- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01913145
Comparison Study of Lay Person Finger Stick Versus Blood Draw
April 18, 2014 updated by: Home Access Health Corporation
Usability and HbA1c Method Comparison Study Using Lay Person Micro-Blood Specimens
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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).
The information and data obtained will be used to finish development of a convenience kit that allows doctors to provide their patients a method to have their blood tested for clinical laboratory tests in the convenience of their home without having to visit the doctor's office or clinic.
Study Type
Interventional
Enrollment (Actual)
128
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Mateo, California, United States, 94401
- Mills-Peninsula Health Services
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Kentucky
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Louisville, Kentucky, United States, 40213
- L-MARC
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Ability to understand and follow verbal and written instructions in English
- Demonstrate a willingness to participate by providing a written informed consent
- Aged between 18 to 80 years of age with no obvious signs of illness (e.g. fever, vomiting)
- Diabetics who were diagnosed 6 months ago or longer are preferred. However, non-diabetics will be accepted into the study.
Exclusion Criteria:
- Withdrawn informed consent
- Mental or physical impairment which would preclude participation
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Usability and HbA1c Method Comparison Study Using Lay-Person Micro-Blood Specimens
Time Frame: Outpoint measured within 3 months
|
To establish that when using capillary blood collected in the Home Access Collection Cassette, lay-users can obtain HbA1c results equivalent to results from professionally-collected samples
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Outpoint measured within 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David Klonoff, MD, Mills-Peninsula Health Services Dorothy L. and James E. Frank Diabetes Research Institute 100 South San Mateo Drive San Mateo, California 94401
- Principal Investigator: Harold E. Bayes, MD, L-MARC, 3288 Illinois Ave., Louisville, KY
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (Actual)
October 1, 2012
Study Completion (Actual)
October 1, 2012
Study Registration Dates
First Submitted
March 21, 2013
First Submitted That Met QC Criteria
July 29, 2013
First Posted (Estimate)
July 31, 2013
Study Record Updates
Last Update Posted (Estimate)
April 21, 2014
Last Update Submitted That Met QC Criteria
April 18, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- 040412
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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