iLet Bionic Pancreas System Receives FDA Breakthrough Device Designation

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Doctor holding pancreas hologram -- iLet Breakthrough Device Designation

The goal of developing a closed-loop artificial pancreas — a device or system of devices that regulates a person’s blood glucose levels completely automatically — has inspired efforts from many different companies in recent years, with products now available that come closer than ever before to meeting that goal. But the race to develop a true, game-changing closed-loop system continues.

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One contestant in that race is Beta Bionics, Inc., which just announced in a press release that it has received the U.S. Food and Drug Administration (FDA)’s Breakthrough Device designation for its iLet Bionic Pancreas System. This designation gives the company priority review in future steps of the FDA’s approval process.

According to the press release, the iLet is “a pocket-sized, wearable” device that’s similar in form factor to an insulin pump. Still in its investigational stages, the device requires users to enter only their body weight in order to begin regulating blood glucose levels. By reading the user’s blood glucose levels continuously, the device is designed to perform all calculations needed to deliver the right amount of insulin at any given time.

What’s more, the device can be configured to deliver insulin only, glucagon only, or both hormones. The insulin-only and dual-hormone setups are designed for people with diabetes, with glucagon being a potentially useful addition to insulin in case someone’s blood glucose drops too low. In that case, glucagon can be delivered to prompt the release of glucose from the person’s liver. The glucagon-only version is designed for rare health conditions that cause chronically low blood glucose.

The algorithms used by the iLet were developed at Boston University’s Damiano Lab, and refined based on clinical trials involving both children and adults with type 1 diabetes. Beta Bionics intends to seek FDA approval first for the insulin-only version of the iLet, followed by the dual-hormone version.

”We believe the iLet Bionic Pancreas System represents a true breakthrough therapy for the management of glycemia, particularly in type 1 diabetes,” says Ed Damiano, President and CEO of Beta Bionics, in the press release. “The iLet may be able to provide safer and more effective therapy in far more people than current therapies due to its simplicity of use.”

Quinn PhillipsQuinn Phillips

A freelance health writer and editor based in Wisconsin, Phillips has a degree in government from Harvard University. He writes on a variety of topics, but is especially interested in the intersection of health and public policy.

Want to learn more about the iLet? Watch our 2015 interview with co-developer Stephen J. Russell, MD, PhD.

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