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Accuracy of Sensocard Glucose Meter: Comparing with Reference Glucose Oxidase Method

Muluken Kassahun, Tadele Melak and Molla Abebe*

Introduction: Diabetes mellitus is a cause of morbidity, disability and mortality worldwide. Glucose measurement by glucose meter is one of the diagnosing and monitoring tools of diabetes mellitus. However, the accuracy of this instrument is in question. Therefore, the aim of this study was to assess the accuracy of SensoCard glucose meter comparing with reference glucose oxidase method at University of Gondar Hospital, Gondar, Ethiopia.
Methods: A prospective cross-sectional study was conducted in March, 2014. A total of 122 (equal number of type 1 and II) diabetic mellitus patients were selected by consecutive sampling technique. Glucose value was determined by SensoCard glucose meter and reference glucose oxidase method. The data were entered and analyzed using SPSS version 20 and Analyse-it version 3.76.1 softwares. Correlation coefficient and bias were calculated to observe the agreement of the glucose meter result with the comparative method. The minimum accuracy of Sensocard was determined based ISO 15197:2003 and ISO 15197:2013 criteria.
Results: Sixty three (51.6%) participants were females. The mean age was 46.16 ± 15.5. The mean serum
glucose value measured by reference method was 164.78 ± 86.33 mg/dl and the mean capillary blood glucose value measured by SensoCard glucose meter was 161.19 ± 78.1 mg/dl. There was no statistically significant difference between the means of SensoCard glucose meter and reference method glucose value (p-value=0.052). The correlation coefficient between the two methods was 0.975. The SensoCard glucose meter underestimated the overall glucose value from the reference method glucose value by a bias of 3.59.
Conclusion: SensoCard did not fulfill the minimum accuracy requirements of ISO 15197:2003 and ISO
15197:2013. Further study should be undertaken including hypoglycemic and normoglycemic individuals to see the accuracy of SensoCard in low and normal levels of blood glucose in addition to high blood glucose level in diabetes mellitus patients.