Recruiting

Observational Study

Sponsor:

University of British Columbia

Code:

NCT01333176

Conditions

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Accepted

Interventions

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

HbA1c blood test

HbA1c finger poke test

Blood test

Blood test

Study Details

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.

Conditions

Type 2 Diabetes

Study ID

NCT01333176

Start date

Apr, 2011

Status verified date

Apr, 2012

Completion date

Dec, 2012

Anticipated

Primary completion date

Jun, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

320 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: All volunteers have HbA1c test

All candidates receive same procedure

Interventions

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?

HbA1c blood test

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

HbA1c finger poke test

All study candidates will have the same HbA1c test performed

Blood test

HbA1c blood test

Blood test

HbA1c finger poke blood test

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Keith G Dawson, MD, PhD

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

Carolyne Neufeld, BscN

604-796-2177carolyne@seabirdisland.ca

Locations

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

Keith G Dawson, MD

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

Jessica MacKenzie-Feder, MD

778-847-1466jessmackfeder@yahoo.com

More Information

Sponsor

University of British Columbia

Last update posted

Apr 25, 2012

Last verified

Apr, 2012

Keywords

  • Type 2 Diabetes
  • Hb A1c screening for diabetes in aboriginals

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2012-04-25.