Comparison Study of Lay Person Finger Stick Versus Blood Draw

Home Access Health

Status and phase: Completed; Phase 1

Conditions: Diabetes

Treatments: Device: A1c, Self-collection, Blood sample

Study type: Interventional

Funder types: Industry

Identifiers

NCT01913145

040412

Details and patient eligibility

About

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).

Full 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.

Enrollment: 128 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Ability to understand and follow verbal and written instructions in English
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

1. Withdrawn informed consent
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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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128 participants in 1 patient group

A1c, Self-collection, Blood sample

Experimental group

Description:

Can a lay-persons safely and effectively self-collect a capillary blood sample of sufficient adequacy for A1c ("HbA1c") testing in a clinical laboratory

Treatment:

Device: A1c, Self-collection, Blood sample