Minimed 780G System's SmartGuard Feature Approved for Pediatric Use in Children 2 Years and Older in Japan

Minimed Japan LLC (Headquarters: Minato-ku, Tokyo; hereinafter 'Minimed Japan') announced that Japan Medtronic Co., Ltd., the manufacturer and distributor, obtained regulatory approval on May 20, 2026, to expand the indicated age for the SmartGuard™ feature equipped on the 'Minimed™ 780G System' from the previous 7 years and older to 2 years and older. The SmartGuard™ feature is designed to reduce the burden of blood glucose management. It continuously reads changes in subcutaneous glucose correlated with blood glucose levels and automatically adjusts and delivers necessary insulin, mimicking the pancreas's natural insulin secretion function. With this regulatory approval, the feature can now be used by children aged 2 to 6, providing a new treatment option called Automated Insulin Delivery (AID) therapy for toddlers with type 1 diabetes who face challenges in glucose management.

[Manufacturer and Distributor] Japan Medtronic Co., Ltd. Product Name: Medtronic Minimed 700 Series Medical Device Approval Number: 30300BZX00256000

The Minimed 780G system is linked with a Continuous Glucose Monitoring (CGM) system that does not require fingerstick calibration. As the only AID system in Japan that automatically adjusts basal insulin and delivers correction boluses based on predicted glucose values, it has been used by many since its launch in Japan in November 2023. In real-world clinical settings, it has received high praise not only for improving the quality of glucose management but also from a Quality of Life (QOL) perspective, providing peace of mind and reducing the daily burden of care.

Global clinical trials and real-world data have consistently demonstrated the efficacy of the Minimed 780G system. Real-world data from 470,000 Minimed 780G system users worldwide represents one of the largest bodies of evidence. Following the initiation of the system, the Time in Range (TIR)—the percentage of time spent within the target glucose range (70–180 mg/dL)—reached an average of 72.1%, while the Time below Range (TBR) (<70 mg/dL), an indicator of hypoglycemia, was kept at 0.3%. Furthermore, the Glucose Management Indicator (GMI), an estimated HbA1c metric, was 7.0%, suggesting that high-quality glucose management is achievable. When the Recommended Optimal Settings are used, it has been shown that TIR can reach 77.1%.

In addition, the results of the LENNY Study, an international clinical research study targeting children, were published in the medical journal The Lancet Diabetes & Endocrinology, demonstrating the efficacy and safety of the Minimed 780G system in children aged 2 to 6 with type 1 diabetes. In this multicenter, randomized, crossover trial, the use of SmartGuard reduced HbA1c by 0.6% and improved TIR by 9.9% compared to when not in use. Parents and caregivers also reported improvements in QOL, such as better night-time sleep quality, reduced time spent on glucose management, and diminished fear of hypoglycemia.

In recent years, the utility of AID has been clearly positioned in domestic and international diabetes treatment guidelines. In Japan, the Japan Diabetes Society strongly recommends AID therapy for pediatric and adolescent type 1 diabetes, as it improves glycemic control without increasing the frequency of hypoglycemia compared to multiple daily insulin injections. The International Society for Pediatric and Adolescent Diabetes (ISPAD) guidelines also strongly recommend AID therapy for pediatric and adolescent type 1 diabetes to improve TIR, reduce hypo- and hyperglycemia, enhance QOL, and specifically alleviate the burden of nighttime care. Guidelines in Europe and other international regions similarly recommend the use of AID for pediatric patients as a treatment option to improve glycemic management.

Regarding this expansion of indications, Dr. Toru Kikuchi, President of the Japanese Society for Pediatric Endocrinology, stated:

'Early childhood is a particularly difficult time for diabetes management because toddlers cannot adequately express their physical condition or symptoms of hypoglycemia in words. In the medical field, we strongly feel the anxiety of parents regarding nighttime hypoglycemia and the heavy burden of continuous management. The availability of the Minimed 780G system's SmartGuard feature for children aged 2 to 6 is a major step forward addressing these challenges, and we believe it will greatly contribute to the peace of mind and improved QOL of patients and their families.'

Mitsuyo Oka, President of Minimed Japan, also stated