User Performance Evaluation of Four Blood Glucose Monitoring Systems Applying ISO 15197:2013 Accuracy Criteria and Calculation of Insulin Dosing Errors.

ABSTRACT:

Introduction

The international standard ISO 15197:2013 requires a user performance evaluation to assess if intended users are able to obtain accurate blood glucose measurement results with a self-monitoring of blood glucose (SMBG) system. In this study, user performance was evaluated for four SMBG systems on the basis of ISO 15197:2013, and possibly related insulin dosing errors were calculated. Additionally, accuracy was assessed in the hands of study personnel.

Methods

Accu-Chek^® Performa Connect (A), Contour^® plus ONE (B), FreeStyle Optium Neo (C), and OneTouch Select^® Plus (D) were evaluated with one test strip lot. After familiarization with the systems, subjects collected a capillary blood sample and performed an SMBG measurement. Study

SUBMITTER: Freckmann G 

PROVIDER: S-EPMC6104257 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature