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Completed

NCT Number: NCT00798486

Evaluation of the A1CNow+ Test Kit

The purpose of this study was to assure that consumers can successfully use the new version of A1CNow+ along with revised instructional materials.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

John Muir Physician Network Clinical Research Center, Concord, California, United States

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About this study

The purpose of this study was to assure that consumers could successfully use the new version of A1CNow+ Test Kit along with revised instructional materials. The primary objective was to establish accuracy and secondary objectives were to establish precision, comprehension of instructional materials, and user feedback about the overall testing experience.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adults (age 18 and older) approximately 80% being ≤55 years old
  • Persons with:
  • known diabetes (type 1 or type 2) and pre-diabetes - approximately 85% of subject population per site
  • no known diagnosis of diabetes - approximately 15% of subject population per site
  • Individuals who are interested in performing a test using the kit at home
  • Individuals willing to complete all study procedures (including venous draw and allowing site staff to perform finger punctures)
  • Individuals who are able to speak, read, and understand English
  • Individuals able to read out loud the first 5 lines of the A1C Test Kit instructional materials to demonstrate ability to read the print (may use glasses, if needed)

Exclusion criteria

  • Individuals taking prescription anticoagulants (such as Warfarin or heparin) or have clotting problems that may prolong bleeding. (Taking Plavix or aspirin daily is not excluded)
  • Individuals with known Rheumatoid Arthritis or other condition causing significant impairment of manual dexterity
  • Individuals with a known hemoglobin variant such as HbS or HbC
  • Individuals with any known disorder of the blood or blood-forming organs (such as recovery from blood loss, hemolytic anemia, or iron deficiency anemia)
  • Individuals who have received a blood transfusion within the 4 months prior to the study.
  • Persons with known infection with a bloodborne pathogen (e.g. HIV, hepatitis)
  • Individuals working for a competitive medical device company
  • Individuals who have participated in previous studies on the A1CNow+ product
  • Persons missing a digit or partial digits on the hand
  • Individuals with the following impairments which, in the opinion of the investigator, would seriously compromise the integrity of the study:
  • Significant visual impairment
  • Significant hearing impairment
  • Cognitive disorder
  • Any other condition as per investigator's discretion

Treatment and study plan

A1C Test Kit

Device

Subjects tested 3 times with A1C test kits. Two tests were performed by the subject and the third test was performed by a healthcare professional (HCP). All results were compared to results from a laboratory glucose analyzer (TOSOH).

Other names: A1CNow SELFCHECK

Primary outcomes

  1. Number of A1C Results Either Equal To Or Within +/- 13.5% of the Laboratory Method (ACCURACY)

    Time frame: One hour

    This outcome measure reports the number of A1c test results for which the percent difference (absolute value) between results from the subject meter and the laboratory method was less than or equal to 13.5%.

Secondary outcomes

  1. Average Within Subject Coefficient of Variation CV (PRECISION)

    Time frame: One hour

    The average Coefficient of Variation (CV) was computed by calculating the square of the CV for each pair of A1c self-test results, averaging this square value over the number of subjects included in the analysis, and then taking the square root.

  2. Percentage of Subjects Who Experienced First Time Failures (FTF) During Testing

    Time frame: One hour

    For the comprehension analysis, subjects were divided into 2 groups. One group (n=56 subjects) was given both written (Quick Reference Guide) and DVD instruction material. The other group (n=54 subjects) was given only written instruction material. First time failure (FTF) was defined as:

    • The subject could not use the product without HCP assistance.
    • The subject could not complete the test. User error rendered one or more parts unusable.
    • The subject completed the test after one or more mistakes; the result was an error code instead of a numerical value.

  3. Number of Participants Who Provided These Ratings For Overall Testing Experience With A1C Test Kit

    Time frame: One hour

    Subjects rated features of the A1C Test Kit, including 'Overall Testing Experience'. The rating scale was 4 (Excellent) to 1 (Poor).

Sponsors and collaborators

Lead sponsor

Ascensia Diabetes Care

Industry

Registry information

Official study title

In-Clinic Evaluation of the Redwood A1c Test Kit With Lay-Users and Professionals

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Nov 26, 2008
Registry last updated
Feb 29, 2016

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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