Performance Assessment of Three Used Glucometers in Côte d'Ivoire: Compliance with ISO 15197 Standards

Abstract

Background: Self-monitoring of blood glucose is essential for effective diabetes management, necessitating the use of glucometers that maintain precision and accuracy. Environmental factors and prolonged usage may impact their performance. However, there is limited knowledge regarding the analytical performance of these devices after extended periods of use. This study assessed the compliance of three commonly used glucometers in Côte d'Ivoire with ISO 15197 standards. Objective: This study assessed the analytical and diagnostic performance of Accu-Chek Go, Accu-Chek Active, and OneTouch Verio IQ glucometers after prolonged use in tropical settings. Methods: A cross-sectional study was conducted at CeDReS, Treichville University Hospital, Abidjan, from June to December 2023. Capillary blood glucose levels were measured in 100 patients aged 16–84 years using three glucometers. Results were compared with venous blood glucose values obtained via hexokinase/glucose-6-phosphate dehydrogenase enzymatic assay on a Roche Cobas c311 analyzer. Clarke and Parkes error grids assessed diagnostic accuracy, while Bland-Altman plots evaluated analytical precision. Results: Clarke error grid analysis showed diagnostic accuracy above 99%, whereas Parkes consensus grid results were lower. Bland-Altman analysis revealed concordance rates of 91% for Accu-Chek Active, 90% for OneTouch Verio IQ, and 88% for Accu-Chek Go. These rates did not meet the minimum precision standards of 95% as stipulated by ISO 15197: 2013. Conclusion: Despite acceptable diagnostic accuracy, none of the glucometers met ISO 15197 precision standards, emphasizing the need for periodic performance reevaluation to ensure reliable diabetes management in tropical environments.