Persons with Diabetes (PWDs), at minimum of (n=120) will successfully collect their urine and test with two Ascensia strip products. The products are: Ketostix and Keto-Diastix.
Persons with Diabetes (PWDs), at minimum of (n=120) will successfully collect their urine and test with two Ascensia strip products. 1. Demonstrate that untrained PWDs can successfully read the Instructions for Use and use Ketostix and Keto-Diastix reagent strips for Urinalysis with no training. Urine samples from the PWDs will be collected and then tested by the PWD and will be compared to the reference assay results. 2. Demonstrate Ease of Use by PWDs with a Labeling Evaluation Survey for Ketostix and Keto-Diastix reagent strips. Participants will respond to a survey using a 5 point Likert scale with 5= Strongly Agree, 4= Agree, 3=Neutral, 2=Disagree, 3=Strongly Disagree. 3. Demonstrate that persons with diabetes (PWDs) can successfully test urinalysis control solutions.
Study Type
OBSERVATIONAL
Enrollment
126
Each PWD will test their self-collected urine.
Each PWD will complete a labeling evaluation.
Each PWD will test four urine control solutions.
University of Maryland
Baltimore, Maryland, United States
Testing of self collected urine
Number of Participants with results from self collected urine that are within one color block of reference analyzer
Time frame: Day 1
Labeling evaluation
Number of Participants with Responses that are a 3,4, or 5 on a 5 point Likert Scale.
Time frame: Day 1
Testing of Urine controls
Number of Participants with Reponses that read within one color block.
Time frame: Day 1
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