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Reproducibility and Method Comparison Studies of the Quo-Test™ A1C System and the Quo-Lab A1C Test and CLIA Waiver Study of the Quo-Test™ A1C System

NCT01829061 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 360

Last updated 2016-03-29

No results posted yet for this study

Summary

The Quo-Test A1C Analyzer and Reagent Test System (Quo-Test A1C System) are intended for the in-vitro quantitative determination of glycated hemoglobin in whole blood samples obtained from fingerstick or venous samples for point-of-care testing. The Quo-Test A1C System is indicated in the management and treatment of diabetes and for monitoring long term glycemic control by diabetics. It is for multiple patient use. Only auto-disabling, single use lancing devices should be used with this system.

Conditions

Sponsors & Collaborators

  • Quotient Diagnostics Limited

    lead INDUSTRY

Principal Investigators

  • Tim Bailey, MD · AMCR Institute

  • Stephanie Svoboda, PharmD · Ridgeview Research

  • Michael Gardner, MD · University of Missouri-Columbia

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-01-31
Completion
2014-04-30

Countries

  • United States

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 NCT01829061 on ClinicalTrials.gov