Two-Year Real-Life Achievements of MiniMed 780G Advanced Closed-Loop System in Youth with Type 1 Diabetes: AWeSoMe Study Group Multicenter Prospective Extended Follow-Up.
Abstract
Objective
To determine whether glycemic benefits of the MiniMed 780G Advanced Hybrid Closed-Loop (AHCL) system are sustained over two years in youth with type 1 diabetes (T1D), and to identify outcome predictors.
Methods
This prospective multicenter study collected CGM and clinical data at 1,3,6,12, and 24 months in 96 children and adolescents with T1D. Outcomes included HbA1c, CGM metrics, composite glycemic control (CGC) score, glycemia risk index (GRI), composite CGM index (COGI), SmartGuard use, and anthropometric changes, analyzed by repeated-measures linear mixed models.
Results
HbA1c and time in range were maintained from 12 to 24 months, but time below range increased (1.8% to 2.5%, P=0.015). Composite targets were rarely met: CGC by 14.6%, best GRI by 9.4%, best COGI by 10.4%. SmartGuard use declined from 91.3% to 82.7% (P=0.013); lower socioeconomic position and lower 12-month SmartGuard use were independently associated with this decline. Girls had lower glycemic variability than boys and greater BMI z-score increase. Five DKA and two severe hypoglycemia events occurred, all device-or behavior-related.
Conclusion
The 780G AHCL system sustained meaningful glycemic benefits over two years, yet most youth failed to achieve optimal composite glycemic control. SmartGuard decline during the second year suggests the 12-month visit as a candidate checkpoint for monitoring device engagement, warranting evaluation in a future interventional trial.