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Trial record 33 of 633 for:    test AND point-of-care

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01333176
Recruitment Status : Unknown
Verified April 2012 by University of British Columbia.
Recruitment status was:  Recruiting
First Posted : April 11, 2011
Last Update Posted : April 25, 2012
Vancouver General Hospital
Information provided by (Responsible Party):
University of British Columbia

Brief Summary:
  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 or disease Intervention/treatment Phase
Type 2 Diabetes Procedure: Point-of-care "finger-poke" HbA1c determination. Procedure: HbA1c blood test Procedure: HbA1c finger poke test Procedure: Blood test Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2011
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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. ]
    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 :
  1. Provide estimates of prevalence of diabetes and prediabetes in a First Nation community [ Time Frame: One year ]
    To estimate the prevalence of undiagnosed diabetes mellitus and pre-diabetes in a random sample of the population from Seabird Island First Nation community.

  2. To identify the response rate of "gold standard" diabetes testing in a First nation community [ Time Frame: One Year ]
    To determine what percentage of those screened "positive" or "at risk" follow up with recommendations for formalized testing and follow up with family physician.

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01333176

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Contact: Keith G Dawson, MD, PhD 604-351-5565
Contact: Carolyne Neufeld, BscN 604-796-2177

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Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Keith G Dawson, MD    604-351-5565   
Contact: Jessica MacKenzie-Feder, MD    778-847-1466   
Sub-Investigator: Sandra Sirrs, MD         
Sponsors and Collaborators
University of British Columbia
Vancouver General Hospital
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Study Director: Jessica MacKenzie-Feder, MD University of British Columbia
Study Director: Sandra Sirrs, MD Universithy of British Columbia

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. .

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Responsible Party: University of British Columbia Identifier: NCT01333176     History of Changes
Other Study ID Numbers: H10-02551
First Posted: April 11, 2011    Key Record Dates
Last Update Posted: April 25, 2012
Last Verified: April 2012

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

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