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First automated insulin-delivery device approved for type 1 diabetes

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The FDA today approved Medtronic’s MiniMed 670G, the first hybrid closed loop system — often referred to as an “artificial pancreas” — designed to monitor glucose and provide appropriate insulin doses for people aged 14 years and older with type 1 diabetes, according to an FDA press release.

‘The FDA is dedicated to making technologies available that can help improve the quality of life for those with chronic diseases — especially those that require day-to-day maintenance and ongoing attention,” Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in the release. “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.”

The new system measures glucose every 5 minutes and automatically administers or withholds insulin. Users of the system will still need to manually request insulin doses to counter meal consumption.

The system includes a sensor that monitors glucose levels under the skin, an insulin pump strapped to the body and an infusion patch connected to the pumps with a catheter that delivers the insulin.

“As part of our commitment to improving diabetes care, the FDA worked interactively with Medtronic from the earliest stages of development to assist in making this technology available to people with type 1 diabetes,” Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in the release. “We encourage companies to work closely with the agency to ensure scientifically sound, highly efficient clinical study designs, helping to expedite the FDA’s evaluation and subsequent approval of novel devices that can make a difference for patients.”

Data from a clinical trial including 123 participants with type 1 diabetes revealed that the device is safe and effective for people aged 14 years and older. No serious adverse events were reported.

An ongoing study is being performed to assess the safety and effectiveness of the system for children aged 7 to 13 years with type 1 diabetes.