You have full access to this open access article. A day run-in phase in Manual mode preceded a 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. Two-hundred seventy participants formed the intent-to-treat population at 6 months.
TIR increased by All glycemic parameters significantly improved. HbA1c decreased by 0. 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. System usage reduced hypoglycemia and fear of hypoglycemia, and increased treatment satisfaction.
No prior data from clinical practice settings on the use of the MiniMed G system in people with type 1 diabetes in France were available before the EQOL study. The EQOL study investigated the effect of initiating the MiniMed G system in people with type 1 diabetes in France on time in range, glycemic targets, hypoglycemia, and quality of life.
The primary outcome was change in absolute time in range from baseline to 6 months, while secondary outcomes included changes in glycemic targets, glycated hemoglobin, and hypoglycemia as well as treatment satisfaction, quality of life, and fear of hypoglycemia. The study also found that Auto mode reduced HbA1c by 0. However, to date, evidence from prospective analyses from routine practice focusing exclusively on people with T1D based in France is sparse.
In France specifically, in there were estimated to be more than , people living with T1D [ 3 ]. The same study also indicated variability in insulin pump use across different centers [ 4 ]. This includes healthcare providers directly involved in the care of people with T1D, as well as payers and policymakers involved in reimbursement decision-making. As per HAS guidance, such studies offer insights into treatment effects within routine practice, encompassing a broader population than RCTs, including people with comorbidities or complex needs [ 6 ].
