FFL (Friends for Life) 2020

July 15-18, 2020; Virtual; Days #1-2 Highlights

Executive Highlights

  • In his 14th consecutive annual update at Friends for Life, Dr. Ed Damiano from Beta Bionics provided an update on the organization’s iLet bionic pancreas. We were thrilled to hear that the insulin-only pivotal trial has now completed enrollment and set to begin “later this summer, with his organization aiming to launch the product either at ADA or CWD next year. The newly updated timeline expects trial completion in 1H21 with clearance by “mid-2021” (a fast approval by anyone’s definition - we’ll check again to make sure we heard this correctly) and launch soon after. Excitingly, Dr. Damiano shared that the company is already starting to prepare for manufacturing scaling and reimbursement discussions. On the bi-hormonal side, a ~12-15 month bi-hormonal pivotal will commence right after the insulin-only trial completes. This would put launch in the “2022, maybe early 2023” timeframe. See below for more details, including the Q&A session, which saw an incredible 180 attendees move straight from Dr. Damiano’s presentation to a separate Zoom line for Q&A. We aren’t at all surprised – this researcher has a following unlike anything we’ve seen at medical meetings or virtually throughout the diabetes ecosystem broadly speaking.

  • See below for more highlights, including Dr. Bruce Buckingham’s review of some of the latest data from ADA 2020 on Tandem’s Control-IQ, Medtronic’s MiniMed 780G, and Insulet’s Omnipod 5 powered by Horizon; Dr. Steve Edelman’s overview of new medications and insulins for type 1s; patient and DCES advice for successful telemedicine visits; and much more.

The 2020 edition of Friends for Life kicked off earlier this week with over 4,600 attendees across all fifty states. See our top highlights from the first half of the meeting below!

Top Six Highlights

1. Beta Bionics iLet Update: Insulin-Only Pivotal to Complete in “First Half of 2021” with US Launch Expected in “Summer 2021”; 12-Month Bi-Hormonal Pivotal to Begin in “2021,” with Launch “in 2022, Maybe Early 2023”

In his 14th consecutive – and first virtual – Friends for Life presentation, Dr. Ed Damiano provided an update on Beta Bionics’ insulin-only and bi-hormonal iLet Bionic Pancreas systems. Screening is now complete for the insulin-only pivotal trial (we heard it was “nearly complete” at ADA 2020), and the trial will begin “later this summer,” finishing up in the “first half of 2021.” This puts FDA submission in the “first half of 2021” with clearance as an ACE pump and iController anticipated by “mid-2021.” Finally, this timeline puts insulin-only launch in “summer 2021.” Per Dr. Damiano, there should be no “significant delay” in rollout, as Beta Bionics will already be working on scaling up manufacturing capability during the pivotal and meet with payers during 2020 and 2021; Dr. Damiano dubbed 2021 “the year of the payer (for Beta Bionics)”.

On the bi-hormonal front, the new timeline was about ~a year behind the schedule outlined at FFL 2019. The bi-hormonal pivotal is slated for “early 2021” when the insulin-only pivotal ends and launch “in 2022, maybe early 2023.” The trial will last a full ~12-15 months, well longer than the six-month Control-IQ pivotal and three-month MiniMed 780G pivotal; per Dr. Damiano, the FDA has been “really accommodating [about the bi-hormonal system] because of the unmet medical need,” and a 12-month trial was the shortest they would allow because the liquid-stable glucagon analog (dasiglucagon) has never been used long-term with type 1s. Notably, the COVID-19 pandemic will likely lengthen the pivotal trial, potentially related to the screening, onboarding, clinic visit, and follow-up processes. Finally, Dr. Damiano also shared outcomes data on the insulin-only and bi-hormonal systems from earlier studies (see our coverage from June 2019 and ADA 2020), repeatedly emphasized the iLet user experience – “It’s 288 decisions a day that you no longer have to make” – and highlighted the potential for broader access through primary care.

Boy, was there interest in the Q&A following the presentation! At one point, there were 180 (!) Zoom participants, and at the end of the 75-minute Q&A, there were still 86 people attentively listening. Claiming “infinite energy” during the lengthy Q&A session, Dr. Damiano provided an abundance of detail on the timelines for the insulin-only and bi-hormonal iLet systems, on product details and future plans, and on the strengths of the iLet system for users and providers. See below for all the details on timelines & clinical trials, outcomes data, highlighted key product features, and more product details and plans.

Timelines & Clinical Trials
  • Dr. Damiano brought updates on the insulin-only iLet pivotal trial, sharing that screening is complete and the trial will begin “later this summer and complete in the first half of 2021” with the FDA submission also in 1H20.  The large-scale (n=440), three-month RCT (ClinicalTrials.gov) is being conducted at 16 sites across the US, including the Barbara Davis Center (Colorado), Nemours Children’s Health System (Florida), and Mass General Hospital (Massachusetts). In the “main study,” one-fifth of the adult participants and one-third pediatric (ages 6+) participants will be randomized to the usual care arm; after the trial, the usual care group will be able to opt to the insulin-only iLet system as part of the three-month extension study. Notably, the system will be tested with Humalog, Novolog, and Fiasp (Fiasp is not currently indicated for use with any AID systems but it’s simple for patients to use it if they want to).

    • Impressively, 99% of the subjects were screened in just seven weeks, beginning just as the COVID-19 pandemic took hold in the US in March. By mid-June, 100% of subjects were screened. Dr. Damiano shared that they adapted quickly to the pandemic and that the FDA was very supportive and flexible as activity progressed. They replaced in-clinic screening with verbal, over-the-phone screening for all 440 subjects and have been approved to conduct the entire study and all associated clinical visits virtually if need be.

      • The screened cohort achieved goal demographics: (i) more than 33% with A1c >8%; (ii) less than 20% with A1c <7%; (iii) more than 1/3 adult cohort <50 years old; and (iv) at least 1/3 on MDI. This is an impressively broad group for an AID pivotal trial, particularly with at least one-third of the group pump-naïve at baseline.

    • The insulin-only pivotal and launch timelines are at a ~ six-month delay compared to the timeline shared at FFL 2019; see “postscript” at the end of the report for more detail. Per the presentation, the trial will begin “later this summer” and end in the “first half of 2021.” FDA submission is slated for the “first half of 2021” and clearance is anticipated by “mid-2021.” The timeline for launch was addressed during Q&A: Dr. Damiano shared that they will target US launch first in “summer 2021,” acknowledging that this is unusual, and then hopefully launching “very soon after” in Europe and Canada with a CE-Mark in “2021,” assuming strong pivotal data. 

      • “Hopefully, this time next year we will have an insulin-only FDA clearance and can launch either at ADA or Friends for Life. 2021 is the year – we do think that that is really realistic.” – Dr. Damiano

    • During Q&A, Dr. Damiano asserted the product could be built “in 30 minutes” and noted that there “should not be a significant delay” of the US launch of the insulin-only iLet system after 510(k) clearance. Beta Bionics plans to begin preparing manufacturing capabilities during the pivotal this year so that they can build the product quickly. Emphasized Dr. Damiano: “Early in the conversation, we included input from the manufacturing arm so that we could build a more practical, scalable, and manufacturable device.”

    • Beta Bionics is already preparing to secure coverage for iLet with payers: “[Beta Bionics is] very vigorously now getting out in front of commercial and government payers. We spent a lot of time in 2018 and 2019 getting investments, and then in 2019 and early 2020 getting in front of investigators. 2020 and 2021 are the ‘years of the payer,’ and we will continue to spend a lot of time getting in front of payers both for the insulin-only and bi-hormonal systems.” His comment about meeting investigators in 2019 and earlier this year was interesting; our sense was that Dr. Damiano already knew everyone and had established those relationships years ago, though due to the size of the pivotal, over 400 patients, establishing these trials sounds like it was more work than is normal,

    • Toward the end of the 75-minute Q&A, Dr. Damiano shared that the insulin-only device should be “competitively priced [to] those out there.” He noted that because the bi-hormonal system has a second drug, it will be more expensive but that there are “ongoing conversations between payers, Zealand and Beta Bionics” and “so far, [we are] enthusiastic about paying for the second hormone.”

  • Just as the three-month “main study” of the insulin-only pivotal ends, the even larger (n=700) Beta Bionics 12-month bi-hormonal pivotal should begin. Given the larger cohort size, Beta Bionics plans to add more participating sites on top of the 16 that are participating in the insulin-only study. Dr. Damiano estimates that the bi-hormonal pivotal will continue “through 2021 and into 2022,” sharing, “We figure that all of 2021 will be a bi-hormonal pivotal with some overflow into 2022.”

    • Beta Bionics will likely submit glycemic data to the FDA halfway through the trial and the remainder of the data at the end. Per his estimates, “we could see the bi-hormonal clearance in 2022, maybe early 2023,” but that partially depends on how long the review process takes. Given the product’s unprecedented design, Dr. Damiano anticipates it could take “six months.”

    • Per Dr. Damiano, the FDA has been “really accommodating because of the unmet medical need,” and that a 12-month trial was the shortest they would allow because the glucagon analog (Zealand’s dasiglucagon) has never been used long-term with type 1s. Zealand just submitted an NDA for dasiglucagon in the form of an autoinjector pen back in March.

    • The COVID-19 pandemic will likely lengthen the pivotal trial. Dr. Damiano notes that it harder and slower to start people on the device over Zoom: “You can’t do one room with 5 to 10 people starting at one time.” He estimates that the one-year trial will take closer to 15 months “from the first person on the device to the last person off.”

  • During Q&A, Dr. Damiano shared plans for a small (n=~40), feasibility study comparing outcomes for iLet users supported by PCPs vs. pump-knowledgeable endocrinologists in collaboration with the Helmsley Charitable Trust. Their hypothesis is that there will be no difference between the groups, showing iLet’s ease of use for providers (see more on this below in Key Features). Dr. Damiano shared that Beta Bionics would also like to conduct a larger follow-up study (n=100-200) and look at telehealth vs. in-person care both with PCPs and endocrinologists. This sounds like a very valuable study and the focus on primary care and ease of use could prove prescient over the next several years as AID sees increasing adoption and broader access.

  • Beta Bionics’ current clinical trials can be found on their website, as well as on the FDA’s website, and include (i) the insulin-only bionic pancreas pivotal trial (NCT04200313); (ii) the feasibility of outpatient closed loop control with the bionic pancreas in cystic fibrosis-related diabetes (NCT03258853); and (iii) profiling in an insulin-only bionic pancreas (NCT0326116). Also, as an aside, check out the new Beta Bionics website that launched this week here!

Key Features Highlighted by Dr. Damiano
  • Dr. Damiano argued that “one of the biggest differentiators” for iLet as an AID system is its simplicity of use, noting that its “set-it-and-forget-it” premise will increase broad access. Dr. Damiano compared the iLet’s complicated internal machinery, but simple user experience, to an automatic car, explaining that users “don’t have to understand how they work.” In particular, the body-weight only set-up (i.e., no entering carb ratios, sensitivity factors, etc.) will be a differentiating factor for iLet. During Q&A, Dr. Damiano went on to claim that the bi-hormonal system should reduce “cognitive and emotional burden,” noting that because the system responds to and minimizes hypoglycemia itself (by delivering glucagon), it does not require users to be as alert to hypoglycemic events, requiring less effort and attention.

  • iLet’s ease of use for providers – especially PCPs – was also highlighted: Dr. Damiano argued that because of its consumer-facing simplicity, any provider should be able to set up the iLet and support their patients’ iLet use without any intense expertise on AID systems. The feasibility study with Helmsley Charitable Trust mentioned above should bring some evidence to whether this claim holds true. Making AID systems easy to use for providers is hugely important for increasing the accessibility of AID systems, especially for patients who do not see endocrinologists and instead rely on their PCP for their diabetes care (which is the majority of adults with diabetes).

    • During Q&A, Dr. Damiano came back to this, noting that “hybrid [closed loop] systems require expertise to control and watch. PCPs will not touch systems other than MDI because they have to revisit, titrate insulin, and all that. With iLet, you’re not learning the system or needing to re-tweak baseline settings. That will dramatically increase access.” We’d also add that some physicians are even reluctant to initiate type 2 patients on insulin therapy, partly due to its difficulty to properly dose and titrate.

  • The automation and personalized adaptation features of the iLet Bionic Pancreas are “unprecedented.” While other hybrid closed loop systems (see our AID competitive landscape) require regular input from the user on food intake and activity, carb counting, supplemental carb intake to treat hypoglycemia, and user input when administering correction boluses, iLet does not. iLet adapts continuously – and in real-time – to the individual user’s “ever-changing insulin and/or glucagon needs,” continuously learning to best meet their personal real-time needs.

    • This personalized adaptation does not require user input. As Dr. Damiano shared, “[Physical] activity, illness, stress – the device doesn’t need to know the reason why blood glucose is changing, but it will react to those glucose changes. It offers automated adaptation to the user’s ever-changing needs and therefore, can dose differently for the same event that happened two weeks ago based on changes since that event.”

  • During the extensive Q&A, Dr. Damiano emphasized the strengths of the iLet system’s flexibility and multiple target settings. Specifically, Dr. Damiano shared that the iLet will have multiple options for glucose set points. Following the aim to allow users to treat their diabetes “without numbers,” the three targets are just called default, higher, and lower. Dr. Damiano cited the previous testing of different targets, sharing that the “vast majority of patients do quite well with the default target” and that the three target options will be different between the insulin-only and bi-hormonal systems (presumably, the bi-hormonal system will be more aggressive). Beta Bionics’ rationale behind this design is that while most users will start on the default target and switch if needed, the three settings also improve usability for the 80% of type 1s who have A1c >7% or who are chronically in hyperglycemia since they can start with the higher target and work their way down, “like titrating medication.”

Product Details
  • During Q&A, Dr. Damiano offered details on the product’s design and what changes they anticipate in the future. As a reminder, the iLet Bionic Pancreas consists of three devices (a CGM, a pump, and a “suite of lifelong, autonomous learning algorithms”) and one or two drug technologies (an insulin analog and/or liquid-stable glucagon analog), so there are many pieces that Beta Bionics can play with and optimize.

    • In terms of insulin, Dr. Damiano shared that currently, the plan is to offer Humalog, Novolog, and pre-filled ultra-rapid insulin (Fiasp). Beta Bionics presented data on use of ultra-rapid insulin Fiasp with iLet at ADA 2020 and if the company receives clearance on the anticipated timeline, iLet would likely be the first device indicated for use with Fiasp.

    • On the glucagon analog front, Beta Bionics is moving forward with its partnership with Zealand to use dasiglucagon, a “really stable” glucagon analog. iLet will be the first AID system – and first pump overall – to use a glucagon analog, which makes the company more conservative on its regulatory timeline.

      • During Q&A, Dr. Damiano noted that they have not seen weight changes due to glucagon use, which has been raised as a potential concern for long-term glucagon use. While he qualified by saying they have not done enough long-term studies to be sure, Dr. Damiano stated that glucagon may actually be associated with weight loss because less “rescue carb” intake would be required to treat hypoglycemia.

    • Dr. Damiano highlighted several key features of the pump itself: (i) it has a rechargeable battery that uses inductive charging (i.e., wireless charging) and lasts 5-7 days and (ii) it has no mechanical parts or buttons because those “tend to break and allow water ingress.” The device is touchscreen-operated, ~15mm thick and has no buttons or ports. See in-person pictures of the iLet Gen 4 here. Dr. Damiano also shared that Beta Bionics is “eager to take [a tubeless version] on” (i.e., a patch pump), but that it is “premature” to go into any details currently.

  • While the iLet currently uses CGM data from Dexcom (and will for its pivotal trials), Beta Bionics anticipates potential partnerships with the other major CGM players, namely Abbott’s FreeStyle Libre 2 cleared in June and Senseonics’ Eversense. Dr. Damiano noted that previous data with Senseonics’ Eversense shows “similar control” to that of Dexcom G6 but that the device needs (i) to be cleared as an iCGM; (ii) obtain an indication for use with children; and (iii) get 90-day wear (i.e., Eversense XL) before Beta Bionics would pursue a partnership. Dr. Damiano also shared that “if [FreeStyle Libre 2] appears as good in the real-world in our own hands as Dexcom and Eversense, then we will be thrilled to use that as well.”

  • Infusion sets were a much-discussed topic of Q&A. Per Dr. Damiano, the insulin-only pivotal will be conducted with a Teflon 6mm infusion set, but at launch, a wider range of infusion sets – both Teflon and steel – will be available. Dr. Damiano also shared intentions to conduct the bi-hormonal pivotal with 2 separate insets (both made by Unomedical), both of which will need to be changed every 3 days. Responding to participants’ interest in the potential for a dual set for the bi-hormonal system, Dr. Damiano says, “We’re working on that,” and that the goal will be a single infusion set with 2 cannulas. The plan is to work on the dual infusion set during the pivotal trial so that it is ready to go for the bi-hormonal system’s launch.

  • Data, reports, and platform collaboration also came up during Q&A. Dr. Damiano shared that they are currently discussing what reports and data from the iLet will be useful (given that their aim is “diabetes without numbers”) and how best to present that data. To questions of a collaboration with Tidepool, Dr. Damiano responded, “Of course, we want to be compatible with Glooko and Tidepool. We have advanced these conversations yet – we’re very early in the conversations. We need to figure out what kind of information it will display.  We probably will need a custom platform since we aren’t trying to present data to drive how you control your insulin since the iLet should do that for you.”

  • Insulin-only vs. glucagon-only vs. bi-hormonal

    • Based on Dr. Damiano’s contextualization of Beta Bionics’ 2019 home-use results, iLet users will still have to supplement glucagon dosing with carb intake during severe hypoglycemia. However, notably, with the bi-hormonal system compared to the insulin-only system, “about half” as many carbs are needed because micro-dose glucagon helps to increase glucose levels. Likewise, less carb intake was required with the insulin-only system than with usual care.

    • Dr. Damiano points out that it is easy to switch between single-hormone and bi-hormonal use of iLet. If a user wants to use iLet as a single-hormone AID system, they can block that chamber with a small plug, making the system incredibly flexible to users’ preferences.

Insulin-Only and Bi-Hormonal iLet Outcomes Data
  • Dr. Damiano showcased the impressive glycemic outcomes for both the insulin-only and bi-hormonal iLet Bionic Pancreas. As a reminder, in the first home-use study using liquid-stable glucagon (published in a press release in 2019 and presented at ADA 2020), participants (n=10) improved their Time in Range from 71% to 79% (+1.9 hours/day) after one week and 91% of participants achieved a mean glucose of 154 mg/dl (corresponding to an A1c of ~7%). For the insulin-only period, 48% of participants achieved the 154 mg/dl target, compared to 40% in the usual care arm. Notably, time in hypoglycemia was also quite low for both the insulin-only and bi-hormonal systems (1.3% and 0.9% <60 mg/dl, respectively).

    • In the figure above, Dr. Damiano compared iLet results to the usual care arm of their study and to age-stratified 2015 data from adult type 1s who saw endocrinologists (Miller et al.’s T1D Exchange study discussed above), which, as a reminder, is likely better than the general population of adults with type 1 who do not access specialty care. Perhaps even more noteworthy than the glycemic outcomes (fair comparisons across AID studies are notoriously difficult), Dr. Damiano highlighted that the results with iLet were achieved with less effort and burden.

  • In a powerful visualization, Dr. Damiano compared the tight range of mean glucose values for those on the insulin-only or bi-hormonal iLet system to the huge variability in average glucose levels for the general type 1 population seeing endocrinologists. Shown above, Dr. Damiano overlaid the mean CGM glucose data with the variability of participants’ mean glucose levels for the three arms of the Bionic Pancreas trial and for the age-stratified segments of the 2015 Miller et al. study, powerfully showcasing the clear efficacy of the iLet system in bringing down glucose levels. This is a really interesting way of displaying the data and we’d be curious to see a similar display for Control-IQ and other AID systems, which oftentimes also deliver the largest benefits to those with higher A1cs and lower Time in Range numbers at baseline.

2. Dr. Bruce Buckingham on New AID Systems: Thoughts, Tips, and Reflections on Tandem’s Control-IQ, Medtronic’s MiniMed 780G, and Insulet’s Omnipod 5

In a session on hybrid closed loop systems, the eminent Dr. Bruce Buckingham (Stanford) reviewed some of the latest data from ADA 2020 on Tandem’s Control-IQ, Medtronic’s MiniMed 780G, and Insulet’s Omnipod 5 powered by Horizon. Dr. Buckingham provided some commentary around these systems and his own tips and tricks for making the most of the technology. We appreciated hearing Dr. Buckingham’s emphasis on patient empowerment, as he noted closed loop systems tend to be very successful not only because of their predictive algorithms, but also because patients are able to take charge of their care and feel in control of their diabetes. Additionally, Dr. Buckingham provided some of his personal highlights from ADA 2020 last month including the importance of CGM, recognizing health disparities, and the importance of health equity and understanding potential biases (read all 13 of our ADA themes here). Finally, Dr. Buckingham touched on the future of closed loop systems saying he hopes for increased adaptability, integration with other devices, and eventually, no need for meal bolusing.

  • Dr. Buckingham provided his advice and tips for Control-IQ users (“more than 40,000” users as of last month). These included: (i) following pump instructions and correction doses (i.e., don’t override the system); (ii) bolus before eating (10 minutes before is best); (iii) adjust the volume on alarms; (iv) don’t give late meal boluses after system auto-correction bolus has already occurred. Dr. Buckingham also suggested patients using Control-IQ should extend their “Sleep Mode” (when the Control-IQ algorithm is more aggressive) to at least 1 hour after their latest anticipated breakfast time to provide improved glycemic control early in the day. Finally, Dr. Buckingham listed several features of t:slim X2 with Control-IQ that users appreciated: (i) sleeping through the night; (ii) better control with fewer highs and lows; (iii) less social life disruption; (iv) decreased burden of diabetes; (v) auto correction bolus capabilities; and (vi) small pump size.

  • On the MiniMed 780G front, Dr. Buckingham focused on results showing decreased active insulin time was related to increased Time in Range. As a reminder, three MiniMed 780G studies read out at ADA (US pivotal, 670G vs. 780G head-to-head, and New Zealand trial). In particular, Dr. Buckingham was impressed by the results using MiniMed 780G with 2-hour active insulin time and 100 mg/dl set point settings. In the US pivotal, participants with these settings saw 79% Time in Range with just 2.6% time <70 mg/dl despite the more aggressive settings. Dr. Buckingham also highlighted results for adolescents (ages 14-21) who saw a particularly large increase in Time in Range from 62% to 73% (+2.5 hours/day) after 3 months. Additionally, mean sensor glucose was reduced from 162 mg/dl at baseline to 150 mg/dl after three months in this group; Dr. Buckingham succinctly summarized, saying, “These are really good numbers.”

  • Finally, Dr. Buckingham provided some commentary on his own ADA presentation of pre-pivotal data from Insulet’s Omnipod 5 powered by Horizon. For this system, Dr. Buckingham highlighted the adjustable targets allowing patients to customize targets at different times of day – these adjustable set points range from 110 mg/dl to 150 mg/dl. Specifically, Dr. Buckingham used the example of a child with type 1 where the parents can adjust the set point higher during the day when the child is away from home (e.g., at school or daycare) to alleviate concerns about hypoglycemia. Similarly, some patients may prefer to raise their set points overnight to avoid hypoglycemia while sleeping. The results from the Omnipod 5 pre-pivotal study showed Time in Range improvements from 66% to 73% (+1.7 hours/day) in adults after two weeks. Additionally, Dr. Buckingham noted that these results were gathered during the holiday season when many people struggle with glycemic control. Dr. Buckingham noted that participants in the pre-pivotal trial “ate whatever they wanted” and still experienced significant reductions in glucose variability, suggesting patients had an improved quality of life and reduced diabetes-related burden. For more of Dr. Buckingham’s thoughts on Insulet’s Omnipod 5 read our coverage of the Insulet ADA Recap Webinar.

3. Dr. Steve Edelman Gives a Scoping Overview of New Medications and Insulins Available for People with Type 1 Diabetes

Dr. Steve Edelman gave a scoping review of the new, off-label medications and approved next-gen insulins that can lead to better outcomes for people with type 1 diabetes. According to the FDA, only insulin and pramlintide are approved therapies for people with type 1, compared to SUs, metformin, TZDs, alpha glucosidase inhibitors, DPP-4 inhibitors, GLP-1 agonists, SGLT-2 inhibitors, pramlintide, and insulin for people with type 2. While taking these therapies off-label may help improve Time in Range, reduce A1c, promote weight loss, and reduce hypoglycemia, they can only be taken as adjuncts to insulin with the risk of side effects and additional burdens.

  • Dr. Edelman highlighted SGLT-2 inhibitors and GLP-1 agonists in type 1 for their ability to improve TIR, promote weight loss, and confer cardio- and renal-protective effects. For example, GLP-1 agonist Victoza (liraglutide) has led to A1c drops of 0.6% and TIR of 57% when used alongside a pump compared to a point 0.2% drop and 45% TIR with an insulin pump alone according to data from ADA 2017. SGLT-2 inhibitors have also shown similar benefits of increased TIR and decreased risk of CVD and DKD. However, patients using SGLT-2 inhibitors need to be aware of euglycemic DKA, as the increased risk for this condition has been the main limitation toward gaining type 1 approval in the US. During Q&A, a diabetes care and education specialist stated that it’s important to monitor ketones with both urine and blood test strips when taking an SGLT-2 inhibitor. Overall, Dr. Edelman emphasized that while these additional medicines may be helpful in promoting blood sugar control, patients with type 1 diabetes can still manage their condition well on insulin alone. 

  • Much of this talk was devoted to amylin’s promise in type 1. Dr. Edelman believes that “amylin is coming back.” Though Symlin (pramlintide; synthetic amylin) entered markets in 2005, the medication never gained widespread favor in the diabetes community. According to Dr. Edelman, this is likely because the company that launched Symlin did not know how to appropriately use or market it. While Symlin can lower A1c by ~0.5%, promote weight loss, reduce glucose fluctuations, and lower insulin doses, it can also lead to nausea and hypoglycemia.

  • New insulins can be especially helpful with blood glucose control. New insulins discussed at length include inhaled insulin Afrezza, rapid-acting insulin aspart Fiasp, and next-gen basal insulins Toujeo and Tresiba. Comparing the efficacies of these insulins to NPH insulin, Dr. Edelman emphasized ease of use, rapid effects, and lower injection burdens. Candidly, he stated that if anyone is still on Lantus, Levemir, or an NPH, they should talk to their caregiver to switch to Toujeo or Tresiba. While we appreciate the sentiment, it is important to discuss cost and limitations in accessing these newer insulins. We hope to see more socioeconomic awareness in future sessions, in which many families attending may feel discouraged from not being able to afford novel medications and insulins.

4. Patient and DCES Recommendations on Telemedicine Visits: Check Insurance, Upload Device Data Before Appointments, Ask Questions

Ms. Michelle Stancil (Prisma Health) and Mr. Jay Hewitt (Novo Nordisk) gave a very informative presentation on best practices and benefits of telemedicine, an especially useful conversation in the context of the COVID-19 pandemic. Ms. Stancil is a certified Diabetes Care and Education Specialist (the new name for diabetes educator) who frequently uses telemedicine with her patients and, offering the patient perspective, Mr. Hewitt has been living with type 1 for 29 years (and, impressively, the only person with type 1 diabetes to qualify for the US long distance triathlon team). In his presentation, Mr. Hewitt focused on three main types of telemedicine: (i) real-time interactive, e.g., live video; (ii) asynchronous messaging, e.g., email, messages through medical portals; and (iii) remote patient data monitoring, e.g., CGM data uploaded to cloud and shared with providers. Mr. Hewitt also urged clinicians to ask themselves, “What’s [available] in your community?” and “What meets your need?,” when picking between telemedicine options. When implemented successfully, Mr. Hewitt shared some of the major benefits he saw as a patient including, improved access to services, connection to specialists, care in the comfort of your home, reduced wait and travel time, improved diabetes management with better treatment understanding, ongoing diabetes data collection, increased data exchange between regular visits, and reduced exposure risks during the pandemic.

  • For the provider perspective, Ms. Stancil provided some best practices and tips for effective telemedicine appointments encouraging patients to: (i) check their insurance and make sure they understand any charges associated with telemedicine; (ii) test their equipment and check in early just as they would for an in-person appointment; (iii) upload devices and send data early so their provider has time to review (how could device manufacturers help facilitate this?); (iv) complete any questionnaires and review materials pre-visit; and (v) list questions that will help them guide the conversation (e.g., successes and challenges with self-management). For the telemedicine appointment itself, Ms. Stancil recommended patients: (i) set reminders to be on time; (ii) find a comfortable place (this could be lying in your bed, resting on your couch, or sitting with your pets!); (iii) address the reason for their visit; (iv) ask questions; (v) and schedule follow-up appointment or services. Of course, we’d note that all of these (except “find a comfortable place”) are valuable recommendations for in-person appointments, as well. Both presenters expressed optimism about the pandemic advancing telemedicine and urging providers to offer more innovative and accessible care options for their patients. We’ve seen similar sentiments expressed by Drs. Satish Garg and Anne Peters in a recent DT&T article.

  • To-date we’ve heard quite a bit around physicians’ experiences with telemedicine, but we enjoyed hearing a DCES perspective from Ms. Stancil. She explained her work as primarily to support patients between regularly scheduled visits with their endocrinologists. Specifically, Ms. Stancil uses telemedicine to answer questions that arise during primary care and specialist visits, deal with unexpected complications and adjust treatment accordingly, support patients through transitions in care/medication therapies, and provide device training.

  • During Q&A, Ms. Stancil and Mr. Hewitt tried to answer the important question of insurance coverage for telemedicine beyond the pandemic. Ms. Stancil was hopeful about the possibility of continued reimbursement, stating medical nutrition therapy is a service that was already delivered via telemedicine and covered by insurance before the pandemic providing a potential model for other reimbursement plans. Mr. Hewitt also discussed the shift in reimbursement toward value-based and quality of care, which may support telemedicine reimbursement. Later on, Mr. Hewitt also noted that he has had experiences doing in-person blood work prior to telemedicine visits, so he and his endocrinologists are able to discuss lab results without having to see each other in-person. Looking ahead, Mr. Hewitt speculated about a future where lab technicians make home visits prior to appointments eliminating the need to go to the clinic at all.

5. Insurance Workshop for Young Adults: People with Diabetes, in Particular, Should Avoid Low Premium, High Deductible Plans

Christine Fallabel (Diabetes Daily) hosted an informative workshop session on how young adults with diabetes can navigate the world of health insurance to have better access to care and more affordable medication. Ms. Fallebel has lived with type 1 diabetes for over 20 years and emphasized throughout the talk how important it is to have good coverage if you have diabetes. The world of health insurance in the United States can be particularly challenging to navigate and we were happy to see this type of session offered at the conference.

  • Ms. Fallabel pointed out four questions to consider when choosing a health insurance plan that fits an individual’s needs. First, “Are you under 26? If so, do either of your parents have insurance?” Under the Affordable Care Act, children can stay on their parents’ plan(s) until the age of 26. Second, “Do you qualify for Medicaid in your state?” Medicaid eligibility is based off of your income, household size, disability status, and other factors. For Medicaid beneficiaries, the typical co-pay for insulin is between $1-3, though we’d note coverage for CGM varies from state to state (including ~12 states who do not cover CGM at all). Third, “Does your employer offer health insurance?” The majority of people in the United States that have health insurance are under a private, employer-based plan. Mr. Fallabel recommended all working people with diabetes to check to see if their employer offers health insurance. Finally, “Do you need to buy a plan on the federal or state exchange?” These are health insurance plans regulated by your state or federal government.

  • For people with diabetes, Ms. Fallabel warned against plans with lower monthly premiums, but higher deductibles. Because diabetes is a chronic condition that might require regular prescriptions and regular visits to an endocrinologist, it is better to get to get a “gold” or “silver” plan that may have higher monthly payments, but lower co-payments on medications, devices, and doctor visits. Speaking from experience, Ms. Fallabel noted that at the beginning the year people with diabetes often pay many expenses out-of-pocket, until hitting their deductible.

6. Diabetes Online Community Panelists: Engage with Social Media at Your Own Comfort Level, Urge to Elevate the Voice of People of Color

A popular panel offered Thursday afternoon engaged the diabetes community in a discussion about the use of social media in developing support. The panel, which included Kerri Sparling (Beyond Type 1), Cherise Shockley (The diaTribe Foundation), Scott Johnson (mySugr), Renza Scibilia (Diabetes Australia), Chris “Grumpy Pumper” Aldred (IDF), Danica B (Diabetic Danica), and Michelle Auerbach (Love, Light, and Insulin), kept the conversation lively and engaging. Each panelist had been deeply involved in social media and the online diabetes community prior to the panel, and brought a deep wealth of knowledge of their participation in these spaces for people with diabetes. While this session was only 45 minutes to cover many talking points, the virtual audience absolutely loved the content offered here; questions popped up continuously through the entire session and were answered in real-time by the panelists.  

  • Panelists shared their experiences using social media as a tool to reduce stigma for those in the diabetes community. By posting photos with their CGMs in everyday life, the panelists discussed how they began to normalize their experiences with diabetes. Although the panelists are all currently well engaged in the diabetes online community, they revealed how they each began as “lurkers,” where they consumed content that reduced the stigma of diabetes rather than produce that content themselves. Importantly, all panelists emphasized for the audience that it is perfectly acceptable to engage with the community at one’s individual comfort level. Finally, they encouraged the viewers to reach out to the panelists and made themselves accessible by listing their social media handles.

  • The goal of social media-based communities for diabetes is to create a welcoming space; as part of that effort, panelists focused in on the importance of elevating the voices of people of color. Having a community on social media can help reach out to these populations in a powerful and effective way, offering support and solidarity when helpful.

Appendix: Deep Dive on the iLet – more on AID

  • We wanted to share some further information on Beta Bionics and its timeline for its pivotal. The timeline for the pivotal began as a very aggressive timeline, and has been set and later pushed back multiple times, including having the following dates for the pivotal, ranging from 2014-2015 to next year. Our source documents are in parentheses, below - we can say that every year we’ve heard Dr. Damiano speak, he draws raves, because he is incredibly patient-driven and embodies a genius that is incredibly appealing to patients and appreciated all over the ecosystem. He has been very committed to CWD FFL over the years, always announcing new data at this venue and being very eager to talk at length to patients and families to get their views and to talk at length about and gather input about their technology. Dr. Damiano is known for having educated so many patients and families about the vast potential of closed loop systems, not just the iLet, and he and his teams understand imperceptively the power of the closed loop.

  • Dr. Damiano’s group, despite the moving target for its pivotal, has seen notable progress with its technology. For example, his group published Outpatient Glycemic Control with a Bionic Pancreas in Type 1 Diabetes” in the NEJM in 2014 this notable piece was the first the hallowed journal ever posted on the closed loop and it has been cited over 350 times to date. The list of authors on this paper has many familiar names and is a reminder as well of how many different careers Dr. Damiano and his co-researcher Dr. Steve Russell as Massachusetts General have helped influence. It’s terrific, now, to look back to see real potential coming from work done last decade.

    • At ADA in 2015, Dr. Jill Weissberg-Benchel presented important human factors feedback on the bionic pancreas, showing advantages including improved glucose control, particularly at night, and less time thinking about diabetes. Some points were particularly poignant, such as the advantage “less time missing out on things to treat lows” – indeed, it is true, hypoglycemia today doesn’t take hours to treat like it used to.

    • On the flip side, it’s startling to see that so many (for some systems, like Dr. Damiano’s, virtually all) of the major negatives of 2015 are now a thing of the past, such as struggles with calibrations, frustrations with alarms, frustrations with size of the devics used, discomfort while sleeping, and too many devices to manage. Today, many with automated insulin delivery may even go so far as to say they simply don’t even remember when calibrations and alarms were major problems. Also poignant was the inclusion of this 2015 piece, “Taking the Artificial Pancreas Home, 24 hours per day,” by Adam Brown and Kelly Close.

    • It seems truly remarkable that we ever asked, “What fraction of patients will be willing to wear some type of artificial pancreas system?” Back then, the estimate for those wearing CGM was just 10-15% of type 1s – in five years, that has tripled to approximately 30%-plus of those with type 1 (this is a challenging number to estimate each quarter – it may be well higher), and even Medicaid pays for this in nearly forty states. Meanwhile, we estimated then that ~30% of US type 1s wear a pump, and that has gone up slightly, driven by CGM. Major reasons to ignore wearing CGM included, by our reckoning, cost, perceived hassle factor, lack of perceived benefit, no desire to switch from current therapy, perceived weakness associated with wearing a device on the body; and alarm fatigue. We literally asked, a bit soulfully, “Will an artificial pancreas address enough of these challenges to expand the market?”

    • We also asked, as well, “Will healthcare provider embrace closed-loop systems? Today, healthcare providers lose money when they prescribe pumps and CGM.” We need to make sure that closed-loop systems make providers’ lives easier, not more complicated.

 

--by Cindy Takigawa, Hanna Gutow, Monica Oxenreiter, Ursula Biba, Katie Mahoney, Albert Cai, and Kelly Close