Abstract
Background: Blood glucose self-monitoring by individuals with diabetes is essential in controlling blood glucose levels. The International Organization for Standardization (ISO) introduced new standards for blood glucose monitoring systems (BGMS) in 2013 (ISO 15197: 2013). The CONTOUR PLUS® (CONTOUR PLUS) BGMS has been demonstrated to meet the 2013 ISO standards; however, no Chinese data on CONTOUR PLUS accuracy and precision have been published.
Methods: This study evaluated the accuracy and precision of CONTOUR PLUS BGMS in quantitative glucose testing of capillary and venous whole blood samples obtained from 363 patients at three different hospitals.
Results: Results of fingertip and venous blood glucose measurements by the CONTOUR PLUS system were compared with laboratory reference values to determine accuracy. Accuracy was 98.1% (96.06%–99.22%) for fingertip blood tests and 98.1% (96.02%–99.21%) for venous blood tests. Precision was evaluated across a wide range of blood glucose values (5.1–17.2 mmol/L), testing three blood samples repeatedly 15 times with the CONTOUR PLUS blood glucose meter using test strips from three lots. All within-lot results met ISO criteria (i.e., SD<0.42 mmol/L for blood glucose concentration <5.55 mmol/L; CV<7.5% for blood glucose concentration ≥5.55 mmol/L). Between-lot variations were 1.5% for low blood glucose concentration, 2.4% for normal and 3.4% for high.
Conclusions: Accuracy of both fingertip and venous blood glucose measurements by the CONTOUR PLUS system was >95%, confirming that the system meets ISO 15197: 2013 requirements.
Acknowledgments
The authors would like to thank Carmine Greene, MS, CCRA and Scott Pardo, PhD, PStat from Bayer HealthCare LLC, Diabetes Care, Whippany, NJ, for revising the statistical plan and statistical results as described in the study report.
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: This study was funded by Bayer Consumer Care AG.
Employment or leadership: None declared.
Honorarium: None declared.
Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
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