Medtronic (NYSE:MDT) has reportedly filed for pre-market approval from the FDA for its MiniMed 670G “artificial pancreas,” which is designed to automatically track and adjust blood sugar levels in patients with diabetes, and expects the federal safety watchdog to issue a decision within a year.
The device measures blood glucose every 5 minutes to keep patients within their target range, according to Bloomberg. Medtronic’s PMA bid is backed by a 124-patient trial that showed better blood glucose control than with manual testing and insulin administration. The average HbA1c blood sugar level at the start of the trial, 7.4, fell to 6.9 by the end of the study, with 58% of patients achieving that goal, the news service reported. There were no malfunctions, hyper- or hypoglycemic events or hospitalizations, lead investigator Dr. Richard Bergenstal, of Park Nicollet’s International Diabetes Center in Minneapolis, told Bloomberg.
Patients using the MiniMed 670G must still recalibrate the device every 12 hours, change out the glucose sensor weekly and refill the insulin reservoir every 3 days, but that’s still a vast improvement over hourly finger-stick tests.
“The work isn’t gone, but it seems to be a lot less,” Bergenstal said. “Patients are working 24 hours a day now. We want them to get control without spending every hour of the day worrying about their diabetes or preparing for the next event.”
“This was them, in their homes, going about their lives,” added Medtronic diabetes chief Francine Kaufman. “There was no remote monitoring. The closed loop is running the train now.”
The device proved so popular with the trial subjects that a group asked the FDA for continued access; the study went into an extended review period with more than 100 volunteers.
“It was totally mind-blowing,” Les Hazelton, who is 1 of the patients who joined the trial extension, told the newswire. “I like being in better control of my body and my disease. The more I know about what’s happening right now, the better I can manage it.”