Medtronic plc has announced the CE Mark approval in Europe for its MiniMed 780G system, expanding its use to individuals aged two years and older, including pregnant women and those with type 2 diabetes. This development follows a review of clinical data on these groups, emphasizing Medtronic’s commitment to enhancing access to automated insulin delivery (AID) technology.
The LENNY trial, published in The Lancet Diabetes & Endocrinology, highlighted the system’s safety and efficacy for children aged 2-6 with type 1 diabetes. Participants using the system in auto mode saw improvements in HbA1C levels and time in range (TIR). Paul Schulz from Barcelona shared his experience: “Ever since Marc was diagnosed with diabetes at age 4, we have been lucky to count on support from Medtronic.”
Automated insulin delivery systems are becoming standard care for children with type 1 diabetes across Europe. Dr. Fiona Campbell noted that these systems relieve families from constant monitoring burdens.
For pregnant women with type 1 diabetes, the MiniMed 780G system offers improved glucose control. A European study showed significant benefits over traditional insulin therapy during pregnancy.
Additionally, the MiniMed 780G is now approved for people with type 2 diabetes in Europe. A pivotal trial demonstrated reductions in HbA1c levels and increased TIR among users.
In the U.S., Medtronic is working with regulatory authorities to expand the system’s use for type 2 diabetes patients. Clinical trials are also underway for young children.
The MiniMed 780G system automates insulin delivery every five minutes using its SmartGuard algorithm. Medtronic continues to innovate in diabetes management through advanced technology and data science.
