Safety and efficacy of the structured onboarding steps and initiation protocol for MiniMed™ 780G system among an Egyptian cohort of young people living with type 1 diabetes

J Pediatr Endocrinol Metab. 2023 Sep 4;36(10):941-948. doi: 10.1515/jpem-2023-0250. Print 2023 Oct 26.

Abstract

Objectives: The aim of the current study was to evaluate the safety and efficacy of initiation protocol for MiniMed ™ 780G system among an Egyptian cohort of young people living with type 1 diabetes (T1D).

Methods: A prospective single-arm study including 72 participants with T1D. Five days of structured education and training were provided to all users and continuous glucose monitoring (CGM) was initiated on the first day of the training. Users initiated the pump initially in manual mode, with suspend before low feature, for 3 days before shifting to Auto Mode.

Results: The mean HbA1c decreased from 8.72 ± 2.01 % to 6.7 ± 0.4 % (p<0.01). Time in range (70-180 mg/dL) substantially improved from 55.24 % ± 10.35 to 81.7 % ± 5.12 % after spending 84 days in auto mode (p<0.001) with 2.03 % of the time spent below 70 mg/dL. Regarding AHCL compatibility, users spent at least 90 % of time in auto mode.

Conclusions: Young people with T1D successfully initiated the AHCL system, using a tailored structured on-boarding protocol. Structured stepwise initiation protocol and onboarding steps are important prerequisite for participants' adherence and engagement with the system. Patient education together with optimized pump settings are important predictors of glycemic outcomes.

Keywords: advanced hybrid closed-loop; hypoglycemia; time in range; type 1 diabetes.