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System Accuracy Evaluation of 2 CE-marked Blood Glucose Monitoring System

NCT02710617 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2016-08-31

No results posted yet for this study

Summary

The objective 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.

However in this study, system accuracy evaluation will be performed for Hemocue Glucose 201+ and Hemocue Glucose 201 RT which are both glucose monitoring systems for professional use only on behalf of the IDT with one reagent system lot for each BGMS.

Main goal is the evaluation of system accuracy of both of the hemocue Systems. (english)

Conditions

Interventions

DEVICE

Blood glucose monitoring systems for point-of-care-testing

Sponsors & Collaborators

  • 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
2016-03-31
Primary Completion
2016-04-30
Completion
2016-05-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT02710617 on ClinicalTrials.gov