Accuracy and Usability Evaluation of Six Commercially Available Blood Glucose Monitoring Systems OC10-OC14
Dr. Nikolaos Tentolouris,
17 Agiou Thoma St, 11527, Athens, Attiki, Greece.
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.