FDA Clears New iLet Bionic Pancreas & Algorithm-Based Software

The U.S. Food and Drug Administration has given its approval for two important diabetes devices called the Beta Bionics iLet ACE Pump and the iLet Dosing Decision Software. These devices are meant for people who are six years old or older and have type 1 diabetes. When used together with a specific FDA-approved continuous glucose monitor (CGM), they create a new system known as the iLet Bionic Pancreas.

What’s best about this system is that it can automatically figure out how much insulin a person needs and tell the insulin pump to deliver it. It does this by using a special computer program called an algorithm. This means that it can help people with diabetes manage their insulin levels more easily and keep their blood sugar in check.

How does iLet Bionic Pancreas work?

The iLet Bionic Pancreas utilizes an advanced closed-loop algorithm that operates with minimal user input. To get started with this device, users only need to provide their body weight, eliminating the need for additional insulin dosing parameters.

Unlike traditional pump therapy, which often requires manual adjustments of settings and variables, the iLet’s adaptive algorithm takes care of these complexities, making it a simpler choice.

One notable feature of the iLet is its mealtime functionality. Instead of the typical carb counting associated with mealtime insulin dosing, the device introduces a novel meal announcement feature. Users can simply categorize their meal size as small, medium, or large. Over time, the algorithm learns from these meal announcements and adjusts insulin delivery to suit each user’s unique insulin requirements.

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