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FDA Approves First-Generation Artificial Pancreas System
October 4, 2013
On September 27, the US Food and Drug Administration (FDA) announced the approval of the MiniMed 530G with Enlite, a first-generation artificial pancreas system that automatically shuts off insulin delivery when blood glucose levels drop too low.
The approval represents the first step toward a fully automated, closed-loop artificial pancreas that would control blood glucose levels without requiring user intervention.
The MiniMed 530G with Enlite, an integrated insulin pump and continuous glucose monitoring system, is the first device approved in the United States with “threshold suspend” — the ability to suspend insulin delivery when glucose levels have fallen too low. When glucose levels reach a predetermined hypoglycemia (low glucose) threshold — which can be set by a health-care provider from anywhere between 60 mg/dl and 90 mg/dl — the system will sound an alarm. If the user is sleeping or otherwise cannot respond to the warning, the device will suspend all insulin delivery for two hours. Insulin delivery can be resumed at any time.
According to Medtronic, the Enlite sensor (which detects glucose levels) is 31% more accurate than previous sensors and, in tests, it has been able to detect up to 93% of hypoglycemic episodes. The Enlite sensor can be worn for up to six days.
“The diabetes community has eagerly awaited approval of this system that stops insulin delivery when sensor glucose values fall below a predetermined threshold,” said Richard M. Bergenstal, MD.
The MiniMed 530G with Enlite is approved for people with diabetes ages 16 and up. It will be available within the next few weeks at a retail price of $7,350; those with insurance will generally pay from $500 to $1,200 out of pocket, according to Medtronic.
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