Medtronic today announced CE (Conformité Européenne) Mark in Europe to expand indications of the MiniMed 780G system for use by individuals aged 2 years and older, during pregnancy, as well as type 2 insulin-requiring diabetes. To gain CE Mark for this expansion of indications, published clinical data in 2–6-year-olds, pregnant women, and people living with type 2 diabetes was reviewed. This expanded indication underscores the commitment Medtronic has to advancing access to automated insulin delivery (AID) technology for broader and more diverse populations, helping to improve outcomes and quality of life for people at every stage of life living with 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."
Pregnancy presents unique challenges for women with type 1 diabetes. Hormonal shifts and physiological changes can make glucose management more complex, while the developing baby is especially vulnerable to both high and fluctuating blood sugar levels. To protect both mother and child, clinical guidelines recommend a much tighter glucose target during pregnancy.
This is where advanced technology like the MiniMed 780G system can make a difference. The system's ability to target glucose levels as low as 100 mg/dL (5.5 mmol/L) offers a tool for achieving tighter control.
The MiniMed 780G system is now also approved for use in Europe for people with type 2 diabetes. In a recently published multi-center, pivotal trial in 95 people with type 2 diabetes, the use of the MiniMed 780G system 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 data of 26,427 MiniMedâ„¢ 780G system 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 2–6-year-olds.
