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 GucoSaprk/GlucoScore as outlined in DIN EN ISO 15197:2015.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
103
measurement of the blood glucose concentration using the blood glucose monitor for personal use
measurement of the blood glucose concentration using a laboratory reference device
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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