The Beta Bionics iLet ACE Pump and the iLet Dosing Decision software, matched with a compatible FDA-cleared integrated continuous glucose monitor, use an algorithm to determine and command insulin delivery to users.
The FDA recently cleared a new insulin pump and insulin dosing software to determine and command insulin delivery for patients with type 1 diabetes (T1D) aged 6 years and older, according to a press release from the agency.
The Beta Bionics iLet ACE Pump and the iLet Dosing Decision software has recently received FDA clearance. The devices, matched with a compatible FDA-cleared integrated continuous glucose monitor (iCGM), form a new system called the iLet Bionic Pancreas. This automated insulin dosing (AID) system uses an algorithm to determine and command insulin delivery to users, according to the FDA.
The agency states more than 11% of Americans are diagnosed with diabetes. T1D patients must consistently monitor glucose levels and have insulin therapy through injection (syringe), an insulin pen, or pump to avoid becoming hyperglycemic. According to the FDA, the iLet Bionic Pancreas uses an adaptive closed-loop algorithm initialized only with a user’s body weight and requires no additional insulin dosing parameters. The need to manually adjust insulin pump therapy settings and variables are removed by the adaptive algorithm. With a new meal announcement feature, the iLet device also simplifies use at mealtime, replacing conventional carb counting. The feature allows users to estimate the amount of carbs in their meal as small, medium, or large. The algorithm learns over time to respond us the individual insulin need of the user.
“[This] action will provide the [T1D] community with additional options and flexibilities for diabetes management and may help to broaden the reach of AID technology,” said Jeff Shuren, MD, JD, director, FDA’s Center for Devices and Radiological Health. “The FDA is committed to advancing new device innovation that can improve the health and quality of life for people living with chronic diseases that require day-to-day maintenance like diabetes through precision medicine approaches.”
"Patients with diabetes face tremendous challenges," said Russell Libby, MD, FAAP, founder and president, Virginia Pediatric Group, assistant clinical professor of pediatrics, University of Virginia School of Medicine. "There have been significant advancements in the understanding, treatment, and research of T1D. It would seem that the evolution of a CGM and insulin dosing system could improve the lives of patients and reduce the demands of self care and ramifications of the impressision of the typical care paradigms. A system that can monitor blood sugar and administer insulin on a biological basis with input on dietary and activity could revolutionize the acute and long-term care of patients with diabetes, especially children. Short of genetic reengineering or pancreatic islet cell transplant, this technology could jump start a new level of care, preventive intervention, and be life-improving technology for those living with T1D."
The FDA granted clearance of the iLet ACE Pump and iLet Dosing Decision Software to Beta Bionics Inc, and reviewed these products through the 510(k) premarket clearance pathway. According to the agency, a 510(k) is a premarket submission made to the FDA to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.
FDA clears new insulin pump and algorithm-based software to support enhanced automatic insulin delivery. FDA. May 19, 2023. Accessed May 22, 2023. https://www.fda.gov/news-events/press-announcements/fda-clears-new-insulin-pump-and-algorithm-based-software-support-enhanced-automatic-insulin-delivery