Comparison Study of Lay Person Finger Stick Versus Blood Draw

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Usability and HbA1c Method Comparison Study Using Lay Person Micro-Blood Specimens

Conditions
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Diabetes

Intervention / Treatment
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* Device: A1c, Self-collection, Blood sample


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Withdrawn informed consent Mental or physical impairment which would preclude participation Any condition which, in the opinion of the Principle Investigator or site or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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A1c, Self-collection, Blood sample<br>Can a lay-persons safely and effectively self-collect a capillary blood sample of sufficient adequacy for A1c (HbA1c) testing in a clinical laboratory | Device: A1c, Self-collection, Blood sample<br>* 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).<br>* Other names: HomeAccess A1c Kit;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability and HbA1c Method Comparison Study Using Lay-Person Micro-Blood Specimens | 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 | Outpoint measured within 3 months |