Continuous Glucose Monitoring System Use in Pediatric Patients with Diabetes
NCT ID: NCT06570551
Last Updated: 2024-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
78 participants
OBSERVATIONAL
2024-03-30
2024-08-21
Brief Summary
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Detailed Description
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This clinical investigation is planned to be conducted in 3 study sites, with a total of 78 subjects to be enrolled, of which no fewer than 15 cases are aged 2-5 years old, and no fewer than 60 cases are aged 6-17 years old. This clinical investigation is to verify the safety and efficacy of the investigational device. Referring to the number of pediatric patients with diabetes in the 3 study sites, it is expected that about 20 subjects will be enrolled in each site every month, and it will take about 2 months to close the site. This clinical investigation is expected to be completed in about 6 months from the first participant recruited.
The real-time glucose values measured by CGM system on the left and right abdomen are compared with the venous blood glucose value (EKF value) measured by EKF analyzer, respectively, and the consistency rate is analyzed.
Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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2-5 year old participants
Wear the investigational device continuously for 15 days.
i3 CGM(continuous glucose monitor)
The i3 CGM consists of a Sensor Pack (including probe, iCGM-S3), a Transmitter Pack (iCGM-t3), and an application (iCGM-APP (released version: V02)).application (i3 CGM App). The user can view their glucose data on the i3 CGM App running on a compatible mobile device.
6-17 year old participants
Wear the investigational device continuously for 15 days.
i3 CGM(continuous glucose monitor)
The i3 CGM consists of a Sensor Pack (including probe, iCGM-S3), a Transmitter Pack (iCGM-t3), and an application (iCGM-APP (released version: V02)).application (i3 CGM App). The user can view their glucose data on the i3 CGM App running on a compatible mobile device.
Interventions
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i3 CGM(continuous glucose monitor)
The i3 CGM consists of a Sensor Pack (including probe, iCGM-S3), a Transmitter Pack (iCGM-t3), and an application (iCGM-APP (released version: V02)).application (i3 CGM App). The user can view their glucose data on the i3 CGM App running on a compatible mobile device.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
2 Years
17 Years
ALL
No
Sponsors
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Sinocare
INDUSTRY
Responsible Party
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Locations
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Hunan Children's Hospital
Changsha, Hunan, China
Children's Hospital of Soochow University
Suzhou, Jiangsu, China
Women and Children's Hospital of Ningbo University
Ningbo, Zhejiang, China
Countries
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Other Identifiers
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NPI031-CIP-005
Identifier Type: -
Identifier Source: org_study_id
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