Clinical System Accuracy Evaluation With OneTouch® Verio Flex Blood Glucose Monitoring System (BGMS)

NACompletedINTERVENTIONAL
Enrollment

109

Participants

Timeline

Start Date

March 16, 2017

Primary Completion Date

April 3, 2017

Study Completion Date

June 1, 2017

Conditions
Diabetes Mellitus
Interventions
DEVICE

Blood glucose monitoring systems for self-testing (BGMS)

"Measurement procedure~* Subjects will be asked to wash and dry their hands before the measurements.~* The measurement procedure for each reagent system lot of a BGMS will be as follows:~* Study personnel will collect a capillary blood sample from the subject's fingertip by skin puncture.~* Duplicate measurements on the sample will be consecutively performed with 2 test meters using reagent system units from the same vial / package.~* Capillary blood for measurements with all 3 test strip lots and for both comparison measurements will be taken from the same finger puncture.~* The sample will be applied to the reagent system units following specifications in the manufacturer's labelling."

Trial Locations (1)

89081

Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

LifeScan

INDUSTRY

lead

Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

OTHER