The expansion brings the automated insulin delivery (AID) system to individuals aged 2 years and older with type 1 diabetes. It also enables the use of MiniMed 780G during pregnancy and by those with type 2 insulin-requiring diabetes.
MiniMed 780G, the company’s latest-generation AID system, offers meal detection technology and provides automatic adjustments and corrections to sugar levels every five minutes. This occurs for both basal (background) and bolus (mealtime) insulin needs.
Medtronic — which plans to separate its Diabetes business into a publicly traded company called MiniMed — said that it offered clinical data for children aged 2-6, pregnant women and people living with type 2 diabetes for review.
The medtech giant said the expanded indication “underscores the commitment Medtronic has to advancing access to 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.”
Targeting the type 2 population
Bringing MiniMed 780G to the type 2 population in Europe marks a milestone for Medtronic as it seeks to offer AID for the large patient population.
Insulet’s Omnipod 5 automated insulin delivery system became the first such system FDA-cleared for type 1 and type 2 diabetes last August. Tandem Diabetes care followed suit in February with its own FDA nod. MiniMed 780G remains investigational for type 2 in the U.S., but Medtronic last month shared positive clinical outcomes for the population and now has the added boost of getting the European nod.
To support European approval, the company offered published trial data from 95 people with type 2 diabetes. Use of MiniMed 780G resulted in a 0.7% reduction in HbA1c and a time in range increase to 80%. Time below range came in under 0.5%.
Additionally, real-world data of 26,427 users identified as having type 2 demonstrated good glycemic control. On average, users exceeded the international consensus of 70% time in range and maintained time below range of less than 1%.
Medtronic said it now continues to work to bring MiniMed 780G to the U.S. type 2 population with an FDA submission currently under review. Additionally, the company has U.S. trials underway to examine the use of the system in children aged 2-6.
Medtronic expands availability to young children
Data from the recently published LENNY trial demonstrated the safety and efficacy of MiniMed 780G in children aged 2-6 with type 1 diabetes.
Participants achieved a 0.6% lower HbA1c and 9.9% higher time in range with the system used in auto mode vs. manual mode. Parents and caregivers also reported improved sleep quality and lower fear of hypoglycemia with the system in auto mode.
Medtronic said European countries continue to push for AID systems becoming the standard of care for children with type 1 diabetes. NHS England has an initiative underway to provide more children with AID systems and the German Diabetes Association has recent guidelines advising offering AID to all pediatric patients.
“Advancements in 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.”
MiniMed gets nod for use during pregnancy
Medtronic says that pregnancy presents unique challenges for women with type 1 diabetes. Hormonal shifts and physiological changes can add hurdles to glucose management. Meanwhile, the developing baby remains vulnerable to high and fluctuating blood sugar levels.
Researchers have recently called for more studies of AID use during pregnancy. Clinical guidelines recommend a much tighter glucose target during pregnancy (between 63 and 140 mg/dL).
According to Medtronic, MiniMed 780G can make a meaningful difference in this type of diabetes management. It can target glucose levels as low as 100 mg/dL to achieve tighter control.
In a European study evaluating MiniMed 780G during pregnancy, users achieved an average time in that more strict range of 66.5%, marking a “significant improvement over traditional insulin therapy.”
Additionally, the system delivered better overnight glucose control, reduced overall and nighttime hypoglycemia and higher treatment satisfaction among expectant mothers. Medtronic said the outcomes align with recent clinical practice guidelines supporting the use of AID systems to improve maternal and fetal health outcomes during pregnancy.
