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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.
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 42 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult patients with T1DM or T2DM | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GS3 CGM | Device | Wearing CGM for a consecutive 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| System performance | The CGM system performance will be assessed by comparing to the Yellow Springs Instrument comparator venous plasma measurements | 14 days |
| System-related Safety | The CGM system will be characterized by adverse device effects experienced by the study participants | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peng Liu | Contact | 0379-64811993 | peng.liu87@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| Hongwei Jiang | Henan University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan University of Science and Technology | Recruiting | Luoyang | Henan | 471003 | China |
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