Evaluation of the A1CNow+ Test Kit

Ascensia Diabetes Care

Status: Completed

Conditions: Diabetes

Treatments: Device: A1C Test Kit

Study type: Interventional

Funder types: Industry

Identifiers

NCT00798486

CTD-2008-14

Details and patient eligibility

About

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

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 1 patient group

Subjects with and without Diabetes

Other group

Description:

Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes.

Treatment:

Device: A1C Test Kit