people should be an individual assessment, there should not be a single treatment.

Dr. Pettus: Steve follows me on CGM. I like to say that if I ever have a bad hypo, I can sue Steve. [Laughter]

Sara Krugman (Tidepool, San Francisco, CA): Are there any designers here? [No hands go up.] It seems like the resounding thing is that we need better design to change the experience of how people take drugs, administer insulin, and use devices. I’m literally the only designer in the room. Design is not something you slap on at the end. It’s a thought process. Everyone’s saying that but no one here represents that. I’m doing my best to bring designers hungry for meaningful work from consultancies making banking apps. There’s a massive opportunity here. We need more of a call to action to engage the design community and the people who understand how to solve problems. We can’t do it alone, and it sounds like everyone is saying it.

Ms. Close: We’re excited you’re here as a designer and we have a whole roomful of people wanting to engage patients, providers, payers, and FDA better. You’re definitely needed here and I’m sure people will seek you out for advice. Where are you from?

Ms. Krugman: I’m a designer at Tidepool. Howard Look, we can’t thank you enough for showing us that design is not an elite thing. You can all be designers – you can all do this.

Dr. Bruce Bode (Atlanta Diabetes Association, GA): I’m looking at the best-in-class sponsors – every company up there has done wonders to improve the lives of people with diabetes. There’s no question that the 670G is the first commercial version of the step toward the artificial pancreas. It isn’t necessarily the best solution for everyone – it doesn’t have the best sensor, and we don’t yet have the best insulin, but it’s amazing that the 670G trial got people to an A1c of 6.9% with zero hypo. But, there’s a lot of alarms. It’s just the first iteration. Any one of the companies on the board [of sponsors] may have better solutions. We’re progressing faster than we ever have. In the computerized age, we’ll individualize therapy for type 2 using software tools in a way that no individual provider has the time to do.

Ms. Close: It’s amazing to hear so much support for patients in the room and so much support for both standardization on the systems and guidelines fronts, and individualization on the patient level.

Ms. Virginia Valentine (Sage Specialty Care, Albuquerque, NM): I love CGM, I love being able to use it in my patients, but it’s a tiny fraction of my patients. I wish I could have 60% of my patients on it. I want to appeal to you all not say “for type 1.” For us with type 2 diabetes, CGM has the same impact. The reason it’s good for you, Jeremy, is it gives you feedback. It has same impact in people with type 2. As we’re all fighting payers to consider CGM as standard of care for diabetes, this is important. When you look at every study out there, the hypoglycemia rate for patients with type 2 diabetes is 40-50% if they’re on a sulfonylurea or insulin. I agree hypoglycemia is a big deal, but there’s nothing better to help you decide not to eat another taco than having a CGM. I agree CGM is the thing that will have a big impact in the coming days, but it’s for all diabetes.

Dr. Edelman: Thank you for this. In closing, to every company on that screen [of sponsors] – and to the others who avoided donating – I appreciate you working to make world of diabetes better. It’s way important and it does take a village. Diabetes is so individualized, in not just type 1 but also type 2. I also want to give a quick BIG thanks to the TCOYD staff here.

Finally, Kelly, you didn’t ask us what advice we have for payers. I want to finish up with my advice: go to hell. [Laughter]

--by Helen Gao, Emily Regier, Manu Venkat, and Kelly Close