Continuous Glucose Monitoring System Use in Pediatric Patients with Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: i3 CGM(continuous glucose monitor)

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.

• Study Type: Observational
• Enrollment (Actual): 78

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China
      • Hunan Children's Hospital
  • Jiangsu
    • Suzhou, Jiangsu, China
      • Children's Hospital of Soochow University
  • Zhejiang
    • Ningbo, Zhejiang, China
      • Women and Children's hospital of Ningbo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

2-17 year old patients with diabetes mellitus.

Description

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
2-5 year old participants; Wear the investigational device continuously for 15 days.	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.
6-17 year old participants; Wear the investigational device continuously for 15 days.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy	percentage of i3 CGM values in the measuring range less than 4.4 mmol/L(80 mg/dL) within ± 1.1 mmol/L(20 mg/dL) of the EKF control.	0-15 days

Collaborators and Investigators

• Sponsor: Sinocare

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2024
• Primary Completion (Actual): August 21, 2024
• Study Completion (Actual): August 21, 2024

Study Registration Dates

• First Submitted: August 12, 2024
• First Submitted That Met QC Criteria: August 21, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): September 26, 2024
• Last Update Submitted That Met QC Criteria: September 24, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: NPI031-CIP-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No