Glycemic outcomes of Advanced Hybrid Closed Loop system in children and adolescents with Type 1 Diabetes, previously treated with Multiple Daily Injections (MiniMed 780G system in T1D individuals, previously treated with MDI)

Abstract

Background: The objective of this study was to evaluate the glycemic outcomes in children and adolescents with Type 1 Diabetes (T1D) previously treated with Multiple Daily Injections (MDI) using a structured initiation protocol for the Advanced Hybrid Closed Loop (AHCL) Minimed 780G insulin pump 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%. All participants followed a 10-day structured initiation protocol which included 4 steps: step 1: AHCL system assessment; step 2: AHCL system training; step 3: Sensor augmented pump therapy (SAP) for 3 days; step 4: AHCL system use for 12 weeks, successfully completing the training from MDI to AHCL in 10 days. 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). The paired student t-test was used for statistical analysis and a value < 0.05 was considered statistically significant. Results: Thirty-four participants were recruited and all 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). No episodes of severe hypoglycemia or DKA were reported. Conclusion: 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%.