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.
Age ≥ 18 years
Diagonsed with T1DM or T2DM
Venous blood sampling access can be established in the forearm
Capable of independently reading instructions and complying with the clinical trial requirements
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
Single group
GS3 CGM
DeviceWearing CGM for a consecutive 14 days
System performance
The CGM system performance will be assessed by comparing to the Yellow Springs Instrument comparator venous plasma measurements
System-related Safety
The CGM system will be characterized by adverse device effects experienced by the study participants
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Henan University of Science and Technology
Lead sponsor
The First Affiliated Hospital of Henan University of Science and Technology
Sponsor institution
