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Evaluating the Clinical Accuracy of a Non-invasive Single-Fasting-Calibration Glucometer in Patients with Diabetes: A Multicentre Study
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 registrati...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Healthcare
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10203088/ https://www.ncbi.nlm.nih.gov/pubmed/37103775 http://dx.doi.org/10.1007/s13300-023-01402-8 |
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author | Li, Ang Li, Xiang Xu, Yuanmeng Wu, Chenyang Geng, Zhanxiao Zhang, Junqing Wang, Xiaohao Li, Yuxiu Li, Hongmei Guo, Xiaohui Tang, Fei |
author_facet | Li, Ang Li, Xiang Xu, Yuanmeng Wu, Chenyang Geng, Zhanxiao Zhang, Junqing Wang, Xiaohao Li, Yuxiu Li, Hongmei Guo, Xiaohui Tang, Fei |
author_sort | Li, Ang |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-10203088 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Springer Healthcare |
record_format | MEDLINE/PubMed |
spelling | pubmed-102030882023-05-24 Evaluating the Clinical Accuracy of a Non-invasive Single-Fasting-Calibration Glucometer in Patients with Diabetes: A Multicentre Study Li, Ang Li, Xiang Xu, Yuanmeng Wu, Chenyang Geng, Zhanxiao Zhang, Junqing Wang, Xiaohao Li, Yuxiu Li, Hongmei Guo, Xiaohui Tang, Fei Diabetes Ther Original Research 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. Springer Healthcare 2023-04-27 2023-06 /pmc/articles/PMC10203088/ /pubmed/37103775 http://dx.doi.org/10.1007/s13300-023-01402-8 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by-nc/4.0/Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Original Research Li, Ang Li, Xiang Xu, Yuanmeng Wu, Chenyang Geng, Zhanxiao Zhang, Junqing Wang, Xiaohao Li, Yuxiu Li, Hongmei Guo, Xiaohui Tang, Fei Evaluating the Clinical Accuracy of a Non-invasive Single-Fasting-Calibration Glucometer in Patients with Diabetes: A Multicentre Study |
title | Evaluating the Clinical Accuracy of a Non-invasive Single-Fasting-Calibration Glucometer in Patients with Diabetes: A Multicentre Study |
title_full | Evaluating the Clinical Accuracy of a Non-invasive Single-Fasting-Calibration Glucometer in Patients with Diabetes: A Multicentre Study |
title_fullStr | Evaluating the Clinical Accuracy of a Non-invasive Single-Fasting-Calibration Glucometer in Patients with Diabetes: A Multicentre Study |
title_full_unstemmed | Evaluating the Clinical Accuracy of a Non-invasive Single-Fasting-Calibration Glucometer in Patients with Diabetes: A Multicentre Study |
title_short | Evaluating the Clinical Accuracy of a Non-invasive Single-Fasting-Calibration Glucometer in Patients with Diabetes: A Multicentre Study |
title_sort | evaluating the clinical accuracy of a non-invasive single-fasting-calibration glucometer in patients with diabetes: a multicentre study |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10203088/ https://www.ncbi.nlm.nih.gov/pubmed/37103775 http://dx.doi.org/10.1007/s13300-023-01402-8 |
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