Comparison Study of Lay Person Finger Stick Versus Blood Draw

Phase 1

Completed

• Conditions: Diabetes
• Interventions: Device: A1c, Self-collection, Blood sample

• Registration Number: NCT01913145
• Lead Sponsor: Home Access Health Corporation

Brief Summary

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

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 Timeline

• Study Start: 2012-05
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Study First Submitted: 2013-03-21
• Study First Submitted QC: 2013-07-29
• Study First Posted: 2013-07-31
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-18
• Last Update Posted: 2014-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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 Withdrawn informed consent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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A1c, Self-collection, Blood sample	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

Primary Outcome Measures

Name	Time	Method
Usability and HbA1c Method Comparison Study Using Lay-Person Micro-Blood Specimens	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

Trial Locations

Locations (2)

Mills-Peninsula Health Services; 🇺🇸 San Mateo, California, United States

L-MARC; 🇺🇸 Louisville, Kentucky, United States