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

Launched by HENAN UNIVERSITY OF SCIENCE AND TECHNOLOGY · Jul 22, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new device that continuously monitors blood sugar levels in real time for adults with type 1 diabetes. The goal is to see how accurate and safe this new glucose monitor is by comparing its readings to standard blood tests taken from a vein in the arm. The study is currently looking for volunteers.

Adults aged 18 and older who have type 1 or type 2 diabetes and can have blood samples taken from their forearm may be eligible to join. Participants should be able to understand and follow the study instructions and agree to take part by signing a consent form. People who have had severe low blood sugar recently, certain heart or skin problems, blood disorders, recent blood donations, pregnancy, or allergies to adhesives used in the device won’t be able to join. During the study, participants will wear the new glucose monitor and have regular blood tests to check how well the device works. This study will help determine if this new monitor can be a safe and reliable tool for managing diabetes.

Gender

ALL

Eligibility criteria

• 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