RecruitingNot ApplicableNCT07745244
Evaluation of the Accuracy and Safety of a Continuous Glucose Monitoring System
Evaluation of the Accuracy and Safety of a Continuous Glucose Monitoring System Across Varying Blood Glucose Ranges
Sponsor
SiBionics, Co, Ltd
Enrollment
36 participants
Start Date
Jun 1, 2026
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria5
- 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 Criteria13
- 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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Interventions
DEVICEGS3 CGM
Wearing CGM for a consecutive 14 days
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07745244
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