Objective: To evaluate the accuracy of noninvasive glucometer based on metabolic heat conformation (MHC) method by multicenter clinical trial.
Methods: This study was a multi-center, open, self-controlled trial. Venous plasma glucose measured by the hexokinase method was taken as reference level. The screening period was 1 to 7 days before the test, and a fasting blood glucose of the subjects who enrolled to this study was recorded as a calibration value. Subjects were tested at 3 time points successively on experimental day: fasting, 2-hour and 4-hour postprandial. On each time point, the noninvasive glucose measurement was performed at first, and followed by venous blood sample collection within 5 minutes. The subjects ate the 80 g standard noodle meal after the fasting test. The meal should be finished within 15 minutes.
Results: 3 centers participated with 210 subjects (M/F=98/112, average age is 61.2 year-old, 200 with T2DM, 7 with T1DM, 3 with prediabetes) were enrolled. The correlation coefficient of noninvasive glucose value and the serum glucose value in fasting, 2h and 4h postprandial status was 0.79, 0.61, 0.63 respectively.
A. Li: None. Z. Geng: None. S. Li: None. X. Guo: None. J. Zhang: None. F. Tang: None.