The Insulin-Only Bionic Pancreas Pivotal Trial Showed Consistent Mean HbA1c Reductions Across a Variety of Subgroups at ADA's 82nd Scientific Sessions

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

• The randomized Insulin-Only Bionic Pancreas Pivotal Trial (IO BPPT) included a more diverse population of participants with type 1 diabetes (T1D) than previous pivotal studies of other AID systems with respect to minority representation, existing method of insulin delivery, and baseline HbA1c levels.¹ 
• In addition to meeting other key endpoints, pre-specified exploratory subgroup analyses in the trial consistently show reduced mean HbA1c across populations regardless of race, education, or income level for those in the bionic pancreas group relative to those in the standard of care group with continuous glucose monitoring (CGM).
• Adult users in the bionic pancreas group experienced reductions in diabetes distress and fear of hypoglycemia with statistically significant differences favoring the bionic pancreas group relative to the standard of care group.
• Parents of children in the bionic pancreas group reported a significant increase in diabetes treatment satisfaction compared to the standard of care group.
• The iLet Bionic Pancreas is a pocket-sized, wearable, investigational medical device designed to autonomously determine and deliver all insulin doses needed to control blood glucose levels in people with diabetes.
  

CONCORD, Mass., June 09, 2022 (GLOBE NEWSWIRE) -- Beta Bionics, Inc. ? The results of the multi-center randomized Insulin-Only Bionic Pancreas Pivotal Trial (IO BPPT) were presented during a session hosted by Dr. Roy W. Beck and clinical investigators at the American Diabetes Association (ADA) 82^nd Scientific Sessions. The trial met key endpoints, including consistently showing reduced mean HbA1c across populations regardless of race, education, or income level in exploratory analyses of subpopulations. Dr. Gregory Forlenza explained the study design, remarking that the iLet Bionic Pancreas helped to "remove numeracy" from the management of type 1 diabetes.

The randomized trial included a more diverse population of participants with T1D than pivotal studies of other AID systems with respect to minority representation, method of insulin delivery, and HbA1c levels. The results from pre-specified subgroup analyses of the iLet in adults, youth, and the iLet with Fiasp^® in adults from the IO BPPT as presented at ADA are summarized below.

• Relative to the standard of care group with continuous glucose monitoring (CGM), a mean reduction in HbA1c of 0.5% was seen on the iLet in each of three cohorts: the iLet in adults, youth, and the iLet with Fiasp in adults.
• 43% of adult participants on the iLet with Humalog^®/NovoLog^® saw a reduction of 0.5% or greater in HbA1c compared to only 17% of those in the standard of care group.  
• In exploratory analyses of different subgroups of adults (race/ethnicity, education, income, and baseline insulin therapies), the 13-week HbA1c results were consistently 7.0-7.3% on the iLet Bionic Pancreas with a greater improvement seen in those populations with higher baseline HbA1c.
• In an exploratory subgroup analysis of youth (ages 6-17 years) with initial HbA1c >9%, those in the bionic pancreas group saw an increase in time in range of 31% compared to the standard of care group ? this increase in time in range is equal to an additional 7.4 hours/day.
• 51% of youth (ages 6-17 years) on the iLet with Humalog/NovoLog saw a reduction of 0.5% or greater in HbA1c compared to only 8% in the standard of care group.
• 29% of youth (ages 6-17 years) saw an HbA1c reduction of 1% or more on the iLet with Humalog/NovoLog compared to 6% of those in the standard of care group. Said presenter and investigator Laurel Messer, Ph.D., RN, CDCES, "In children who are going to have a lifetime of diabetes, this [1% HbA1c reduction] is significant in reducing morbidity and mortality."
• Adult users in the bionic pancreas group experienced a reduction in diabetes distress and fear of hypoglycemia with statistically significant differences favoring the bionic pancreas group relative to the standard of care group.
• Parents of children in the bionic pancreas group reported a significant increase in diabetes treatment satisfaction compared to the standard of care group.

"We know that health inequities exist in almost every aspect of healthcare delivery: Type 1 diabetes is no exception," said Martha Goldberg Aronson, Interim CEO and Board Director, Beta Bionics. "Beta Bionics is thrilled to see that exploratory analyses consistently indicate glycemic improvements across race, education, and income from the IO BPPT. This supports our public benefit commitment to making type 1 diabetes management technology accessible to the many."

The session provided details on the iLet in adults, youth, and the iLet with Fiasp in adults in the IO BPPT. The following investigators participated in the session moderated by Dr. Roy Beck:

• Gregory P. Forlenza, MD: iLet Bionic Pancreas and IO BPPT Study Design
• Davida Kruger, MSN APN-BC: Adult Cohort Humalog/NovoLog versus Standard of Care
• Laurel H. Messer, Ph.D., RN, CDCES: Pediatric Cohort Humalog/NovoLog versus Standard of Care
• Steven J. Russell, MD, Ph.D.: RCT Results for Fast Acting Insulin Aspart (Fiasp)
• Jill Weissberg-Benchell, Ph.D., CDCES: Patient-Reported Outcomes
• Steven J. Russell, MD, Ph.D.: Ancillary Studies and Discussion of the Results

"As a nurse practitioner and diabetes care and education specialist, I have always said a diagnosis of diabetes does not come with a math degree," said Jeanne Jacoby, FNP, CDCES, Director of Medical Affairs, Beta Bionics, and a person living with diabetes. "I was excited to see that the exploratory sub-group analysis shows consistently reduced mean HbA1c regardless of education level for those in the bionic pancreas group."

Insulin-Only Bionic Pancreas Pivotal Trial (IO BPPT) Results & Background
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 automated insulin delivery (AID) systems, 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®.

The trial was designed to reach a broad demographic with respect to race, ethnicity, age, therapy type, and baseline glycemic control. The IO BPPT population was more diverse and representative of people with type 1 diabetes in the United States than any previous pivotal trial of an AID system. The racial and ethnic composition in the primary analysis included 74% White non-Hispanic, 10% Black non-Hispanic, 10% Hispanic or Latino, and 6% other or more than one race.

The IO BPPT was a multi-center, randomized controlled trial funded, in part, by a grant from the National Institutes of Health to Boston University, and conducted in collaboration with the IDE sponsor and study coordinator, the Jaeb Center for Health Research, and 16 clinical research centers across the U.S.

For more information on the IO BPPT results, read the previous data release: The iLet^® Bionic Pancreas Significantly Reduced HbA1c and Improved Time in Range vs Standard of Care for a Diverse Range of People with Type 1 Diabetes.

About the iLet^® Bionic Pancreas
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.

About Beta Bionics
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 Duotm) 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 Corporationtm. 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., Kruger, D., Messer, L.,& Russell, S. (2022, June 3). The Insulin-Only Bionic Pancreas Pivotal Trial?Randomized Clinical Trial Results [Mini Symposium]. ADA's 82nd Scientific Sessions, New Orleans, LA, United States.

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