Medtronic’s MiniMed 780G Insulin Pump Wins Several EU Nods

Medtronic has received CE mark clearance to expand the indications of the MiniMed 780G system for use by people aged two and older, during pregnancy, and for type 2 insulin-requiring diabetes.

Automated insulin delivery (AID) systems are rapidly becoming the standard of care for children with type 1 diabetes across Europe. In England and Wales, NICE guidelines (TA943) recommend hybrid closed-loop systems for all children and adolescents with type 1 diabetes.

“Advancements in Automated Insulin Delivery (AID) systems are revolutionizing how we care for children with type 1 diabetes,” said Dr. Fiona Campbell, a leading pediatric endocrinologist in the UK. “For families, these systems lift the relentless burden of constant monitoring and insulin adjustments. Better glucose control in children can support healthier growth and brain development, better sleep, and the freedom to simply enjoy being a child. It’s a transformative shift in both outcomes and quality of life.”

In a European study evaluating its use during pregnancy, women using the MiniMed 780G system achieved an average TIRp of 66.5%—a significant improvement over traditional insulin therapy. The system also delivered better overnight glucose control, reduced overall and nighttime hypoglycemia, and higher treatment satisfaction among expectant mothers.

In a recently published multi-center, pivotal trial in 95 people with type 2 diabetes, use of MiniMed 780G resulted in a 0.7% reduction in HbA1c (from a baseline of 7.9%) and an increase in TIR to 80% (from a baseline of 72%) with a time below range (70 mg/dL; 3.9 mmol/L) under 0.5%. Additionally, real-world datavii of 26,427 MiniMed 780G users who were identified as having type 2 diabetes (based on self-reported diagnosis and/or total daily insulin dose), demonstrated good glycemic control, on average exceeding the international consensus of 70% time in range (70-180 mg/dL) and maintaining time below range of less than 1%.

In the U.S., Medtronic is actively working with regulatory authorities to bring the benefits of advanced diabetes technology to a broader population. A submission to expand the use of the MiniMed 780G system for individuals with type 2 diabetes is currently under review by the U.S. Food and Drug Administration (FDA). Additionally, U.S. clinical trials are underway to examine the use of the MiniMed 780G system in two- to six-year-olds.

The company is currently in the process of spinning off its diabetes business into new company MiniMed.