Medtronic’s MiniMed 670G artificial pancreas system filed for FDA approval
Medtronic has filed for premarket approval of a brand new insulin pump, the MiniMed 670G, which could become the first artificial pancreas system to hit the public market.
The closed loop system continuously measures the glucose levels via a continuous glucose monitor, monitoring sensor. The glucose level data is wirelessly linked to the insulin pump which uses an algorithm to work out how much insulin to respond with throughout the day.
The new submission to the Food and Drug Administration is based on data which Medtronic presented to the American Diabetes Association’s 76th Annual Scientific Sessions conference. Data evidenced that the system, comprised of the MiniMed 670G insulin pump, fourth-generation glucose monitors and a control algorithm, lowered the HbA1c levels of 124 patients with type 1 diabetes.
HbA1c levels were reduced from 7.4 down to 6.9% over the three-month study period and 58 per cent of were able to achieve a target of 7.0% or lower. Over the 12,389 patient-days of the trial, there were no adverse events.
At the end of the study, most of the patients opted onto the continued-access program, showing that they approved and felt it bettered their lives. “Patients are working 24 hours a day now,” Richard Bergenstal, executive director of Park Nicollet’s International Diabetes Center in Minneapolis, who led the trial, told Bloomberg.
“We want them to get control without spending every hour of the day worrying about their diabetes or preparing for the next event.”
Automating the process means that people with diabetes will no longer be chasing their target blood glucose levels, won’t miss a dose, and, consequently, will be less likely to develop complications as a result of high blood glucose levels.
The insulin pump needs to be refilled every three days, while the sensor can last for seven days before needing recharging. Furthermore, users will have to recalibrate the device twice a day with a traditional finger prick test.
The system could be approved as early as next spring.
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