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Application of closed-loop insulin delivery system in children with type 1 diabetes

Application of closed-loop insulin delivery system in children with type 1 diabetes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067288
Enrollment
Unknown
Registered
2023-01-03
Start date
2023-01-03
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Type 1 diabetes

Interventions

Group 1:insulin pump+dynamic blood glucose monitoring
Group 2:insulin pump+dynamic blood glucose monitoring+closed loop treatment for 3 months
Group 3:insulin pump+dynamic blood glucose monitoring+cosed loop treatment for 6 months

Sponsors

Shandong Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1. Meeting the diagnosis of diabetes: In 2019, WHO issued the new classification criteria, and meeting one of the following 4 criteria can diagnose diabetes: (1) Fasting blood glucose >=7.0 mmol/L; (2) Blood glucose >=11.1 mmol/L 2 h after oral glucose tolerance load [glucose 1.75 g/kg (body weight), maximum glucose 75 g]; (3) HbA1c>=6.5% (HbA1c determination method requires certification by the United States Glycosylated Hemoglobin Standardization Program); (4) Random blood glucose >=11.1 mmol/L with diabetes symptoms and signs; For those who meet the above criteria but are asymptomatic, repeat testing on the following 1 day is recommended to confirm the diagnosis. 2. Patients with T1DM who have been diagnosed for at least 6 months. 3. Use insulin pump for >=3 months. 4. Live with an adult willing to care for the subject during the study period, and the guardian will sign an informed consent.

Exclusion criteria

Exclusion criteria: 1. Severe acute or chronic diabetic complications, including microvascular or macrovascular complications; 2. Severe hypoglycemia occurred frequently in the recent 3 months; 3. Recurrent diabetic ketoacidosis in the recent 3 months (>2 times); 4. People who used closed loop before participating in the experiment; 5. Physical or psychological conditions deemed unsuitable for inclusion by the researcher.

Design outcomes

Primary

MeasureTime frame
The percentage of time within the target range;

Countries

China

Contacts

Public ContactSun Yan

Shandong Provincial Hospital

sunyan6150@163.com+86 151 6888 9589

Outcome results

None listed

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