System Accuracy and Interference Evaluation of a New Glucose Dehydrogenase-Based Blood Glucose Meter for Patient Self-Testing
Study context
- Population
- Healthy subjects and people with T1D or T2D (44 female, 56 male; 43 healthy, 23 T1D, 34 T2D; age 53.7 ± 15.8 years)
- Participants
- 100 subjects
- Outcome
- System accuracy (ISO15197:2015)
Methodological detailsISO15197:2015-conform system performance evaluation, laboratory interference test
- ISO15197:2015-conform system performance evaluation
- Laboratory interference test
Performance
As reported in the abstract
Mean absolute relative difference (MARD)
4.7%
Values in zones A and B of the consensus error grid
100%
Values in zone A
99.7%
Values in zone B
0.3%
Further findings
Interference with ten selected substances (substance-induced bias > 10%)
- Interference observed with xylose only, a known interfering substance for glucose dehydrogenase (GDH)-based blood glucose meters (BGMs)
- Manipulated heparinized whole blood
Original publication
System Accuracy and Interference Evaluation of a New Glucose Dehydrogenase-Based Blood Glucose Meter for Patient Self-Testing. J Diabetes Sci Technol. Published 2 October 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →