title: Assessing the analytical performance of systems for self-monitoring of blood glucose: concepts of performance evaluation and definition of metrological key terms.
abstract: Reliability of blood glucose (BG) measurements is a prerequisite for successful diabetes management. Publications on the evaluation of self-monitored glucose values, however, are frequently characterized by a confusion in terminology. We provide an inventory of key terms such as accuracy, trueness, precision, traceability, calibration, and matrix effect to avoid future misunderstanding. Definitions are taken from the metrological literature and international norms and explained in a language intended for nonspecialists in metrology. The terms are presented in light of the need to apply generally accepted definitions. In addition, a description of requirements and components for a sound evaluation of BG measurement systems is presented. These factors will also enable improvement in future comparisons of study results.
authors.affiliation: Forschergruppe Diabetes e.V., Helmholtz Center Munich, Ingolstaedter Landstrasse 1, 85764 Munich-Neuherberg, Germany. oliver.schnell@lrz.uni-muenchen.de.
authors.forename: Oliver
authors.initials: O
authors.lastname: Schnell
authors.forename: Rolf
authors.initials: R
authors.lastname: Hinzmann
authors.forename: Bernd
authors.initials: B
authors.lastname: Kulzer
authors.forename: Guido
authors.initials: G
authors.lastname: Freckmann
authors.forename: Michael
authors.initials: M
authors.lastname: Erbach
authors.forename: Volker
authors.initials: V
authors.lastname: Lodwig
authors.forename: Lutz
authors.initials: L
authors.lastname: Heinemann
mesh_terms: D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation / Q000379:methods* / Q000592:standards*; D002138:Calibration; D003920:Diabetes Mellitus / Q000097:blood; D006801:Humans; D012015:Reference Standards; D015203:Reproducibility of Results; D009626:Terminology as Topic
chemical_list: D001786:Blood Glucose