Clinical data collections
cognitive impairment
EVENTS, SEVERE HYPOGLYCEMIA
Clinical data were recorded by the investigators on an electronic case report form (eCRF) at Visit 1 (inclusion visit), Visit 2 (1 month) and Visit 3 (3 months). Data generated by the insulin pump systems and the CGM were recorded throughout the study and extracted from web platforms available for the study. CGM wearing rate, glucose metrics, and glycemic events were obtained automatically on the last 4 weeks at Visit 1 and Visit 2, and on the last 8 weeks at Visit 3. Time spent in range (70–180 mg/dL) (TIR), below range (< 70 mg/dL) (TBR) and above range (> 180 mg/dL) (TAR) were defined according to the recommendations from the international consensus on time in range [Hypoglycemic events were defined as a glycemia under 70 mg/dL for at least 15 minutes, according to the Freestyle Libre sensor definition. Severe hypoglycemia was defined by severe cognitive impairment requiring external assistance for recovery.Venous blood sample was taken at inclusion and at Visit 3 in order to determine the laboratory A1C.The doses of insulin (basal and bolus) determined by the patient and injected by the pump were recorded by the medical device. These data were displayed and downloaded by the investigators using the online application provided by the manufacturer.