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Effectiveness and Safety Study of the G7 Continuous Glucose Monitoring System in Pediatric Subjects with Diabetes Mellitus

Clinical Trial of Continuous Glucose Monitoring System Used in Pediatric Subjects with Diabetes Mellitus

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059569
Enrollment
Unknown
Registered
2022-05-04
Start date
2022-05-10
Completion date
Unknown
Last updated
2023-03-20

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

Conditions

Diabetes

Interventions

Group C:Continuously wear the study medical device for 14 days
Group A:Continuously wear the study medical device for 14 days
Group B:Continuously wear the study medical device for 14 days

Sponsors

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

Eligibility

Sex/Gender
All
Age
2 Years to 17 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 2 years (including 2 years old) and 18 years (excluding 18 years old); 2. Clinical diagnosis of diabetes mellitus; 3. Be willing to wear the device continuously for 14 days, and collect blood to test the blood glucose value according to the requirements of this program; 4. Weight not less than 10.0kg; 5. Agree to participate in the clinical trial and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. MRI is required during clinical trials; 2. Diffuse subcutaneous nodules; 3. Acute complications of diabetes; 4. Abnormal coagulation function (not coagulation too fast or too slow), the abnormal criteria are: (1) Activated partial thromboplastin time (APTT) was higher than 1.5 times the upper limit of normal, or lower than the lower limit of normal; (2) The prothrombin time (PT) was higher than 1.5 times the upper limit of normal value, or lower than the lower limit of normal value; 5. Participated in other clinical trials within 1 month; 6. Researchers think it is not suitable to be included in the group.

Design outcomes

Primary

MeasureTime frame
Accuracy;

Countries

China

Contacts

Public ContactFu Junfen

The Children's Hospital of Zhejiang University School of Medicine

fjf68@zju.edu.com+86 15924179737

Outcome results

None listed

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