Status:
COMPLETED
Evaluation of the A1CNow+ Test Kit
Lead Sponsor:
Ascensia Diabetes Care
Conditions:
Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
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 acc...
Eligibility Criteria
Inclusion
- Adults (age 18 and older) approximately 80% being ≤55 years old
- 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
- Individuals who are interested in performing a test using the kit at home
- Individuals willing to complete all study procedures (including venous draw and allowing site staff to perform finger punctures)
- Individuals who are able to speak, read, and understand English
- 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
- 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)
- Individuals with known Rheumatoid Arthritis or other condition causing significant impairment of manual dexterity
- Individuals with a known hemoglobin variant such as HbS or HbC
- Individuals with any known disorder of the blood or blood-forming organs (such as recovery from blood loss, hemolytic anemia, or iron deficiency anemia)
- Individuals who have received a blood transfusion within the 4 months prior to the study.
- Persons with known infection with a bloodborne pathogen (e.g. HIV, hepatitis)
- Individuals working for a competitive medical device company
- Individuals who have participated in previous studies on the A1CNow+ product
- Persons missing a digit or partial digits on the hand
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00798486
Start Date
November 1 2008
End Date
December 1 2008
Last Update
February 29 2016
Active Locations (2)
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1
John Muir Physician Network Clinical Research Center
Concord, California, United States, 94520
2
Consumer Product Testing Co., Inc.
Fairfield, New Jersey, United States, 07004