This study assesses the system accuracy a blood glucose monitoring systems pursuant to ISO 15197
This study assesses the system accuracy the blood glucose monitoring systems for personal use TJ100 pursuant to ISO 15197:2015 guidelines
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
114
measurement of the blood glucose concentration using the blood glucose monitor for personal use (TJ100)
measurement of the blood glucose concentration using a laboratory reference device (YSI 2300 Stat Plus)
Institut für Diabetes Karlsburg GmbH
Karlsburg, Mecklenburg-Vorpommern, Germany
Analysis of system accuracy based on DIN EN ISO 15197
Assessment of the analytical measurement performance of the blood glucose monitor based on procedures defined in DIN EN ISO 15197
Time frame: day 1
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