Comparison Study of Lay Person Finger Stick Versus Blood Draw

NCT01913145 | Completed Phase 1 DMC

• 1 other identifier: 040412
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 2

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).

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

A1c, Self-collection, Blood sample

EXPERIMENTAL

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

Interventions

A1c, Self-collection, Blood sample DEVICE

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).

Also known as: HomeAccess A1c Kit

A1c, Self-collection, Blood sample

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Withdrawn informed consent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.

Sponsors & Collaborators

• Home Access Health Corporation: lead

Study Sites (2)

Mills-Peninsula Health Services

San Mateo, California, 94401, United States

Location

L-MARC

Louisville, Kentucky, 40213, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2013
• First Posted: July 31, 2013
• Study Start: May 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: April 21, 2014

Record last verified: 2014-04

Locations

US (2)