Point of Care HbA1c as a Screening Test for Type 2 Diabetes in First Nations
Recruitment status was: Recruiting
- 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.
|Type 2 Diabetes||Procedure: Point-of-care "finger-poke" HbA1c determination. Procedure: HbA1c blood test Procedure: HbA1c finger poke test Procedure: Blood test|
|Study Design:||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|
- 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.
- 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.
- 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.
|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)|
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.
Other Name: Ames/Bayer DCA 2000 Hemoglobin A1c AssayProcedure: 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 performedProcedure: Blood test
HbA1c blood testProcedure: Blood test
HbA1c finger poke blood test
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01333176
|Contact: Keith G Dawson, MD, PhDfirstname.lastname@example.org|
|Contact: Carolyne Neufeld, BscNemail@example.com|
|Canada, British Columbia|
|Vancouver General Hospital||Recruiting|
|Vancouver, British Columbia, Canada, V5Z 1M9|
|Contact: Keith G Dawson, MD 604-351-5565 firstname.lastname@example.org|
|Contact: Jessica MacKenzie-Feder, MD 778-847-1466 email@example.com|
|Sub-Investigator: Sandra Sirrs, MD|
|Study Director:||Jessica MacKenzie-Feder, MD||University of British Columbia|
|Study Director:||Sandra Sirrs, MD||Universithy of British Columbia|