Successful Transitioning Children and Adolescents with Type 1 Diabetes from Multiple Daily Injections to Advanced Hybrid Closed Loop System in 10 Days: A Prospective Intervention Study on MiniMed 780G System

Abstract

Background: Advanced Hybrid Closed Loop (AHCL) systems provide superior glycemic control in children and adolescents with Type 1 Diabetes (T1D). Current studies included participants with previous pump and Continuous Glucose Monitoring (CGM) experience. We aimed to study transitioning these patients on Multiple Daily Injections (MDI) without prior pump experience to AHCL systems within a short period, utilizing a structured initiation protocol and the glycemic control they achieved with the MiniMed 780G system. Methods: In this prospective open label single-arm, single-center, clinical investigation, we recruited children and adolescents (aged 7-17 years) with T1D on MDI therapy and HbA1c below 12.5% from Sidra Medicine (Doha, Qatar). All participants followed a structured initiation protocol including 4 steps: step 1: AHCL system assessment (1 hour discussion with educator); step 2: AHCL system training (2-hours sessions in 4 consecutive days with groups of 2 to 3 participants and caregivers); step 3: SAP use for 3 days; step 4: AHCL system use for 12 weeks, cumulating in 10 days from MDI to AHCL initiation. The primary outcome of the study was the change in the time spent in the target in range (TIR) of 70-180 mg/dl and HbA1c from baseline (MDI + CGM, 1 week) to study phase (AHCL, 12 weeks). This study is registered with ClinicalTrials.gov, number NCT04308291, and is completed. Findings: Between October 25, 2020, and February 5, 2021, 34 participants were recruited and all of them completed the 12 weeks study. TIR increased from 42.1±18.7% at baseline to 78.8±6.1% in the study phase ( p <0.001). HbA1c decreased from 8.6±1.7% (70±18.6 mmol/mol) at baseline, to 6.5±0.7% (48±7.7 mmol/mol) at the end of the study ( p =0.001). The participants used the sensor for a median of 96% of the time and spent a median of 90% in AHCL during the 12 weeks. No episodes of severe hypoglycemia or DKA were reported. Interpretation: Children and adolescents with T1D on MDI therapy who initiated the AHCL system following a 10-days structured protocol achieved the internationally recommended goals of glycemic control with TIR >70% and a HbA1c of <7%. Clinical Trial Registration: This study is registered with ClinicalTrials.gov, number NCT04308291, and is completed. Funding: This study was funded by Sidra Medicine in Doha, Qatar. Declaration of Interest: Authors declare no competing interests. Ethical Approval: The study was approved by the local and National Ethics Committee in Qatar and all participants, and their guardians signed a written informed assent/consent before the start of study-related procedures.