Daily continuous glucose monitoring is very helpful in the control of glucose levels for people with diabetes and impaired glucose tolerance. In this study, a multisensor-based, noninvasive continuous glucometer was developed, which can continuously estimate glucose levels via monitoring of physiological parameter changes such as impedance spectroscopy at low and high frequency, optical properties, temperature and humidity. Thirty-three experiments were conducted for six healthy volunteers and three volunteers with diabetes. Results showed that the average correlation coefficient between the estimated glucose profiles and reference glucose profiles reached 0.8314, with a normalized root mean squared error (NRMSE) of 14.6064. The peak time of postprandial glucose was extracted from the glucose profile, and its estimated value had a correlation coefficient of 0.9449 with the reference value, wherein the root mean square error (RMSE) was 6.8958 min. Using Clarke error grid (CEG) analysis, 100% of the estimated glucose values fell in the clinically acceptable zones A and B, and 92.86% fell in zone A. The application of a multisensor-based, noninvasive continuous glucometer and time series analysis can endure the time delay between human physiological parameters and glucose level changes, so as to potentially accomplish noninvasive daily continuous glucose monitoring.

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Introduction The aim of this study was to evaluate the stability and accuracy of glucose measurements determined using the metabolic heat conformation (MHC)-based non-invasive glucometer in a multicentre, self-controlled clinical trial. This device is the first to obtain a medical device registration certificate awarded by the National Medical Products Administration of China (NMPA). Methods The multicentre clinical study was conducted at three sites and enrolled 200 subjects whose glucose was measured with a non-invasive glucometer (the Contour Plus blood glucose monitoring system) and by venous plasma glucose (VPG) measurements, in a fasted state and at 2 and 4 h after meals. Results Based on both the non-invasive and VPG measurements, 93.9% (95% confidence interval 91.7–95.6%) of the blood glucose (BG) values fell within consensus error grid (CEG) zones A + B. The measurements obtained in a fasted state and at 2 h after meals were more accurate, with 99.0% and 97.0% of the BG values, respectively, falling within zones A + B. Compared to those subjects who received insulin, the proportion of values in zones A + B and the correlation coefficients were 3.1% and 0.0596 higher, respectively. The accuracy of the non-invasive glucometer was influenced by the level of insulin resistance calculated by the homeostatic model assessment method, which had a correlation coefficient with the mean absolute relative difference of − 0.1588 ( P = 0.0001). Conclusion The MHC-based non-invasive glucometer assessed in the present study demonstrates generally high stability and accuracy in the glucose monitoring of people with diabetes. The calculation model needs to be further explored and optimised for patients with different diabetes subtypes, levels of insulin resistance and insulin secretion capacity. Clinical trial registry number ChiCTR1900020523. Supplementary Information The online version contains supplementary material available at 10.1007/s13300-023-01402-8.

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. Conclusion: The noninvasive glucometer based on MHC method showed a good correlation with the venous plasma glucose, especially in fasting state. Disclosure A. Li: None. Z. Geng: None. S. Li: None. X. Guo: None. J. Zhang: None. F. Tang: None.