Continuous Glucose Monitoring System Use in Pediatric Patients with Diabetes

NCT06570551 | Completed

• 1 other identifier: NPI031-CIP-005
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 3

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

2-5 year old participants

Wear the investigational device continuously for 15 days.

Device: i3 CGM(continuous glucose monitor)

6-17 year old participants

Wear the investigational device continuously for 15 days.

Device: i3 CGM(continuous glucose monitor)

Interventions

i3 CGM(continuous glucose monitor) DEVICE

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.

2-5 year old participants; 6-17 year old participants

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

2-17 year old patients with diabetes mellitus.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sinocare: lead

Study Sites (3)

Hunan Children's Hospital

Changsha, Hunan, China

Location

Children's Hospital of Soochow University

Suzhou, Jiangsu, China

Location

Women and Children's Hospital of Ningbo University

Ningbo, Zhejiang, China

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 26, 2024
• Study Start: March 30, 2024
• Primary Completion: August 21, 2024
• Study Completion: August 21, 2024
• Last Updated: September 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)