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

NCT ID: NCT01829061

Last Updated: 2016-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

360 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes

Study Groups

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No Treatment

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Quotient Diagnostics Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tim Bailey, MD

Role: PRINCIPAL_INVESTIGATOR

AMCR Institute

Stephanie Svoboda, PharmD

Role: PRINCIPAL_INVESTIGATOR

Ridgeview Research

Michael Gardner, MD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

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AMCR Institute

Escondido, California, United States

Site Status

Ridgeview Research

Chaska, Minnesota, United States

Site Status

University of Missouri

Columbia, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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QDL Clinical Studies

Identifier Type: -

Identifier Source: org_study_id

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