title: Accuracy Evaluation of a CE-Marked Glucometer System for Self-Monitoring of Blood Glucose With Three Reagent Lots Following ISO 15197:2013.
abstract: Continuous standardized verification of the accuracy of blood glucose meter systems for self-monitoring after their introduction into the market is an important clinically tool to assure reliable performance of subsequently released lots of strips. Moreover, such published verification studies permit comparison of different blood glucose monitoring systems and, thus, are increasingly involved in the process of evidence-based purchase decision making.
authors.affiliation: 1 Institute of Diabetes "Gerhardt Katsch," Karlsburg, Germany.
authors.forename: Bernd
authors.initials: B
authors.lastname: Hehmke
authors.affiliation: 1 Institute of Diabetes "Gerhardt Katsch," Karlsburg, Germany.
authors.forename: Sabine
authors.initials: S
authors.lastname: Berg
authors.affiliation: 1 Institute of Diabetes "Gerhardt Katsch," Karlsburg, Germany.
authors.forename: Eckhard
authors.initials: E
authors.lastname: Salzsieder
mesh_terms: D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000592:standards*; D000068598:Data Accuracy; D003920:Diabetes Mellitus / Q000097:blood; D006801:Humans; D011358:Product Surveillance, Postmarketing; D011934:Reagent Strips / Q000592:standards
chemical_list: D001786:Blood Glucose; D011934:Reagent Strips
keywords: ISO 15197:2013; accuracy; glucometer; precision; self-monitoring of blood glucose