An Innovative Advanced Hybrid Closed-Loop System for Glucose Control in Children and Adolescents with Type 1 Diabetes: A One-Year Real-World Study

The objective of this Ph.D. project was to investigate glucose control and identify potential predictors of the achievement of glycemic outcomes in children and adolescents during their first 12 months of an advanced hybrid closed loop (AHCL) system use. We conducted a multicenter, longitudinal, real-world study, recruiting 368 children and adolescents with type 1 diabetes (T1D) starting AHCL therapy between June 2020 and June 2022. Ambulatory glucose profile data were collected during a 15-day run-in period (baseline), two weeks after automatic mode activation, and every 3 months. The influence of covariates on glycemic outcomes after 1 year of AHCL use was assessed. We found that after 15 days of automatic mode use, all glucose metrics improved compared to baseline (p<0.001), except for time below range and coefficient of variation (p=0.113 and p=0.330, respectively). After one year, time in range (TIR) remained significantly higher than at baseline (75.3% vs 62.8%, p<0.001). The mean glycated hemoglobin (HbA1c) over the study duration was lower than the previous year (6.9 ± 0.6% vs 7.4 ± 0.9%, p<0.001). Time spent in tight range (70-140 mg/dl) was 51.1% and glycemia risk index was 27.6. Higher TIR levels were associated with a reduced number of automatic correction boluses (p<0.001), fewer SmartGuard exits (p=0.021), and longer time in automatic mode (p=0.030). Individuals with baseline HbA1c > 8% showed more relevant improvement in TIR levels (from 54.3% to 72.3%). In conclusion, our study highlights the sustained effectiveness of AHCL therapy among youths with T1D. Findings suggest that even children and adolescents with low therapeutic engagement may benefit from this innovative technology.