Comparison Study of Lay Person Finger Stick Versus Blood Draw
NCT ID: NCT01913145
Last Updated: 2014-04-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
128 participants
INTERVENTIONAL
2012-05-31
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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A1c, Self-collection, Blood sample
Can a lay-persons safely and effectively self-collect a capillary blood sample of sufficient adequacy for A1c ("HbA1c") testing in a clinical laboratory
A1c, Self-collection, Blood sample
This is a study to evaluate the safety and effectiveness of Micro-Serum/Micro-Blood (finger Stick) Specimen Collection as compared to samples obtained by standard venipuncture (blood taken from the arm vein).
Interventions
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A1c, Self-collection, Blood sample
This is a study to evaluate the safety and effectiveness of Micro-Serum/Micro-Blood (finger Stick) Specimen Collection as compared to samples obtained by standard venipuncture (blood taken from the arm vein).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Demonstrate a willingness to participate by providing a written informed consent
3. Aged between 18 to 80 years of age with no obvious signs of illness (e.g. fever, vomiting)
4. Diabetics who were diagnosed 6 months ago or longer are preferred. However, non-diabetics will be accepted into the study.
Exclusion Criteria
2. Mental or physical impairment which would preclude participation
3. Any condition which, in the opinion of the Principle Investigator or site or study coordinator, makes the participant unsuitable for this study. This includes but is not limited to any mental or physical impairment, which would preclude provision of adequate and knowledgeable consent.
18 Years
80 Years
ALL
Yes
Sponsors
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Home Access Health Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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David Klonoff, MD
Role: PRINCIPAL_INVESTIGATOR
Mills-Peninsula Health Services Dorothy L. and James E. Frank Diabetes Research Institute 100 South San Mateo Drive San Mateo, California 94401
Harold E. Bayes, MD
Role: PRINCIPAL_INVESTIGATOR
L-MARC, 3288 Illinois Ave., Louisville, KY
Locations
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Mills-Peninsula Health Services
San Mateo, California, United States
L-MARC
Louisville, Kentucky, United States
Countries
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Other Identifiers
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040412
Identifier Type: -
Identifier Source: org_study_id
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