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

NCT01333176 | Unknown

• 1 other identifier: H10-02551
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

• 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.
• 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.

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes; Hb A1c screening for diabetes in aboriginals

Outcome Measures

Primary Outcomes (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

  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.

  One Month between individual comparative samples; One year for recruitment of all subjects.

Secondary Outcomes (2)

• Provide estimates of prevalence of diabetes and prediabetes in a First Nation community

  One year

• To identify the response rate of "gold standard" diabetes testing in a First nation community

  One Year

Study Arms (1)

All volunteers have HbA1c test

EXPERIMENTAL

All candidates receive same procedure

Procedure: Point-of-care "finger-poke" HbA1c determination.; Procedure: HbA1c blood test; Procedure: HbA1c finger poke test; Procedure: Blood test

Interventions

Point-of-care "finger-poke" HbA1c determination. PROCEDURE

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?

Also known as: Ames/Bayer DCA 2000 Hemoglobin A1c Assay

All volunteers have HbA1c test

HbA1c blood test PROCEDURE

All candidates will have a HbA1c blood test (Finger poke)

All volunteers have HbA1c test

HbA1c finger poke test PROCEDURE

All study candidates will have the same HbA1c test performed

All volunteers have HbA1c test

Blood test PROCEDURE

HbA1c blood test

All volunteers have HbA1c test

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• Vancouver General Hospital: collaborator

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

Related Publications (1)

• 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 Jul;28(1):49-57. doi: 10.1590/s1020-49892010000700008.

  PMID: 20857021 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Jessica MacKenzie-Feder, MD

  University of British Columbia

  STUDY DIRECTOR

• Sandra Sirrs, MD

  Universithy of British Columbia

  STUDY DIRECTOR

Central Study Contacts

Keith G Dawson, MD, PhD

CONTACT

604-351-5565; kdaw@interchange.ubc.ca

Carolyne Neufeld, BscN

CONTACT

604-796-2177; carolyne@seabirdisland.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2011
• First Posted: April 11, 2011
• Study Start: April 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 25, 2012

Record last verified: 2012-04

Locations

CA (1)