Beta Bionics Inc. received U.S. FDA clearance for its Ilet Bionic Pancreas, an automated insulin-delivery (AID) system that calculates 100% of insulin doses without requiring carb counting or manual boluses. The system—a pump plus dosing decision software—is indicated for people aged six years and up with type 1 diabetes.
Several companies showed promising results for automated insulin delivery (AID) systems at the American Diabetes Association (ADA) annual meeting in New Orleans. Studies of the systems, also known as artificial pancreas systems, indicate that integration with continuous glucose monitoring (CGM) systems enables substantially improved glycemic control, with more time in range (TIR) and less hypoglycemia than seen with multiple daily injection (MDI) therapy or insulin-pump therapy.
Boston startup Beta Bionics Inc. is headed into a pair of ambitious pivotal trials in 2020: one starting for an autonomous bionic pancreas device with insulin only and another to follow for a bihormonal version that also includes glucagon. These are expected to offer more precise, easy-to-use blood glucose maintenance for type 1 diabetes patients.
