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Completed

NCT Number: NCT01913145

Comparison Study of Lay Person Finger Stick Versus Blood Draw

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).

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mills-Peninsula Health Services, San Mateo, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Withdrawn informed consent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.

Treatment and study plan

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).

Other names: HomeAccess A1c Kit

Primary outcomes

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Home Access Health Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 31, 2013
Registry last updated
Apr 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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