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
Henan University of Science and Technology
Lead sponsor
The First Affiliated Hospital of Henan University of Science and Technology
Sponsor institution