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Clinical Trials in China / NCT07745244
Recruiting Not applicable

Evaluation of the Accuracy and Safety of a Continuous Glucose Monitoring System

NCT07745244 · tracked via the Priya Life Science China tracker
Sponsor
SiBionics, Co, Ltd
Phase
Not applicable
Started
2026-06-01
Last updated
2026-08-04

Condition(s) studied

type1diabetesCGMT1D

Investigational drug(s) / intervention(s)

GS3 CGM

GS3 CGM: Wearing CGM for a consecutive 14 days

Study summary

The study is to evaluate the accuracy and safety of a real-time CGM system among adult patients with type 1 diabetes with respect to reference venous plasma sample measurements.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 18 years * Diagonsed with T1D * Venous blood sampling access can be established in the forearm * Capable of independently reading instructions and complying with the clinical trial requirements * Willing to sign the Informed Consent Form (ICF) Exclusion Criteria: * Severe hypoglycemia within the past 6 month * Heart failure or hemiplegic sequelae due to prior cerebrovascular disease * Severe skin conditions at the sensor wear site * Extensive systemic skin disorders * Coagulation disorders confirmed by the investigator * Anemia or abnormal hematocrit * Blood donation within the past 6 months * Pregnancy (defined as positive urine test in women ≤55 years), lactation, or plans for pregnancy within ≤30 days * Current or recent (≤1 month) participation in other clinical trials * Planned MRI/CT scans during sensor wear * Allergy to medical adhesives or alcohol * Conditions impairing comprehension of informed consent or study procedures * Other exclusionary conditions per investigator's discretion

Primary outcome measure(s)

  • System performance — 15 days
    The CGM system performance will be assessed by comparing to the Yellow Springs Instrument comparator venous plasma measurements
  • System-related Safety — 15 days
    The CGM system will be characterized by adverse device effects experienced by the study participants

Trial sites (1)

FacilityCityRegionStatus
Zibo Central Hospital Zibo Shandong Recruiting

Other trials for the same condition

China Diabetes Type 1 Study (CD1S) by China Alliance for Type 1 Diabetes Recruiting
Evaluation of the Accuracy and Safety of A Novel Real-Time Continuous Glucose Monitoring System Recruiting
Safety and Effectiveness of A Novel Continuous Glucose and Ketone Monitoring System Recruiting
Cyclophosphamide in the Treatment of Associated Acquired Lipodystrophy Syndrome With Type 1 Diabetes Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07745244 on ClinicalTrials.gov ↗ ← All trials in China