Beta Bionics Announces Data Lock of the Insulin-Only Bionic Pancreas Pivotal Trial and Enrollment into the Screening Protocol of the Bihormonal Bionic Pancreas Pivotal Trial
The iLet® Bionic Pancreas is an investigational device limited by Federal (or United States) law to investigational use.
Not available for sale.
- The iLet® Bionic Pancreas is a pocket-sized, wearable investigational medical device that is designed to autonomously determine and deliver insulin and/or glucagon doses to control blood-glucose levels in people with diabetes and other conditions of glycemic dysregulation
- Data lock has been completed for the randomized controlled trial period of the Insulin-Only Bionic Pancreas Pivotal Trial, which tested the insulin-only configuration of the iLet Bionic Pancreas in approximately 440 adults and children 6 years and older with type 1 diabetes
- Enrollment has begun into the screening protocol of the Bihormonal Bionic Pancreas Pivotal Trial at Massachusetts General Hospital. This pivotal trial will test the bihormonal configuration of the iLet Bionic Pancreas in approximately 700 adults and children 6 years and older with type 1 diabetes
CONCORD, Mass., Dec. 22, 2021 (GLOBE NEWSWIRE) -- Beta Bionics, Inc. — a clinical stage medical technology company committed to the design, development, and commercialization of the iLet® Bionic Pancreas System — today announced the completion of the randomized controlled trial for the Insulin-Only Bionic Pancreas Pivotal Trial and enrollment into the screening protocol of the Bihormonal Bionic Pancreas Pivotal Trial at Massachusetts General Hospital. The iLet Bionic Pancreas is designed to mimic the biological pancreas by autonomously calculating and dosing insulin and/or glucagon as needed based on an input signal from a continuous glucose monitor worn by a person with type 1 diabetes. Insulin dosing decisions (basal, bolus, and correction) are made autonomously by the proprietary algorithm embedded on the iLet. The intent of the technology is to achieve near-normal glycemia and lift the cognitive daily burden of diabetes management in as many people with diabetes as possible.
The cognitive and emotional impact of diabetes can lead to data and decision-making overload for people living with diabetes. Despite advances in medications and technology, approximately 80%1 of people who live with type 1 diabetes are not meeting the ADA therapy goal of an HbA1c below 7%.
Recent advances in type 1 diabetes technology lack the flexibility to support the different needs, experiences, and resources of those living with 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.
Data Lock of the Insulin-Only Bionic Pancreas Pivotal Trial
The Insulin-Only Bionic Pancreas Pivotal Trial was an investigator-initiated, 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 study coordinator, the Jaeb Center for Health Research, and 17 clinical research centers across the U.S. It was designed to test the safety and efficacy of the insulin-only configuration of the iLet Bionic Pancreas System relative to a standard-of-care control group over a 13-week study period. The trial was conducted in the home-use setting and enrolled approximately 440 adults and children 6 years and older with type 1 diabetes. It was the largest sample size to date for a randomized controlled trial of an automated insulin delivery system.
Beta Bionics is committed to making its type 1 diabetes management technology accessible to the many, not just the few. Consequently, the trial was designed to reach a broad demographic with respect to race, ethnicity, age, therapy type, and baseline glycemic control. A large cross-section of trial participants was recruited in an attempt to represent, as closely as possible, the type 1 diabetes population in the U.S.
Data lock for the randomized controlled trial occurred last week. Data lock is the process of locking a clinical trial database to prevent further changes to the database. This is also the time when the data are “unblinded” or released to the statisticians who will analyze the data. Public presentation of the clinical data is expected in the first half of 2022.
“Data lock of the Insulin-Only Bionic Pancreas Pivotal Trial represents a major milestone for our organization as we work to bring autonomous insulin-delivery solutions to those living with type 1 diabetes,” said Dr. Ed Damiano, President and CEO of Beta Bionics. “We are grateful to the study participants, sponsors, and clinical collaborators for their commitment and dedication to testing the iLet in this well-designed, real-world, hypothesis-driven clinical trial. The time and effort they have brought to their work will be instrumental in helping us at Beta Bionics fulfill our mission of providing safe and effective glycemic control to people living with type 1 diabetes while helping reduce the emotional and cognitive burden of diabetes management.”
Enrollment into the Screening Protocol of the Bihormonal Bionic Pancreas Pivotal Trial
Enrollment into the screening protocol of the Bihormonal Bionic Pancreas Pivotal Trial began last week at Massachusetts General Hospital. The screening protocol identifies potential participants for the pivotal trial. This trial is being coordinated by the Jaeb Center for Health Research and will test the bihormonal configuration of the iLet Bionic Pancreas System using Zealand Pharma’s dasiglucagon in adults and children 6 years and older with type 1 diabetes. The trial includes three sub-trials, which are anticipated to provide the clinical data necessary to support the market application for the bihormonal configuration of the iLet Bionic Pancreas and the new-drug application (NDA) for the use of dasiglucagon in bihormonal artificial pancreas systems.
The first of these three sub-trials will be an initial three-month single-arm, bihormonal-only safety and test-run period that will enroll two participants at each of the approximately 30 clinical sites. A six-month, three-arm, randomized controlled trial will follow the test-run period and will enroll approximately 700 participants. A six-month extension study will immediately follow the randomized controlled trial for all of the approximately 700 participants.
CAUTION: The iLet® Bionic Pancreas is an investigational device limited by Federal (or United States) law to investigational use. Not available for sale.
About the iLet® Bionic Pancreas
The iLet is a pocket-sized, wearable investigational medical device designed to autonomously dose insulin and/or glucagon. 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 infuse insulin and/or glucagon without requiring the user to count carbohydrates, set insulin-to-carbohydrate ratios, set insulin basal rates, set correction factors, or deliver 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; not just people with type 1 diabetes on the iLet, but also their healthcare providers who have time and resource limitations and potentially no access to subspecialists.
About Beta Bionics
Beta Bionics® is a clinical stage medical technology company focused on the design, development, and commercialization of its iLet® Bionic Pancreas System. The iLet Bionic Pancreas 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. The iLet® Bionic Pancreas system is an investigational device, limited by federal (or United States) law to investigational use only.
Beta Bionics is a for-profit, public benefit corporation and Certified B Corporation™. Since its founding in 2015, its mission has been 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.
The iLet® Bionic Pancreas is an investigational device limited by Federal (or United States) law to investigational use. Not available for sale.
1. Pettus et al., Diabetes Care. 2019;42:2220–2227
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