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

NCT03085251 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2017-09-26

No results posted yet for this study

Summary

The objective of this study is the evaluation of system accuracy based on EN ISO 15197:2015 (ISO 15197:2013), 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. ISO 15197:20132 was harmonized with the regulations of the European Union as EN ISO 15197:2015. This harmonization had no impact on the requirements and procedu¬res in ISO 15197:2013; changes were made to the foreword and an informative annex. In this study, system accuracy evaluation will be performed for OneTouch® Verio Flex (LifeScan Europe) on behalf of LifeScan Scotland Limited (customer) with three different reagent system lots.

Conditions

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.

Sponsors & Collaborators

  • LifeScan

    collaborator INDUSTRY

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

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-16
Primary Completion
2017-04-03
Completion
2017-06-01

Countries

  • Germany

Study Locations

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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 NCT03085251 on ClinicalTrials.gov