Medtronic has secured the CE mark for the expanded use of its MiniMed 780G System for individuals as young as two years old, pregnant women, and those with type 2 diabetes.
The approval is expected to widen access to automated insulin delivery (AID) technology and enhance outcomes and quality of life for diverse populations living with diabetes.
The MiniMed 780G System, Medtronic’s most advanced insulin pump, leverages the SmartGuard algorithm to automate insulin delivery every five minutes.
The system personalises doses to auto-correct high glucose levels based on continuous glucose monitoring (CGM) readings.
Its target glucose level is set at 100 mg/dl (5.5 mmol/L) but can be adjusted individually.
The LENNY trial, published in The Lancet Diabetes & Endocrinology, validated the safety and efficacy of the MiniMed 780G System in children aged two to six with type 1 diabetes.
Participants using the system in auto mode achieved a 0.6% lower HbA1C and a 9.9% higher time in range compared to manual mode.
Parents also reported improved sleep and reduced fear of hypoglycaemia.
Paul Schulz, whose son Marc lives with type 1 diabetes, said: “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.
“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.”
The MiniMed 780G System offers a tool for achieving tighter control, with studies showing significant improvements in pregnancy time in range and reduced hypoglycemia.
The outcomes align with guidelines from the European Society of Endocrinology and the US Endocrine Society.
The MiniMed 780G System is also approved in Europe for type 2 diabetes, based on results from a trial that showed a 0.7% reduction in HbA1c and increased time in range to 80%.
Real-world data from over 26,000 users with type 2 diabetes demonstrated good glycemic control, exceeding international consensus targets.
In the US, Medtronic is working with regulatory authorities to expand the use of the MiniMed 780G System, with a submission for type 2 diabetes under review by the US Food and Drug Administration (FDA), and clinical trials underway for children aged two to six years.
UK-based paediatric endocrinologist Fiona Campbell said: “Advancements in Automated Insulin Delivery (AID) systems are revolutionising how we care for children with type 1 diabetes.
“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.”
