ABSTRACT Objective To evaluate the glycaemic outcomes of a novel calibration‐free hybrid closed‐loop (HCL) system in adolescents and adults with type 1 diabetes (T1D). Methods This multicentre pivotal trial enrolled 123 participants (21 adolescents aged 14–17 years and 102 adults aged ≥ 18 years) with T1D. All participants used the MicroTech Medical Equil S HCL system, which integrates a patch insulin pump with the AIDEX G7 calibration‐free continuous glucose monitor. After a 2‐week run‐in period with the pump in manual mode, automated insulin delivery (auto mode) was enabled for a 12‐week study phase. The primary outcome was the change in CGM‐derived time in range (TIR; 70–180 mg/dL) from the run‐in to the study phase. Results The median time spent in automated mode was 88.4% (IQR 76.6%–92.0%) in adolescents (mean age 15.5 ± 1.0 years) and 91.6% (IQR 87.8%–94.1%) in adults (mean age 39.4 ± 13.2 years). TIR increased significantly from 63.7% to 68.3% in adolescents (mean difference 4.6% 95% CI: 0.7–8.6; p = 0.024) and from 69.6% to 78.0% in adults (mean difference 8.0% 95% CI: 6.3–9.8; p < 0.001). Time below range (< 70 mg/dL) decreased from 4.1% to 3.0% in adolescents ( p = 0.032) and from 3.8% to 2.7% in adults ( p < 0.001). HbA1c decreased from 7.0% to 6.9% in adolescents ( p = 0.011) and from 6.6% to 6.3% in adults ( p < 0.001). No episodes of severe hypoglycaemia or diabetic ketoacidosis occurred. Patient‐reported outcomes showed significantly higher treatment satisfaction and convenience scores at study end compared with baseline. Conclusions In this first pivotal trial of a novel integrated HCL system, 3‐month use was safe and significantly improved glycaemic control—increasing TIR while reducing HbA1c and hypoglycaemia—accompanied by enhanced treatment satisfaction in both adolescents and adults with T1D. Trial Registration Chinese Clinical Trial Register Identifier: ChiCTR2300074200
Liu et al. (Mon,) studied this question.