The FDA announced today that it cleared the Beta Bionics iLet ACE automated insulin pump and iLet dosing decision software.
FDA clearance covers the devices for people 6 years of age and older with type 1 diabetes. Combined with a compatible, FDA-cleared integrated continuous glucose monitor (iCGM), they form the iLet Bionic Pancreas. Using an algorithm, the automated insulin delivery system determines and commands insulin delivery.
“Today’s action will provide the type 1 diabetes community with additional options and flexibilities for diabetes management and may help to broaden the reach of AID technology,” said Dr. Jeff Shuren, director of the 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.”
How the Beta Bionics iLet Bionic Pancreas works
The Beta Bionics iLet Bionic Pancreas uses an adaptive, closed-loop algorithm. It initializes only with a user’s body weight and requires no additional insulin dosing parameters. The algorithm removes the need to manually adjust insulin pump therapy settings and variables.
iLet also simplifies mealtime use by replacing conventional carb counting with a new meal announcement feature. This feature enables users to estimate the amount of carbs in their meal as “small,” “medium” or “large.” Over time, the algorithm learns to respond to users’ individual insulin needs.
The iLet dosing decision software determines and commands the increase, decrease, maintenance or suspension of basal insulin doses. It commands correction doses of insulin based on the input from an iCGM. The software also independently determines and commands meal doses of insulin based on the meal announcement feature.
Last year, the company reported that a trial of its iLet Bionic Pancreas met key endpoints, including reduced HbA1c. Endpoints included consistently demonstrating reduced mean HbA1c across populations regardless of race, education, or income level in exploratory analyses of subpopulations.
Adult users of the iLet Bionic Pancreas experienced a reduction in diabetes distress and fear of hypoglycemia. They demonstrated statistically significant differences relative to the standard of care group.
