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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

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Journal of Diabetes Mellitus 2021年第4期11卷 132-142页

作者： Lotfi S. Bin Dahman Ahmed M. Daakeek Hussein S. Alghazali Abdullah M. Kaity Munir S. Obbed Department of Medical Biochemistry College of Medicine and Health Sciences Hadhramout University Mukalla Yemen Department of Internal Medicine College of Medicine and Health Sciences Hadhramout University Mukalla Yemen Department of Community Medicine and Public Health College of Nurse Hadhramout University Mukalla Yemen Department of Chemistry College of Science Hadhramout University Mukalla Yemen

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, P = 0.159;12.50 ± 7.18 mmol/L vs. 12.85 ± 8.83 mmol/L, P = 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, P = 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.

关键词： Diabetes Mellitus Blood Glucose Levels glucometers Cobas Integra 400 Plus Autoanalyzer

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