Medtronic secures CE Mark for MiniMed 780G System

Medtronic (MDT) announced CE Mark in Europe to expand indications of the MiniMed 780G system for use by individuals aged 2 years and older, during pregnancy, as well as type 2 insulin-requiring diabetes. To gain CE Mark for this expansion of indications, published clinical data in 2-6-year-olds, pregnant women, and people living with type 2 diabetes was reviewed. Data from the LENNY trial, recently published in The Lancet Diabetes & Endocrinology, demonstrated the safety and efficacy of the MiniMed 780G system in children aged 2-6 years old with type 1 diabetes. Participants in the multi-center, randomized controlled, crossover trial achieved a 0.6% lower HbA1C and 9.9% higher time in range when the system was used in auto mode, compared to those using it in manual mode. Parents and caregivers also reported improved sleep quality and lower fear of hypoglycemia when the system was used in auto mode. In a recently publishedvi multi-center, pivotal trial in 95 people with type 2 diabetes, the use of the MiniMed 780G system resulted in a 0.7% reduction in HbA1c from a baseline of 7.9% and an increase in TIR to 80% from a baseline of 72% with a time below range.