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FDA Clears New Insulin Pump and Algorithm-Based Software to Support Enhanced Automatic Insulin Delivery

Saturday, May 20, 2023

Today, the U.S. Food and Drug Administration (FDA) has granted clearance to the Beta Bionics iLet ACE Pump and the iLet Dosing Decision Software for individuals aged six and above with type 1 diabetes. These devices, combined with a compatible integrated continuous glucose monitor (iCGM), will form the iLet Bionic Pancreas system. This automated insulin dosing (AID) system utilizes an algorithm to determine and regulate insulin delivery.

The FDA's approval of these devices offers the type 1 diabetes community more options and flexibility in managing their condition, potentially expanding the accessibility of AID technology. Dr. Jeff Shuren, the director of the FDA's Center for Devices and Radiological Health, expressed the agency's commitment to advancing innovative devices that enhance the health and quality of life for individuals with chronic diseases like diabetes through precision medicine approaches.

Type 1 diabetes affects over 11% of Americans, impairing the body's ability to produce or effectively utilize insulin, a hormone that regulates blood glucose levels. Individuals with type 1 diabetes must continually monitor their glucose levels and administer insulin therapy through injections or insulin pumps to prevent hyperglycemia. Disease management also involves adhering to a healthy diet and engaging in physical activity.

The iLet Bionic Pancreas incorporates an adaptive closed-loop algorithm that only requires the user's body weight for initialization, eliminating the need for additional insulin dosing parameters. This adaptive algorithm removes the manual adjustment of insulin pump settings, making it easier to initiate compared to conventional pump therapy and other available AID systems. The iLet device simplifies mealtime usage by introducing a new meal announcement feature, replacing conventional carbohydrate counting. Users can estimate their meal's carbohydrate content as small, medium, or large, and the algorithm learns over time to tailor insulin delivery to individual needs.

In individuals without diabetes, the pancreas continuously produces a basal insulin rate. However, patients with type 1 diabetes lack this natural insulin production. The iLet Dosing Decision Software independently determines and regulates all basal insulin doses, including adjustments and suspensions, as well as correction doses based on iCGM data. It also calculates and administers meal doses of insulin according to meal announcements.

The FDA evaluated the iLet ACE Pump and iLet Dosing Decision Software through the 510(k) premarket clearance pathway, which demonstrates substantial equivalence to a legally marketed predicate device.

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