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User Performance Evaluation of Contour® Next One, Accu-Chek® Aviva Connect, FreeStyle Freedom Lite, OneTouch® Verio and GlucoMen® Areo Blood Glucose Monitoring Systems Following ISO 15197:2013

NCT03033849 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 189

Last updated 2017-09-12

No results posted yet for this study

Summary

The user performance evaluation shows whether people with diabetes are able to obtain accurate measurement results with a blood glucose monitoring system. In this study, user performance evaluation will be performed for Contour® Next One (Ascensia Diabetes Care GmbH), Accu-Chek® Aviva Connect (Roche Diabetes Care GmbH), FreeStyle Freedom Lite (Abbott Diabetes Care Inc.), OneTouch® Verio (LifeScan Europe) and GlucoMen® areo A. Menarini Diagnostics S.r.l. (based on ISO 15197:2013; EN ISO 15197:2015, clause 8.

For each BGMS, measurement procedures for user performance evaluation will be performed with 1 test meter and 1 reagent system lot by the study subjects.

The same meter and an additional test meter will be used for double measurements performed by study personnel (with the same reagent system lot used by subjects).

Conditions

Interventions

DEVICE

Blood glucose monitoring system for self-testing Contour® Next One

This is a user performance study, that is intended to show whether people with diabetes are able to obtain accurate measurement results with a blood glucose monitoring system (BGMS). The subjects' measurement technique (e.g. applying blood onto the system reagent, reading the result) will be observed and documented by study personnel. Immediately after the measurement by the subject, the study personnel will perform a measurement with the same test meter. Measurement results obtained by the subjects with the BGMS will be compared to measurement results obtained with the comparison method. Sample collection for the comparison measurement will be performed by study personnel within 5 min after the subject's measurement with the test meter. The samples will be collected from the subjects' skin puncture (if possible), an additional skin puncture (if required) will be documented. An additional skin puncture will be performed by study personnel with single-use lancing devices.

DEVICE

Blood glucose monitoring system for self-testing Accu-Chek® Aviva Connect

DEVICE

Blood glucose monitoring system for self-testing FreeStyle Freedom Lite

DEVICE

Blood glucose monitoring system for self-testing OneTouch® Verio

DEVICE

Blood glucose monitoring system for self-testing GlucoMen® areo

Sponsors & Collaborators

  • Ascensia Diabetes Care

    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
2017-01-31
Primary Completion
2017-03-31
Completion
2017-03-31

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 NCT03033849 on ClinicalTrials.gov