This study assesses the system accuracy of a blood glucose monitoring system in accordance with DIN EN ISO 15197:2015
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
105
measurement of the blood glucose concentration of subject using BGM and capillary finger tip blood
measurement of the blood glucose concentration of subject using reference method and capillary finger tip blood
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: 1 Day
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