The MiniMed 670G hybrid closed looped system (Medtronic), which automatically monitors glucose and provides appropriate basal insulin doses, has been approved by the Food and Drug Administration (FDA) for use in individuals aged 7 to 13 who have type 1 diabetes. The system was first approved in 2017 for patients with type 1 diabetes aged ≥14 years.
The MiniMed 670G system measures glucose levels every 5 minutes and automatically adjusts insulin delivery to avoid highs and lows. The expanded age approval was based on results from a clinical trial involving 105 children (7 to 13 years old) with type 1 diabetes; study participants wore the MiniMed 670G device for 3.5 months. Results showed that among study participants, the percentage of time spent in the optimal glycemic range of 70-180mg/dL (Time in Range) increased from 56.2% to 65%, while A1C levels decreased from 7.9% to 7.5%; no serious adverse events were reported during the study period.
“In the pediatric clinical trial, there was an increase in Time in Range 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,” 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.
As per FDA requirements, the device developer will conduct a post-market study to evaluate the device in real-world settings.
For more information visit Medtronic.com.