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iLet Bionic Pancreas Cleared by FDA

Conn Hastings |

The iLet Bionic Pancreas for use by type 1 diabetes patients has been cleared by the FDA and is now available commercially. The device is offered by Beta Bionics, a medtech company based in Massachusetts and California, but the underlying technology originally developed by researchers at Boston University. The system can be paired with a Bluetooth glucose monitor to deliver personalized insulin dosing every five minutes, and calculates doses based on past and current glucose levels and its experience of how the user reacted to previous insulin doses. The technology has a personal origin story, as one of the researchers drove its development based on his experiences caring for his son with type 1 diabetes.

Controlling blood glucose levels in type 1 diabetes patients is a 24/7, 365 days a year kind of job, with an ongoing risk of dangerously low blood sugar levels occurring. This is particularly challenging at night, when sleep is the preferred option, and waking regularly to check that things are ok is difficult. This challenge inspired the creation of this technology, as one of the researchers cared for their son with type 1 diabetes on a nightly basis, and grew to appreciate these risks and the potential that this technology had.  

“Sleeping is the scariest part of all this,” said Ed Damiano, a researcher involved in the project, who drove the research forward based on his experiences with his son. “It’s what put this project on a high-speed rail. It’s a very scary prospect that blood sugars could go low at night. When you’re sleeping, you’re checked out—you don’t want to check out permanently.”

The iLet Bionic Pancreas has been cleared for people aged six and up with type 1 diabetes. The company reports that all users have to do is enter their weight into the system, and then the device will begin to automatically regulate blood glucose levels, learning as it goes. The device is small enough to sit in a pocket or be clipped to a strap or belt.

The FDA clearance decision was likely helped by a study published by the researchers in September 2022 that showed the bionic pancreas was better than the current standard of care at helping type 1 diabetes patients (both children and adults) to maintain optimal blood glucose levels.

 “Today’s action will provide the type 1 diabetes community with additional options and flexibilities for diabetes management and may help to broaden the reach of AID [automated insulin dosing] technology,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. “The FDA is committed to advancing new device innovation that can improve the health and quality of life for people living with chronic diseases that require day-to-day maintenance, like diabetes, through precision medicine approaches.”      

Product page: iLet Bionic Pancreas…

Flashback: Beta Bionics iLet Bionic Pancreas System Gets FDA Breakthrough Designation

Via: Boston University

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