Medtronic presented compelling clinical data at the American Diabetes Association's 85th Scientific Sessions demonstrating the potential of its MiniMed 780G automated insulin delivery system to transform diabetes management across different patient populations. The results support expanding indications for the device beyond its current approval for type 1 diabetes in patients aged 7 years and older.
Breakthrough Results in Type 2 Diabetes Management
A 31-site single-arm trial evaluated the MiniMed 780G system paired with the Simplera Sync sensor in 236 adults with type 2 diabetes requiring intensive insulin therapy. Participants achieved remarkable improvements in glycemic control, with an average 8.6% increase in Time in Range (TIR), reaching 84.9% - well above the ADA goal of 70%. The study also demonstrated a clinically significant HbA1c reduction from 7.7% to 6.9%, meeting ADA targets for diabetes management.
"As the industry moves toward broader indications of automated insulin delivery systems, we see tremendous potential to improve outcomes and quality of life for millions of people managing type 2 diabetes with insulin," said Dr. Robert Vigersky, Chief Medical Officer, Medtronic Diabetes. "Our teams are committed to advancing smart, connected technologies that reduce the daily burden of care and bring precision to insulin therapy like never before."
The results showed promising improvements across all clinical outcome metrics including Time in Range, Time in Tight Range, and Time Above Range compared to the run-in period where hybrid closed loop or open-loop delivery was used. Importantly, Time Below Range remained stable, indicating maintained safety profiles.
LENNY Trial Validates Benefits for Young Children
The LENNY trial, published in The Lancet Diabetes & Endocrinology, represents a significant advancement for pediatric diabetes care. This multi-center, randomized controlled, crossover trial evaluated the MiniMed 780G system in 98 young children aged 2-6 years with type 1 diabetes across 12 centers in 4 countries.
The study design included a 12-week auto mode period using advanced hybrid closed loop technology, a 2-week wash-out phase, and a 12-week manual mode period with suspend before low feature activated. Results showed significantly better glycemic management in auto mode, with participants achieving a 0.6% lower HbA1c and 9.9% higher Time in Range compared to manual mode or hybrid closed loop without autocorrections.
"To preserve brain development and minimize long-term diabetes complications, it is essential that blood glucose concentrations are maintained close to healthy ranges from disease onset in early life," said Prof. Tadej Battelino, MD, Head of Department of Pediatric and Adolescent Endocrinology, UMC Ljubljana, Slovenia. "We are hopeful that if the data continues to be strong, the MiniMed 780G system can help make this possible."
Participants in auto mode spent an average of 145 minutes per day more in range than those in manual mode. This improvement was primarily driven by a reduction in hyperglycemia, which is a major contributor to long-term complications. The study showed an acceptable safety profile with no severe hypoglycemic events reported.
Impact on Family Quality of Life
The LENNY trial also assessed the emotional and practical burden on families managing type 1 diabetes in young children. Managing diabetes in toddlers and young children can be emotionally stressful for parents and caregivers due to the need for constant blood sugar monitoring, dietary management, insulin administration, and disrupted routines and sleep.
Survey results from caregivers in the LENNY trial indicated that when their child used auto mode, they experienced relatively low fear of hypoglycemia and high sleep quality compared to manual mode. This finding highlights the broader impact of automated insulin delivery technology beyond clinical metrics.
Regulatory Recognition and Future Expansion
The clinical significance of these findings is underscored by the American Diabetes Association's 2025 Standards of Care, which now endorse the use of automated insulin delivery systems for adults with insulin-intensive type 2 diabetes. This endorsement recognizes the potential of these systems to significantly improve clinical outcomes and validates the growing role of diabetes technology in transforming chronic disease management.
Currently, the MiniMed 780G system is not approved for use in type 2 diabetes or young children under 7 years old by the U.S. Food and Drug Administration or other regulatory bodies. However, Medtronic intends to work with global regulators toward expanding access to its diabetes technology for insulin-intensive type 2 diabetes, as well as seeking a lower age indication for those with type 1 diabetes.
"We're hopeful that if the data continues to be strong, we will receive future indication expansion so the most vulnerable group, small children under 7 years, and their families can also benefit from this technology," said Prof. Ohad Cohen, M.D., senior global medical affairs director, Medtronic Diabetes.
The data presented at ADA 2025 represents a significant step forward in diabetes technology, potentially expanding access to automated insulin delivery for millions of patients who could benefit from improved glycemic control and enhanced quality of life.
