Medtronic also plans to seek a label expansion for its MiniMed 780G system in the U.S. The company said a submission to expand the use of the system for people with Type 2 diabetes is currently under FDA review. In addition, Medtronic is running clinical trials in the U.S. to assess the use of the insulin delivery system in 2- to 6-year-olds. 

The CE mark label expansion was supported by clinical data, including the results of a single-arm, pivotal trial of 95 people with Type 2 diabetes. The results, published in May in Diabetes Technology and Therapeutics, found people with Type 2 diabetes who used the 780G pump had a 0.7% reduction in hemoglobin A1c from a baseline of 7.9%. They also had an increase in time in range, a measurement that indicates the percentage of time a person’s blood glucose stays within a target range, from 72% to 80%.