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Point of Care HbA1c as a Screening Test for Type 2 Diabetes in First Nations

This study is currently recruiting participants.
Verified April 2012 by University of British Columbia
Sponsor:
Collaborator:
Vancouver General Hospital
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01333176
First received: April 5, 2011
Last updated: April 24, 2012
Last verified: April 2012
History of Changes
  Purpose

  1. Purpose

    • to estimate the prevalence of undiagnosed diabetes mellitus and pre-diabetes in a BC First Nation community
    • to determine the utility of community based screening by examining how many positively screened people follow up with the recommended subsequent testing and family physician visit
    • to determine if point-of-care HbA1c test (Ames/Bayer DCA 2000) correlates with the confirmatory fasting and 2 hour post challenge blood glucose tests.
  2. Hypothesis The Point-of-Care test will correlate well with the gold standard diagnostic tests and prove to be a useful tool for community-based screening. This test obviates the need for fasting and repeat glucose tolerance testing.

Condition Intervention
Type 2 Diabetes
 Procedure: Point-of-care "finger-poke" HbA1c determination.
Procedure: HbA1c blood test
Procedure: HbA1c finger poke test
Procedure: Blood test

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Community-based Screening for Diabetes Using a Validated Point-of-care HbA1c Assay in a British Columbia First Nations Community

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Does the HbA1c identify the same individuals as fasting and 2-hr pc glucose tests to identify diabetes and pre-diabetes in a First Nation community [ Time Frame: One Month between individual comparative samples; One year for recruitment of all subjects. ] [ Designated as safety issue: No ]
    We will obtain A1c, fasting glucose, and 2 hour post glucose drink glucose tests in First Nation volunteers. An A1c result of 6-6.4% will be considered diagnostic of pre-diabetes, a result ≥6.5% diabetes, a fasting glucose of 6.1-6.9 mmol/L pre-diabetes, and a fasting glucose ≥7 mmol/L, diabetes. Individual A1c results will be compared to fasting and 2 hour post glucose drink results. We will determine the sensitivity and specificity of the A1c test compared to the fasting and post glucose drink glucose tests.


Secondary Outcome Measures:
  • Provide estimates of prevalence of diabetes and prediabetes in a First Nation community [ Time Frame: One year ] [ Designated as safety issue: No ]
    To estimate the prevalence of undiagnosed diabetes mellitus and pre-diabetes in a random sample of the population from Seabird Island First Nation community.

  • To identify the response rate of "gold standard" diabetes testing in a First nation community [ Time Frame: One Year ] [ Designated as safety issue: No ]
    To determine what percentage of those screened "positive" or "at risk" follow up with recommendations for formalized testing and follow up with family physician.


Estimated Enrollment: 320
Study Start Date: April 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All volunteers have HbA1c test
All candidates receive same procedure
 Procedure: Point-of-care "finger-poke" HbA1c determination.

All volunteers receive finger-poke HbA1c test. Result: If < 6: Offered a requisition to have gold standard testing for diabetes screening. If 6-6.5: Given requisition for FBG, HbA1c and OGTT. If A1c result >6.5: Counseled that they may have diabetes. Given requisition as above.

Estimates about how many have undiagnosed diabetes will be calculated.

  1. Did the clients who were counseled to do so get follow-up blood tests?
  2. Were all the formal diagnostic tests performed?
  3. Did the formal tests correlate to the POC HbA1c test or was there significant discrepancy? Thus is this new test for diagnosing diabetes confirmed as a valid test for screening in First Nation Communities in Canada?
  4. Did the family physicians find this useful?
Other Name: Ames/Bayer DCA 2000 Hemoglobin A1c Assay
Procedure: HbA1c blood test
All candidates will have a HbA1c blood test (Finger poke)
Procedure: HbA1c finger poke test
All study candidates will have the same HbA1c test performed
Procedure: Blood test
HbA1c blood test
Procedure: Blood test
HbA1c finger poke blood test

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Members of Seabird Island or surrounding communities
  • self-identified as First Nation1
  • 14 years old and older

Exclusion Criteria:

  • Known diabetes
  • age less than fourteen years old
  • pregnancy or less than six weeks post-partum
  • medications known to interfere with glucose metabolism
  • acute illness,
  • life-expectancy of less than six months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01333176

Contacts
Contact: Keith G Dawson, MD, PhD 604-351-5565 kdaw@interchange.ubc.ca
Contact: Carolyne Neufeld, BscN 604-796-2177 carolyne@seabirdisland.ca

Locations
Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Keith G Dawson, MD     604-351-5565     kdaw@interchange.ubc.ca    
Contact: Jessica MacKenzie-Feder, MD     778-847-1466     jessmackfeder@yahoo.com    
Sub-Investigator: Sandra Sirrs, MD            
Sponsors and Collaborators
University of British Columbia
Vancouver General Hospital
Investigators
Study Director: Jessica MacKenzie-Feder, MD University of British Columbia
Study Director: Sandra Sirrs, MD Universithy of British Columbia
  More Information

Publications:
Piette JD, Milton EC, Aiello AE, Mendoza-Avelares MO, Herman WH. Comparison of three methods for diabetes screening in a rural clinic in Honduras. Rev Panam Salud Publica 2010;28(1):49-57. Diagnosis and Classification of Diabetes Mellitus. Diabetes Care 2010;33(Suppl 1):S62-S69. .

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01333176     History of Changes
Other Study ID Numbers: H10-02551
Study First Received: April 5, 2011
Last Updated: April 24, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Type 2 Diabetes
Hb A1c screening for diabetes in aboriginals

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 21, 2013