Evaluation of the A1CNow+ Test Kit

NCT ID: NCT00798486

Last Updated: 2016-02-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2008-12-31

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.

Conditions

Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Subjects with and without Diabetes

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

Group Type: OTHER

A1C Test Kit

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

Other Intervention Names

A1CNow SELFCHECK

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ascensia Diabetes Care

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anna Chang, MD

Role: PRINCIPAL_INVESTIGATOR

John Muir Physician Network Clinical Research Center

Joy Frank, RN

Role: PRINCIPAL_INVESTIGATOR

Consumer Products Testing

Locations

John Muir Physician Network Clinical Research Center

Concord, California, United States

Consumer Product Testing Co., Inc.

Fairfield, New Jersey, United States

Countries

United States

Other Identifiers

CTD-2008-14

Identifier Type: -

Identifier Source: org_study_id