Evaluation of the Three Glucometer Devices Performance in Comparison with the Cobas Integra 400 Plus Autoanalyzer in Measuring Blood Glucose Levels: A Comparative Cross-Sectional Study

Abstract

Objective: The study aimed to evaluate the performance of the three glucometers compared to standard the laboratory method (Cobas Integra 400 Plus) in measuring blood glucose levels. Patients and Methods: A total of 100 Yemeni diabetic patients were randomly recruited into a comparative cross-sectional study. Venous and finger-pricked blood samples were obtained from all participants and used for blood glucose levels measurement following the standard procedures. Results: The mean blood glucose levels for one-hundred diabetic patients using the Gluco Contour TS and Gluco SD Codefree were not significantly different compared with the Cobas Integra 400 Plus (12.14 ± 6.89 mmol/L vs. 12.85 ± 8.83 mmol/L, <i> P </i> = 0.159; 12.50 ± 7.18 mmol/L vs. 12.85 ± 8.83 mmol/L, <i>P</i> = 0.490), respectively. However, there is a significant difference using the Gluco Alert device from that of the Cobas Integra 400 Plus (11.83 ± 6.94 mmol/L vs. 12.85 ± 8.83 mmol/L, <i> P </i> = 0.046). Furthermore, using the ROC curve at a 95% confidence interval, the Cobas Integra 400 Plus showed a significant agreement with the Gluco Contour TS (51.4%), Gluco SD Codefree (50.4%), and Gluco Alert (39.3%), respectively. For determining accuracy, the sensitivity of the glucometer devices was the following: Gluco SD Codefree (87.3%), Contour TS (85.9%), and Gluco Alert (78.9%). In this regard, the highest specificity was related to Gluco Contour TS (65.5%). Conclusion: The correlation between both methods was good, with high sensitivity and specificity in measuring blood glucose levels as indicated by the ROC curve. Thus, we suggest using these glucometers at homes and hospitals as a point of care for diabetic patients.