OneTouch Verio Flex System Accuracy Evaluation

NCT03138174 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2017-06-28

No results posted yet for this study

Summary

Clinical System Accuracy Evaluation of the CE Marked One Touch Verio Flex blood glucose monitoring device as per requirements stated in ISO 15197:2015. To meet the requirements, glucose samples must be distributed over the operating range of the blood glucose monitor as stipulated in ISO:15197

Conditions

Interventions

DEVICE

OneTouch Verio Flex Blood Glucose Monitoring System

Blood Glucose Monitoring System

Sponsors & Collaborators

  • LifeScan

    lead INDUSTRY

Principal Investigators

  • Alan Patrick · National Health Service, United Kingdom

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-23
Primary Completion
2017-05-02
Completion
2017-05-02
FDA Device
Yes

Countries

  • United Kingdom

Study Locations

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Entities

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 NCT03138174 on ClinicalTrials.gov