Comparison Study of Lay Person Finger Stick Versus Blood Draw

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01913145

Enrollment

128

Registered

2013-07-31

Start date

2012-05-31

Completion date

2012-10-31

Last updated

2014-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Brief summary

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.

Interventions

DEVICEA1c, Self-collection, Blood sample

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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 Withdrawn informed consent 2.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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026