Medtronic plc , a global leader in medical technology, today announced the CE (Conformité Européenne) Mark approval in Europe for expanded indications of its MiniMed™ 780G system. The system is now approved for use in children as young as 2 years old, during pregnancy, and in individuals with insulin-requiring type 2 diabetes. This significant milestone follows an extensive review of published clinical data involving young children, pregnant women, and adults with type 2 diabetes.
This expansion reflects Medtronic’s continued commitment to broadening access to automated insulin delivery (AID) technologies to support diverse populations, enhancing glycemic control and quality of life across all ages and stages of life.
The expanded pediatric indication marks a major advance for families managing type 1 diabetes (T1D) in young children. Data from the LENNY trial, recently published in The Lancet Diabetes & Endocrinology, validated the safety and effectiveness of the MiniMed™ 780G system in children aged 2–6 years. The trial showed a 0.6% reduction in HbA1c and a 9.9% increase in Time in Range (TIR) when the system was used in auto mode versus manual mode. Caregivers also reported better sleep quality and reduced fear of hypoglycemia.
“Since starting the MiniMed™ 780G system, it's like we've gained a teammate—one that works 24/7 to help manage my son's diabetes,” shared Paul Schulz, a parent from Barcelona whose child was diagnosed with T1D at age 4.
Automated insulin delivery systems are increasingly becoming the standard of care across Europe. In England and Wales, NICE guidelines (TA943) recommend hybrid closed-loop systems for all pediatric and adolescent patients with T1D. Similarly, Germany’s 2023 national guidelines and the 2024 ISPAD recommendations strongly advocate for AID use in pediatric patients to enhance glycemic control and quality of life, particularly overnight.
“These systems are transformative,” said Dr. Fiona Campbell, a UK-based pediatric endocrinologist. “They relieve families from the constant burden of diabetes management, improve sleep, and support better physical and cognitive development in children.”
Pregnancy brings unique challenges for women living with T1D, as glycemic control becomes more difficult yet more critical. Pregnancy-specific glycemic targets (TIRp: 63–140 mg/dL or 3.5–7.8 mmol/L) demand greater precision.
The MiniMed™ 780G system’s ability to maintain glucose targets as low as 100 mg/dL (5.5 mmol/L) has proven beneficial in meeting these tighter goals. A European study found that pregnant users of the system achieved an average TIRp of 66.5%, alongside improved overnight control, reduced hypoglycemia, and high user satisfaction.
These findings are in line with recently updated Clinical Practice Guidelines from the European Society of Endocrinology and the U.S. Endocrine Society, both of which support the use of AID systems to improve maternal and fetal outcomes.
The CE Mark now also includes individuals with type 2 diabetes who require insulin therapy. A pivotal multicenter trial involving 95 participants demonstrated a 0.7% reduction in HbA1c (from a baseline of 7.9%) and an increase in TIR to 80%, with minimal time spent below range.
Real-world data from over 26,000 MiniMed™ 780G users identified as having type 2 diabetes further corroborated the system’s effectiveness, showing average TIRs above the internationally recommended 70% and time below range under 1%.
In the U.S., Medtronic has submitted an application to the FDA to expand the system’s use for type 2 diabetes and is currently conducting clinical trials to evaluate its safety and efficacy in children aged 2–6 years.
The expanded CE Mark approval of the MiniMed™ 780G system represents a major step forward in diabetes care—empowering young children, expectant mothers, and people with type 2 diabetes to access advanced AID technology. With growing clinical support and adoption across Europe, Medtronic continues to lead efforts in transforming diabetes management and improving lives.