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.
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."
Hyperglycemia can results in confusion, unresponsiveness, loss of consciousness and, in rare cases, even death, according to the release. Researchers published a study in February finding that an automated on/off feature in insulin pumps could significantly reduce the severity and duration of hypoglycemia.
"We are excited about the potential to bring low glucose suspend innovation to market in the United States to meet the unmet clinical needs in the treatment of diabetes ," Medtronic diabetes business president Katie Szyman said in prepared remarks. "This PMA application is a demonstration of our commitment to advance the science and development of insulin delivery and continuous glucose monitoring systems to commercialize an artificial pancreas."
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have been calling on the FDA to spur progress in the field, and in December 2011 the agency released a long-awaited draft guidance aimed at clearing a path for the devices to enter the U.S. market.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.
The company hopes to be the first to bring automated insulin delivery technology to patients in the U.S., but it’s not alone.
"The development of a fully implantable glucose sensor is one of the essential requirements for the successful development of an artificial pancreas," chairman & CEO William Caragol said at the time. "We are well positioned to play a potentially significant role in making an artificial pancreas a reality for people with type 1 diabetes."