Accuracy and precision of the certified Glucometer-Strips System Contour Plus One in clinical practice

Abstract

Abstract Aims 1. To revise the accuracy and precision of the glucometer-strips system (GSS) in a professional routine. 2. To support the feasibility of capillary plasma glucose (cPG) monitoring. Methods Prospective single-center study. Triplets of cPG were investigated on GSS Contour Plus One (Ascensia, Switzerland) using glucosedehydrogenase strips. To obtain one triplet, one LOT of strips was used in three glucometers Contour Plus One. Following the cPG readings, venous blood was taken into a Grainer tube to measure venous plasma glucose (vPG) on a Cobas Integra 400 analyzer using hexokinase. IBM SPSS Statistics for Windows, V. 23.0 was applied. A total of 258 pairs of cPG vs vPG were compared using the Wilcoxon signed rank test with Bonferroni correction. P<0.05 was considered significant. Precision was estimated using the SD of average differences between individual cPG measurements. Results Deviations of cPG measured on GSS Contour Plus One from vPG (in range ≥5.55 mmo/L) measured on Cobas Integra Analyzer were -0.63±0.71 mmol/L (mean±SD). The number of cPG values measured on Contour Plus One within the required interval ±15% of vPG values was 200/207 (96.6%). For vPG <5.55 mmol/L, the required interval of ±0.83 mmol/L was reached in 51/51 (100%) cPG values measured on GSS Contour Plus One. PG precision/variability in triplets of GSS Contour Plus One was demonstrated by SD 0.204±0.247 mmol/L. Conclusions The required accuracy and precision of GSS Contour Plus One in clinical practice was confirmed and corresponds to the Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus ISO 15197 (2015). In addition to sustainable reviews of registered GSS, experienced data communication between health care professionals and GSS users should also be considered.