CWD FFL (Friends for Life)

July 5-7, 2017; Orlando, FL; Highlights – Draft

Executive Highlights

Adam returned last week from another uplifting Friends for Life conference at Disney World in Orlando, Florida– Jeff Hitchcock, Laura Billetdeaux, and the entire CWD team continue to outdo themselves! This was the 18th annual edition, and the content continues to ambitiously expand to hit a wider audience (Spanish track) and a larger breadth of sessions (research, tech, psychosocial, complications, etc.). See below for some of our favorite highlights!

Top Six Highlights

1. In his annual Bionic Pancreas update, Dr. Ed Damiano shared updated (delayed) launch timing: pivotal trials starting in 2H18, with a possible insulin-only launch in late 2019 (about a ~9-12 month delay). He also unveiled the next-gen integrated iLet device with several key hardware upgrades and showed the first-ever smartphone/watch companion app screenshots (developed by newly hired John Costik of Nightscout fame).

2. What we noticed in diabetes tech observing attendees around FFL: (i) a notable 95%+ of Adam’s teen presentation attendees were on pumps and ~2/3 were on CGM (Dexcom, Insulet, and Tandem seemed to be dominant devices); (ii) remote monitoring was consistently touted as the biggest pediatric/parent gamechanger; (iii) there seemed to be little uptake of the MiniMed 670G (not approved for peds, and Medtronic was not present in the exhibit hall); (iv) several were using DIY automated insulin delivery systems or planning to; and more.

3. In the diaTribe Panel Discussion Dr. Irl Hirsch, Dr. Bruce Buckingham, dQ&A CEO Richard Wood, JDRF Senior Scientist Dr. Frank Martin, and our own Adam Brown touched on best practices for families with diabetes, sharing CGM data, the daunting task of choosing a new device, the power of CareLink and improvements with Tidepool, the disturbing state of being an endocrinologist and the shrinking pipeline of fellows, diabetes research, and beyond.

4. Educator extraordinaire Gary Scheiner shared several nuggets on maximizing CGM and analyzing the data that comes from it, including his favorite CGM stats (mean, time in/above/below range; standard deviation); key ingredients for CGM success; views on Medtronic vs. Dexcom CGM calibration, the “most accurate” meter (Contour Next), etc.

5. The incomparable Dr. Irl Hirsch won the Children with Diabetes Friends for Life Distinguished Service Award. With his classic humility, Dr. Hirsch was totally surprised on stage in front of the excited dinner banquet crowd (cowboy hats included!).

6. The always-great Dr. Des Schatz reprised his ADA presentation on Diabetes at 212 Degrees, urging greater patient advocacy (a la the HIV/AIDS movement) and memorably calling diabetes “the global warming of healthcare – another calamity in the making.”

Top Six Highlights

1. Bionic Pancreas Update: Pivotal Trials Now in 2H18, Possible Insulin-only Launch Pushed Back to End of 2019; Significant Hardware Upgrades for iLet; First Mobile/Watch App Screenshots

In his annual Bionic Pancreas update, Dr. Ed Damiano shared updated (delayed) insulin-only pivotal/launch timing (back ~9-12 months), unveiled plans for a next-gen integrated iLet device (57% smaller) with several key hardware upgrades, and showed the first-ever smartphone/watch companion app screenshots (developed by recent hire John Costik of Nightscout fame).

  • iLet insulin-only pivotal trial and launch timing has been delayed by ~9-12 months: the current plan is to start the insulin-only AND bihormonal Bionic Pancreas pivotal trials in 2H18, which is back ~9-12 months from the previous insulin-only plan (“late 2017/early 2018”). Assuming things go well, an insulin-only FDA submission is possible in mid-2019, with a possible launch as early as the end of 2019 (assuming a quick FDA review). An insulin+glucagon system could launch “18-24 months later,” meaning sometime in 2021. (Approval of a commercial, bihormonal, drug-device combination will require a chronic exposure study, so launch the timing is less certain here.) A significant portion of the bihormonal pivotal trial is NIH funded, de-risking a big piece of commercialization; Dr. Damiano did not comment on insulin-only pivotal trial funding. With this update, the pivotal studies will now more or less progress in parallel (but as separate studies), rather than the previous staggered approach with a 9-12 month head start for insulin-only. Dr. Damiano reminded attendees that Beta Bionics has been collaborating with Zealand to test its dasiglucagon analog in the iLet device – a trial in the actual iLet integrated device is expected in early 2018, with an FDA IDE submission in 4Q17. Near term, the focus is on an insulin-only bridging study in 4Q17-1Q18, allowing a final move from the iPhone-based research system to the integrated iLet commercial platform. Dr. Damiano was honest about the delays and positioned them as a learning experience for the young company, particularly as it transitions into a commercial and hardware-building stage: “Our timeline has slipped. We underestimated the project and our contract manufacturers did too. However, it’s important to be ambitious.”
  • Dr. Damiano also unveiled pretty significant hardware improvements for the fully integrated iLet device, a key step to modernize the experience and stay competitive. The new iLet (now a fourth-gen prototype) is 57% smaller than the previous planned version (just 80 cm3 and thinner than the t:slim), brings the same large capacitive touchscreen display area as the third-gen iLet, embeds dual-mode Bluetooth and a rechargeable battery (the hope is an inductive charging pad, not a cable), and will add significant improvements to manufacturability, durability, serviceability, and water resistance. It has the same Tidepool-developed user interface that Dr. Damiano has shown in past years with the second-gen and third-gen iLet. See pictures of a prototype of the new fourth-gen iLet planned below, which Dr. Damiano hopes will be operational by the end of the year.
  • The iLet will use Novo Nordisk’s 1.6-ml, prefilled, glass, PumpCart cartridge in Europe. Users will also have a manual fill option that would accommodate either investor Novo Nordisk’s Novolog in the US or investor Lilly’s Humalog in the US and Europe. Notably, Novo Nordisk assisted Beta Bionics in the development of the iLet ready-to-fill glass cartridge so that it would be virtually identical to the glass prefilled PumpCart. It’s impressive to see the public benefit corporation working with both insulin giants, who both sit on its board of directors.
  • The iLet’s smaller 1-ml glucagon cartridge will only come in a prefilled version and will be manufactured for the bihormonal bridging study on a cartridge fill-line developed by Zealand. Use of a 1ml prefilled glucagon cartridge is one of several ways Beta Bionics has worked to prevent users from accidentally putting glucagon or insulin in the wrong chamber. The insulin-only and insulin+glucagon versions of the iLet will be identical, since the device can automatically recognize when a drug is not in the chamber – upon launching the insulin-only version, Beta Bionics will place an aluminum cap over the glucagon chamber. Once the iLet is approved for use with a stable glucagon, users will be able to add the second hormone if they wish.

 

 

  • Beta Bionics recently hired John Costik of Nightscout fame to build out mobile and watch companion display apps for the iLet – what a coup! The pictures below were the first we’ve ever seen of the iLet mobile platform, which looks terrific and definitely resembles some of the beloved Nightscout user interfaces. These display apps will allow users to check on system status without having to pull out a pump, while caregivers will have remote monitoring capabilities – both are great moves to keep up with Insulet and Tandem’s near-term plans for display apps (Medtronic must have this in the pipeline too for the 670G, but no timing has been shared). Mr. Costik serves as Senior Software Engineer at Beta Bionics.

  • For the first time, Dr. Damiano mentioned that Beta Bionics is “very interested in Europe and other markets.” No further details were shared in this area, but this is a lot to take on for a small company.
  • Dr. Damiano did not show dedicated pictures of the planned dual-cannula, dual-tubing infusion set, but did reference “new” designs. The team has worked to improve human factors and ergonomics, though we did not get a chance to see them up close in the Beta Bionics booth in the exhibit hall the following morning. We’ll be fascinated to see how this goes, since infusion sets are often an underappreciated and mission-critical component of closing the loop.
  • The Beta Bionics team is now 16 people (soon to be 17), roughly doubling since this time last year. The public benefit corporation seems to be transitioning into a more commercial stage, pushing the hardware forward and thinking more about design needs that will be competitive in the market – this is a very good sign in our view. It also might imply that the updated timeline will be more accurate and realistic, since the team continues to get a better handle on the hardware and path forward to a launch.

2. Teens and Parents on Diabetes Tech – Our Observations from the FFL Hallways and Sessions

Friends for Life always offers a great look into what’s happening with devices “on the ground” in young patients and engaged parents; here’s what we observed in the hallways and sessions.

  • Adam spoke to the teens twice about diabetes technology (see his slides here), with a notable 95%+ of the room on pumps and a good two-thirds wearing CGM. Dexcom’s G5 CGM and Insulet and Tandem pumps seemed to be the dominant devices, at least from those we saw. There was the most excitement among teens for Dexcom’s improved one-button inserter (we expect this will come with G6 at this point, but we should hear an update on the August call) and Abbott’s FreeStyle Libre. One young attendee was actually wearing Libre and shared how much she loved it with the entire room. Another teen reminded Adam that it’s not all about smaller hardware – after showing the blue-colored Dexcom/Verily transmitter pictures, a very young teen asked, “Will it come in other colors than blue?”
  • We ran into scores of parents touting remote monitoring as a tremendous game changer for their families – in our view, every product is going to need this to see optimal pediatric penetration. Indeed, several parents were hesitant to go on the MiniMed 670G, simply because they don’t want to give up Nightscout or Dexcom Share. Medtronic has not yet shared specific timing on Bluetooth and remote monitoring for the 670G, though we have to imagine this is in the near-term pipeline and will be a critical pediatric enabler.
  • We only met one attendee on the MiniMed 670G (as a reminder, it’s only approved for 14+ years), and for the second straight year, Medtronic was not present in the exhibit hall. The 670G’s lack of pediatric approval probably plays a role, but can’t be the only reason for this absence.
  • Several adults and kids were using the do-it-yourself “Loop” iPhone app (with Dexcom CGM, an old Medtronic pump, and a Riley Link) or planning to get on it. “Are you looping?” was a common question in the hallways, and those Adam talked to were very eager to see the Loop user interface on his phone and understand how it worked. Patients’ fascination with this app is on the level that we often see when people see FreeStyle Libre for the first time.
  • Bolusing from a smartphone remains a highly desired improvement – patients’ and parents’ eyes would light up as Adam explained this feature to anyone asking for a demo of Loop.
  • The upper arm was a highly popular wear location among Dexcom CGM and Insulet OmniPod users at FFL. Of course, this is not an “FDA approved” location for the Dexcom, but patients are doing it anyways. (Abbott clearly saw the potential here with FreeStyle Libre.) Separately, we saw one sensor on someone’s calf (!), another on a forearm (!), and still others talked about wearing CGM on their upper back! It’s great to see this variety and another reminder that engaged patients will go far beyond the label to find what works for them. It will be fascinating to see how this “I’m-going-to-do-what-works-for-me” trend transfers to automated insulin delivery – what creative solutions will patients come up with to work around system safeguards? (e.g., making systems more aggressive by changing baseline parameters).

3. diaTribe Panel Discussion – Drs. Buckingham, Hirsch, Martin, Richard Wood, and Adam Brown on New Devices, Families Best Practices, Endocrinology, and More

In the diaTribe Panel Discussion Dr. Irl Hirsch, Dr. Bruce Buckingham, dQ&A CEO Richard Wood, JDRF Senior Scientist Dr. Frank Martin, and our own Adam Brown touched on best practices for families with diabetes, sharing CGM data, the daunting task of choosing a new device, the power of CareLink and improvements with Tidepool, the disturbing state of being an endocrinologist and the shrinking pipeline of fellows, diabetes research, and beyond. See our favorite quotable quotes below, and read the detailed section for a more comprehensive recap.

On Devices, Diabetes Data, and Research

  •  “At the end of last year, our clinic had 3,800 patients and did over 10,000 visits a year. 50% of our patients are type 1, and of those, 60% are on pumps. And it’s my prediction that in the next 2-3 years, CGM will be more than pumps – because we now have reimbursement in the Pacific Northwest.” – Dr. Hirsch
  • “Unfortunately, when you look at data, still only about 20% of people with type 1 diabetes are using a CGM. The big group that’s really seeing a lot of CGM use are those less than 6 years old – now the parents have sharing and remote monitoring. If you have a little kid in preschool, that’s really important.” – Dr. Buckingham
  • “From the physician’s point of view, CareLink has made Medtronic the king because of the data I can see about my patients. It’s the data. And especially with the CGM, but even without it, I can see how my patients are thinking, and I can help them, especially those who are having trouble…The good news is that Howard Look at Tidepool, which gets funding from JDRF, has developed something for other devices to combine pump and CGM data. It’s evening the playing field between the different pumps, and it hasn’t fully happened yet, but it’s getting close. And once that happens, then from my point of view as a physician, it doesn’t matter what pump you choose. When the information goes into the cloud and we can see the data, it’s so powerful from a doctor’s point of view.” – Dr. Hirsch
  • “I have totally relied on CareLink software. Software from the other companies has not been great and doesn’t give you good integration with data. It’s very helpful as a provider to have that. I happen to live in the same town as Howard and so we have Tidepool too – it’s been a game changer in terms of taking people on different pumps and sensors and integrating the data. – Dr. Buckingham
  • “With closed loop, now we’re going down to 5-6 year-olds. At the end of this month we’re doing 2-6 year olds in closed loop.” – Dr. Buckingham
  • “When people come ask me, ‘What pump should I get,” I tell them to wait as long as possible – when you get a pump, you’re locked in for four years. Right now, there is only one hybrid closed loop option on the market (Medtronic’s MiniMed 670G). In the next 2-3 years, there are going to be several more closed loop options available. As David Lee Strasberg said to me earlier today, “You want to be a free agent in the 2019 season.” It’s such a big decision to get a new pump, and companies are moving faster in terms of innovating. But when you’re locked in for 4 years it’s a very tough model for those of us with diabetes. I’m excited that companies are also working on remote software updates for pumps (e.g., Tandem), meaning these decisions are going to become much easier.” – Adam Brown
  • “We’re seeing plenty of change in the attitudes of companies. It used to be: ‘what can we do to get glucose data onto our pump?” Now it’s more like ‘what can we do to get more pump data onto the CGM?’ The idea of the pump being the central repository of everything you know about your diabetes: we’re kind of leaving it behind.” – Richard Wood
  • “The biggest gap probably is with the MDI patients, since I can’t see the insulin. That’s about to change, it hasn’t yet, but we’re going to have Bluetooth enabled smart pens. There are many companies working on them, and Companion Medical in San Diego has one that is FDA cleared. I want to see the information and data.” – Dr. Hirsch
  •  “One of the most important things about scientific research is proving it’s true in human samples. What we’ve learned in a mouse doesn’t translate into a human. We’ve cured type 1 in a mouse almost 1,000 times. So we rely very heavily on samples from patients. That’s really important to the research.” – Dr. Martin

On Best Practices for Families

  • “The number one [best practice for families with type 1], by far, is having diabetes discussed. The biggest problems in adults with type 1 are the patients who keep everything to themselves and never talk about it. We know all the medical issues are important, but there are also emotional issues. Those are sometimes never discussed. What I often do is for the next appointment I bring in the other family members. People do better as a team than as individuals.” – Dr. Hirsch
  • “Another thing that helps bring people together is the sharing of Dexcom CGM data. I encourage the spouse, or even the children and grandchildren, to share glucose data…On the adult side, too many adults don’t want to talk about it. Or they only talk about it when they come in or there’s a bad low and they have to talk about it. Not enough families are open enough with the rest of the family.” – Dr. Hirsch
  • “Having a child diagnosed with diabetes is a huge emotional sledgehammer. Most families come together – they start working together, problem solving, and figuring out a routine. In a few families, diabetes tears them apart, and there are even slightly higher rates of divorce. The same thing happens in pediatrics as for adults. Kids who try and hide it and keep it to themselves and try to check without others seeing, have many more difficulties. We try to get kids from the beginning to present to their class, teachers, etc. that they have diabetes, and that there is nothing to hide.” – Dr. Buckingham
  • “We have a question that we ask people every year: “Is your diabetes management better this year than last year, or worse?” And it’s encouraging to see that over the years, the mix of the answers has moved from 25% worse/25% better/50% same to something more like 13% worse/37% better/50% same. The technology we have now is clearly making a difference. In our panel, we have about 800 people on CGM and about 1,500 on pumps, so it’s a pretty savvy group. One of things that struck me reading through the “better” comments was the power of independence…This quote from a 12 year-old on his diabetes doing “better” really illuminates a key part of what Bruce was just talking about. He said: “I’m more independent with my diabetes management. I am making dosing and correction choices. It makes me feel strong and free.” When I looked through the responses, that word ‘independence’ kept popping up, and of course it’s the technology that makes it possible. But on the flip side, “Every day is Groundhog Day with diabetes” – it’s a marathon and a continual challenge. And sadly, some parents are still really struggling with inadequate tools. One comment stood out: ‘We’re still fighting highs and lows - still testing 12-15 times a day - we can’t win at this game.’” – Richard Wood
  • “At JDRF, we have developed a tool called Clinical Trials Connection. You can go on there and enter your data, the time of your diagnosis, and your location, and it will tell you the trials that are available near your child.” – Dr. Martin

On the Endocrinology Field

  • “Many of the patients I have seen for 20-25 years with diabetes, and at the end of the visit, they thank me. I don’t think a day goes by where I get half a dozen hugs. 20-25 years ago, 8% of my patients were on Medicare. The population is now 30% Medicare – I’m taking care of a geriatric population, and that is a good thing, but it’s also a new problem and there is not a lot of research on this population.” – Dr. Hirsch
  • “We started new fellows this last week, and we can’t fill our fellowship positions anymore. I don’t want to get into the politics, but my concern is the NIH trained fellows might go away. Everyone’s really worried about what will happen in the next few months – I’m really concerned about the next 20 years as we see few physicians going into the field. It’s a very scary world we’re living in right now.” – Dr. Hirsch
  • “Endocrinology is the third lowest compensated specialty in the United States. That means if you go into 2-3 year endocrine fellowship, after those 2-3 years, you get rewarded by making less money. These kids coming out of medical school are $200,000 in debt. It’s a big problem that no one has really addressed. – Dr. Hirsch
  • “People go into endocrine for altruistic reasons – they do not do it to make money. The problem is we do not have enough young doctors going into endocrinology. Fellowships across United States in pediatrics are also not being filled. There is not a pipeline to replace us.” – Dr. Buckingham
  • “I am always blown away by how hard people in diabetes work, especially endocrinologists. I think when you’re the person with diabetes and you’re frustrated by your endo, it always helps me to remember what doctors have to do every day – and how much of their time they spend not doing the face-to-face care, but simply admin that keeps the system moving. – Adam Brown

4. Gary Scheiner on CGM: Favorite Stats, Ingredients for Success, Calibration Tips on Dexcom vs. Medtronic, Data Analysis, Issues with Predictive Alerts and Threshold Suspend

Educator extraordinaire Gary Scheiner shared several nuggets on maximizing CGM and analyzing the data that comes from it, including his favorite CGM stats (mean, time in/above/below range; SD); ingredients for success; views on Medtronic vs. Dexcom CGM calibration (2-4 times per day vs. 1-2 times per day), and beyond. See below!

  • Mr. Scheiner’s favorite CGM stats are: mean average glucose (“much more helpful than a meter’s average glucose,” since fingersticks have a bias to be taken at certain times like pre-meal); time above, below, and in range; and standard deviation. As he has in the past, Mr. Scheiner said he likes to see a standard deviation that is less than 1/3 of the average glucose – this indicates little variability. He did not comment on a target time-in-range that he shoots for, though Dr. Buckingham separately has said 70%+ time-in-range (70-180 mg/dl) is what he likes to see in closed-loop studies, with <2% in hypoglycemia <70 mg/dl.
  • CGM Ingredients for Success: Have the right expectations; Wear the CGM at least 90% of the time; Look at the monitor 10-20 times per day; Do not overreact to the data – take IOB into account; Adjust your therapy based on trends/patterns; Calibrate appropriately; and Minimize nuisance alarms. We wonder which of those drives the worst experiences with CGM, which will be best addressed with better product design (e.g., factory calibration), and which need far better education. This will be especially critical as CGM starts moving beyond early adopters into more of a mass market.
  • “With Medtronic’s CGM, you do need to calibrate four times per day. With Dexcom, two per day is all you need – first thing in the morning and last thing at night. If you only do one per day with Dexcom, that’s okay much of the time.” Mr. Scheiner did not otherwise comment on the accuracy of Medtronic’s new Guardian Sensor 3, but this recommendation was in line with the label. 
  • He urged use of an accurate meter for calibration, calling Ascensia’s Contour Next the “most accurate” – almost always within 10% of the lab value. Conversely, Mr. Scheiner criticized J&J’s One Touch Ultra meter as fairly inaccurate, with values within 10% of the true value ~67% of the time (“that means you are getting significant errors in one out of three tests”).
  • For adjusting insulin doses based on trend information, Mr. Scheiner recommends a +25 mg/dl addition to the current value with one rising trend arrow, and a +50 mg/dl addition with two trend arrows.
  • Regarding alerts, Mr. Scheiner was clear that everyone must balance benefit vs. nuisance. He recommended a low alert at least 80 mg/dl and a high alert starting at 300 mg/dl at CGM initiation and titrating down (Gary uses 200 mg/dl, which was still fairly high for the engaged users in the room – we usually see 140, 160, or 180 mg/dl as high alerts).
    • He was also skeptical on the value of predictive CGM alerts, noting high potential for false positives – the current predictive alerts assume glucose will continue to change at the same rate as it has, which is not always the case. (We’d note that the combination of projected CGM glucose + insulin on board tends to be much more accurate, which is what we’ll see with hybrid closed loop systems and hopefully CGM + smart pens + decision support.) The one predictive alert exception that is “potentially useful” is the rate of change alarm for >3 mg/dl/min fall rate – this can help prevent lows, since it would indicate a 60 mg/dl drop (or more) within 20 minutes.
  • Mr. Scheiner was not particularly enthusiastic about threshold suspend (MiniMed 530G, 630G): “It has some potential value if you live alone or have severe lows or hypoglycemia unawareness. However, false positives are common. For your ‘garden variety lows,’ you don’t want to treat them by shutting the pump off.”
  • “CGM turns mountains in molehills – it allows you to fix things before you are excessively high or low.” We liked this way of putting it, and it’s also a reminder that CGM is a tool, not a therapy – to get maximum benefit, the user must react in real time and change insulin dosing/eating accordingly.
  • In terms of analyzing CGM data, “Do not go into this with an open mind. Have an agenda and know what you are looking for.” Mr. Scheiner goes in with the following list of objectives – we wonder if this would make a nice checklist for clinicians, or even enable far more actionable automatic pattern recognition once CGM data is combined with insulin data across all devices.
    • Are bolus amounts appropriate (meal doses, corrections).
    • How long do boluses work?
    • What is the magnitude of postprandial spikes?
    • Is the basal right?
    • Hypoglycemia patterns – what precedes and follows them?
    • How does exercise affect blood glucose? Immediate, delayed
    • (If applicable) Is amylin/GLP-1 doing the job?

5. Dr. Irl Hirsch Wins CWD’s FFL Distinguished Service Award

The incomparable Dr. Irl Hirsch won the Children with Diabetes Friends for Life Distinguished Service Award. With his classic humility, Dr. Hirsch was totally surprised on stage in front of the excited dinner banquet crowd (cowboy hats included!). We cannot think of anyone that fights harder for his patients – congrats Dr. Hirsch!

6. Dr. Des Schatz on Diabetes at 212 Degrees – What Can We Learn From HIV/AIDS?

The always-great Dr. Des Schatz reprised his ADA presentation on Diabetes at 212 Degrees, urging greater patient advocacy (a la the HIV/AIDS movement) and memorably calling diabetes “the global warming of healthcare – another calamity in the making.” He reviewed some of the grim statistics on rates of diabetes growth and noted the financial hardship many families are now facing: “Insulin is not a luxury drug.” Dr. Schatz highlighted the ADA’s Stand Up for Affordable Insulin petition, which has an impressive 250,000+ signees and aims to increase transparency in insulin pricing. He was cautious, however, to note that industry profits have gone down at the same time insulin prices have gone up (“I didn’t even know what a PBM was!”). Dr. Schatz called on everyone in the room to be an advocate, especially given the enormous NIH funding discrepancies for diabetes ($34.71/patient) vs. cancer ($371) vs. HIV/AIDS ($2,500).  

Detailed Discussion and Commentary

diaTribe Panel Discussion

Bruce Buckingham, MD (Stanford University), Irl Hirsch, MD (University of Washington), Frank Martin, PhD (JDRF), Richard Wood (dQ&A), and Adam Brown (Close Concerns)

Adam Brown: Thanks to everyone for coming! Our goal with this panel is to give you some actionable takeaways that you can use in your/your family’s daily life with diabetes. To start, can each of you introduce yourself, tell us what you spend most of your time doing, and what the best part of your job is?

Richard Wood (CEO, dQ&A): I’m Richard Wood and I lead dQ&A, a diabetes market research company based in San Francisco. Our goal is to amplify the voices of people with diabetes and relay what they are experiencing to the companies that make products. We want to see devices that are more user friendly and more effective. We have a panel of over 10,000 people with diabetes, including hundreds of parents that take surveys on behalf of their children.

Dr. Irl Hirsch: My name is Irl Hirsch. I work at the University of Washington in Seattle where I am a physician and medical director of a large academic diabetes clinic. Our patients are all adults, though we are starting a transition clinic as we speak, which we are very excited about for the teenagers. At the end of last year, our clinic had 3,800 patients and did over 10,000 visits a year. 50% of our patients are type 1, and of those, 60% are on pumps. And it’s my prediction that in the next 2-3 years, CGM will be more than pumps – because we now have reimbursement in the Pacific Northwest. It’s weird to be able to say that, and I couldn’t say that a few years ago. I myself have had type 1 diabetes for over 50 years. My brother Jim Hirsch also has diabetes, as does my nephew has diabetes. I spend 40% of my time seeing patients, the rest doing research and other administrative things. I absolutely love what I do. I’m involved in many things with Bruce, who is sitting to my right. I work in both type 1 and type 2, including on technologies, and my problem is I have way too many interests. We also see lot of patients with type 2 diabetes, genetic forms of diabetes, pancreatic forms, fibrosis – that type of thing. The best part of what I do is that I’ve been at the University of Washington for now my 28th year. Many of the patients I have seen for 20-25 years with diabetes, and at the end of the visit, they thank me. I don’t think a day goes by where I get half a dozen hugs. 20-25 years ago, 8% of my patients were on Medicare. The population is now 30% Medicare – I’m taking care of a geriatric population, and that is a good thing, but it’s also a new problem and there is not a lot of research on this population. We don’t know much about T1D in the elderly population, but we’re working on it, and that’s become one of my research interests. So it’s clearly the best seeing the same patients over the years, over the decades, and now I’m taking care of many bi-generational patients – women get pregnant and now I’m taking care of their kids. It’s been a lot of fun.

Dr. Bruce Buckingham: I’m Bruce Buckingham, and I’m a pediatric endocrinologist, I’m at Stanford. I started out taking care of kids with diabetes back in the 70’s – that was before blood testing, before meters, before pumps. And I have become involved in the technology, really seeing each one of these advances really begin to make a difference. Coming to Stanford, I have been looking at continuous glucose monitoring. I used to come to CWD conferences and talk about the Glucowatch – it just seemed like if we had a glucose reading every 5 minutes, it would be transformative. Unfortunately, when you look at data, still only about 20% of people with type 1 diabetes are using a CGM. The big group that’s really seeing a lot of use are those less than 6 years old – now the parents have sharing and remote monitoring. If you have a little kid in preschool, that’s really important. And recently, we’ve been taking that information and applying to a pump. The concept was always to take the burden away. People would not have to carb count and you could just sit down and eat. You wouldn’t get perfect glucose control, but it would be good enough to prevent long term complications and keep people from severe lows. In the last few years, I have been doing closed loop studies, starting at diabetes summer camps – first the MiniMed 670G study in 2014 in diabetes summer camp, then we moved to Airbnbs, and now we’re going down to 5-6 year-olds. At the end of this month we’re doing 2-6 year olds in closed loop. It clearly makes a difference in control overnight, and you can really get good control by the morning. I feel very fortunate to have seen this happen. I put my first kid on a pump in 1979, and it’s been a nice ride. I used to see kidney disease and renal transplants in our pediatric clinic in 17 and 18 year olds. I’ve really seen a huge difference.

Adam: A quick show of hands, how many of you in the room are on the 670G or thinking about going on the 670G?

[No hands go up.]

Adam: How many of you are on a DIY systems like Open APS or Loop? Or if you’re not on one, how many of you are thinking about trying one of these DIY systems?

[About 10 hands go up.]

Dr. Frank Martin: I am a senior scientist at JDRF. I’ve been there for about three years now. My background is around discovery research. I used to work in a lab at different companies. At JDRF, I focus on discovery research around beta cell survival – we’re looking for drugs to camouflage the beta cells from the immune system, to change the way the immune system is functioning, and also to improve the proliferation of beta cells. We’re trying to develop drugs that will increase beta cell mass, and we see a lot of exciting research. There’s about 13 people like me, PhDs, who work for JDRF and manage over 600 projects that are funded by JDRF research scholars. Those are mostly in the preclinical research – high in the sky ideas. Some of them are more late-stage where we have a lot of data. Some of those are in clinics. Probably the most exciting thing for me is as a PhD I don’t do research anymore myself, but I stand on shoulders of giants like Irl and Bruce here. But I get to see what everyone is doing, and we get to identify and support the best and brightest scientists with the most innovative ideas that will hopefully prevent, cure, and treat diabetes. One thing I really enjoy is seeing senior scientists all sort of center on the same findings, but they don’t know what the other are working on or finding. That’s what tells us there’s probably truth in that finding. And what people like me do is bring those people together to accelerate research, and then start identifying pharma companies who are interested in continuing research. JDRF doesn’t have the funds to develop new products. We need pharma partners to get interested in type 1 diabetes and in developing drugs. It’s been pretty exciting!

Adam: How many of you have raised money for JDRF or been involved with JDRF?

[About 25 hands go up.]

Dr. Martin: How many people have participated in a clinical trial?

[About 10 hands go up.]

Dr. Martin: How many of you have given samples to researchers?

[A few hands go up.]

Dr. Martin: One of the most important things about scientific research is proving it’s true in human samples. What we’ve learned in a mouse doesn’t translate into a human. We’ve cured type 1 in a mouse almost 1,000 times. So we rely very heavily on samples from patients. That’s really important to the research.

Adam: I am a senior editor and columnist at diaTribe.org. I have had diabetes since 2001. I like to say I “moonlight” at diatribe, since I volunteer my time. My day job is at a company called Close Concerns. It’s my role to follow diabetes technology really closely. I try to understand what different companies are doing, test products, write about them, follow them, go to conferences, go to regulatory meetings, and write reports on that. I’m very steeped in diabetes technology and writing about it every day. My writing in diaTribe is based on my personal experience living with diabetes, and it’s typically focused on food, mindset, exercise, and sleep. I just published a book, Bright Spots & Landmines: The Diabetes Guide I Wish Someone Had Handed Me, that shares all the most helpful advice and tips I’ve learned in these four areas. Dexcom purchased enough books to give every family here a copy; go to their booth and get one. 

Dr. Buckingham: [Pulls out a copy of Bright Spots & Landmines] Adam, I wanted you to sign it for me.

Adam: [Signs book]

Dr. Buckingham: [jokingly] That’s your signature? [Laughter] This is a great quick read; I read it on the plane over here. It’s a very, very helpful book.

Adam: Thanks Bruce! Okay the first question I have for you is about families: some cope really well with type 1 diabetes, and others find it a struggle. What sets apart the families that do really well with type 1 diabetes? What’s the secret?

Dr. Hirsch: I see hundreds, maybe thousands of families. It’s very interesting the differences I see between type 1 and type 2 with coping issues. The number one thing, by far, is having diabetes discussed. The biggest problems in adults with type 1 are the patients who keep everything to themselves and never talk about it. We know all the medical issues are important, but there are also emotional issues. Those are sometimes never discussed. What I often do is for the next appointment I bring in the other family members. People do better as a team than as individuals. another big issue I see is women in pregnancy. During pregnancy there are two people needed, at minimum, helping to manage diabetes in the ladies. But what happens when the pregnancy is over and now the husband/spouse gets a free pass. It’s not his problem anymore. I see that so often and what I try to do is bring them back. There are occasions where the wife doesn’t want the husband in her space. But more often than not, the spouse should be in the diabetes space. WE talk about science and tech and the cellular level, but this issue is even more important. Another thing that helps bring people together is the sharing of Dexcom CGM data. I encourage the spouse, or even the children and grandchildren, to share glucose data with their grandma, their mother, their spouse. When they share that, all of sudden they are getting woken up at 3 am. Now the diabetes is shared. There’s just so much to talk about. On the adult side, too many adults don’t want to talk about it. Or they only talk about it when they come in or there’s a bad low and they have to talk about it. Not enough families are open enough with rest of family.

Adam: How many use Dexcom Share? How many have found it helpful?

[Almost every hand in the room goes up.]

Dr. Buckingham: Having a child diagnosed with diabetes is a huge emotional sledgehammer. Most families come together – they start working together, problem solving, and figuring out a routine. In a few families, diabetes tears them apart, and there are even slightly higher rates of divorce. The same thing happens in pediatrics as for adults. Kids who try and hide it and keep it in and try to check on their own have many more difficulties. We try to get kids from the beginning to present to their class, teachers, etc. that there is nothing to hide. It’s something to live with. To teach others. To be ambassadors and to help other people understand. In very young kids, sharing is a no brainer. But I think when you get to an adolescent stage, you realize how long can you be low or high before they’re going to contact you. In adolescence – some people say they are a different species for a while – they do come around. I think it’s an issue that is specific to different people in different age groups. In a number of closed loop studies, some people share data with someone else for the first time. It’s very important.

Adam: For those of you using Dexcom Share, how many of you set ground rules about how often the parent/caregiver should contact and in what cases?

[Few hands go up.]

Adam: Bruce, what would you recommend for all the people in the room who haven’t set ground rules for CGM data sharing? What should those look like?

Dr. Buckingham: I think you just need to sit down with the person with diabetes that needs to decide when they want someone to contact them. It’s hard if you’re the parent and you see your child is low and not to immediately call them up. But you have to give them some time if they can bring it up on their own – to see if they resolve it on their own. It would be great if everything was integrated, and then the remote monitor could see if they gave the bolus if they’re high. Information is always the key. In pediatrics, the hard part is the transition from a child where the parent completely manages the diabetes, to allow them to be in control – especially since they’re going to be in college.

Richard Wood: To dive into some of our dQ&A research. We have a question that we ask people every year: “Is your diabetes management better this year than last year, or worse?” And it’s encouraging to see that over the years, the mix of the answers has moved from 25% worse/25% better/50% same to something more like 13% worse/37% better/50% same. The technology we have now is clearly making a difference. In our panel, we have about 800 people on CGM and about 1,500 on pumps, so it’s a pretty savvy group. One of things that struck me reading through the “better” comments was the power of independence…This quote from a 12 year-old on his diabetes doing “better” really illuminates a key part of what Bruce was just talking about. He said: “I’m more independent with my diabetes management. I am making dosing and correction choices. It makes me feel strong and free.” When I looked through the responses, that word ‘independence’ kept popping up and of course it’s the technology that makes it possible. But on the flip side, “Every day is Groundhog Day with diabetes” – it’s a marathon and a continual challenge. And sadly, some parents are still really struggling with inadequate tools. One comment stood out: “We’re still fighting highs and lows - still testing 12-15 times a day - we can’t win at this game.” We see quite often in these quotes that people are just struggling with the same tools but are not able to sit back and ask, “How could we do this differently?”

Adam: When those of you in the room think about your diabetes this year vs. last year, how many feel like it’s better? The same? Worse?

[Most hands in the room suggest ‘better’ or ‘same’.]

Adam: I think one question I’ve been feeling here is, “Okay Adam, I’m coming up for a new pump. What device should I get?” Irl and Bruce are going to tell us the answer! [Laughter] For people looking at a new CGM or for their pumps coming up for warranty, what advice do you give that group? It’s a very big decision and often a tough one to figure out what to do.

Dr. Hirsch: It’s a great question and there’s no one answer. I have to think about the point of view – are we talking about me as a physician or you as a patient? Because I get this all the time.

Adam: Ooh, please tell us both!

Dr. Hirsch: For me as a physician... What I’m about to tell you has changed in evolution. What happened was Medtronic many years ago invested a lot of money in their software. Many of you are familiar with Carelink for Medtronic pumps and CGM. Here’s the thing: Medtronic has the vast majority of the market of pumps in the US. From my point of view, it’s a very individual decision for the patient and what he or she wants, but from the physician’s point of view, CareLink has made Medtronic the king because of the data I can see about my patients. It’s the data. And especially with the CGM, but even without it, I can see how my patients are thinking, and I can help them, especially those who are having trouble – e.g., why they’re overriding or underriding bolus recommendations. I can see their glucose levels going up and they’re giving what the bolus calculator is recommending or not. Or I can see they’re always overriding with corrections at dinner time... I can’t see that with other software, I can really tweak the pump settings whether it’s the correction doses, the carb ratios, and it’s based on really good data when I see the patterns. The good news is that Howard Look at Tidepool, which gets funding from JDRF, has developed something for other devices to combine pump and CGM data. It’s evening the playing field between the different pumps, and it hasn’t fully happened yet, but it’s getting close. And once that happens, then from my point of view as a physician, it doesn’t matter what pump. When the information goes into the cloud and we can see the data, it’s so powerful from a doctor’s point of view.

Now from a patient’s POV, it’s an extremely different situation. They don’t care about the data. I get that and I have no problems with that. So it’s a very personal decision. For example. I don’t want to get into the details of each pump, but with the Insulet Omnipod, patients either love it or don’t like it at all. There’s no in between on that. The only thing I want to really know is whether a patient will wear it, and once they see it, we can ask, ‘Is this right for you?’ Each pump has its differences. The Animas pump, for a long time, patients did not really give it up because of the screen and because of the water resistance, but from my point of view, I want you to be happy and comfortable. The second thing that’s very interesting is we’re not quite where we need to be with the sensors – the biggest gap probably is with the MDI patients, since I can’t see the insulin. That’s about to change, it hasn’t yet, but we’re going to have Bluetooth enabled smart pens. There are many companies working on them, and Companion Medical in San Diego has one that is FDA approved. I want to see the information and data. I want to have an app on the phone where everything I see now on these pump downloads I can see on patients who don’t wear pumps. I can’t do that now as a physician.

On a separate note, I want you all to know that you’re not normal, which is a good thing, but you guys are very high up in sophistication, in resources, in affluence. My guess is there is no one in this room who has to struggle about where they’re going to get their next vial of insulin or insulin pen. The things I have to deal – getting enough strips, getting access to CGM – happens with many of my patients. With every patient I have at least one fight in terms of getting stuff they need. And so this group in the room is not the norm which is very fortunate, but the thing that really makes it difficult for me is all of the discussions and fighting I have to have with insurance companies to get people what they need to survive. In a poster we presented at ADA – and we still have to write the data up – was about this issue. For one full time physician, we tallied up the amount of time we have to spend on everything for patients outside of a visit. It’s over 1500 hours! That translates to $28,000 of uncompensated time that involves things you have to do for patients. And so this is a big, big deal. And I take it back to JDRF and NIH - how are we going convince physicians to go into this field to take care of your kids when they’re older adults and then seniors? We started new fellows this last week, and we can’t fill our fellowship positions anymore. I don’t want to get into the politics, but my concern is the NIH trained fellows might go away. Everyone’s really worried about what will happen in the next few months – I’m really concerned about the next 20 years as we see few physicians going into the field. It’s a very scary world we’re living in right now. For people like Bruce and me, we’re not going to be doing this forever. And it’s easier to get things for children than adults. This is a big concern as we get more adjunctive therapies like sotagliflozin, a pill that really does help with type 1 diabetes – it’s very far in clinical trials. That’s going to become a miracle in terms of how difficult it is to get those drugs. By way of comparison, we have three drugs in type 2 diabetes that have shown besides being great drugs to lower blood sugar they also reduce cardiovascular deaths – yet I can’t get those drugs for patients because they’re not covered. The data looks so good that it’ll help blood sugars and CV death, but the problem is three months of that drug costs $1600. These are things were have to look forward to. It scares me.

Adam: How many in the room have tried to get diabetes supplies and had to fight with insurance companies? [About 15-20 hands go up.]

Dr. Hirsch: I had to talk to an insurance company to get someone with type 1 diabetes access to INSULIN! Doctors are saying, “I can’t do this anymore.” I can’t spend 40% of my time fighting with the insurance companies. Now when you graduate medical school you need a pair of boxing gloves.

Adam: As an aside, I am always blown away by how hard people in diabetes work, especially endocrinologists. I think when you’re the person with diabetes and you’re frustrated by your endo, it always helps me to remember what doctors have to do every day – and how much of their time they spend not doing the face-to-face care, but simply admin that keeps the system moving.

Dr. Hirsch: These physician compensation surveys come every year. Endocrinology is the third lowest compensated specialty in the United States. That means if you go into 2-3 year endocrine fellowship, after those 2-3 years, you get rewarded by making less money. These kids coming out of medical school are $200,000 in debt. It’s a big problem that no one has really addressed.

Dr. Martin: JDRF has a department that works with regulatory authorities and insurance companies to try to get reimbursements for pumps and CGMs. We are working on both. As far as stealing people to stay in type 1 diabetes research and care, we have decided that training is a very important thing. About 10%-15% of our budget every year goes to supporting young scientists or young clinicians to keep them engaged in type 1 diabetes.

Dr. Buckingham: People used to go into endocrine for altruistic reasons. The problem is people just aren’t going into it anymore. Fellowships across United States in pediatrics are also not being filled. There is not a pipeline to replace us. All our complaints are because we have a broken health care system. We’re not going to be able to fix that here. What we do for choosing a device  is we have a pump class. We show them all the pumps, where they see them all, and see what they like. It’s the patient’s decision. I 100% agree with Irl, however – I have totally relied on CareLink software. Software from the other companies has not been great and doesn’t give you good integration with data. It’s very helpful as a provider to have that. I happen to live in the same town as Howard Look and so we have Tidepool too – it’s been a game changer in terms of taking people on different pumps and sensors and integrating the data. It’s really nice to have and makes me more open to whatever pump decision is coming up.

We mentioned remote monitoring of CGM data earlier. The story behind that development is one of the vice presidents at Dexcom did a summer camp study of CGM remote monitoring with us. As kids were sleeping in camp, I assigned him to one kid. This gentleman was up all night bringing this kid’s blood sugar up. He recognized that had he not been there, this child had a high risk of having a seizure. I think then he realized that the Dexcom Share project needed to be accelerated.

Adam: When people come ask me, ‘What closed loop should I get,” I tell them to wait as long as possible – when you get a pump, you’re locked in for four years. Right now, there is only one option on the market (Medtronic’s MiniMed 670G). In the next 2-3 years, there are going to be several closed loop options available. As David said to me earlier today, “You want to be a free agent in the 2019 season.” A young girl came up to me yesterday and said, “Adam, my t:slim expires in August.” I told her to use it until it breaks – as long as possible without getting a new pump. Then she told me she has an Omnipod in her closet. “Great!” I said, “Once the t:slim breaks, use your Omnipod until it breaks. [Laughter] By that time, hopefully more systems will be out and you can choose from the full menu.” It’s such a big decision to get a new pump, and companies are moving faster in terms of innovating. But when you’re locked in for 4 years it’s a very tough model for those of us with diabetes. I’m excited that companies are also working on remote software updates for pumps (e.g., Tandem), meaning these decisions are going to become much easier.

Q: I’m coming up on my four years with my pump. Am I correct in saying that CGM technology is accelerating faster than pump technology?

Adam: Yes. With an integrated pump, you are tied to one CGM. If you keep the pump and CGM separate for longer, you can get the latest CGM. I agree with you that CGM is moving faster than pumps. Pumps are about $5000 (depending on the company and insurance), while CGMs are less expensive. The turnover from a business model allows patients to get a new CGM more frequently.

Q: How long until we devices or drugs that require much less user input and burden? Is anything coming soon? Even with closed-loop devices, you still have to do stuff.

Dr. Martin: What we’re working on at JDRF is shrinking the size of devices, perhaps moving towards a dual hormone system. That’s years away right now. As far as insulin independence, that is also years away. But we are working actively on developing drugs. Logistically, I hate to put a timeline on it…

Adam: What about glucose-responsive insulin and SGLT-1/2 inhibitors? I think that’s more what she’s alluding to…

Dr. Martin: Yes, how can we decrease the burden? Metformin, SGLT-1/2 inhibitors, GLP-1 receptor agonists, these can reduce your insulin requirements and possibly improve glucose control. Those are available now.

Richard Wood: Going back to the earlier question, there are a couple of things to consider when you’re looking at a new device and may see claims manufacturers are making or advertising. You will see companies saying, “We have the number one pump recommended by patients or the highest satisfaction numbers.” That data comes from dQ&A straight from those of you in the room. A tip when you’re trying to make choices about diabetes devices: when we ask about patient satisfaction for a diabetes device, it’s usually highest when devices are new, and then it declines. The performance of a device actually does not change. What’s happened with Dexcom is when the Seven Plus came out, it had the highest patient satisfaction rating of anything we had ever seen, until the G4 came out. Then the G4 had the highest patient satisfaction rating; at the same time, the Seven Plus went down. It happens again and again and again. When you see these numbers, look at how long the product has been on the market as well as what the functional information is. It’s just a tip when you’re trying to make those decisions.

On a separate note, we’re seeing plenty of change in the attitudes of companies. It used to be: ‘what can we do to get glucose data onto our pump?” Now it’s more like ‘what can we do to get more pump data onto the CGM?’ The idea of the pump being the central repository of everything you know about your diabetes: we’re kind of leaving it behind.

Q: Dr. Buckingham, you mentioned doing closed loop studies in 2-6 year olds soon. When is that happening and where?

Dr. Buckingham: We’re doing it at a number of centers – Stanford, Indiana, Florida. It’s happening in about 3-4 weeks

Adam: Frank, do you want mention how people can find and get involved in research? JDRF has a great resource.

Dr. Martin: Yes, we have developed a tool called Clinical Trials Connection. You can go on there and enter your data, the time of your diagnosis, and your location, and it will tell you the trials that are available near your child.

Adam: Participating in research is awesome. It’s fun, you get to try new things and often pay more attention to your diabetes, and you get amazing care from people like Bruce and Irl. I would highly recommend doing a trial if you haven’t done one before.

 

--by Adam Brown, Divya Gopisetty, and Kelly Close