Encouraging Results of Pilot Study Testing Bionic Pancreas
Beta Bionics, Inc., a medical technology company developing and aiming to commercialize the world’s first fully automated bionic pancreas, recently announced its bionic pancreas glucose control algorithms that use lifelong autonomous learning were deployed in a pilot study comparing usual care with automated insulin-only and bihormonal (insulin and glucagon) delivery in three patients with cystic fibrosis related diabetes (CFRD). Results of the study were published in the Journal of Cystic Fibrosis (J.S. Sherwood, R.Z. Jafri, C.A. Balliro, et al., Automated glycemic control with the bionic pancreas in cystic fibrosis-related diabetes: A pilot study, Journal of Cystic Fibrosis, https://doi.org/10.1016/j.jcf.2019.08.002).
Researchers at the Massachusetts General Hospital performed a three-arm, random-order, cross-over, pilot study comparing the bihormonal bionic pancreas versus the insulin-only bionic pancreas versus usual care for CFRD. The bionic pancreas dosing algorithms utilized in this pilot study were identical to those used in other studies in subjects with type 1 diabetes. There were no restrictions on activity and subjects continued their normal diet, exercise, and work throughout the study. The bionic pancreas was initialized only with subject body weight, without any information regarding their usual insulin regimen.
Given the sample size of the study, only descriptive statistics were reported for the group. The group mean blood-glucose level, as measured by continuous glucose monitoring (CGM), was nominally lower in both the bihormonal (139 ± 15 mg/dl) and insulin-only (149 ± 10 mg/dl) bionic pancreas study arms relative to the usual care study arm (159 ± 35 mg/dl). During bionic pancreas arms, subjects used the meal announcement feature on average less than once per day, and survey data suggested that subjects had a decreased diabetes-management burden. Subjects reported they spent less time thinking about diabetes, felt more freedom with food choices, and had overall greater peace of mind.
“We are encouraged by the results of this pilot study suggesting that our bionic pancreas technology can potentially be deployed in multiple conditions of glycemic disregulation, including CFRD,” said Ed Damiano, President and Chief Executive Officer of Beta Bionics. “We look forward to continuing our commitment to innovation through clinical research as we plan to test multiple applications of our technology in further clinical studies in an effort to maximize the potential good our technology and company can bring to the diabetes community.”
This pilot study was supported by the National Institutes of Health under award number R01DK119699-01.
Beta Bionics is a for-profit Massachusetts public benefit corporation founded in 2015 to commercialize the iLet, a revolutionary bionic pancreas that is driven by mathematical dosing algorithms, which incorporate lifelong autonomous learning to automatically control glycemia. These mathematical dosing algorithms were developed in the Damiano Lab at Boston University and refined based on results from home-use clinical trials in adults and children with T1D. Beta Bionics is a Certified B Corporation whose founders — in addition to Ed Damiano — include other parents of children with type 1 diabetes and people with type 1 diabetes. Beta Bionics is committed to acting in the best interests of the diabetes community and to profoundly disrupting the diabetes medical device industry by bringing the iLet to market as expeditiously and responsibly as possible. Beta Bionics is pursuing regulatory approval of its insulin-only bionic pancreas, followed by its dual-hormone system, which will also administer a glucagon analog in order to raise blood-sugar levels without the need to consume carbohydrates. Beta Bionics operates in Massachusetts and California. For more information, visit www.betabionics.com.
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