Accuracy and Usability Evaluation of Six Commercially Available Blood Glucose Monitoring Systems
Journal Title: Journal of Clinical and Diagnostic Research - Year 2018, Vol 12, Issue 6
Abstract
ABSTRACT Introduction: Self-Monitoring of Blood Glucose (SMBG) is essential for achieving glycaemic control in individuals with diabetes mellitus. Aim: The aim of the study was to evaluate the accuracy and the usability of six different commercially available SMBG systems. Materials and Methods: A total of 120 individuals with both types of diabetes, aged between 18-80 years, were recruited. Capillary Blood Glucose (BG) was measured on six SMBG systems, while the YSI 2300 STAT PLUS was used as a reference method. Accuracy performance was based on requirements resembling the ISO 15197:2013 (95% of the BG results within ±15 mg/dL of the reference method at BG concentrations <100 mg/dL and within ±15% of the reference method at BG concentration ≥100 mg/dL). Usability testing of the SMBG was performed using the Likert Scale Questionnaire. Results: Four out of six and five out of six glucometers demonstrated excellent performance in BG values <100 mg/dL (n=40) and in BG values ≥100 mg/dL (n=80), respectively. Across the overall BG range tested, five out of six SMBG systems had good accuracy performance. Among the three SMBG systems with the highest performance (>99%) in the overall BG range (29-475 mg/dL) the one with an innovative strip insertion technique was less favoured by the participants. Conclusion: Most of the examined commercially available SMBG devices demonstrated adequate performance when they were tested in requirements resembling the ISO 15197:2013. Regarding usability, the Accu-Chek Aviva Plus and the Contour Next were the most convenient devices.
Authors and Affiliations
Anastasios Tentolouris, Ioanna Eleftheriadou, Pinelopi Grigoropoulou, Maria Nikoloudi, Evangelia Siami, Diamantis I. Tsilimigras, Nikolaos Tentolouris
Keywords
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- EP ID EP524119
- DOI 10.7860/JCDR/2018/34055.11671
- Views 76
- Downloads 0
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