CGM, T1D, type1diabetes
Conditions
Brief 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.
Detailed description
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. No less than 36 patients will be enrolled. Each patient will wear two sensors. Interstitial glucose readings from each sensor will be obtained immediatedly following each venous blood sample test. Each participant will make 4 visits to the clinical study site, including the screening visit.
Interventions
DEVICEGS3 CGM
Wearing CGM for a consecutive 14 days
Sponsors
SiBionics, Co, Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
CONTACTXiaodong Zhao
Outcome results
None listed