Paper
Performance Evaluation of Three Blood Glucose Monitoring Systems Using ISO 15197
Published Jan 1, 2016 · J. Bedini, J. Wallace, S. Pardo
Journal of Diabetes Science and Technology
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Abstract
Background: Blood glucose monitoring is an essential component of diabetes management. Inaccurate blood glucose measurements can severely impact patients’ health. This study evaluated the performance of 3 blood glucose monitoring systems (BGMS), Contour® Next USB, FreeStyle InsuLinx®, and OneTouch® Verio™ IQ, under routine hospital conditions. Methods: Venous blood samples (N = 236) obtained for routine laboratory procedures were collected at a Spanish hospital, and blood glucose (BG) concentrations were measured with each BGMS and with the available reference (hexokinase) method. Accuracy of the 3 BGMS was compared according to ISO 15197:2013 accuracy limit criteria, by mean absolute relative difference (MARD), consensus error grid (CEG) and surveillance error grid (SEG) analyses, and an insulin dosing error model. Results: All BGMS met the accuracy limit criteria defined by ISO 15197:2013. While all measurements of the 3 BGMS were within low-risk zones in both error grid analyses, the Contour Next USB showed significantly smaller MARDs between reference values compared to the other 2 BGMS. Insulin dosing errors were lowest for the Contour Next USB than compared to the other systems. Conclusions: All BGMS fulfilled ISO 15197:2013 accuracy limit criteria and CEG criterion. However, taking together all analyses, differences in performance of potential clinical relevance may be observed. Results showed that Contour Next USB had lowest MARD values across the tested glucose range, as compared with the 2 other BGMS. CEG and SEG analyses as well as calculation of the hypothetical bolus insulin dosing error suggest a high accuracy of the Contour Next USB.
Observational StudyContour Next USB blood glucose monitoring system has the lowest mean absolute relative difference (MARD) values and lowest insulin dosing errors compared to FreeStyle InsuLinx and OneTouch Verio IQ systems.
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