Abstract
INTRODUCTION: The MiniMed™ 780G system uses an advanced hybrid closed loop algorithm to improve outcomes in people with type 1 diabetes (T1D). The MiniMed™ 780G Glycemic Control and Quality of Life (EQOL) study aimed to provide routine clinical practice data on system effectiveness and associated patient-reported outcomes (PROs) in France. METHODS: Individuals aged ≥ 7 years with T1D were enrolled. A 14-day run-in phase in Manual mode preceded a 12-month study phase using Auto mode. The primary endpoint was absolute change in time in range (TIR) from baseline to 6 months. Secondary endpoints included changes in glycemic targets, glycated hemoglobin (HbA1c), and hypoglycemia. PROs included treatment satisfaction, quality of life (QoL), and fear of hypoglycemia. RESULTS: Two-hundred seventy participants formed the intent-to-treat population at 6 months. TIR increased by 11.8 percentage points (standard deviation [SD] 8.96, 95% confidence interval 10.7 to 12.9, p < 0.0001), from 61.9% (SD 11.0) to 73.7% (SD 7.4), equivalent to 2.8 h per day more in range. Time < 70 mg/dL decreased by 1.5 percentage points (p < 0.0001), from 4.0% to 2.5%. All glycemic parameters significantly improved. HbA1c decreased by 0.52% and 0.42% at 6 and 12 months, respectively. More patients met glycemic targets, while severe hypoglycemia was reduced. At 12 months, treatment satisfaction increased across age groups, and QoL improved in adults. Fear of hypoglycemia decreased in adults and children. CONCLUSION: In France, people with T1D initiating the MiniMed™ 780G system demonstrated sustained TIR and HbA1c improvements. System usage reduced hypoglycemia and fear of hypoglycemia, and increased treatment satisfaction. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT04308291.