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

March 28, 2016 updated by: Quotient Diagnostics Limited

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

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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

360

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Escondido, California, United States, 92026
        • AMCR Institute
    • Minnesota
      • Chaska, Minnesota, United States, 55318
        • Ridgeview Research
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

From site's patient database

Description

Inclusion Criteria:

  • Aged 18 years or over
  • Able to read English
  • Read, understood and signed the Informed Consent Form
  • Agrees to participate and does not withdraw\
  • Either healthy (without diabetes) or has Type 1 or Type 2 diabetes

Exlcusion Criteria:

• Declines participation or withdraws before study completion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

Group / Cohort
No Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The objective is to conduct reproducibility testing using duplicates of each of 3 levels of HbA1C
Time Frame: 10 Days
The objective is to conduct a method comparison between both the Quo-Test and Quo-Lab investigational devices and the reference method [Tosoh G8 (K071132)]. The reference method also serves as the predicate for the premarket notifications for both investigational devices. Both capillary and venous samples will be tested on the Quo-Test A1C System and Quo-Lab A1C Test, while only venous samples will be tested on the reference method.
10 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
Obtain CLIA Waiver Status for the Quo-Test
Time Frame: 10 Days
10 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Quotient Diagnostics Limited

Investigators

  • Principal Investigator: Tim Bailey, MD, AMCR Institute
  • Principal Investigator: Stephanie Svoboda, PharmD, Ridgeview Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ACTUAL)

January 1, 2014

Study Completion (ACTUAL)

April 1, 2014

Study Registration Dates

First Submitted

April 1, 2013

First Submitted That Met QC Criteria

April 10, 2013

First Posted (ESTIMATE)

April 11, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 29, 2016

Last Update Submitted That Met QC Criteria

March 28, 2016

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • QDL Clinical Studies

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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