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FDA Approves Artificial Pancreas to Manage Diabetes

Federal regulators have approved the first “artificial pancreas,” a device that can help some diabetes patients manage their disease by constantly monitoring their blood sugar and delivering insulin as needed.

According to BAW:

The device from Medtronic was approved Wednesday for patients with Type 1 diabetes, the kind usually diagnosed during childhood. About 5 percent of the nation’s 29 million Americans with diabetes have this type.

Doctors said they have long awaited a device that could help patients around the clock. Medtronic said the device will cost between $6,000 and $9,000, similar to its other insulin pumps. The Food and Drug Administration said it approved the device based on a three-month study of more than 120 patients. The study reported no major adverse events, such as dangerously low blood sugar, showing that the device is safe for those 14 years and up, regulators said in a release.

The pump is about the size of a deck of cards and can be worn on a belt or carried in a pocket.

The device “can provide people with Type 1 diabetes greater freedom to live their lives,” said Dr. Jeffrey Shuren, director of the FDA’s device center.

While the device can currently only be marketed for Type 1, doctors said it could eventually be used by those with Type 2 diabetes, where the body gradually loses the ability to produce or use insulin. Many of those patients are overweight or obese and face increased risk of heart attack, stroke and kidney failure.

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