Point of Care HbA1c as a Screening Test for Type 2 Diabetes in First Nations
|ClinicalTrials.gov 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
- 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.
|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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||320 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01333176
|Contact: Keith G Dawson, MD, PhDemail@example.com|
|Contact: Carolyne Neufeld, BscNfirstname.lastname@example.org|
|Canada, British Columbia|
|Vancouver General Hospital||Recruiting|
|Vancouver, British Columbia, Canada, V5Z 1M9|
|Contact: Keith G Dawson, MD 604-351-5565 email@example.com|
|Contact: Jessica MacKenzie-Feder, MD 778-847-1466 firstname.lastname@example.org|
|Sub-Investigator: Sandra Sirrs, MD|
|Study Director:||Jessica MacKenzie-Feder, MD||University of British Columbia|
|Study Director:||Sandra Sirrs, MD||Universithy of British Columbia|