Friends for Life (FFL) 2018

July 12-13; Orlando, FL; Highlights – Draft

Executive Highlights

  • Thursday at Friends for Life was headlined by a pair of terrific CEO talks from Beta Bionics’ Ed Damiano and Bigfoot’s Jeffrey Brewer. Both are targeting 2019 pivotals for their insulin-only automated insulin delivery (AID) systems, followed by targeted 2020 launches. We were struck by how both companies are not pushing to commercial products and taking standout approaches to simplify user experience – around system startup, meals, adaptation, prefilled insulin, and much more.

  • In a commitment to interoperability, Beta Bionics announced FDA IDE approval to begin testing Senseonics’s 90-day Eversense CGM in its integrated iLet device, becoming the first AID player working with two commercial CGMs. The first Eversense trial will start in August, alongside the currently running Dexcom trials. Both will pave the way for a 2H19 insulin-only pivotal start (adults and pediatrics), with a 2020 launch goal. We got to hold the much-improved Gen 4 iLet device, which is smaller and sleeker than the currently in-use Gen 3; it really looks like a commercial product. Pooled data comparing Bionic Pancreas outcomes to the T1D Exchange was also fascinating.

  • Bigfoot CEO Jeffrey Brewer made his first-ever FFL appearance, noting a pivotal of the Loop system will start in 2Q19 (14+ years old and up) and that the next-gen Abbott FreeStyle Libre CGM with Bluetooth is coming “sooner than people realize.” Wow, on that last point (Abbott reported 2Q18 results this morning and things are sounding very positive.) Bigfoot’s Inject system (MDI auto-titration) is also expected to launch in 2020. The Inject dose capture device (acquired from Timesulin last year) now has a screen on the smart cap, which has not been shown in recent talks. We were impressed with the first glimpse of Bigfoot’s monthly supplies packaging, as well as its planned portfolio of device offerings ranging from type 2 basal-only (BGM, app, smart pen cap) to AID with a pump/CGM. Many images of the slides are enclosed below.

  • It’s also worth noting these companies’ different approaches: (i) Beta Bionics is focused on clinical data and step-wise studies before its pivotal, while Bigfoot is focused on modeling/simulation to understand edge cases in silico (both approaches have pros and cons); (ii) Beta Bionics is promoting choice through two external CGM partners and multiple hormones, while Bigfoot’s choice is focused within its own portfolio of automation services (BGM, CGM, app, smart pen caps, pump – depending on user needs); (iii) Beta Bionics is a public benefit corporation focused on type 1 diabetes, while Bigfoot has a broader Silicon Valley blend of consumer tech and design; and (iv) Beta Bionics is focused on pediatrics and adults at launch, while Bigfoot is targeting 14+ years to start (pediatrics is a separate product). We hope that both approaches are successful; we certainly wouldn’t bet against either leader!

  • Below, we also include highlights from Dr. Des Schatz on type 1 diabetes prevention/cure, Dr. Korey Hood on psychosocial barriers, and links to slides/live streams from a diaTribe panel discussion and Adam's talks on tech and Bright Spots & Landmines.

We have returned from a packed Friends for Life conference brimming with energy around diabetes technology and the progress on more user-centric, radically convenient product designs. Nowhere was this more apparent than in talks from Beta Bionics and Bigfoot, who both showed their takes on where automated insulin delivery needs to go. See these and more highlights below!

Top Six Highlights

1. Beta Bionics’ Ed Damiano: iLet Insulin-only Pivotal to Begin in 2H19; first use of Senseonics in iLet starting in August; screenshots of system start, meal entry; prefilled Fiasp insulin cartridge

Beta Bionics CEO Ed Damiano shared an updated study timeline for the iLet: an insulin-only pivotal study to begin in 2H19, with an insulin-only FDA approval expected in 2H20 (adults and pediatrics); and (ii) an insulin-glucagon pivotal study start in late 2019/early 2020 and approval targeted for 2022 (with Zealand dasiglucagon). The insulin-only study timing has slipped slightly from the prior April 2019 planned start, though 2020 is the key, as many systems are targeting a launch at that time. Of course, the bihormonal timing could also change meaningfully, depending on guidance from the FDA’s CDER division on Zealand’s dasiglucagon. Dr. Damiano also announced that the FDA has approved an IDE to use Senseonics’s Eversense in the integrated iLet device’s home-use bridging studies (running from now until October), in addition to Dexcom. This is great news and very quick following the initial iLet device FDA IDE approval in May. The press release nicely emphasizes the company’s commitment to interoperability and patient choice, as it’s the only closed-loop system now compatible with two companies’ CGMs – at launch, the plan is both Dexcom G6 and Senseonics’ Eversense. Added Dr. Damiano in the talk, “We’re trying to build a platform that allows people to have a meaningful choice. We now have a system that can give you choice: single hormone, dual hormone, three different insulins (Fiasp, Humalog, Novolog), and two sensors.” We love it!  The first dosing in adults with the iLet using the Dexcom CGM and Novo Nordisk’s Fiasp insulin in the prefilled PumpCart (!) began earlier this month at Stanford and MGH (n-36); children will be dosed with the iLet/Dexcom CGM starting this month; and the first adults will use the iLet/Senseonics Eversense CGM beginning in August at MGH. Notably, the iLet is the only clinical trial ongoing right now testing Fiasp in the prefilled PumpCart – wow! Dr. Damiano had a working prototype of the Gen 4 iLet, which looks outstanding and has meaningfully improved on size, weight, touchscreen, and user experience relative to the current Gen 3 device – see pictures below. The tagline is, “Carry your glucose metabolism in your pocket” – very much harkening to the original iPod’s tagline to “Carry 1,000 songs in your pocket.” Dr. Damiano was wearing both iLet devices on his body, including one driven by a Senseonics’ Eversense CGM that Dr. Steven Russell inserted into his arm – what a guy! Other highlights below include pooled Bionic Pancreas data in adults (outpatient studies so far vs. T1D Exchange outcomes) and encouraging first data from ongoing tests of the Gen 3 iLet.

  • The Gen 4 touchscreen iLet device is slimmer, lighter, and places the insulin and glucagon chambers on opposite sides of the pump (instead of side-by-side in Gen 3). Beta Bionics has hired several former Tandem Diabetes engineers, and the improvement in the iLet’s hardware certainly shows between Gen 3 (left) and Gen 4 (right). The Gen 4 device shown below was not fully operational (only a couple screens were setup), but will obviously get there in the next 12 months for the 2H19 pivotal study start. The Gen 4 iLet will be compatible with manual fill glass insulin cartridge (1.6 mL, Humalog, Novolog) and Novo Nordisk’s Fiasp insulin in the prefilled PumpCart – there is definitely an advantage to having Novo Nordisk as an investor (alongside Lilly and Zealand) and on Beta Bionics’ board of directors! The glucagon cartridge will be 1mL (cannot be mixed up with the insulin chamber) and compatible with Zealand’s pumpable dasiglucagon. The Gen 4 iLet device is inductively charged with a pad – similar to the Apple Watch, this should bring water resistance/proof advantages, since there will be no cable plugins.

    • The user interface truly revolves around the “diabetes without numbers” concept. It’s striking to see how small the CGM value is on the home screen below, which was not commented on but certainly reflects the no-numbers approach to diabetes – set the system and (mostly) forget about it. We think many users will appreciate this.

  • Dr. Damiano ran attendees through the simple iLet Bionic Pancreas startup process: apply and connect CGM, insert insulin cartridge, insert glucagon cartridge (optional), apply and connect infusion set, enter body weight, and GO BIONIC! (The graphic for the latter is a really nice touch.) Though some have criticized the Bionic Pancreas’ bihormonal approach as complicated, we think the team is wrapping it in a beautifully simple design – more on this related to meals is below.

  • The Bionic Pancreas’ qualitative approach to meals is the best we’ve seen in automated insulin delivery system design: (i) answer “Where in your day are you?” (Begin, Middle, End, Sleeping); and (ii) answer “How many carbs you are having? (typical, tiny, small, large). That’s it! No counting and entering carbs is a major advantage relative to other systems. The algorithm adapts over time based on performance. The insulin-only iLet appears to target 120 mg/dl, while the bihormonal system targets a default 110 mg/dl.

  • On the new data front, Dr. Damiano shared pooled data from all the Bionic Pancreas studies to date. We caught a picture of the adult data, shown below, which highlights: (i) average CGM levels based on T1D Exchange A1c data at different ages (18-25, 26-49, >50 years); (ii) the Bionic Pancreas “usual care” control arm (n=121, a self-selected group); (iii) the Bionic Pancreas automating insulin-only; and (ii) Bionic Pancreas bihormonal. The stepwise improvement in mean glucose and % achieving A1c goal (<7%) is impressive: ~171-203 mg/dl in the T1D Exchange (18%-29% at A1c goal) to 161 mg/dl in usual care (42% at goal) to 154 mg/dl with insulin-only (48% at goal) and 140 mg/dl with bihormonal (87% at goal). Hypoglycemia <60 mg/dl, hyperglycemia >180 mg/dl, and standard deviation decline across the board as automation increases. A very impressive graph!


  • Dr. Damiano also briefly flashed n=7 data from the ongoing bridging study, showing the integrated iLet device is delivering very similar outcomes to the previous iPhone-driven research platform. The insulin-only system is targeting 120 mg/dl and thus far has achieved a mean glucose of 145 mg/dl, a remarkably low standard deviation of 10 mg/dl, 1.7% time <60 mg/dl, 23% time >180 mg/dl, and 71% achieving a mean <154 mg/dl (~7% A1c).

2. Bigfoot’s Jeffrey Brewer: 2Q19 Pivotal Trial for Loop; Launch in 2020 for Loop and Inject; Portfolio Includes Slew of T2D Titration Offerings; FreeStyle Libre 2.0 “Sooner Than People Realize”; Nice Packaging

Bigfoot CEO Jeffrey Brewer made his first ever FFL appearance, sharing the Bigfoot story and some never before-seen product portfolio screenshots. He said a pivotal of the Loop system will start in 2Q19 for 14+ year-olds – more specific timing than previously shared (“2019” and “early 2019”) – with a launch ambitiously maintained for 2020. (The company has only run one clinical feasibility study so far with Dexcom CGM; see comments on simulation modeling below.) Bigfoot’s slide design implied a Loop “phased pivotal” might actually initiate in 2018, though that was not stated. The Inject system to titrate basal/bolus insulin for MDI users is also expected to launch in 2020; no pivotal timing was shared. Mr. Brewer said the next-gen Abbott FreeStyle Libre no-calibration CGM with Bluetooth is coming “sooner than people realize.” Whoa – we can’t wait to hear more about its feature set relative to the current Libre! (Will it launch as a standalone mobile CGM prior to Bigfoot’s Loop/Inject?) Interestingly, the Inject insulin dose capture cap (acquired from Timesulin) now includes a screen, which has not been shown in recent talks. Mr. Brewer also showed a very expansive portfolio of Bigfoot offerings, ranging from BGM and a smart cap for basal-only type 2s all the way to the pump-based Loop system with FreeStyle Libre CGM – clearly the company aims to go broad and the AgaMatrix Bluetooth BGM is also going to be part of its offering. (No timing was shared on these other products, which are presumably going to come after Loop and Inject.) We enjoyed a mockup of the monthly Bigfoot supplies packaging, which was all color-coded and looked extremely consumer friendly – it reminded us of PillPack, but for diabetes supplies. The whole system retains the goal of being so easy a PCP could prescribe it, and Bigfoot clearly has the clinician experience top of mind. In Q&A, Mr. Brewer highlighted that the price of the 670G is the “high-water mark of what any insurance company will ever pay for automated insulin delivery. Everything in the future will have to cost less. We’re building a business that will do that.” He even said Medtronic is having to discount the 670G in order to get payers to cover it. See many cool slides and our favorite quotes below.

  • The compelling product vision for Loop remains the same: (i) a smartphone app that will serve as the window to the system and complete closed loop user interface (including meal announcements); (ii) a disposable pump body (Asante) married to a durable controller with an embedded control algorithm; and (iii) a next-gen FreeStyle Libre CGM (factory calibrated) with continuous communication to the pump (i.e., like Insulet’s Horizon, it will remain in closed loop even when the phone is out of range). Bigfoot’s pump does have a single button on the device (purpose not disclosed), as well as an icon display that presumably indicates system status; however, the clear goal is to push as much of the user interface to the phone, meaning most Bigfoot users won’t been pulling the pump out of the pocket and interacting with it. An Ypsomed Orbit infusion set will be used in the pivotal study. We believe Bigfoot’s system will only do basal modulation and will not issue automatic correction boluses.

  • Mr. Brewer showed the most comprehensive Bigfoot “portfolio” ever, ranging from insulin-dependent type 2s on basal-only (smart Inject cap + BGM + app) to those on full AID with a pump/app/CGM and BGM. “I want to promote the most choice and the most benefit in the most technologies, which is going to require a variety of options.” This is the first time we’ve seen this laid out so specifically and so broadly on a slide; talks over the past year have only focused on Loop and Inject (right-most side), with some mentions on Bigfoot’s website that this kind of portfolio was in the cards. We love the scope of what Bigfoot is trying to do to simplify insulin therapy for all; of course, executing on all these pieces will need to be staged, especially because Loop itself is running years behind the initial hope for a 2016 pivotal. In line with previous pictures we’ve noticed on the website, it seems that Bigfoot is using the AgaMatrix Jazz Wireless 2 Bluetooth BGM, which One Drop also uses (with external modifications) for its Chrome/Premium offerings.

  • This presentation offered the closest look yet at Inject, which uses a smart dose capture cap (acquired from Timesulin last June) that fits over disposable pens. No pivotal timing was shared, but it’s presumably running behind last fall’s plan to do a pivotal sometime this year. The cap reads how much insulin is in the pen and sends the data to the phone app, which recommends dose changes based on BGM or CGM trends. The cap now includes a screen; the most recent mockups did not have a screen, including those shown by Bigfoot’s John Sjölund last fall. It appears one color cap will be used for basal and another for bolus insulin. Overall, we’re very glad to see a whole portfolio here from earlier-stage type 2 to full MDI for type 1 and 2 – all these solutions are very much needed. It will be fascinating to see how this system compares to Lilly’s MDI titration offering, as well as what kind of outcomes Bigfoot Inject can deliver relative to closed loop with a pump/CGM. How will Bigfoot price each iteration as complexity/cost increase? How will outcomes differ between the options? How much financial burden will payers vs. patients shoulder? What criteria will push users to one model over another?

  • “We’re going to allow people to transition from shots to pumps gracefully. We’ll tell you how much insulin you need to go back and forth. This switching back and forth is relatively easy with technology. People should not have to be ‘pump’ people or ‘shots’ people.” We like this idea, which is novel in the field. We’re not sure how common this use case is – e.g., is it mostly as a backup for pumpers going on a beach vacation? Or is the swapping back and forth a true market need that more would take advantage of if it was possible?

  • Mr. Brewer showed Bigfoot’s cool packaging for the first time and emphasized the compelling vision of one prescription, one monthly copay, a monthly service model, and in-app home training: “You get as many sensors as you need, as many infusion sets as you need; besides the insulin, it’s one fixed copay and one fixed price for the insurance company. We can design it to work all together. As a Bigfoot customer, you’ll always have the most recent version, and most of the upgrading will happen in the software – over-the-air, on the app or in the firmware on the pump. Training will be in-home – you’ll get a box, open it up, and the app walks you through what you need to know. If you ever need to talk to someone, it’s through the phone. Everything is designed to be easier and simpler. You get better training and more durable training at a self-paced level using the phone and video vs. in front of a person. None of us likes to feel stupid– in person, you get explained something on average 2.5 times before you say, “I got it,” even if you still don’t understand it.”

  • The Bigfoot pump (acquired from Asante) will not need charging or a battery and will continue to use prefilled insulin cartridges – nice advantages over competitors. Secure smartphone communication seems deep into development. Mr. Brewer did not comment specifically on the prefilled piece, though the slide showed Humalog; we assume a Novolog-compatible offering is already done or is in development. (Will it has Fiasp PumpCart compatibility, like Beta Bionics?) The disposable pump body where the insulin cartridge is inserted contains the battery and is thrown out after all the insulin is used. When a new disposable pump is inserted into the controller, it comes with a new battery. The pump will be “splash proof,” but not totally waterproof (e.g., for submerging).


  • To initiate Bigfoot’s Loop system, a user only needs to enter total daily basal dosage; the system automatically configures settings and adapts them over time. This is very exciting and should put Bigfoot’s simplicity on par Beta Bionics’ startup process (only enter body weight). Relative to other systems that tack on automation to an existing pump with traditional settings, both Bigfoot and Beta Bionics are taking radically different approaches – this is a new class of therapy, rather than adding on automation over existing manual therapy. Nice!

  • “FreeStyle Libre is the best use case for us. It bans fingersticks, and we think it’s an opportunity: bad calibrations represent one of the biggest risks to closed loop insulin therapy. Hand washing isn’t always done, alcohol swabs aren’t used, and it’s hard to avoid calibrating when blood glucose is changing. We’re using the second-gen Libre which has Bluetooth and the ability to transmit data wirelessly to the pump.”

  • Notably, Bigfoot estimates 66% of US type 1s are seen by PCPs for their diabetes care, with only 34% seen by endocrinologists. We have not heard this stat before and it was not cited; Bigfoot’s team told us the stat comes from “two different sets of health analytics data we acquired.” If this true, it is absolutely remarkable and certainly thought-provoking for every pump and CGM company. For instance, could this explain why CGM and pump adoption have been so gradual? We’re following up with Bigfoot to learn the source of this statistic.

  • “Infusion set technology is ridiculous. The lack of innovation in sets has been pretty discouraging. At JDRF, that was one of our innovations, and we funded BD to do this. They’ve had some challenges. We’re using an infusion set – both a metal one and a teflon one – from a company called Ypsomed. The Orbit infusion set had limited distribution here in the US, but we did an evaluation, and we think it’s the best of the bunch. But there is substantial need for innovation. Bigfoot 2.0 and 3.0 is going to see some more interesting progress in that regard, but to launch, we’re going to go with the best of what’s out there.”

  • “Bigfoot will be available for adolescents, but the question is timing. Our pivotal will be for 14+ years, but we have a commitment to go as broad as possible. I actually think the pediatric version of Bigfoot is a different product; it’s not the adult version. You are the controller as an adult. When you’re an eight-year old, you have responsibility sharing – is the app on the kid’s phone a different app than the parent? What about the parent and child collaborating? That’s a new system that needs to be tested by itself. We’ve done some thinking and have a preliminary set of ideas, but it needs to be very different. Another example is the nursing home environment, especially as people are living normal lifespans with type 1 diabetes. But as people in nursing homes are dosing insulin, what is the app for that environment? How does that fit into the healthcare ecosystem?

    • Later in Q&A on the same topic of pediatrics: “The key advancements are the ones you can do in software – how can you have remote control over insulin dosing that is safe? You want parent to be keeping tabs on how things are going remotely, but to meaningfully contribute to the care of a child who doesn’t have the skills. There are a lot of meaty design issues to tease out there. We haven’t focused there. We’re focused on the first, broadest launch, and then going downstream. We are very sensitive to this, because a number of us have kids with type 1 diabetes and remember what it was like.”

  • “Everything we do has to live gracefully in the lives of people with diabetes, and then it also has to work with clinicians and payers.” Mr. Brewer later shared a slide with Bigfoot’s goal to hit the “Quadruple Aim” – improving the health of a population (healthier/safer), improving the experience of care (easier), improving per capita cost (accessible), and improving the clinician experience (healthier, safer, easier). Read more on the quadruple aim here and here.

  • What are the requirements for broad adoption of diabetes technology? Improves glycemic control (“that’s just table stakes”); minimal lifestyle disruption; easy to use – accessible without technology expertise; can be managed by a primary care physician / general practitioner; does not require excessive tuning or follow-up visits; training is automated and accessible at all times; integration with other devices; no increase in out-of-pocket costs. Wow – what a great list!

  • Mr. Brewer on the cost of Medtronic’s MiniMed 670G and how Bigfoot will compare: “In my view, the cost of the 670G and everything you need to use with it is the high-water mark of what any insurance company will ever pay for automated insulin delivery. Everything in the future will have to cost less. We’re building a business that will do that.” In Q&A, he added, “In discussions with the payers, there is tremendous pressure on price. Medtronic is having to discount that system in order to get insurance companies to cover it. What Medtronic was able to sell that for when it first came out is the most anyone would pay for closed loop. Medtronic is now getting less, and this is how the market is evolving. Anybody who comes to market and the system costs twice as much as the 670G is not going to be covered. We’re under constraints, and having it be cost competitive is fundamental for success.”

  • “Innovation is going to take place on the software side at Bigfoot. The things that cost lots of money and take a long time are electromechanical engineering.”

  • “There are ~80 people now at Bigfoot, and a high percentage have a direct connection to diabetes…We are also talking to people;’ Bigfoot has 92,000 Facebook likes. Social media is going to be a powerful way for people to get products and get access to products. This is the way the world works nowadays.” Bigfoot’s team has >400 years of personal insulin-requiring diabetes experience across its team of 80. The team is also >40% female.

3. Dr. Korey Hood on Barriers to Device Adoption, AID Expectations, and Optimal Sharing CGM Data

Stanford’s Dr Korey Hood did a deep dive on the psychology of diabetes devices and closed loop, including barriers to adoption, patient and clinician hopes/expectations for AID (many recent papers) and “rules of engagement” sharing CGM data. The papers are linked below, which could have big implications as the field grows to reach broader populations – especially teenagers, where device adoption remains lowest and diabetes distress remains high.

  • Dr. Hood noted his team’s 2016 Diabetes Care paper on barriers to pump and CGM uptake, which we felt was a crucial paper at the time (and still is). Drs. Korey Hood, Molly Tanenbaum, and colleagues conducted an online survey of adults in the T1D Exchange (n=1,503). Most survey respondents (57%-61%) endorsed cost/insurance coverage as a barrier to device use, far and above other barriers. Given the survey population (patients at the best US centers; 75% on a pump, on a CGM, or on both), these were concerning findings. Several “modifiable” barriers to using pumps and CGMs were reported too, including the hassle of wearing devices all the time (endorsed by 47% of respondents) and having devices on the body (35%).

    • A follow-up JDST paper in 2017 examined clinician perspectives on barriers and adherence to diabetes device use. There was a lot of agreement between patients and clinicians on how devices look on the body and cost/insurance, though there were some mismatches too: Clinicians perceived the need for education/what to do with the data as a major barrier to device uptake; however, only 5% of people with diabetes said this was a major barrier. Fascinating!

    • Dr. Hood concluded that many barriers still exist for devices that are components of closed loop, and the mismatches between patient-reported and clinician barriers are important, alongside age, diabetes distress, and diabetes technology attitudes. We are highly optimistic that many components of this are going to improve as cost becomes a bigger focus of next-gen innovation and devices continue to get smaller on the body.

  • Dr. Hood also noted that he has been wearing the DIY Loop system for 15-16 months. He showed the smartphone user interface and highlighted how much he likes the closed-loop display – the green circle in the top left to indicate he is in closed loop, his CGM glucose, what the basal rate is actually doing relative to his background rate, and graphs showing the dosing under the CGM graph. We agree that the user interface on Loop is awesome, though also wonder how much of the design relates to early adopters of technology (DIY community) vs. the majority – early adopters like seeing everything, while the average user might not need so much graphs. It will be fascinating to see how commercial systems pull from the DIY community vs. doing something simpler or different (e.g., MiniMed 670G is pretty simple on the home screen [blue shield and CGM value], Bigfoot’s display as shown above).

  • Dr. Hood highlighted several interesting papers on the psychology of automated insulin delivery:

    • What End Users and Stakeholders Want From Automated Insulin Delivery Systems (Naranjo et al., Diabetes Care 2017): Children were most concerned about specific social situations and settings such as school and friends. Adolescents were concerned about devices’ physical features, wearability, and comfort. Adults and parents were concerned with device safety and reliability. Similarly, partners raised trust and control themes.

    • Automated Insulin Delivery Systems: Hopes and Expectations of Family Members (Garza et al., Diabetes Technology & Therapeutics 2018): Three main themes emerged: (i) there is an expectation that this diabetes technology will alleviate diabetes-specific worry and burden for the people with diabetes and other family members; (ii) hope that this system may reduce day-to-day stress; and (iii) hope that it will improve family relationships.

    • Trust in hybrid closed loop among people with diabetes: Perspectives of experienced system users (Tanenbaum et al., Journal of Health Psychology 2017): “This qualitative study explored trust in 32 individuals following a hybrid closed loop trial…Notably, participants attempted to override the system when they lacked trust, while trusting the system decreased self-management burdens and decreased stress…Systems may be able to engage users by offering varying levels of controls to match trust preferences.” Noted Dr Hood, “We need to come up with options of starting people on these systems and at different time points to feel safe.”

    • Expectations and Attitudes of Individuals With Type 1 Diabetes After Using a Hybrid Closed Loop System (Iturralde et al., The Diabetes Educator 2017): This focus group study followed the MiniMed 670G after 4-5 days of system use. “Some participants felt misled by terms such as “closed loop” and “artificial pancreas,” which seemed to imply a more “hands-off” experience. Perceived benefits were improved glycemic control, anticipated reduction of long-term complications, better quality of life, and reduced mental burden of diabetes. Hassles and limitations included unexpected tasks for the user, difficulties wearing the system, concerns about controlling highs, and being reminded of diabetes. Users are willing to accept some hassles and limitations if they also perceive health and quality-of-life benefits beyond current self-management. It is important for clinicians to provide a balanced view of positives and negatives to help manage expectations.”

  • Dr. Hood also provided some “rules of engagement” for sharing CGM in families:

    • Have a calm discussion about the topic when there is no acute conflict or concern. “Have this conversation of when to share and what works when it’s calm and when everything else is going well. If you’re doing it during an acute conflict situation, you will fail.”

    • State clearly what it is you’re interested in having done (e.g., for the school to notify me if there is a signal loss, how they should handle that, etc.)

    • Use active listening to hear the other side. Make eye contact, do not talk when the other person is talking, and reflect back what they have stated

    • May not need to share ALL the time. “For a college student, maybe the share function needs to be on overnight only, but not when the college student goes out with friends.”

  • Stanford’s Dr. Diana Naranjo has been leading research on virtual reality to simulate experiences of wearing diabetes devices. VR allows researchers to test real situations – e.g., sitting in the lunch room and hearing an obnoxious alert or alarm – and branch them into different scenarios. For instance, a person can decide to clear the alarm or make a decision about what to do. VR can help people understand how large devices look on the body – e.g., a reflection in a mirror. Really cool stuff!

4. Dr. Desmond Schatz’s Overview of T1D Prevention: Wrong Combination, Wrong Time, Wrong Approach? Highlights ATG Data from ADA 2018

In a sweeping overview of type 1 diabetes prevention, University of Florida’s Dr. Desmond Schatz covered what has been learned in the past 10 years and why he’s optimistic about the future – download a PDF of his slides here. Despite 71 completed trials and 35 ongoing to prevent or intervene in type 1 diabetes over the past 10 years, little tangible progress has been made in terms of a cure or delay of disease onset. Harkening back to optimistic inventor Thomas Edison, Dr. Schatz summarized it well, “I have not failed. I’ve just found 10,000 ways that won’t work.” Dr. Schatz noted the heterogenous nature of type 1, little knowledge about mechanisms (“Is type 1 really a primary autoimmune disease?” – whoa), animal model-to-human translation issues, and little success of immune interventions so far. He questioned what has been the driver(s) of low success: Wrong approach? Wrong combination? Wrong time? (Or maybe all three…) Nevertheless, Dr. Schatz is hopeful we’re entering a new era, referencing TrialNet’s study of low-dose ATG (Sanofi’s Thymoglobulin for kidney transplant immunosuppression), which demonstrated significant c-peptide attenuation and reduced A1c at one year in a presentation at ADA 2018. “Low-dose ATG, alone or in combination, should be considered as a potential means of preventing T1D.” Notably, the one-year data was just published online in this month’s Diabetes Care (Haller et al.), and two-year data will be completed this fall. Moving forward, Dr. Schatz proposed that prospective type 1 diabetes prevention therapies need to address all three components of the immune system (innate, adaptive, regulatory) and improve beta cell health – aggressive combination and primary prevention strategies may be the most attractive avenues. To finish, Dr. Schatz gave a call to action, refreshing his ADA 2016 talk on bringing diabetes to 212 degrees – “We need YOU to participate.” Preventing type 1 diabetes – the gateway to a cure, in Dr. Schatz’s view –  remains a long road ahead, but his enthusiasm gives us hope that the field has many irons in the fire. Following ADA 2017’s mixed/bleak results for this field, the ATG results seem promising and our competitive landscape suggests a lot more interest is in the field! See some of our favorite slides from this talk below, and download the PDF here.


5. diaTribe Panel Discussion, including Drs. Bruce Buckingham and Des Schatz on Best Practice for Families with T1D

diaTribe held a fascinating panel discussion with the insightful Dr. Bruce Buckingham (Stanford), Dr. Des Schatz (UFL), Scott Johnson (mySugr), and Erik Shoger (dQ&A). Watch the Facebook video of the discussion here, which touches on best practices for coping with diabetes in families, how Drs. Schatz and Buckingham approach appointments (~45 minutes is what they typically spend with each patient/family!), what has most recently made the biggest different in their patients/their own lives, and more. All emphasized how behavioral type 1 diabetes is, even with all the technology and data patients now have access to. Dr. Schatz noted that he only looks at glucose data with ~10 minutes left in the appointment; otherwise, it dominates the discussion (often in a negative way). Wow! We’ll update this report with quotable quotes, though the full panel discussion is definitely worth listening to!

6. Adam Brown on What’s New in Diabetes Technology, Bright Spots & Landmines, and Advice to for Teens with Diabetes

Adam gave three presentations at Friends for Life this year – two to adults (diabetes tech and Bright Spots & Landmines) and one to the teenagers. See links to slides below and videos of the adults presentations!

  • What’s New in Diabetes Technology and Appsslides, video

  • Bright Spots & Landmines: The Diabetes Guide I Wish Someone Had Handed Meslides, video

  • Adam’s Advice for Teens with Diabetesslides


--by Adam Brown, Peter Rentzepis, and Kelly Close