The MiniMed Paradigm Real-Time insulin management system, an earlier generation of the device.
Medtronic Inc. (NYSE:MDT) crept closer to realizing an artificial pancreas for diabetics with the release of clinical trial results finding that its MiniMed Paradigm insulin delivery system met clinical endpoints with low-glucose suspend technology.
The next-generation MiniMed Paradigm system delivers and halts insulin automatically, based on sensor readings of a patient’s glucose levels.
Patients using the new LGS-enabled system in the Aspire trial spent 19% less time below the low-glucose threshold than patients using conventional pump therapy, according to a press release.
"Until now we have never had a therapy designed to automatically intervene when blood glucose becomes dangerously low, which is the greatest fear and biggest challenge in achieving better glucose control in patients with diabetes," Dr. Satish Garg, professor of medicine and pediatrics at Barbara Davis Center for Childhood Diabetes, said in prepared remarks. "It makes sense to stop insulin delivery when a low-glucose threshold is met and that is how LGS is designed.”
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.
Advocates of artificial pancreas technology have been calling on the FDA to spur progress in the field, and in December 2011 the agency released a long-awaited draft guidance aimed at clearing a path for the devices to enter the U.S. market.
By then the watchdog agency already had 20 artificial pancreas systems with IDEs for study purposes, the FDA’s Artificial Pancreas Working Group & Critical Path Initiative leader Charles "Chip" Zimliki said at the time.
Minneapolis-area medical device giant Medtronic won FDA approval in October 2011 to conduct in-home trials, the second phase of the Aspire study, and that branch is enrolling now, according to a press release.
