Abstract

During MiniMed™ advanced hybrid closed-loop (AHCL) use by adolescents and adults in the pivotal trial, A1C was significantly reduced, time in range (TIR) was significantly increased, and there were no episodes of severe hypoglycemia or diabetic ketoacidosis (DKA). The present study investigated the same primary safety and effectiveness endpoints during AHCL use by a younger cohort with T1D.An intention to treat population (N=160, aged 7-17 years) with T1D was enrolled in a single-arm study at 13 investigational centers. There was a baseline run-in (~25 days) using HCL or sensor-augmented pump with/without predictive low glucose management, followed by a three-month study period with AHCL activated at two glucose targets (100mg/dL and 120mg/dL) for ~45 days each. The mean±SD of A1C, TIR, mean sensor glucose (SG), coefficient of variation (CV) of SG, time at SG ranges, and insulin delivered between baseline or run-in and study were analyzed (Wilcoxon signed-rank test or t-test).Compared to baseline, AHCL use was associated with reduced A1C from 7.9±0.9% (N=160) to 7.4±0.7% (N=136) (p<0.001) and overall TIR increased from the run-in 59.4±11.8% to 70.3±6.5% by end of study (p<0.001), without change in CV, TBR <70mg/dL or TBR <54mg/dL. Relative to longer active insulin time (AIT) settings (N=52), an AIT of 2 hours (N=10) with the 100mg/dL glucose target (GT) increased mean TIR to 73.4%, reduced TBR <70mg/dL from 3.5% to 2.2% and reduced TAR >180mg/dL from 28.7% to 24.4%. During AHCL use, there was no severe hypoglycemia or DKA.In children and adolescents with T1D, MiniMed™ AHCL system use was safe, A1C was lower, and TIR was increased. The lowest GT and shortest AIT was associated with the highest TIR and lowest TBR and TAR, all of which met recommended glycemic targets.

View details for DOI 10.1089/dia.2023.0255

View details for PubMedID 37782145