Medtronic’s MiniMed 780G system has received European CE Mark approval to expand the indications for use by people aged two years and above, during pregnancy, and for those with type 2 insulin-requiring diabetes.
The approval follows a review of published clinical data encompassing two to six-year-olds, pregnant women, and those with type 2 diabetes (T2D).
The LENNY trial highlighted the efficacy and safety of the MiniMed 780G system in children aged two to six years with type 1 diabetes (T1D).
Subjects who used the system in auto mode achieved a 0.6% reduction in HbA1C and a 9.9% increase in time in range against manual mode.
An improved sleep quality and reduced fear of hypoglycaemia in the auto mode were reported by parents and caregivers.
The company noted that the pregnancy poses distinct challenges for glucose management in women with T1D.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataThe MiniMed 780G system’s ability to address lower glucose levels offers a potent tool for maintaining tighter control, the company added.
Additionally, a European study showed that women using the system during pregnancy achieved an average Pregnancy Time in Range (TIRp) of 66.5%, against traditional insulin therapy.
The system has also proved beneficial for individuals with T2D. A pivotal trial reported a 0.7% decrease in HbA1c and an 80% increase in TIR.
Real-world data from 26,427 T2D users of the system indicated good glycaemic control, with TIR exceeding international consensus targets.
The company is working with the US Food and Drug Administration (FDA) to expand the system’s use to a broader population, including individuals with T2D and young children.
The SmartGuard algorithm within the system is said to automate insulin delivery based on continuous glucose monitoring (CGM) readings.
The system is tailored to be used at an adjustable target glucose of 100mg/dl (5.5mmol/L) and customised on an individual basis.
This month, Medtronic obtained CE mark approval for LigaSure RAS, a vessel-sealing instrument for use with the company’s Hugo robotic-assisted surgery (RAS) system.
