Diabetes Clinical Trial
Official title:
System Accuracy Evaluation of Karajishi Contour and Karajishi TS Blood Glucose Monitoring Systems Following ISO 15197:2013
The study consists of 2 parts:
The objective of part 1 of this study is the performance of a short evaluation of system
accuracy for 25 subjects in order to familiarize the study personnel with the study BGMS to
be used during the planned evaluation of system accuracy (see IDT-1416-BL (Part 2)), ensure
that the Karajishi meters are fully functioning, assure and document the accuracy of the
comparison method, evaluate and validate the processes and procedures of the study
methodology. The objective of part 2 of this study is the evaluation of system accuracy
following ISO 15197:2013 (E), clause 6.3 in which accuracy requirements and applicable test
procedures for blood glucose monitoring systems intended for self-monitoring of blood
glucose by patients are stipulated.
This study will be performed for Karajishi Contour and Karajishi Contour TS (manufacturer:
Bayer Healthcare Diabetes Care) with 3 reagent system lots for each BGMS.
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