Accuracy and Usability Evaluation of Six Commercially Available Blood Glucose Monitoring SystemsCorrespondence Address :
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.
Blood glucose meters, Diabetes mellitus, ISO 15197:2013 requirements, Precision
Anastasios Tentolouris, Ioanna Eleftheriadou, Pinelopi Grigoropoulou, Maria Nikoloudi,
Evangelia Siami, Diamantis I. Tsilimigras, et al.. ACCURACY AND USABILITY EVALUATION
OF SIX COMMERCIALLY AVAILABLE BLOOD
GLUCOSE MONITORING SYSTEMS. Journal of Clinical and Diagnostic Research [serial online] 2018 June [cited: 2018 Jun 23 ]; 12:OC10-OC14. Available from
Date of Submission: Oct 02, 2017
Date of Peer Review: Nov 22, 2017
Date of Acceptance: Jan 24, 2018
Date of Publishing: Jun 01, 2018
FINANCIAL OR OTHER COMPETING INTERESTS: None.
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