Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-05 @ 9:14 PM
Study NCT ID:
NCT06570551
Status:
COMPLETED
Last Update Posted:
2024-09-26
First Post:
2024-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous Glucose Monitoring System Use in Pediatric Patients with Diabetes
Sponsor:
Sinocare
Organization:
Study Overview
Official Title:
Continuous Glucose Monitoring System Use in Pediatric Patients with Diabetes
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 with diabetes.
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 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: