User Performance Evaluation and System Accuracy Assessment of Four Blood Glucose Monitoring Systems With Color Coding of Measurement Results.

Abstract

Blood glucose monitoring systems (BGMSs) are a cornerstone in diabetes management. They have to provide sufficiently accurate results in the hands of lay users, particularly in insulin-treated patients. The aim of this study was user performance evaluation and system accuracy assessment of four BGMSs with color coding of results. Study procedures were based on ISO 15197:2013. User performance evaluation included data from 100 participants, each of whom used every system with one reagent lot. Study personnel observed user techniques. For the system accuracy assessment, 100 capillary samples were obtained for measurement in duplicate with each of three reagent system lots per system, resulting in 600 results per system. All assessed BGMSs exhibited a sufficient level of accuracy, with small differences between them. In the user performance evaluation, study personnel observed the smallest total number of user errors with Contour Next (Ascensia), followed by Accu-Chek Instant (Roche), Medisafe Fit Smile (Terumo), and OneTouch Ultra Plus Reflect (LifeScan). Approximately 90% of participants stated that a consistent color scheme, eg, for low blood glucose (BG) values, should be used across all BGMSs. There was no clear preference among the four tested BGMSs regarding the specific way of displaying color coding. The four BGMSs assessed in this study showed only small differences in an overall sufficient level of accuracy. User handling errors, as observed by study personnel, differed between the systems.