Diabetes: Medtronic launches FDA bid for 1st automated insulin pump

June 8, 2012 by MassDevice staff

Medtronic filed for FDA pre-market approval for the world's first insulin pump with an automated system to suspend insulin delivery when glucose levels get too low.

insulin management

Medical device industry titan Medtronic (NYSE:MDT) filed a bid for FDA approval of its MiniMedR 530G system, which the company bills as the world's first insulin pump that delivers and halts insulin automatically, based on sensor readings of a patient's glucose levels.

Regulatory approval for the MiniMedR 530G would bring the market one step closer to an "artificial pancreas," a system that would require minimal patient intervention to monitor and management blood glucose and insulin levels for patients with diabetes.

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Medtronic's bit includes data from its ongoing Aspire clinical trial, which showed that diabetic patients spent less time below the low glucose threshold when using the company's MiniMed system when compared with conventional pump therapy.

Patients using the MiniMed device also had less severe drops in blood glucose values and none of the patients were hyperglycemic at the end of observation. The device is already commercially available outside of the U.S., but is limited to investigational device use by the FDA.

"There is a clear need for new therapies that can stop insulin delivery when glucose becomes dangerously low, which could be of great benefit if a person with diabetes is asleep or unable to react," International Diabetes Center executive director Dr. Richard Bergenstal said in prepared remarks. "Reducing the amount of time spent below the low glucose threshold without rebound hyperglycemia (high blood sugar) could help people with diabetes stay in better, overall glucose control."