Beta Bionics said this week that it won FDA approval to start recruiting patients with Type I diabetes for home-use studies of its iLet bionic pancreas system.
The trial is slated to test Novo Nordisk’s fast-acting insulin, Fiasp, with the company’s autonomous infusion pump in adults with Type I diabetes. The study will also evaluate insulin lispro and conventional insulin aspart combined with the iLet system in adults and kids with Type I diabetes, according to Beta Bionics.
The company’s latest device can dose insulin, glucagon or both – as needed. Using dosing algorithms and machine learning, the iLet system calculates and doses insulin or glucagon based on data from Dexcom’s G5 continuous glucose monitor.
“The design of this ambitious insulin-only bionic pancreas study builds on the foundation of previous studies we have conducted with our clinical collaborators testing our bionic pancreas algorithms with previous investigational platforms,” founder & CEO Ed Damiano said in prepared remarks.
“This trial is exciting not only because it represents the first time we will be able to test our bionic pancreas algorithms with our own proprietary iLet platform, and not only because it will include both children and adults with T1D, and not only because it will draw upon those who use MDI therapy in equal number to those who use insulin pumps for their usual care, but also because we will be breaking new ground by being the first group to test autonomous insulin delivery using Fiasp,” he added.
Beta Bionics has attracted a number of funding and development partners, including Dexcom (NSDQ:DXCM), Eli Lilly (NYSE:LLY) and Novo Nordisk (NYSE:NVO).
“We have worked with Beta Bionics and Ed Damiano’s team for many years to provide our highly accurate and reliable CGM technologies to drive the bionic pancreas,” Steve Pacelli, EVP of strategy & corporate development at Dexcom, said. “We support the efforts of Beta Bionics to bring their iLet bionic pancreas system to market and look forward to seeing our G6 system incorporated into their future iLet platform and validated in future clinical trials.”
Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.