The aim of this study was to evaluate the effectiveness of a 10-day structured protocol to on-board patients from Multiple Daily Injection (MDI) to the MiniMed 670G system in achieving glycaemic control.
An open single-arm, single-center, clinical investigation in children aged 7 to 18 years on MDI following a structured protocol: 2 days - selection and introduction; 5 days - Minimed 670G system training (2-hours session in 5 consecutive days with groups of 3 to 5 patients and families); 3 - days in Manual Mode; 84 days in Auto Mode, cumulating in 10 days from MDI to Auto Mode activation of the MiniMed 670G system.
30 children (age 10.24 ± 2.6 years) were enrolled in the study and completed the planned 84 days on Auto Mode. The participants used the sensor for a median of 89% of the time and spent a median of 92 % in Auto Mode. The mean HbA1c decreased from 8.2±1.4% at baseline to 6.7±0.5% at the end of the study phase (p=0.017). Time in Range (70-180mg/dL) increased from 46.9±18.5% at baseline to 75.6±6.9% in Auto Mode (p<0.001). This was achieved while spending 2.8% below 70 mg/dL and without any severe hypoglycemia nor DKA.
Patients with T1D on MDI therapy on-boarded to the MiniMed 670G system, using a structured 10-day protocol, while significantly improved their glycemic control in a safe manner.