Clinical trial NCT00798486: Evaluation of the A1CNow+ Test Kit
Official title: In-Clinic Evaluation of the Redwood A1c Test Kit With Lay-Users and Professionals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Ascensia Diabetes Care
Sponsor class: INDUSTRY
First posted: 2008-11-26
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

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 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

Primary outcomes:
measure: Number of A1C Results Either Equal To Or Within +/- 13.5% of the Laboratory Method (ACCURACY)
timeFrame: One hour
Secondary outcomes:
measure: Average Within Subject Coefficient of Variation CV (PRECISION)
timeFrame: One hour
measure: Percentage of Subjects Who Experienced First Time Failures (FTF) During Testing
timeFrame: One hour
measure: Number of Participants Who Provided These Ratings For Overall Testing Experience With A1C Test Kit
timeFrame: One hour
Other outcomes:
Locations:
city: Concord
country: United States
facility: John Muir Physician Network Clinical Research Center
state: California
city: Fairfield
country: United States
facility: Consumer Product Testing Co., Inc.
state: New Jersey
Study officials:
affiliation: John Muir Physician Network Clinical Research Center
name: Anna Chang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Consumer Products Testing
name: Joy Frank, RN
role: PRINCIPAL_INVESTIGATOR
References: