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.
The study is to evaluate the accuracy and safety of a novel real-time continuous glucose and ketone monitoring (CGKM) system among adult patients with type 1 diabetes mellitus with respect to YSI and Randox reference venous plasma sample measurements. Up to 14 patients will be enrolled. Interstitial glucose and ketone readings from the sensors will be obtained immediatedly following each venous blood sample test. Each participant will make 3 visits to the clinical study site, including the screening visit.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
12
Wear for a consecutive 15 days
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
RECRUITINGHenan University of Science and Technology
Luoyang, Henan, China
RECRUITINGSystem 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
Time frame: 15 days
System performance on ketone measurement
The CGK system performance for ketone measurement will be assessed by comparing to the Randox comparator venous plasma measurements
Time frame: 15 days
System-related Safety
Records of the adverse events and device-related incidence rates.
Time frame: 15 days
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