FDA OKs “Artificial Pancreas” for Type 1 Diabetes

Sep 28, 2016

The U.S. FDA approved Medtronic’s MiniMed 670G hybrid closed looped system, the first FDA-approved device that is intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses in people 14 years of age and older with type 1 diabetes.

“This first-of-its-kind technology can provide people with type 1 diabetes greater freedom to live their lives without having to consistently and manually monitor baseline glucose levels and administer insulin,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

The MiniMed 670G hybrid closed looped system, often referred to as an “artificial pancreas,” is intended to adjust insulin levels with little or no input from the user. It works by measuring glucose levels every five minutes and automatically administering or withholding insulin. The system includes a sensor that attaches to the body to measure glucose levels under the skin; an insulin pump strapped to the body; and an infusion patch connected to the pump with a catheter that delivers insulin. While the device automatically adjusts insulin levels, users need to manually request insulin doses to counter carbohydrate (meal) consumption.

The MiniMed 670G hybrid closed looped system is manufactured by Medtronic, headquartered in Dublin, Ireland.

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