FDA Approves Investigation of Longer-Use Insulin Infusion Set

The last few years have brought amazing strides in wearable devices for diabetes, particularly “smart” insulin pumps that communicate with other devices and continuous glucose glucose monitoring (CGM) systems. These advances allow a growing number of people with diabetes — especially type 1 diabetes — to worry less about their blood glucose going out of target range and to do fewer traditional blood glucose checks.

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While many sensors for CGM systems have recently been redesigned to have longer wearing times — up to 10 days for some models — current insulin pump infusion sets can only be worn for 2 to 3 days. That may be about to change, with the U.S. Food and Drug Administration (FDA) approving a proposed trial for an infusion set that can be worn for 7 days.

The approval, announced last week in a press release from pump manufacturer Medtronic, is for a multi-center study that will enroll up to 150 people, ages 18 to 80, with type 1 diabetes who currently use an insulin pump. According to Medtronic, the new infusion set incorporates new adhesive technology for extended wear, along with newly designed mechanisms to ensure stable insulin delivery for days on end.

Medtronic notes that if approved for widespread use, the new infusion set could be changed simultaneously with the company’s 7-day CGM sensors, making scheduling these changes much easier.

”It is time for an infusion set to extend wear to a week and beyond,” writes Satish Garg, MD, director of the Adult Diabetes Division of Barbara Davis Center at the University of Colorado and an advisor to Medtronic, in the press release. “This is long overdue and will likely improve quality of life for patients on insulin pumps, and many more patients may accept insulin pump as an option.”

Want to learn more about type 1 diabetes? Read “Type 1 Diabetes Questions and Answers,” “Six Type 1 Diabetes Symptoms You Need to Know” and see our type 1 diabetes videos.

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.

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