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

Recruiting now · Not applicable

Conditions studied: Type1diabetes

In brief

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.

Key facts

Study ID

NCT07092761

Run by

Henan University of Science and Technology

People needed

82

Starts

2025-04-01

Expected to finish

2026-09-01

Last updated by the study team

2026-05-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Henan University of Science and Technology — Luoyang, Henan, China (enrolling)

Full record on ClinicalTrials.gov

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