Glycaemic Outcomes of a Novel Model-Predictive-Control-Based Hybrid Closed-Loop System in Chinese Adolescents and Adults With Type 1 Diabetes: A Multicentre Pivotal Trial.

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.