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Medtronic plc announced CE 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.
Expanded age indication extends benefits of AID systems for young children with type 1 diabetes
Data from the LENNY trial, recently published in The Lancet Diabetes & Endocrinology(opens new window), demonstrated the safety and efficacyi of the MiniMed™ 780G system in children aged 2-6 years old with type 1 diabetes (T1D). Participants in the multi-center, randomized controlled, crossover trial achieved a 0.6% lower HbA1C and 9.9% higher time in range (TIR) when the system was used in auto mode, compared to those using it in manual mode. Parents and caregivers also reported improved sleep quality and lower fear of hypoglycemia when the system was used in auto mode.
“As a parent, nothing is more important than giving my child the freedom to just be a kid — but managing type 1 diabetes made that feel nearly impossible,” said Paul Schulz, based in Barcelona, Spain, whose son Marc lives with type 1 diabetes. “Ever since Marc was diagnosed with diabetes at age 4, we have been lucky to count on support from Medtronic. This doesn’t mean it has always been easy, but since starting the MiniMed™ 780G system, so much has changed. It’s like we’ve gained a teammate — one that works around the clock to help manage his diabetes. It’s very freeing.”
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)(opens new window) recommend hybrid closed-loop systems for all children and adolescents with T1D. Recognizing the importance of AID therapy, NHS England has a 5-year plan to roll out AID systems to most people with T1D, with children up to the age of 18 years old being prioritized because of their high need to optimize care. 2023 guidelines(opens new window)ii from the German Diabetes Association advise offering AID to all pediatric patients, provided they or their caregivers can use the technology safely. In addition, the 2024 ISPAD guidelinesiii strongly recommend AID systems to improve time in range, reduce hypo- and hyperglycemia, enhance quality of life, and ease the burden of care — especially overnight.
“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.”
Navigating pregnancy with type 1 diabetes: A smarter, safer path forward
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—known as Pregnancy Time in Range (TIRp)—set between 63 and 140 mg/dL (3.5-7.8 mmol/L).
This is where advanced technology like the MiniMed™ 780G system can make a meaningful difference. The system’s ability to target glucose levels as low as 100 mg/dL (5.5 mmol/L) offers a powerful tool for achieving tighter control. In a European studyiv 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. These outcomes align with a growing body of evidence and a recent Clinical Practice Guideline jointly published by the European Society of Endocrinology and the U.S. Endocrine Societyv supporting the use of AID systems with the goal of improving maternal and fetal health outcomes during pregnancy.
MiniMed™ 780G system now indicated for type 2 diabetes
The MiniMed™ 780G system is now also approved for use in Europe for people with type 2 diabetes. In a recently publishedvi 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 datavii of 26,427 MiniMed™ 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.
i Battelino et al. Efficacy and safety of automated insulin delivery in children aged 2–6 years (LENNY): an open-label, multicentre, randomised, crossover trial; Lancet Diabetes Endocrinol 2025
ii Deutsche Diabetes Gesellschaft Diagnostik, Therapie und Verlaufskontrolle des Diabetes mellitus im Kindes- und Jugendalter 2023, Version 4, AWMF-Registernummer: 057-016
iiiISPAD Clinical Practice Consensus Guidelines 2024: Diabetes technologies: Insulin delivery(opens new window).
iv Benhalima K, Beunen K, Van Wilder N, et al. Comparing advanced hybrid closed loop therapy and standard insulin therapy in pregnant women with type 1 diabetes (CRISTAL): a parallel-group, open-label, randomised controlled trial. Lancet Diabetes Endocrinol 2024
v Wykoff JA et al. J Clin Endo Metab 2025; July 13:dgaf288. https://doi.org/10.1210/clinem/dgaf288(opens new window).
vi Bhargava A et al. Diab Tech Ther 2025; 27(5):366-375
vii Thijs I, et al. J Diabetes Sci Technol. 2025 Mar 12:19322968251318373.
Source: Medtronic
