Draft guidance on early form of artificial pancreas for diabetes management

Tue, 21 Jun 2011
The Food and Drug Administration (FDA) in the United States has issued draft guidance that recommends an artificial pancreas system for treating type 1 diabetes should undergo clinical trials. The artificial pancreas being developed is based on an automated, closed-loop system that offers an insulin infusion pump, a continuous glucose monitor and a glucose meter, which work together to check on blood sugar levels and manage insulin doses.

The guidance from the FDA regards an early version of an artificial pancreas system, called a low glucose suspend system, which helps to reduce the severity of hypoglycemia, although diabetes patients still have to manage their glucose levels and give themselves insulin, where necessary.

Jeffrey Shuren, director of the Center for Devices and Radiological Health at the FDA, commented "Our goal is to provide a clear pathway for artificial pancreas development so that people with diabetes can benefit from innovative medical devices ."

He added "Getting a safe and effective artificial pancreas system to Americans with type 1 diabetes is an FDA priority."

The FDA is now looking for feedback on the draft guidance from the industry and the clinical community about the system, especially regarding what types of studies that should now be conducted and what they need to achieve to progress the system for FDA approval.
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