Shots:
- Medtronic has received CE mark to extend label of MiniMed 780G system to pts (≥2yrs.), pregnant women & T2D pts; application is under the FDA’s review for T2D, plus US trial for use in pts (2-6yrs.) is underway
- Approval was backed by extensive clinical data incl. LENNY trial data in T1D pts (2–6 yrs), showing a 0.6% HbA1C reduction & 9.9% higher TIR in auto mode vs manual; caregivers also reported better sleep & reduced fear of hypoglycemia with auto mode use
- Data also incl. an EU study in pregnant women showing TIRp of 66.5, improved overnight glucose control, & reduced hypoglycemia; a pivotal trial for T2D (n=95) showed 0.7% HbA1c reduction, 80% TIR & time below range under 0.5%, plus RWE data showed superior glycemic control
Ref: Medtronic | Image: Medtronic | Press Release
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