Accuracy Evaluation of a CE-Marked Glucometer System for Self-Monitoring of Blood Glucose With Three Reagent Lots Following ISO 15197:2013
نویسندگان
چکیده
منابع مشابه
System accuracy evaluation of 43 blood glucose monitoring systems for self-monitoring of blood glucose according to DIN EN ISO 15197.
BACKGROUND The accuracy of systems for self-monitoring of blood glucose is important, as reliable measurement results are a prerequisite for therapeutic decisions. METHODS This system accuracy evaluation study was performed according to DIN EN ISO 15197:2003 for 43 Conformité Européenne (CE)-labeled blood glucose (BG) monitoring systems. Measurement results of each system were compared with r...
متن کاملSystem accuracy evaluation of 27 blood glucose monitoring systems according to DIN EN ISO 15197.
BACKGROUND Blood glucose (BG) monitoring systems enable diabetes patients to effectively control and adjust their therapy. BG monitoring systems with a Conformité Européenne (CE) label should meet the standard DIN EN ISO 15197:2003: > or =95% of the BG results shall fall within +/-15 mg/dL of the reference method at BG concentrations <75 mg/dL and within +/-20% at BG concentrations > or =75 mg/...
متن کاملSystem accuracy of blood glucose monitoring devices according to the current and proposed ISO 15197 standards.
Corresponding Author: Guido Freckmann, M.D., Institut für Diabetes-Technologie Forschungsund Entwicklungsgesellschaft mbH, Helmholtzstrasse 20, 89081 Ulm, Germany; email address [email protected] In a letter to the editor, Teodorczyk and coauthors1 comment on our data2 published in Journal of Diabetes Science and Technology. In studies2 conducted at the Institut für Diabetes-Technologi...
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INTRODUCTION Self-monitoring of blood glucose (SMBG) is important in diabetes management. Reliable and user-friendly instruments are essential. OneTouch Verio(®) is a new blood glucose concentration-measuring system designed to be used by patients with diabetes and healthcare professionals. The objective of the present study was to evaluate the analytical performance of the OneTouch Verio(®). ...
متن کاملAccuracy of the EasyTouch blood glucose self-monitoring system: a study of 516 cases.
BACKGROUND Self-monitoring blood glucose device is an important tool for diabetes patients to efficiently control their blood glucose concentrations. We evaluated the accuracy of EasyTouch glucose monitoring system. METHODS Capillary blood glucose concentrations measured using EasyTouch and the reference values obtained from Yellow Springs Instruments (YSI) 2300 STAT were performed in the Dep...
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ژورنال
عنوان ژورنال: Journal of Diabetes Science and Technology
سال: 2016
ISSN: 1932-2968,1932-2968
DOI: 10.1177/1932296816670401