Automated Pump: FDA Approves Next-Gen Insulin System

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

The U.S. Food and Drug Administration (FDA) has cleared the Beta Bionics iLet ACE Pump and the iLet Dosing Decision Software for individuals aged six and older with type 1 diabetes. These innovative devices, along with an FDA-cleared integrated continuous glucose monitor (iCGM), will be integrated into a comprehensive system known as the iLet Bionic Pancreas. This system utilizes a sophisticated algorithm to determine and regulate insulin delivery automatically.

This milestone development in automated insulin dosing (AID) technology brings additional options and flexibility to the type 1 diabetes community. Dr. Jeff Shuren, the director of the FDA’s Center for Devices and Radiological Health, emphasized the agency’s commitment to advancing new device innovations that enhance the health and quality of life for individuals managing chronic diseases like diabetes through precision medicine approaches.

With over 11% of Americans diagnosed with diabetes, the need for effective diabetes management solutions is paramount. Type 1 diabetes hampers the body’s ability to produce or utilize insulin, the hormone responsible for regulating blood glucose levels. Individuals with type 1 diabetes must vigilantly monitor their glucose levels and administer insulin therapy via injections with a syringe, an insulin pen, or an insulin pump to prevent hyperglycemia.

The iLet Bionic Pancreas incorporates an adaptive closed-loop algorithm that solely relies on the user’s body weight for initialization, eliminating the need for additional insulin dosing parameters. Unlike conventional pump therapy, this adaptive algorithm streamlines the process by removing the requirement for manual adjustment of insulin pump settings and variables. Additionally, the iLet device simplifies mealtime by introducing a novel meal announcement feature that replaces conventional carb counting. Users can estimate the carb content of their meals as small, medium, or large, and the algorithm learns and adapts to individual insulin needs over time.

In individuals with type 1 diabetes, the human pancreas naturally supplies a continuous low rate of insulin, known as basal or background insulin. As the body’s insulin production is impaired in these patients, the iLet Dosing Decision Software takes charge of determining and administering basal insulin doses, as well as correction doses based on data received from the iCGM. Moreover, the software independently calculates and delivers meal doses of insulin in response to meal announcements.

The FDA reviewed the iLet ACE Pump and iLet Dosing Decision Software through the 510(k) premarket clearance pathway, which demonstrates that the devices are substantially equivalent to legally marketed predicate devices. Beta Bionics Inc. was granted clearance for the iLet ACE Pump and iLet Dosing Decision Software.

The FDA, as an agency within the U.S. Department of Health and Human Services, ensures the safety, effectiveness, and security of human and veterinary drugs, vaccines, and medical devices. It also plays a crucial role in safeguarding our nation’s food supply, cosmetics, dietary supplements, electronic radiation-emitting products, and regulating tobacco products.

This recent FDA clearance signifies a significant stride in diabetes management technology, offering individuals with type 1 diabetes a new and advanced automated insulin delivery system. The iLet Bionic Pancreas’s streamlined functionality, simplified mealtime calculations, and adaptive algorithm hold promise for improving the lives of those living with this chronic condition.

Here are some of the key benefits of the iLet Bionic Pancreas:

• Automatically delivers insulin based on real-time glucose levels, eliminating the need for manual injections or pump adjustments.
• Uses an adaptive algorithm that learns and adapts to individual insulin needs over time.
• Simplifies mealtime by eliminating the need for carb counting.
• Provides peace of mind by giving users more control over their diabetes management.
• First and only, automated insulin-delivery system that determines 100% of all insulin doses.
• No carb counting*, no corrections, no calculating boluses.
• Only needs your body weight to get started.

The iLet Bionic Pancreas is a significant advancement in diabetes management technology, and it has the potential to improve the lives of millions of people living with type 1 diabetes.