Results of the Insulin-Only Bionic Pancreas Pivotal Trial, Which Were Presented at ADA's 82nd Scientific Sessions, Are Published This Week in the New England Journal of Medicine

Caution: The iLet® Bionic Pancreas is an investigational device limited by Federal (or United States) law to investigational use. Not available for sale. Pending 510k clearance.

CONCORD, Mass., Sept. 30, 2022 /PRNewswire/ -- Beta Bionics, Inc. — The results of the multi-center randomized Insulin-Only Bionic Pancreas Pivotal Trial (IO BPPT), which were presented in June at the 82^nd Scientific Sessions of the American Diabetes Association (ADA),¹ are published this week in the New England Journal of Medicine.² The trial, which tested the iLet bionic pancreas ­– a wearable investigational medical device designed to autonomously dose insulin - was conducted at 16 clinical sites across the United States.

The trial was designed to test the safety and efficacy of the iLet relative to a standard-of-care control group over a 13-week study period in children and adults 6 years and older with type 1 diabetes who had been using insulin for at least one year. Participants were randomly assigned to either a treatment group using the iLet or a standard-of-care control group using their personal pre-study insulin delivery method and continuous glucose monitoring (CGM). The standard-of-care cohort was comprised approximately one-third each of participants on hybrid closed-loop therapy, insulin-pump therapy with CGM, and multiple daily injection therapy with CGM. The primary analysis of the trial compared the iLet using rapid-acting insulin (Humalog® or Novolog®) to the standard of care in 326 adults and children; an additional 114 adult participants used the iLet with a newer rapid-acting insulin (Fiasp®).

In participants using the iLet with Humalog or Novolog, glycated hemoglobin — an average measure of a person's long-term blood-glucose level — improved from 7.9 to 7.3%, yet remained unchanged among the standard-of-care control group. The iLet group participants spent 11% more time, approximately 2.5 hours per day, within the targeted blood-glucose range compared to the control group. These results were similar in youth and adult participants, and improvements in blood glucose-control were typically greatest among participants who had higher blood-glucose levels at the beginning of the study.

"In the study, investigators found that participants randomized to the iLet bionic pancreas had on average a lower hemoglobin A1C, a lower average glucose, and more time in range, despite the reduced requirement for input from the users in the iLet group compared to participants randomized to the standard-of-care group. These improvements in glycemic control were achieved with no difference in CGM-measured hypoglycemia between the study groups. These findings have implications for people living with type 1 diabetes, particularly those not meeting goals for therapy with their current method of insulin delivery," said Dr. Steven Russell, study chair, Associate Professor of Medicine at Harvard Medical School, and Staff Physician at the Massachusetts General Hospital in Boston.

The pivotal trial was coordinated by the JAEB Center for Health Research, and the data, analysis, and results of the trial were shared with Beta Bionics to include in a comprehensive submission package to the U.S. Food and Drug Administration (FDA) for regulatory review of the market application for the iLet earlier this year. The iLet received breakthrough device designation from the FDA in 2019.

"The completion of this study represents a major milestone for the bionic pancreas initiative, which began over two decades ago, and simply would not have been possible had it not been for the support provided by the NIDDK over the years," said Dr. Edward Damiano, project principal investigator, Professor of Biomedical Engineering at Boston University, and Founder and Executive Chair of Beta Bionics. 

Funding for the study was provided by a grant from the National Institutes of Health (NIH) to Boston University, by an Investigator-Initiated Study award from Novo Nordisk, and by Beta Bionics, which also provided the experimental bionic pancreas devices used in the study. Insulin and some supplies were donated by Novo Nordisk, Eli Lilly, Dexcom, and Ascensia Diabetes Care. Partial support for the development of the experimental bionic pancreas device was provided by a NIH SBIR grant to Beta Bionics.

"Today, I couldn't be more excited about these results," said Sean Saint, President and CEO of Beta Bionics. "It was great to have collaborated with Ed and his team and Boston University 10 years ago to build the first prototype version of the bionic pancreas on a mobile platform, and to have seen the results from that system published in the NEJM back in 2014. It's even more exciting to be where we are today with the iLet — to see the results from this historic pivotal trial published again in the NEJM, but also to now have those results in front of the FDA."

An accompanying editorial about the study published in the New England Journal of Medicine was provided by Dr. Jennifer Sherr, professor of pediatrics (endocrinology) at Yale School of Medicine. Four companion papers were also published in Diabetes Technology and Therapeutics, two of which provided more detailed results among the adult and youth participants. The third paper reported results from an extension study in which the participants from the standard-of-care control group switched to using the iLet for 13 weeks and experienced improvements in glucose control similar to the iLet group in the 13-week randomized trial. In the fourth paper, results showed that using the iLet with Fiasp in 114 adult participants improved glucose control as effectively as using the device with standard insulin.

The iLet® is a pocket-sized, wearable investigational medical device designed to autonomously dose insulin. It is designed to be worn like an insulin pump; however, iLet® users would enter only their body weight to initialize therapy and would not set any insulin regimen parameters. 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 technology is designed to help a broad base of people who wish to use technology to manage diabetes.

Beta Bionics® is a clinical stage medical technology company focused on the design, development, and commercialization of its iLet® Bionic Pancreas in both the insulin dosing (the iLet®) and bihormonal (iLet Duo™) configurations. The iLet® Bionic Pancreas platform is designed to use adaptive, self-learning, control algorithms, together with continuous glucose monitoring and pump technology, to autonomously compute and administer doses of insulin and/or glucagon and mimic the body's natural ability to maintain tight glycemic control.

Beta Bionics is a for-profit, public benefit corporation and Certified B Corporation™. Since its founding in 2015, its mission is to help improve health outcomes and the quality of life of children and adults living with diabetes and other conditions of glycemic dysregulation.

Beta Bionics operates in Massachusetts and California. For further information, visit www.betabionics.com or follow Beta Bionics on Facebook, YouTube, Instagram, LinkedIn, and Twitter @BetaBionics.

Caution: The iLet® Bionic Pancreas is an investigational device limited by Federal (or United States) law to investigational use. Not available for sale.

1. Beck, R., Forlenza, G.P, Kruger, D., Messer, L.H., Weissberg-Benchell, J. & Russell, S.J. (2022) The Insulin-Only Bionic Pancreas Pivotal Trial—Randomized clinical trial results [Mini Symposium]. 82nd Scientific Sessions of the American Diabetes Association, New Orleans, LA, United States. 
2. Russell et al. (2022) Multicenter, randomized trial of a bionic pancreas in type 1 diabetes. New England Journal of Medicine, 387(13): 1161-72.

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SOURCE Beta Bionics, Inc.