FDA Approved “Artificial Pancreas” for Diabetes Treatment read more at here www.spinonews.com/index.php/item/1067-fda-approved-artificial-pancreas-for-diabetes-treatment

The U.S. Food and Drug Administration on Wednesday approved the first automated insulin delivery system called “artificial pancreas” for people with type 1 diabetes.

The device offers type 1 diabetics "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 medical device division, said in a statement.

Insulin pumps are currently used by more than a third of U.S. patients with type 1 diabetes, but they require manual adjustment to administer the needed insulin dose. Many patients also wear sensors that continually monitor their glucose levels.

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.

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Patients take insulin injections at various times of the day. But blood sugar can drop to dangerously low levels if too much insulin circulates in the bloodstream, requiring patients to frequently or continually monitor their insulin levels throughout the entire day.

The “artificial pancreas” 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.

Medtronic is studying whether the ‘Artificial Pancreas’ device could work for people younger than 14. The device does carry risks, like the possibility of developing hypoglycemia, hyperglycemia and skin irritation.

Medtronic has not announced a price for the MiniMed 670G, Denhoy estimated it may cost $5,000 to $8,000, with the annual cost of disposable sensors another few thousand dollars.

You can read more about the approval here.

 

Source: FDA