FDA Approves First ‘Artificial Pancreas’ for People With Type 1 Diabetes

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The U.S. Food and Drug Administration on Wednesday approved the first automated insulin delivery system — a so-called “artificial pancreas” — for people 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,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in an agency news release.

The device — Medtronic’s MiniMed 670G — is what’s known as a hybrid closed-loop system. That means it monitors blood sugar and then delivers necessary background (also known as basal) insulin doses. The device will also shut off when blood sugar levels drop too low.

However, this device isn’t yet a fully automated artificial pancreas​. People with type 1 diabetes will still need to figure out how many carbohydrates are in their food, and enter that information into the system, the agency noted.

Medtronic said the new device will be available by Spring 2017. The FDA approval is currently only for people aged 14 and older. The company is now conducting clinical trials with the device in younger patients.

Type 1 diabetes is an autoimmune disease caused by a mistaken attack on healthy insulin-producing cells in the body, destroying them. Insulin is a hormone necessary for ushering sugar into cells in the body and brain to provide fuel for the cells. People with type 1 must replace the insulin their bodies no longer produce, through multiple daily injections or through a tiny catheter attached to an insulin pump.

However, figuring out exactly how much insulin to give is no easy task. Both too much and too little insulin can have dangerous, even deadly consequences.

And that’s where this new technology will help. The device has a continuous glucose monitor that constantly measures blood sugar levels. A sophisticated computer algorithm then figures out if someone’s blood sugar levels are too low or too high, and when too high, will give the correct insulin dose to bring the blood sugar level down.

The device does this via a small catheter inserted beneath the skin and attached to a tube that’s attached to an insulin pump. This insulin delivery site needs to be changed approximately every three days.

If blood sugar levels are too low, the device will shut down insulin delivery.

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SOURCE: HealthDay, Serena Gordon