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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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 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
Primary outcome measure(s)
System performance — 15 days The CGM system performance will be assessed by comparing to the Yellow Springs Instrument comparator venous plasma measurements
System-related Safety — 15 days The CGM system will be characterized by adverse device effects experienced by the study participants
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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