Evaluation of the A1CNow+ Test Kit

Completed · Not applicable

Conditions studied: Diabetes

In brief

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

Key facts

Study ID

NCT00798486

Run by

Ascensia Diabetes Care

People needed

110

Starts

2008-11-01

Expected to finish

2008-12-01

Last updated by the study team

2016-02-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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