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. Up to 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
36
Wearing CGM for a consecutive 14 days
Henan University of Science and Technology
Luoyang, Henan, China
RECRUITINGSystem performance
The CGM system performance will be assessed by comparing to the Yellow Springs Instrument comparator venous plasma measurements
Time frame: 14 days
System-related Safety
The CGM system will be characterized by adverse device effects experienced by the study participants
Time frame: 14 days
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