NCT06570551

Continuous Glucose Monitoring System Use in Pediatric Patients with Diabetes

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 78 (actual)
• Sponsor: Sinocare · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2024-03-30
• Primary completion: 2024-08-21
• Completion: 2024-08-21
• First posted: 2024-08-26
• Last updated: 2024-09-26

Locations

3 sites across 1 country: China