System accuracy evaluation of the systems for selfmonitoring of blood glucose GL50 evo and GL 44 following DIN EN ISO 15197:2015 – A comparison of accuracy in hypo (<70 mg/dL)- and hyper glycemic (≥180 mg/dL) glucose ranges

Abstract

Ongoing standardized verification of the accuracy of blood glucose meters systems for self-monitoring post-launch is important clinically and helps confirm appropriate continues performance of selfmonitoring blood glucose (SMBG) systems [1]. In addition, publication of such studies is increasingly becoming a component of evidence-based purchase decision making. ISO 15197:2015, [2] for which mandatory compliance is recommended for SMBG systems by 2015, [3] has tighter accuracy requirements than ISO 15197:2003, [4] and outlines current minimum accuracy standards necessary in Europe for CE marking. In the present study, a postmarketing evaluation of the CE-marked GL50 evo and GL44 systems were performed in accordance with ISO 15197:2015 protocols and requirements. The GL50 evo and GL44 systems were supplied in Germany from the Beurer GmbH, Germany. A declaration of conformity from the manufacturer of the two measuring systems was available before the start of the study, so that only the GL50 evo was used in the tests, but the results documented the quality of bothsystems. Two GL50 evo systems (serial number: GL55 T1 and GL55 T2) and strips from 3 different lots (A 10/1, A 10/3,A 10/4) with expiry dates March 2017 respectively) were supplied by the manufacturer. The study was