Medtronic Receives FDA Approval of New Pediatric Indication for the MiniMed(TM) 670G Hybrid Closed Loop System in Children Ages 7-13

Medtronic plc (NYSE:MDT) has announced that the US Food and Drug Administration (FDA) has approved the use of MiniMed 650G system in patients with type 1 diabetes seven years of age and older.

As quoted in the press release:

This newest system by Medtronic features the company’s most advanced SmartGuard(TM) technology and most accurate CGM – the Guardian Sensor 3 – which work together to automate the delivery of a personalized amount of basal insulin every five minutes based on sensor glucose values. The system constantly self-adjusts to help avoid highs and lows, allowing patients to spend more Time in Range (the percentage of time spent in the optimal glycemic range of 70-180 mg/dL).

“The MiniMed 670G system is the most advanced insulin delivery system on the market today and proven to effectively manage type 1 diabetes,” said Dr. Jennifer Sherr, a pediatric endocrinologist at Yale New Haven Children’s Hospital’s diabetes clinic and an associate professor of pediatric endocrinology at the Yale School of Medicine. “In the pediatric clinical trial, there was an increase in Time in Range (70-180mg/dL) for sensor glucose values and a reduction in time spent in both hypoglycemia and hyperglycemia, which is compelling in light of the well-known challenges associated with maintaining stable glucose levels throughout the day and night in this younger age group.”

FDA approval was based on positive results from a pediatric clinical trial, which demonstrated the safety of the MiniMed 670G system in this younger patient population.¹ Data was analyzed from 105 children between seven and 13 years of age with type 1 diabetes during a two-week baseline period in open-loop mode (traditional pump therapy), followed by a three-month in-home study period with the hybrid-closed loop (SmartGuard Auto Mode) enabled. The results showed the percentage of Time in Range increased from 56.2 percent to 65.0 percent. A1C levels were also reduced from 7.9 percent to 7.5 percent. There were no incidences of diabetic ketoacidosis (DKA) in the study phase in Auto Mode and no severe hypoglycemic or serious device-related adverse events were reported. Almost all children continued to use the pump after the study concluded.

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