Status:
COMPLETED
Continuous Glucose Monitoring System Use in Pediatric Patients with Diabetes
Lead Sponsor:
Sinocare
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
2-17 years
Brief Summary
To verify and evaluate the efficacy and safety of i3 CGM system manufactured by Changsha Sinocare Inc. for continuous or regular monitoring of interstitial fluid glucose level in pediatric patients wi...
Detailed Description
This clinical investigation is of a multi-center and self-controlled design. This clinical investigation is planned to be conducted in 3 study sites, with a total of 78 subjects to be enrolled, of wh...
Eligibility Criteria
Inclusion
- Aged 2 (inclusive) - 18 years (exclusive);
- Clinically diagnosed with diabetes;
- Being willing to wear the device continuously for 15 days and conduct blood collection for blood glucose testing in accordance with the requirements of this protocol;
- Body weight not less than 10.0 kg;
- Consent to participate in this clinical investigation, and sign the Informed Consent Form (ICF).
Exclusion
- Need to undergo magnetic resonance imaging (MRI) during the clinical investigation;
- Diffuse subcutaneous nodules;
- Acute complications of diabetes;
- Abnormal coagulation function (coagulation cannot be too quick or too slow); the criteria for judging abnormalities are: The activated partial thromboplastin time (APTT) is higher than 1.5 times the upper limit of normal value or lower than the lower limit of normal value; or The prothrombin time (PT) is higher than 1.5 times the upper limit of normal value or lower than the lower limit of normal value
- Participation in other clinical investigations within the past 1 month;
- Where the investigator does not consider the patient suitable for enrollment.
Key Trial Info
Start Date :
March 30 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 21 2024
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT06570551
Start Date
March 30 2024
End Date
August 21 2024
Last Update
September 26 2024
Active Locations (3)
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1
Hunan Children's Hospital
Changsha, Hunan, China
2
Children's Hospital of Soochow University
Suzhou, Jiangsu, China
3
Women and Children's Hospital of Ningbo University
Ningbo, Zhejiang, China