ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2023
Evaluating the Clinical Accuracy of a Non-invasive Single-Fasting-Calibration Glucometer in Patients with Diabetes: A Multicentre Study.
Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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3 citing papers in PubMed, 2 citations in OpenAlex.
- High-Sensitivity Non-Invasive Microwave Glucose Sensor with ZnO/CNT Composite Optimized by Deep Learning for Wearable Medical Devices.ACS omega · 2026Article
- GlucoNeo Check in the community: feasibility of photoplethysmography-based non-invasive glucose screening.International journal of public health · 2026Article
- Non-invasive blood glucose estimation method based on the phase delay between oxy- and deoxyhemoglobin using visible and near-infrared spectroscopy.Journal of biomedical optics · 2024Article
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11 authors at 4 institutions in 1 country.
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Abstract
introductionThe 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).
methodsThe 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.
resultsBased 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).
conclusionThe 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.
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