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, 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.
Highlights
Diabetes mellitus is one of the chronic metabolic disorders characterized by hyperglycemia resulting from either defect in insulin secretion, insulin action, or both [1]
The blood glucose levels of diabetic Yemeni patients enrolled in this study were measured using the three different glucometer devices versus the standard laboratory method (Cobas Integra 400 Plus) at the National Center for Public Health Laboratories of Mukalla, Yemen
Our results didn’t show any significant statistical difference between Gluco Contour TS and Gluco standard deviation (SD) Codefree compared with Cobas Integra 400 Plus autoanalyzer (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
Summary
Diabetes mellitus is one of the chronic metabolic disorders characterized by hyperglycemia resulting from either defect in insulin secretion, insulin action, or both [1]. Retinopathy, nephropathy, neuropathy, and cardiovascular disorders as complications of diabetes may cause premature death in diabetic patients. These complications would impose additional costs on the family, community, and health care system [3]. Blood glucose level monitoring is being recognized as a priority in treating critically ill diabetic patients as it has helped reduce complications of diabetes [4] [5]. Today, regarding the importance of diabetes care management, the researchers have suggested “Self-Monitoring of Blood Glucose” (SMBG) to reduce the burden and increase cost-effectiveness [6] [7]. SMBG is a process of blood glucose checking by the patient known as a glucometer device. According to the American Diabetes Association (ADA), SMBG is commonly applied three times a day [9]
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