|Medtronic's artificial pancreas system pairs the MiniMed insulin pump with continuous glucose monitoring.--Courtesy of Medtronic|
On the heels of Johnson & Johnson's ($JNJ) early progress on a fully automated artificial pancreas, Medtronic ($MDT) has started enrolling patients for an overnight study of its closed-loop system.
Medtronic's device combines continuous glucose monitoring with its MiniMed insulin pump, using an algorithm to predict blood glucose fluctuations and mete out insulin to keep patients at healthy levels. The company will recruit up to 85 diabetics at 6 U.S. sites, testing whether its system can normalize blood sugar overnight.
However, unlike J&J's two artificial pancreas feasibility studies, Medtronic's trial will simulate system failures to test its algorithm's ability to detect problems and prevent over- or under-infusion, a wrinkle the company said will pay off when the time comes for FDA application.
"The safety and reliability of these artificial pancreas technologies is absolutely critical," Medtronic Diabetes Vice President Francine Kaufman said in a statement. "This study is the first to put closed-loop algorithms to the test, simulating the 'worst case' scenarios to ensure patient safety should a fault occur."
Medtronic's smartphone-compatible system requires virtually no patient input to regulate blood glucose, the company said, and the new U.S. study overlaps with two trials running in the U.K. and Australia.
Meanwhile, J&J's Animas unit has completed an overnight study of its own, studying 20 Type 1 diabetics and finding that the Hypoglycemia-Hyperglycemia Minimizer System helped them spend about 90% of the night within a healthy blood glucose range. And competitors Becton Dickinson ($BDX) and Tandem are chasing the same goal, partnering with the Juvenile Diabetes Research Foundation (JDRF) to develop artificial pancreas technology.
The FDA is yet to approve any of the systems, but J&J won the agency's blessing to study the device in the U.S. in 2011, and Medtronic got the same green light this year.
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