Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06570551
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-12
Brief Title:
Continuous Glucose Monitoring System Use in Pediatric Patients with Diabetes
Sponsor:
None
Organization:
None
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:
No
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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None