The study is to evaluate the accuracy and safety of a novel real-time continuous glucose and ketone monitoring system among adult patients with type 1 diabetes mellitus (T1DM) with respect to Yellow Spring Instrument (YSI) and Randox reference venous plasma sample measurements.
Age ≥ 18 years
Diagonsed with T1DM on Continuous subcutaneous insulin infusion (CSII)
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 months
A diagnosed history of Diabetic ketoacidosis (DKA) in the past 3 months
Heart failure or hemiplegic sequelae due to prior cerebrovascular disease
Severe skin conditions at the sensor wear site
Single group
GK5 CGKM
DeviceWear for a consecutive 15 days
System performance on glucose measurement
The CGK system performance for glucose measurement will be assessed by comparing to the Yellow Springs Instrument comparator venous plasma measurements
System performance on ketone measurement
The CGK system performance for ketone measurement will be assessed by comparing to the Randox comparator venous plasma measurements
System-related Safety
Records of the adverse events and device-related incidence rates.
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