Comparison Study of Lay Person Finger Stick Versus Blood Draw

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01913145
• Other study ID #: 040412
• Status: Completed
• Phase: Phase 1
• First received: March 21, 2013
• Last updated: April 18, 2014
• Start date: May 2012
• Est. completion date: October 2012

Study information

• Verified date: April 2014
• Source: Home Access Health Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Withdrawn informed consent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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes

Intervention

Device:
• 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).

Locations

Country	Name	City	State
United States	L-MARC	Louisville	Kentucky
United States	Mills-Peninsula Health Services	San Mateo	California

Sponsors (1)

Lead Sponsor	Collaborator
Home Access Health Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No