Evaluation of the A1CNow+ Test Kit

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00798486
• Other study ID #: CTD-2008-14
• Status: Completed
• Phase: N/A
• First received: November 24, 2008
• Last updated: January 29, 2016
• Start date: November 2008
• Est. completion date: December 2008

Study information

• Verified date: January 2016
• Source: Ascensia Diabetes Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes

Intervention

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).

Locations

Country	Name	City	State
United States	John Muir Physician Network Clinical Research Center	Concord	California
United States	Consumer Product Testing Co., Inc.	Fairfield	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Ascensia Diabetes Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No