Major Push for Quicker Approval of Artificial Pancreas


Study: Artificial Pancreas a Promising Option

Research published in April found that using the artificial pancreas was better at controlling blood sugar than an insulin pump. Low blood sugar during the night is often a problem for type 1 diabetics.

"[The system] has the potential to improve safety and efficacy of insulin delivery and may in future allow more flexible lifestyles in conjunction with improved glycemic control for people with type 1 diabetes," the authors, led by Roman Hovorka of the University of Cambridge.

The FDA, in response to the JDRF's criticism, says it's making proress with the artificial pancreas. The agency expects to deliver its draft guidance on the artificial pancreas by Dec. 1 and says it's currently on target to meet that goal.

One of the sticking points that could potentially delay approval is the fact that continuous glucose monitors are not approved to provide insulin dosages, only to alert a person that blood sugar is high or low.

"Today's insulin systems are basing all dosing decisions on that monitor, so we need to make sure we test them appropriately," said Charles Zimliki of the FDA's Office of Device Evaluation and chair of the agency's Artificial Pancreas Critical Path Initiative.

Zimliki also said the agency has never approved an artificial pancreas for use outside medical settings, but is making good progress on this one. The recommendations for the low glucose suspend system only took four months to complete; he said was a major achievement.

The FDA will release its draft guidance by Dec. 1. The public then has 90 days to offer feedback on it, and after that, the final recommendations are expected in 2012.

Zimliki, a type 1 diabetic himself, said he wants the device to be approved as quickly as possibly.

But Brewer said it still takes too long to get this life-saving equipment into the hands of the people who need it.

"We don't need guidance. We need to have the products," he said.

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