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.
|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|
- 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%.
- 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).
|Study Start Date:||November 2008|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00798486
|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|
|Principal Investigator:||Anna Chang, MD||John Muir Physician Network Clinical Research Center|
|Principal Investigator:||Joy Frank, RN||Consumer Products Testing|