FDA Sets Guidelines for Artificial Pancreas

by Mark Benson on December 2, 2011

New pancreas guidelines set

Last Thursday, the Food and Drug Administration has provided guidelines as to the development of the artificial pancreas to assist Type 1 diabetes sufferers. The announcement was made by the Director of the FDA Center for Devices and Radiological Health, Dr. Jeffrey Shuren, which stated the agency would provide maximum flexibility to manufacturers seeking to make the device available in the United States.

He said, “We understand how this device could change the lives of millions of Americans and diabetes and we want our safety and effectiveness review to give patients the confidence that the device works.”

The FDA has been working with advocates for patients, researchers and developers of the device. The artificial pancreas is a system of pumps and sensors able to address insulin needs of type 1 diabetes patients. This system ensured greater accuracy in the delivery of insulin by making better computations as to insulin needs at any given time. The whole package would be worn outside the body and is designed not only to provide insulin but also to replace cells in the pancreas that produce insulin. These cells, called beta cells, often are decimated in Type 1 diabetes patients.

The whole artificial pancreas contains an insulin pump and monitor for glucose levels. These individual parts work together to pump insulin in the right dosages according to an algorithm specifically attuned to the needs of the individual diabetic.

The FDA is setting a three-part clinical trial that would lead up to outpatient trials. While this process would speed up availability to the public allowing for innovation but would ensure safe devices for eventual use of the patient.

According to the latest statistics, there are about three million Americans that suffer from Type 1 diabetes. This is the condition where the pancreas is unable to produce the right amount of insulin to manage blood sugar levels. With this condition, the individual must strictly monitor blood sugar levels constantly. This often leads to errors when it comes to computing the right amount of insulin to keep blood glucose at the right levels.

This system of computation is exhausting and error prone, according to the Juvenile Diabetes Research Foundation. This patient advocacy group has been pushing to develop an artificial pancreas that would take the place of blood sugar control in the body. The artificial pancreas would monitor glucose levels, deliver the right amount of insulin into the body.

While the guidelines have been announced, the availability of the device for patients in the United States still remains to be seen in the future.


The opinions expressed in this article do not necessarily reflect the views of the DiabetesForum.com Community and should not be interpreted as medical advice. Please see your doctor before making any changes to your diabetes management plan.

{ 1 comment… read it below or add one }

Tony December 4, 2011 at 11:12 pm

Artificial pancreas are not being developed for Type 2s ?

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