Benchmarking Point-of-Care Glucometers: A Comparative Study Using the Hexokinase Test and International Organization for Standardization (ISO) Standards.

Autor:	George K; Community Medicine, Amrita Institute of Medical Sciences, Amrita Vishwa Vidyapeetham, Kochi, IND., Joy S; Community Medicine, Amrita Institute of Medical sciences, Amrita Vishwa Vidyapeetham, Kochi, IND., Kaladi Palliyalil H; Community Medicine, Amrita Institute of Medical Sciences, Amrita Vishwa Vidyapeetham, Kochi, IND., Shaji SM; Community Medicine, Amrita Institute of Medical Sciences, Amrita Vishwa Vidyapeetham, Kochi, IND., Ajayakumar Sunanda V; Community Medicine, Amrita Institute of Medical Sciences, Amrita Vishwa Vidyapeetham, Kochi, IND., Sreedevi A; Community Medicine, Amrita Institute of Medical Sciences, Amrita Vishwa Vidyapeetham, Kochi, IND.
Jazyk:	angličtina
Zdroj:	Cureus [Cureus] 2024 Oct 07; Vol. 16 (10), pp. e70981. Date of Electronic Publication: 2024 Oct 07 (Print Publication: 2024).
DOI:	10.7759/cureus.70981
Abstrakt:	Introduction The International Diabetes Federation states that India accounts for one in seven of all adults with diabetes. Adherence to self-monitoring of blood glucose is essential for effective management of diabetes. Despite the wide variety of glucometers and their clinical applicability, there is a lot of ambiguity regarding their accuracy. Therefore, this study aimed to evaluate if three point-of-care glucometers using three different methods for the estimation of blood glucose fulfil the minimum accuracy needed by ISO15197:2013 when compared with the gold standard hexokinase test. Methods A cross-sectional study was conducted at two primary health care centers in Ernakulam district, which included 73 participants with diabetes and 73 without diabetes. We evaluated three different enzymes in the test glucometers: glucose dehydrogenase with pyrroloquinoline quinone (GDH-PQQ), glucose dehydrogenase with flavin adenine dinucleotide (GDH-FAD), and glucose oxidase (GOD). The glucometer readings were compared with the gold standard hexokinase test and ISO15197:2013 standards. To compare the accuracy of each glucometer with the reference method, the Bland-Altman plot was used and to evaluate the clinical significance of the differences between the glucometer and reference value the Clarke error grid analysis was performed. Results When compared with the gold standard hexokinase result, only 78.08% (GOD), 92.4% (GDH-PQQ), and 95.8 (GDH-FAD) of results were within the limits stipulated by ISO15197:2013. All three glucometers showed blood glucose results within zones A and B of the consensus error grid, implying that it is clinically acceptable, and the Bland-Altman plot showed that the GDH-FAD method had the narrowest range between the upper and lower limit of agreement and a minimum bias of -0.89. Conclusion Only one test glucometer with the GDH-FAD method met the ISO15197:2013 criteria. Glucometers must meet the accuracy standards for the safety of the patients. Competing Interests: Human subjects: Consent was obtained or waived by all participants in this study. Ethics Committee of Amrita School of Medicine issued approval ECASM-AIMS-2023-052. The committee reviewed the submitted documents of the research protocol. No ethical issues has been observed in the study, hence clearance is granted. . Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: Received grant of 255.53 GBP as part of ReachSci Mini PhD programme in collaboration between ReachSci Society Cambridge University and Amrita Vishwa Vidyapeetham, Kochi. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work. (Copyright © 2024, George et al.)
Databáze:	MEDLINE
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