Dive Brief:
- Medtronic received an expanded indication for its MiniMed 780G system in Europe.
- The CE mark would allow the automated insulin delivery system to be during pregnancy, by children as young as two, and by people with Type 2 diabetes who take insulin.
- Automated insulin delivery systems, which pair an insulin pump and a glucose sensor to adjust insulin dosing, are becoming available for more people with Type 2 diabetes after they were primarily used to manage Type 1 diabetes. The Food and Drug Administration cleared the first expanded labels for AID systems for Type 2 diabetes for Insulet last year and Tandem Diabetes Care in February.
Dive Insight:
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 two- to six-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%.
The company also shared data from a randomized controlled trial published in the Lancet Diabetes & Endocrinology demonstrating the 780G system’s safety and effectiveness in children ages two to six with Type 1 diabetes. A separate, open-label randomized controlled trial published last year evaluated use of the system during pregnancy, when clinical guidelines recommend a much tighter glucose target range. The study found the system did not improve the overall time in target range, but it improved overnight time in target range.
All three studies were funded by Medtronic.
Ahead of the label expansion, Medtronic CEO Geoff Martha said in a May earnings call that diabetes segment revenue grew by nearly 12% year over year to $647 million, as the company grows its MiniMed 780G installed base in the U.S. and international markets. Medtronic has been working to turn around its diabetes business as it plans to spin out the unit into a separate, public company.
