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

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.

Conditions

• Type 2 Diabetes

Interventions

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?

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

Sponsors & Collaborators

• Vancouver General Hospital

  collaborator OTHER

• University of British Columbia

  lead OTHER

Principal Investigators

• Jessica MacKenzie-Feder, MD · University of British Columbia

• Sandra Sirrs, MD · Universithy of British Columbia

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

14 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-04-30

Primary Completion

2012-06-30

Completion

2012-12-31

Countries

• Canada

Study Locations