Thursday, December 1, 2011

Insight: Diabetes breakthrough stalled in safety debate from Rueters

By Julie Steenhuysen

CHICAGO | Thu Dec 1, 2011 8:33am EST

(Reuters) - It's a dream of medical science that looks tantalizingly within reach: the artificial pancreas, a potential breakthrough treatment for the scourge of type 1 diabetes.

Meant to mimic the function of a real pancreas, the artificial version is a complex device that combines a pager-sized continuous glucose monitor and sensor that tracks blood sugar with a pump that automatically delivers the correct dose of insulin at just the right time.

That technology could make a major difference to the three million Americans with the disease who must vigilantly monitor their blood sugar, even at night, and risk deadly consequences if they are slow to notice a dangerous change.

But it is caught up in America's long-running tug of war between supporters of more rapid medical innovation and those who seek better safety for new devices. A fresh confrontation is about to break open this week as the Food and Drug Administration lays out a path toward regulatory approval for such devices, expected as early as Thursday.

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