Actively Recruiting
Evaluation of the Accuracy and Safety of A Novel Real-Time Continuous Glucose Monitoring System
Led by Henan University of Science and Technology · Updated on 2025-11-20
36
Participants Needed
1
Research Sites
74 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of the Accuracy and Safety of A Novel Real-Time Continuous Glucose Monitoring System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Henan University of Science and Technology
Luoyang, Henan, China, 471003
Actively Recruiting
Research Team
P
Peng Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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