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A Single-Arm, Prospective, Multicenter, Clinical Trial Accompanying Study Evaluating the Efficacy and Safety of a Hybrid Closed-Loop Insulin Infusion System in Pediatric Patients with Diabetes Mellitus

A Single-Arm, Prospective, Multicenter, Clinical Trial Accompanying Study Evaluating the Efficacy and Safety of a Hybrid Closed-Loop Insulin Infusion System in Pediatric Patients with Diabetes Mellitus

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116051
Enrollment
Unknown
Registered
2026-01-05
Start date
2026-01-23
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Interventions

Closed-loop pump automatic mode therapy group:Treatment using closed-loop pump in automatic mode
Other treatment options group:Using methods other than the closed-loop pump automatic mode (including but not limited to closed-loop pump manual mode therapy, injections, medication, treatment with ot

Sponsors

Children's Hospital of Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ?Subjects who are enrolled and complete the main clinical trial may participate in the accompanying trial if they withdraw from the main trial within 12 weeks and sign the accompanying trial informed consent form.

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

MeasureTime frame
Changes in glycated hemoglobin (HbA1c);—

Secondary

MeasureTime frame
Change in Time in Range (TIR) of Sensor Glucose (SG): Target range is 3.9–10 mmol/L;Change in Fasting C-Peptide;—

Countries

China

Contacts

Public ContactFu Junfen

Children's Hospital of Zhejiang University School of Medicine

fjf68@zju.edu.cn+86 137 7745 7849

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026