FDA Grants Breakthrough Device Status: iLet Bionic Pancreas

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Earlier this week, Beta Bionics announced that the Food and Drug Administration (FDA) has granted breakthrough device designation to the company’s iLet Bionic Pancreas System, a wearable pocket-sized device used for blood sugar control in people with diabetes. The device can be adjusted to work as an insulin-only, glucagon-only or bi-hormonal artificial pancreas using both insulin and glucagon.


JDRF funded Ed Damiano, Ph.D., CEO of Beta Bionics, for his early research testing the safety and efficacy of a novel closed-loop system that incorporated the use of glucagon in addition to insulin. The results of this work helped to inform the development of the iLet bionic pancreas, which includes a configuration with a dual-chamber pump containing insulin in one chamber and glucagon in the other.


How is the iLet bionic pancreas system different than other artificial pancreas systems? Well, unlike most closed-loop systems on the market and in development, which use only insulin to normalize blood sugar levels, iLet has the ability to pump two hormones: insulin and glucagon. Glucagon, a key hormone whose response is impaired in type 1 diabetes (T1D), can help raise blood sugar levels when they become too low. This dual-hormone approach may enable the device to achieve tighter blood sugar control while minimizing low blood sugar, called hypoglycemia.


The Breakthrough Device Program is an FDA platform for more effective treatments of serious diseases, like T1D, and enables timely access to these devices by speeding their development, assessment and review. Other companies that have received the FDA Breakthrough Device designation for T1D technologies include JDRF partners EOFlow, Medtronic and Bigfoot.


What’s more, the iLet is designed to have the users enter only their weight for the iLet to initialize therapy. Immediately thereafter, the iLet begins controlling blood sugar levels automatically, without requiring the user to count carbohydrates, set insulin delivery rates or deliver additional insulin for meals or corrections.

 The iLet, if results are positive, would be a welcomed additional approach to help people manage their T1D.

By Alexandra Mulvey