Evaluation of System Accuracy, Precision, Hematocrit Influence, and User Performance of Two Blood Glucose Monitoring Systems Based on ISO 15197:2013/EN ISO 15197:2015

Stefan Pleus; Nina Jendrike; Annette Baumstark; Jochen Mende; Stephanie Wehrstedt; Cornelia Haug; Guido Freckmann

doi:10.1007/s13300-023-01517-y

Evaluation of System Accuracy, Precision, Hematocrit Influence, and User Performance of Two Blood Glucose Monitoring Systems Based on ISO 15197:2013/EN ISO 15197:2015

Diabetes Ther. 2024 Feb;15(2):447-459. doi: 10.1007/s13300-023-01517-y. Epub 2023 Dec 15.

Authors

Stefan Pleus¹, Nina Jendrike¹, Annette Baumstark¹, Jochen Mende¹, Stephanie Wehrstedt², Cornelia Haug¹, Guido Freckmann¹

Affiliations

¹ Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Lise-Meitner-Strasse 8/2, 89081, Ulm, Germany.
² Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Lise-Meitner-Strasse 8/2, 89081, Ulm, Germany. stephanie.wehrstedt@idt-ulm.de.

Abstract

Introduction: Sufficiently high analytical quality of blood glucose monitoring systems (BGMS) is a prerequisite for efficient diabetes therapy. In this study we assessed system accuracy, measurement repeatability, intermediate measurement precision, user performance, and the influence of hematocrit on two CE-marked blood glucose monitoring systems. For one BGMS, measurement accuracy using venous samples was additionally investigated.

Methods: Study procedures were based on the International Organization of Standardization (ISO) 15197:2013/EN ISO 15197:2015 ("ISO 15197"). User performance included data from 100 subjects who used one test strip lot, whereas for all other analyses three different reagent system lots were used. For system accuracy assessment, 100 capillary samples were measured in duplicate with each of three reagent system lots per system, resulting in 600 results per system.

Results: CareSens S Fit and CareSens H Beat both fulfilled the ISO 15197 accuracy criteria with 97.5-100% of each test strip lot's results falling within ± 15 mg/dL or ± 15% of the results of the comparison method and 100% of results in consensus error grid (CEG) zone A for all three lots. User performance evaluation revealed sufficient accuracy in the hands of lay users although some handling errors were documented by study staff. Assessment of measurement repeatability and intermediate measurement precision is given by standard deviation (SD) (glucose levels < 100 mg/dL) and by coefficient of variation (CV) (glucose concentrations ≥ 100 mg/dL). SD was ≤ 4.1 mg/dL and CV ≤ 4.2% for measurement repeatability and SD was ≤ 2.2 mg/dL and CV ≤ 2.6% for intermediate measurement precision. In case of hematocrit influence, both BGMS complied with all three tested lots with the defined criteria.

Conclusion: Both BGMS analyzed in this study fulfilled the required accuracy criteria of ISO 15197. They showed high precision, good performance in the hands of lay users, and the influence of hematocrit was acceptable in the labeled range.

Keywords: Blood glucose monitoring system; EN ISO 15197:2015; Hematocrit influence; ISO 15197:2013; Intermediate measurement repeatability; Measurement precision; System accuracy; User performance.