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The FDA has approved a device that automatically shuts off an insulin pump when blood glucose levels drop too low -- a very small step towards the "artificial pancreas."
The agency gave the green light to Medtronic's MiniMed 530G with Enlite sensor technology, which will turn off the insulin pump for at least 2 hours if a patient doesn't respond to alarms that blood sugar is dipping dangerously low.
However, the device isn't the holy grail of a fully automated, closed-loop artificial pancreas that would use an algorithm to adjust insulin dose based on blood sugar levels. Those devices are still at least 5 years away from clinical use, if not longer, experts have said.
With the Medtronic device, patients still control the insulin dose. However, the automatic shut-off feature could be incorporated into a closed-loop system.
The device uses what's known as low glucose suspend technology in conjunction with sensor-augmented pump therapy in order to prevent hypoglycemia.
The Medtronic system is approved for use by people with diabetes ages 16 and older. The company will conduct a post-approval study including children ages 2 and up.
The Enlite sensor can be worn for 6 days.