Comparison Study of Lay Person Finger Stick Versus Blood Draw

NCT ID: NCT01913145

Last Updated: 2014-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2012-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

A1c, Self-collection, Blood sample

Intervention Type 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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

HomeAccess A1c Kit

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Home Access Health Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David Klonoff, MD

Role: PRINCIPAL_INVESTIGATOR

Mills-Peninsula Health Services Dorothy L. and James E. Frank Diabetes Research Institute 100 South San Mateo Drive San Mateo, California 94401

Harold E. Bayes, MD

Role: PRINCIPAL_INVESTIGATOR

L-MARC, 3288 Illinois Ave., Louisville, KY

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mills-Peninsula Health Services

San Mateo, California, United States

Site Status

L-MARC

Louisville, Kentucky, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

040412

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Glucose Monitoring Comparison in Primary Care
NCT05222815 ACTIVE_NOT_RECRUITING NA