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FDA Clears iLet Bionic Pancreas Insulin Delivery System

The US Food and Drug Administration (FDA) has cleared Beta Bionics’s iLet ACE Pump and the iLet Dosing Decision Software for people ages 6 years and older with type 1 diabetes.

Working together with a previously cleared integrated continuous glucose monitor (CGM), the entire new system is called the iLet Bionic Pancreas. It differs from current automated insulin delivery (AID) systems in its increased level of automation. The adaptive algorithm is initialized using only the patient’s body weight, without other insulin dosing parameters. Rather than entering specific carbohydrate counts, users only input whether the carbohydrate amount of a meal is “small,” “medium,” or “large.” The algorithm adapts over time to users’ individual 24/7 insulin needs.

Pivotal data for the system were presented at the American Diabetes Association 82nd Scientific Sessions in 2022, as reported by Medscape Medical News.

In the 16-center trial involving 440 adults and children ages 6 years and older with type 1 diabetes, the system reduced A1c by 0.5 percentage points at 13 weeks, without an increase in hypoglycemia. Patients spent an average of 2.6 hours more in time in range compared with standard care (currently available AIDs, stand-alone pump and CGM devices, or multiple daily insulin injections plus CGM).

The FDA granted the iLet a breakthrough device designation in December 2019.

Anne L. Peters, MD, a professor of medicine at the University of Southern California (USC) Keck School of Medicine and director of the USC clinical diabetes program, commented on the pivotal study and the system for Medscape Medical News in 2022. She called the study “cool” because it enrolled more than 25% ethnic minority individuals “who aren’t routinely studied in these insulin device trials,” and it included people with a range of baseline A1c levels, with more than 30% of patients having an A1c greater than 8%.

Regarding the system’s algorithm, she pointed out that it “doesn’t allow for the individual using the pump to fidget with it. They can’t override the system and they can’t put in other insulin doses. The system is just there to take care of their diabetes.”

That might represent a limitation for some with type 1 diabetes, study coprincipal investigator Roy W. Beck, MD, PhD, told Medscape Medical News during the ADA meeting. “The iLet could dramatically reduce type 1 diabetes management burden for many patients, but it might not suit everyone. For example, somebody who’s very compulsive, and has an A1c of 6.5%, and is used to manipulating what they do, this is probably not a good system for them because the system is kind of taking over.”

On the other hand, Peters said, “I think what’s important about this system is that it may allow for greater use of automated insulin delivery systems. It may allow primary care providers to use these systems without needing all sorts of support, and patients may be able to use these devices more simply than a device where they have to do carb counting and adjusting in ways that I think tend to be pretty complicated and require higher numeracy and literacy skills.”

The Bionic Pancreas was originally conceived as a dual-hormone system including glucagon delivery as well as insulin. Beta Bionics is continuing to work with the FDA on that front.

Miriam E. Tucker is a freelance journalist based in the Washington, DC, area. She is a regular contributor to Medscape, with other work appearing in The Washington Post, NPR’s Shots blog, and Diabetes Forecast magazine. She is on Twitter: @MiriamETucker.

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