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System Accuracy Evaluation of Karajishi Contour and Karajishi TS Blood Glucose Monitoring Systems Following ISO 15197:2013

NCT02358408 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2016-01-28

No results posted yet for this study

Summary

The study consists of 2 parts:

The objective of part 1 of this study is the performance of a short evaluation of system accuracy for 25 subjects in order to familiarize the study personnel with the study BGMS to be used during the planned evaluation of system accuracy (see IDT-1416-BL (Part 2)), ensure that the Karajishi meters are fully functioning, assure and document the accuracy of the comparison method, evaluate and validate the processes and procedures of the study methodology. The objective of part 2 of this study is the evaluation of system accuracy following ISO 15197:2013 (E), clause 6.3 in which accuracy requirements and applicable test procedures for blood glucose monitoring systems intended for self-monitoring of blood glucose by patients are stipulated.

This study will be performed for Karajishi Contour and Karajishi Contour TS (manufacturer: Bayer Healthcare Diabetes Care) with 3 reagent system lots for each BGMS.

Conditions

Interventions

DEVICE

Blood glucose monitoring systems for self-testing

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

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

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-02-28
Completion
2015-04-30

Countries

  • Germany

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02358408 on ClinicalTrials.gov