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T1D Exchange was recently offered an opportunity to interview Martha Goldberg Aronson, the interim CEO of Beta Bionics. Beta Bionics is the developer of the much anticipated bi-hormonal (insulin and glucagon) automated insulin delivery system, the iLet Duo. In this interview Aronson brings us up to date on the results of the Insulin Only Bionic Pancreas Pivotal Trial (IO-BPPT) conducted on the insulin-only iLet and the status of potential FDA clearance. We also get an update on the timetable for the availability of FDA-approved liquid stable glucagon (a must-have for the bi-hormonal system [iLet Duo]), the role founder Dr. Ed Damiano is now playing at Beta Bionics, and more.
Q1: Tell us about your current role(s) at Beta Bionics, your background in diabetes care and insulin delivery devices. What excites you about being at Beta Bionics?
A1: I was previously at Medtronic and was responsible for the diabetes sector in the early 2000s. What I quickly noticed about the diabetes business was it served such a different and special community. Diabetes is for life for those living with it—you cannot be cured or grow out of it. I enjoyed working in the space to support those living with diabetes.
When I heard about Beta Bionics and I met Ed Damiano, I was incredibly impressed with what he had built. I have always been a big believer in the philosophy that businesses must be responsive to all stakeholders. Even if you’re not legally a public benefit corporation (see below for explanation), you should act like one. I joined the board two years ago, and one year later Ed asked me to be Chair of the Board. Today, I am serving as interim CEO as the company now transitions from being a clinical-focused organization to preparing for commercialization upon FDA clearance. I’m focusing with the team on commercial readiness—manufacturing, sales, marketing, quality systems, compliance, and more.
Q2: Over the long term what is the role Beta Bionics wants to have in making living with type 1 diabetes just a bit easier?
A2: Beta Bionics is committed to making its type 1 diabetes management technology accessible to the many, not just the few, by reducing the cognitive burden of living with type 1 diabetes. If cleared by the FDA, Beta Bionics hopes the iLet Bionic Pancreas will improve the lives of people living with diabetes by improving glycemic control relative to the standard of care and by helping reduce data and decision-making overload. The iLet Bionic Pancreas received breakthrough device designation in 2019 from the FDA and its regulatory submission is currently under review.
Q3: Can you share basic details about the design of the pivotal research study required by FDA for approval and recently completed and presented at recent scientific meetings?
A3: The Insulin Only Bionic Pancreas Pivotal Trial (IO BPPT) was designed to reach a broad demographic with respect to not only race, ethnicity, age, and therapy type but also baseline glycemic control. The breakdown for the entire study population (440 participants) is 77% white non-Hispanic, 10% Black non-Hispanic, 9% Hispanic/Latino and 3% other or more than one race. About three-fourths of the trial participants had A1c values >7% at the start of the study. When looking at the very strong results in that specific demographic, I think about many people living with diabetes who can get excited about what this product could potentially mean for their lives.
The IO BPPT was a multi-center, randomized controlled trial conducted in 16 clinical research centers across the U.S. The pivotal trial was designed to test the safety and efficacy of the iLet Bionic Pancreas relative to a standard of care control group over a 13-week study period. The standard of care group was comprised approximately one-third each on an automated insulin delivery (AID) system, or an insulin-pump therapy with continuous glucose monitoring (CGM), and multiple daily injection therapy with CGM. The trial was conducted in a home-use setting and enrolled 440 adults and children aged 6 years and older with type 1 diabetes. The primary analysis of the trial compared the iLet, using Humalog® or Novolog®, versus standard of care in 326 adults and children; the remaining 114 adult participants used the iLet with Fiasp®.
Q4: Can you share some of the topline results from this pivotal study and why the results are meaningful?
A4: The iLet Bionic Pancreas met primary and key secondary endpoints in the IO BPPT. The primary analysis demonstrated improved outcomes over standard of care in the following domains:
- Significant reduction in HbA1c: After 13 weeks, the average HbA1c in the participants who used the iLet Bionic Pancreas with Humalog/Novolog was reduced by 0.5% compared to those using standard of care and a 0.7% -0.8% (for the Humalog/Novolog and Fiasp arms respectively) reduction for participants with an HbA1c greater than 7.0%
- Exploratory analyses in the adult and pediatric Humalog/Novolog study participants showed consistent mean HbA1c outcomes across populations regardless of race, education level or income level
- No increased risk of hypoglycemia: Participants who used the iLet Bionic Pancreas did not experience any significant increase in the average time they spent with their CGM values less than 54 mg/dL over 13 weeks compared to those using standard of care
- Increased time in range (TIR): Participants who used the iLet Bionic Pancreas had an average of 2.6 hours more time in range per day over the 13 weeks than those using standard of care; those with A1c >7% at baseline had an average TIR increase of 15% (3.6 hours per day) and 20% (+4.8 hours per day) with H/N Fiasp respectively
Q5: How will the insulin-only system be different from or more simplistic than other AID systems or advanced hybrid-closed loop systems currently available?
A5: The iLet Bionic Pancreas is designed to serve people who do not reach their ADA management goals, are overloaded by data or are tired of math and numbers. The iLet Bionic Pancreas is designed to require only one numerical input to get started—the user’s weight. The iLet® is designed to then automatically titrate and infuse insulin without requiring the user to count carbohydrates, set insulin-to-carbohydrate ratios, set insulin basal rates, set correction factors, or determine bolus insulin for meals or corrections. The user only uses a qualitative “meal announcement.”
Q6: What is the status of the insulin-only iLet regarding FDA clearance?
A6: We are unable to predict timing for FDA review. We anticipate the FDA will prioritize the review of our submission due to our Breakthrough Device Designation. However, we are also aware other diabetes devices have taken more than a year, even with Breakthrough Device Designation, given the significant strain on the FDA resources in keeping up with COVID-related submission reviews.
Q7: We realize that for a number of years now Beta Bionics, and the founder, Ed Damiano, have been talking about and developing a bi-hormonal approach to automated insulin delivery. Why is Beta Bionics just moving forward with an insulin-only (single hormone) system now?
A7: We began enrollment into the screening protocol for the Bihormonal Bionic Pancreas Pivotal Trial in December 2021 (the screening protocol identifies potential participants for the pivotal trial), but I do not have more to say on this point besides that the efforts will continue throughout the year. The Bihormonal Bionic Pancreas, which we’re calling, iLet Duo, will have 2 chambers – one for glucagon and one for insulin – while the iLet will have only one chamber for insulin delivery.
Q8: Why is Beta Bionics set up as a certified B Corporation and public benefit company? What does this mean for the population of people with type 1 diabetes and their loved ones?
A8: Being a certified B Corporation and public benefit company is important to Beta Bionics and our work because we believe in multi-stakeholder governance and serving all of our stakeholders. The stakeholder group, first and foremost for us, is the type 1 diabetes community—those currently living with T1D or caring for someone who does. We keep our mission of serving the community front and center in all of our work and decisions. This includes being a good steward with our resources, including the $200 million from investors, and balancing purpose with profit.
Q9: What role is Ed Damiano now playing at Beta Bionics?
A9: Ed is a co-founder of Beta Bionics. Ever since his son, who is now a college graduate, developed type 1 diabetes at 11 months of age, Ed has been committed to building a bionic pancreas. As Beta Bionics transitions from being solely an Research & Development and clinical-focused organization to preparing to be commercially ready upon FDA clearance, the needs of the organizations have evolved to be ready to promote this innovative device on the day the FDA, hopefully, gives us clearance. As a result, Ed Damiano is now the Founder and Executive Chair. He remains a board member and an employee.
Q10: What drives you and others at Beta Bionics to continue to push the boundaries of insulin delivery systems for people with diabetes who use insulin?
A10: The extraordinary dedication and passion for what we want to accomplish for people living with type 1 diabetes is truly what drives the Beta Bionics team. And it is inspiring to witness first hand. Many of our employees at Beta Bionics are people living with type 1 or currently caring for someone who does, and so this is not “just a job” for them. Our team really believes in what we are aiming to do and they are excited to see how we really can help the community. There is so much energy at Beta Bionics right now. Between the FDA submission, the IO BPPT results, and looking forward to the initiation of the bihormonal trial, these milestones are no small feat in this industry. There is positive momentum to continue to push the boundaries of insulin delivery systems for people with diabetes.
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Latest News on Beta Bionics’s iLet - Interview with interim CEO, Martha Goldberg Aronson
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