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Evaluation of the Accuracy and Safety of A Novel Real-Time Continuous Glucose Monitoring System

RecruitingNAAges 18 Years - anyAllHenan University of Science and Technology
NCT07092761 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥ 18 years * Diagonsed with T1DM or T2DM * 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
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What it tests

  • GS3 CGM
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Where

1 site
Henan University of Science and Technology
Luoyang, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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