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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Quotient Diagnostics Limited
ClinicalTrials.gov Identifier:
NCT01829061
First received: April 1, 2013
Last updated: November 5, 2013
Last verified: November 2013
  Purpose

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.


Condition
Diabetes

Study Type: Observational
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Quotient Diagnostics Limited:

Primary Outcome Measures:
  • The objective is to conduct reproducibility testing using duplicates of each of 3 levels of HbA1C [ Time Frame: 10 Days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Obtain CLIA Waiver Status for the Quo-Test [ Time Frame: 10 Days ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Whole Blood Venous Draw and Capillary Blood - IVD Study


Estimated Enrollment: 360
Study Start Date: April 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
No Treatment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

From site's patient database

Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01829061

Locations
United States, California
AMCR Institute
Escondido, California, United States, 92026
United States, Minnesota
Ridgeview Research
Chaska, Minnesota, United States, 55318
United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
Quotient Diagnostics Limited
Investigators
Principal Investigator: Tim Bailey, MD AMCR Institute
Principal Investigator: Stephanie Svoboda, PharmD Ridgeview Research
Principal Investigator: Michael Gardner, MD University of Missouri-Columbia
  More Information

No publications provided

Responsible Party: Quotient Diagnostics Limited
ClinicalTrials.gov Identifier: NCT01829061     History of Changes
Other Study ID Numbers: QDL Clinical Studies
Study First Received: April 1, 2013
Last Updated: November 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Quotient Diagnostics Limited:
Type I Diabetes
Type II Diabetes
HbA1C

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 20, 2014