Diabetes management system MiniMed 780G developed by Medtronic gains CE Mark approval
The MiniMed 780G system, a groundbreaking automated insulin delivery (AID) technology, has received a CE Mark expansion in Europe, making it suitable for individuals aged 2 years and older with type 2 diabetes, pregnant women, and children with type 1 diabetes. This approval is supported by robust clinical trial data demonstrating improved glycemic outcomes.
In a significant development, the MiniMed 780G system has shown promising results for people with type 2 diabetes. Real-world data from 26,427 users revealed good glycemic control, with an average Time in Range (TIR) exceeding the international consensus of 70%. Moreover, a multi-centre, pivotal trial involving 95 people with type 2 diabetes showed a 0.7% reduction in HbA1c.
The benefits of the MiniMed 780G system extend to expectant mothers during pregnancy. It has been shown to deliver better overnight glucose control, reduce overall and nighttime hypoglycemia, and increase treatment satisfaction. A Clinical Practice Guideline jointly published by the European Society of Endocrinology and the U.S. Endocrine Society supports the use of AID systems with the goal of improving maternal and fetal health outcomes during pregnancy.
In England and Wales, the National Institute for Health and Care Excellence (NICE) guidelines recommend hybrid closed-loop systems for all children and adolescents with type 1 diabetes. Similarly, the 2023 guidelines from the German Diabetes Association advise offering AID to all paediatric patients.
In the United States, the MiniMed 780G system is currently FDA-approved for use in people with type 1 diabetes, having received approval on April 21, 2025. However, the expanded use of the MiniMed 780G system for people with type 2 insulin-requiring diabetes is still under FDA review. Medtronic has submitted an application to the FDA to extend the label to include type 2 diabetes, but this expanded indication has not yet been approved.
U.S. clinical trials are underway to examine the use of the MiniMed 780G system in 2-6-year-olds with type 1 diabetes. The results of these studies are yet to be published.
The MiniMed 780G system offers a powerful tool for achieving tighter glucose control during pregnancy, with women using the system achieving an average Pregnancy Time in Range (TIRp) of 66.5%. Parents and caregivers also reported improved sleep quality and lower fear of hypoglycemia when the system was used in auto mode.
As AID systems become the standard of care for children with type 1 diabetes across Europe, the expanded approval of the MiniMed 780G system for people with type 2 diabetes and pregnant women marks a significant step forward in diabetes management. The 2024 ISPAD guidelines strongly recommend AID systems to improve time in range, reduce hypo- and hyperglycemia, enhance quality of life, and ease the burden of care.
References: [1] Medtronic. (2023). Medtronic Announces Submission of MiniMed 780G System for Type 2 Diabetes to U.S. Food and Drug Administration. Retrieved from https://www.medtronicdiabetes.com/us/news/2023/medtronic-announces-submission-of-minimed-780g-system-for-type-2-diabetes-to-us-food-and-drug-administration [2] Medtronic. (2025). Medtronic Receives FDA Approval for MiniMed 780G System for People with Type 1 Diabetes. Retrieved from https://www.medtronicdiabetes.com/us/news/2025/medtronic-receives-fda-approval-for-minimed-780g-system-for-people-with-type-1-diabetes [3] Medtronic. (2024). Medtronic Announces Pending FDA Decision for MiniMed 780G System for Type 2 Diabetes. Retrieved from https://www.medtronicdiabetes.com/us/news/2024/medtronic-announces-pending-fda-decision-for-minimed-780g-system-for-type-2-diabetes [4] Medtronic. (2023). Medtronic Receives CE Mark for MiniMed 780G System in Type 2 Diabetes, Pediatric Population and Pregnancy. Retrieved from https://www.medtronicdiabetes.com/us/news/2023/medtronic-receives-ce-mark-for-minimed-780g-system-in-type-2-diabetes-pediatric-population-and-pregnancy [5] The Lancet Diabetes & Endocrinology. (2023). Safety and efficacy of the MiniMed 780G system in children and adolescents with type 1 diabetes (LENNY): a multicentre, randomised, controlled, open-label, crossover trial. Retrieved from https://www.thelancet.com/journals/landia/article/PIIS2213-8587(23)00136-6/fulltext
- The MiniMed 780G system, a technology for medical-conditions like type 2 diabetes and type 1 diabetes, has demonstrated promising results in real-world data and clinical trials, potentially offering improved glycemic outcomes and reducing HbA1c levels.
- The benefits of the MiniMed 780G system are not limited to adults but extend to pregnant women and young children, as it delivers better glucose control during pregnancy, reduces hypoglycemia, and increases treatment satisfaction.
- In line with the recommendations of the National Institute for Health and Care Excellence (NICE) and the German Diabetes Association, hybrid closed-loop systems such as the MiniMed 780G system are being considered as the standard of care for children and adolescents with type 1 diabetes.
- As the MiniMed 780G system gains broader approval for use in various medical-conditions and populations, it contributes significantly to the advancement of science in diabetes management, aiming to improve time in range, reduce hypo- and hyperglycemia, and enhance quality of life.
