An interventional study of Blood glucose monitoring systems for self-testing in Diabetes, sponsored by Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm. Completed at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-26.
Sponsored by Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm · Not applicable, Interventional, and Other
Assessment of the system accuracy of different blood glucose monitoring systems available in Europe
A variety of blood glucose monitoring systems (BGMS) are available on the European market. For many of these BGMS, the system accuracy is unknown or it has not yet been assessed in manufacturer-independent studies. The IDT surveillance program aims at assessing the system accuracy of different BGMS that are available in Europe in a manufacturer-independent, investigator-initiated study. The initial study will cover 18 BGMS from 18 different manufacturers. Per BGMS, one test strip lot will be assessed based on procedures stated in the international standard ISO 15197:2013 / EN ISO 15197:2015.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 126 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm is the lead sponsor of 13 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Capillary blood samples will be used for the evaluation of system accuracy.
Also known as: 18 BGMS from 18 different manufacturers: ABRA, Accu-Chek Guide, AURUM Blutzucker-Messsystem, CareSens Dual, CERA-CHEK 1 Code, Contour next ONE, eBsensor, FreeStyle Freedom Lite, GL 50 (evo), GlucoCheck GOLD, GlucoMen areo 2K, GluNEO, MyStar DoseCoach, OneTouch Verio Flex, Pic GlucoTest, Rightest GM700S, TRUEyou Blutzuckermesssystem, WaveSense JAZZ WIRELESS
Analysis of system accuracy based on ISO 15197
Assessment of the analytical measurement performance of 18 blood glucose montoring systems based on procedures defined in ISO 15197
Time frame: For each subject, the experimental phase has an expected duration of up to 6 hours
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm