10-Day structured initiation protocol from multiple daily injection to hybrid closed-loop system in children and adolescents with type 1 diabetes

Abstract

Aim: The aim of this study was to evaluate the 10-day initiation protocol for MiniMed 670G hybrid closed-loop (HCL) system in individuals with type 1 diabetes on multiple daily injection (MDI) in achieving desirable glycemic control. Methods: An open-label single-arm, single-center, clinical investigation in children aged 7–18 years on MDI following a structured protocol: 2 days, HCL system assessment; 5 days, HCL system training (2-h sessions on 5 consecutive days with groups of 3–5 participants and families); 3 days, Manual Mode use of HCL system; 84 days, Auto Mode use of the HCL system, cumulating in 10 days from MDI to Auto Mode activation. Results: A total of 30 children (age 10.24 ± 2.6 years) were enrolled in the study, and all completed the planned 84 days on Auto Mode. The participants used the sensor for a median of 92% of the time and spent a median of 89% in Auto Mode. The mean HbA1c decreased from 8.2 ± 1.4% (66 ± 15.3 mmol/mol) at baseline to 6.7 ± 0.5% (50 ± 5.5 mmol/mol) at the end of the study (p = 0.017). Time in range (70–180 mg/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% of the time below 70 mg/dL and without any severe hypoglycemia or DKA. Conclusion: Children and adolescents with type 1 diabetes on MDI therapy can successfully initiate the HCL system, using a concise structured 10-day protocol.