User Performance Evaluation and System Accuracy Assessment of Four Blood Glucose Monitoring Systems With Color Coding of Measurement Results
Authors' conclusion
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.
Study context
- Population
- Lay users (user performance evaluation; each used every system with one reagent lot) and capillary samples (system accuracy)each used every system
- Participants
- 100 users
- Comparison
- Four blood glucose monitoring systems with color coding of results
- Outcome
- System accuracy and user performance
Methodological detailsbased on ISO 15197:2013, user performance evaluation, system accuracy assessment, Study personnel observed user techniques
- Based on ISO 15197:2013
- User performance evaluation
- System accuracy assessment
- Study personnel observed user techniques
Performance
As reported in the abstract
- All BGMSs exhibited a sufficient level of accuracy, with small differences between them
- Smallest total number of user errors with Contour Next, followed by Accu-Chek Instant, Medisafe Fit Smile and OneTouch Ultra Plus Reflect
- 600 results per system (100 capillary samples in duplicate × 3 reagent lots)
Further findings
User opinion on color coding
- Participants stating a consistent color scheme should be used across all BGMSs
- ≈90%
- No clear preference among the four BGMSs regarding the way of displaying color coding
Original publication
User Performance Evaluation and System Accuracy Assessment of Four Blood Glucose Monitoring Systems With Color Coding of Measurement Results. J Diabetes Sci Technol. Published 26 November 2022. doi:10.
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