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
Authors' conclusion
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.
Study context
- Population
- Adolescents and adults with T1D using the MicroTech Medical Equil S hybrid closed-loop (HCL) system (patch insulin pump with AIDEX G7 calibration-free CGM)
- Participants
- 123 adolescents
- Comparison
- HCL auto mode vs manual mode
- Adolescentsn = 21
- Adultsn = 102
- Outcome
- Change in CGM-derived TIR (70-180 mg/dL) from run-in to study phase
- Follow-up
- 12-week study phase
Methodological detailsmulticentre, 2-week run-in in manual mode, 12-week auto mode study phase
- Multicentre
- 2-week run-in in manual mode
- 12-week auto mode study phase
Main finding
As reported in the abstract
Change in CGM-derived TIR (70-180 mg/dL), run-in to study phase
Mean difference, % (95% CI)P value
Adolescents
4.6(0.7–8.6)
P = 0.024Adults
8.0(6.3–9.8)
P < 0.001- Adolescents: Time in range (TIR) run-in to study phase
- 63.7% to 68.3%
- Adults: TIR run-in to study phase
- 69.6% to 78.0%
Further findings
Median
| Outcome | Adolescents | Adults |
|---|---|---|
| Time in automated mode | 88.4% (IQR 76.6%–92.0%) | 91.6% (IQR 87.8%–94.1%) |
TBR (< 70 mg/dL), run-in to study phase
- Adolescents: decreased from 4.1% to 3.0%
- P = 0.032
- Adults: decreased from 3.8% to 2.7%
- P < 0.001
HbA1c
- Adolescents: decreased from 7.0% to 6.9%
- P = 0.011
- Adults: decreased from 6.6% to 6.3%
- P < 0.001
Patient-reported outcomes · study end vs baseline
- Significantly higher treatment satisfaction and convenience scores at study end vs baseline
Safety
- Episodes of severe hypoglycaemia or DKA
- 0
Original publication
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. Diabetes Obes Metab. Published 30 March 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →