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- The trial achieved key primary and secondary endpoints, demonstrating improved outcomes over standard of care for people living with type 1 diabetes.
- The study population — 440 adults and children 6 years and older with type 1 diabetes — was more diverse and representative of the US type 1 diabetes population than any previous pivotal trial of automated insulin delivery systems.
- The iLet® Bionic Pancreas is a pocket-sized, wearable, investigational medical device designed to autonomously determine and deliver insulin doses to control blood glucose levels in people with diabetes.
- Dr. Steven J. Russell, principal investigator, presented the results from the multi-center randomized Insulin-Only Bionic Pancreas Pivotal Trial at Advanced Technologies & Treatments for Diabetes (ATTD) on Saturday, April 30, 2022.
- The study results have been included in a comprehensive submission package to the FDA for regulatory review.
CONCORD, Mass., April 30, 2022 (GLOBE NEWSWIRE) — Beta Bionics, Inc. — The results of the multi-center randomized Insulin-Only Bionic Pancreas Pivotal Trial (IO BPPT) were presented today by Dr. Steven J. Russell, Associate Professor of Medicine, Harvard Medical School, at the International Conference on Advanced Technologies & Treatments for Diabetes (ATTD).
Insulin-Only Bionic Pancreas Pivotal Trial 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 iLet Bionic Pancreas met all key 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 people who used the iLet Bionic Pancreas was reduced by 0.5% compared to those using standard of care. In an analysis of participants who had a baseline HbA1C greater than 7%, there was a 0.7% reduction of HbA1c in the iLet Bionic Pancreas arm vs standard of care.
- No increased risk of hypoglycemia: People with diabetes 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 …
Full story available on Benzinga.com
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