Evaluation of the A1CNow+ Test Kit

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

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

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Device: A1C Test Kit

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.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Concord, California, United States, 94520
      • John Muir Physician Network Clinical Research Center
  • New Jersey
    • Fairfield, New Jersey, United States, 07004
      • Consumer Product Testing Co., Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: A1CNow SELFCHECK

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of A1C Results Either Equal To Or Within +/- 13.5% of the Laboratory Method (ACCURACY)	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%.	One hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Within Subject Coefficient of Variation CV (PRECISION)	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.	One hour
Percentage of Subjects Who Experienced First Time Failures (FTF) During Testing	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.	One hour
Number of Participants Who Provided These Ratings For Overall Testing Experience With A1C Test Kit	Subjects rated features of the A1C Test Kit, including 'Overall Testing Experience'. The rating scale was 4 (Excellent) to 1 (Poor).	One hour

Collaborators and Investigators

• Sponsor: Ascensia Diabetes Care
• Investigators: Principal Investigator: Anna Chang, MD, John Muir Physician Network Clinical Research Center; Principal Investigator: Joy Frank, RN, Consumer Products Testing

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: November 24, 2008
• First Submitted That Met QC Criteria: November 25, 2008
• First Posted (Estimate): November 26, 2008

Study Record Updates

• Last Update Posted (Estimate): February 29, 2016
• Last Update Submitted That Met QC Criteria: January 29, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: CTD-2008-14