Medtronic secures CE Mark for MiniMed™ 780G System for insulin-requiring people with diabetes including expanded indications in children as young as two, during pregnancy, and for type 2 diabetes

Core Insights - Medtronic plc has received CE Mark approval in Europe to expand the indications for the MiniMed™ 780G system, allowing its use for individuals aged 2 years and older, during pregnancy, and for those with type 2 diabetes [1] Group 1: Expanded Indications - The MiniMed™ 780G system is now indicated for children aged 2-6 years with type 1 diabetes, showing a 0.6% reduction in HbA1C and a 9.9% increase in time in range when used in auto mode compared to manual mode [2] - The system has been recognized as a standard of care for children with type 1 diabetes across Europe, with guidelines from NICE and the German Diabetes Association recommending its use [3][4] Group 2: Pregnancy Management - The MiniMed™ 780G system offers significant benefits for managing type 1 diabetes during pregnancy, achieving an average Pregnancy Time in Range (TIRp) of 66.5%, which is an improvement over traditional insulin therapy [6] - Clinical guidelines emphasize the importance of tighter glucose control during pregnancy, with the MiniMed™ 780G system providing better overnight glucose control and higher treatment satisfaction among expectant mothers [5][6] Group 3: Type 2 Diabetes Indication - The MiniMed™ 780G system is now also approved for individuals with type 2 diabetes, demonstrating a 0.7% reduction in HbA1c and an increase in time in range to 80% in a pivotal trial [7] - Real-world data from 26,427 users with type 2 diabetes showed good glycemic control, exceeding the international consensus of 70% time in range [7] Group 4: Future Developments - Medtronic is working with U.S. regulatory authorities to expand the use of the MiniMed™ 780G system for individuals with type 2 diabetes, with ongoing clinical trials for children aged 2-6 years [8]