The expanded indication provides an important treatment option for clinicians and patients with type 1 diabetes.
The US Food and Drug Administration (FDA) expanded the indication of the MiniMed 670G hybrid closed looped system to include use in patients with type 1 diabetes 7 years of age and older, announced Medtronic.
The approval was backed by positive results from a pediatric clinical trial that demonstrated the safety of the MiniMed 670G system in this younger patient population.
“The MiniMed 670G system is the most advanced insulin delivery system on the market today, and proven to effectively manage type 1 diabetes,” Jennifer Sherr, pediatric endocrinologist, Yale New Haven Children’s Hospital’s diabetes clinic, associate professor, pediatric endocrinology, Yale School of Medicine, said in a statement. “In the pediatric clinical trial, there was an increase in Time in Range (70-180 mg/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.”
In the clinical trial, researchers analyzed data from 105 children between 7—13 years old with type 1 diabetes throughout a 2-week baseline period in open-loop mode, followed by a 3-month in-home study period with the hybrid-closed loop enabled.
Study results show that the percentage of Time in Range increased from 56.2% to 65%, while A1C levels decreased from 7.9% to 7.5%.
No incidences of diabetic ketoacidosis, severe hypoglycemic or serious device-related adverse effects were reported. Almost all of the children continued to utilize the pump once the study concluded.
This new system features Medtronic’s SmartGuard technology and CGM—the Guardian Sensor 3— which works to automate the delivery of a personalized amount of basal insulin every 5 minutes based on sensor glucose values. The system self-adjusts to avoid highs and lows, so patients can spend more Time in Range.
The FDA noted that the device is not approved for use in children 6 years of age or younger and in those who require less than 8 units of insulin per day.
MiniMed 670G is available commercially for immediate shipment.
This device was originally approved by the FDA in September 2017 for use in patients 14 years of age and older with type 1 diabetes.