Evaluation of the Accuracy and Safety of a Portable Metabolic Heat Conformation-Based Non-invasive Glucose Meter: A Multicentre Clinical Study. (Preprint)

Abstract

BACKGROUND Non-invasive blood glucose measurement is expected to be an ideal way for glucose monitoring, although most of the methods are under study and yet to be verified in large-scale clinical trials. OBJECTIVE We intend to evaluate the stability, accuracy of the metabolic heat conformation (MHC)-based non-invasive glucometer in a multicentre, self-controlled clinical trial. This device obtained the first medical device registration certificate awarded by the National Medical Products Administration of China (NMPA). METHODS The clinical study was conducted at three sites on 200 subjects who received glucose measurement with a non-invasive glucometer, the Contour Plus blood glucose monitoring system, and venous plasma glucose (VPG) measurements, in a fasted state and at 2 and 4 hours after meals. Trial Registration: ChiCTR1900020523. RESULTS The non-invasive and VPG measurements showed 93.9% (95% CI, 91.7–95.6%) of the values in zone A + B in a Consensus Error Grid. The measurements obtained in a fasted state and at 2 hours after meals are more accurate, with 99.0% and 97.0% of the values in zone A + B, respectively. The proportion of values in zone A + B and the correlation coefficients in subjects who did not receive insulin were 3.1% and 0.0596 higher than in those who received insulin. The accuracy of the non-invasive glucometer was influenced by the level of islet cell function and insulin resistance, which had a correlation coefficient with the MARD of -0.0961 (p=0.020) and -0.1577 (p=0.00012), respectively. CONCLUSIONS The MHC-based non-invasive glucometer demonstrates generally high stability and accuracy in the glucose monitoring of diabetic patients. The calculation model needs to be further explored and optimised for patients with different diabetes subtypes, levels of insulin resistance and insulin secretion capacity. CLINICALTRIAL the name of the trial registry : A multi-center study for evaluating the accuracy and safety of noninvasive glucose meter in people with diabetes or impaired glucose regulation (impaired fasting glucose and impaired glucose tolerance), using an experimental test system as a reference. registration number : ChiCTR1900020523 URL : https://www.chictr.org.cn/showproj.aspx?proj=33857