Evaluation of the A1CNow+ Test Kit

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier:
NCT00798486
First received: November 24, 2008
Last updated: January 26, 2012
Last verified: January 2012
  Purpose

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


Condition Intervention
Diabetes
Device: A1C Test Kit

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: In-Clinic Evaluation of the Redwood A1c Test Kit With Lay-Users and Professionals

Resource links provided by NLM:


Further study details as provided by Bayer HealthCare, Diabetes Care:

Primary Outcome Measures:
  • Number of A1C Results Either Equal To Or Within +/- 13.5% of the Laboratory Method (ACCURACY) [ Time Frame: One hour ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Average Within Subject Coefficient of Variation CV (PRECISION) [ Time Frame: One hour ] [ Designated as safety issue: No ]
    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.

  • Percentage of Subjects Who Experienced First Time Failures (FTF) During Testing [ Time Frame: One hour ] [ Designated as safety issue: No ]

    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.

  • Number of Participants Who Provided These Ratings For Overall Testing Experience With A1C Test Kit [ Time Frame: One hour ] [ Designated as safety issue: No ]
    Subjects rated features of the A1C Test Kit, including 'Overall Testing Experience'. The rating scale was 4 (Excellent) to 1 (Poor).


Enrollment: 110
Study Start Date: November 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Subjects with and without Diabetes
Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes.
Device: A1C Test Kit
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 Name: A1CNow SELFCHECK

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Adults (age 18 and older) approximately 80% being ≤55 years old
  2. 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
  3. Individuals who are interested in performing a test using the kit at home
  4. Individuals willing to complete all study procedures (including venous draw and allowing site staff to perform finger punctures)
  5. Individuals who are able to speak, read, and understand English
  6. 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:

  1. 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)
  2. Individuals with known Rheumatoid Arthritis or other condition causing significant impairment of manual dexterity
  3. Individuals with a known hemoglobin variant such as HbS or HbC
  4. Individuals with any known disorder of the blood or blood-forming organs (such as recovery from blood loss, hemolytic anemia, or iron deficiency anemia)
  5. Individuals who have received a blood transfusion within the 4 months prior to the study.
  6. Persons with known infection with a bloodborne pathogen (e.g. HIV, hepatitis)
  7. Individuals working for a competitive medical device company
  8. Individuals who have participated in previous studies on the A1CNow+ product
  9. Persons missing a digit or partial digits on the hand
  10. 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00798486

Locations
United States, California
John Muir Physician Network Clinical Research Center
Concord, California, United States, 94520
United States, New Jersey
Consumer Product Testing Co., Inc.
Fairfield, New Jersey, United States, 07004
Sponsors and Collaborators
Bayer HealthCare, Diabetes Care
Investigators
Principal Investigator: Anna Chang, MD John Muir Physician Network Clinical Research Center
Principal Investigator: Joy Frank, RN Consumer Products Testing
  More Information

No publications provided

Responsible Party: Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier: NCT00798486     History of Changes
Other Study ID Numbers: CTD-2008-14
Study First Received: November 24, 2008
Results First Received: December 3, 2009
Last Updated: January 26, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 16, 2014