Ketostix® and Keto-Diastix® Performance Study

Study Overview
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Brief Summary
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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.

Detailed Description
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Persons with Diabetes (PWDs), at minimum of (n=120) will successfully collect their urine and test with two Ascensia strip products. 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. 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. Demonstrate that persons with diabetes (PWDs) can successfully test urinalysis control solutions.

Official Title
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Ketostix® and Keto-Diastix® Performance Study

Conditions
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Urinalysis

Intervention / Treatment
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* Device: Testing of self collected urine
* Device: Labeling Evaluation
* Device: Urine Control testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females over 18 years of age. Diagnosed with Diabetes Mellitus (Type 1 or Type 2) Able to speak, read and understand English (subjects must demonstrate ability to read a paragraph from the first page of the package insert to qualify for the study). Willing to complete all study procedures. Exclusion Criteria: Physical, visual, or neurological impairments that would make the person unable to perform urine collection and testing with the urine strips as determined by the PI. Intake of Vitamin C supplements (multi-vitamins are permitted) Prior experience testing glucose or ketones in urine with Ketostix and Keto-Diastix Reagent strips. Currently taking compounds such as mesna (Mesnex) Currently taking any medications containing azo dyes (e.g., Pyridium, Ganstrisin, Gantanol), nitrofurantinin (Macrodantin, Furadantin). Currently taking medications such as levodopa. Working for a medical laboratory, hospital or other clinical setting that involves training in the urinalysis lab or use of urinalysis test strips. Working for a competitive medical device company (Urine Strip manufacturer) or having an immediate family member or living with someone who works for such a company. A condition, which in the opinion of the investigator or designee, would put the person or study conduct at risk (reason for exclusion will be clearly documented by investigator or designee on the study form).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Testing of Ketostix by Persons with Diabetes.<br>Each PWD will test Ketostix in their self-collected urine, complete a labeling evaluation, and test four urine control solutions. | Device: Testing of self collected urine<br>* Each PWD will test their self-collected urine.<br>Device: Labeling Evaluation<br>* Each PWD will complete a labeling evaluation.<br>Device: Urine Control testing<br>* Each PWD will test four urine control solutions.<br>|
| Experimental: Testing of Keto-Diastix by Persons with Diabetes.<br>Each PWD will test Keto-Diastix in their self-collected urine, complete a labeling evaluation, and test four urine control solutions. | Device: Testing of self collected urine<br>* Each PWD will test their self-collected urine.<br>Device: Labeling Evaluation<br>* Each PWD will complete a labeling evaluation.<br>Device: Urine Control testing<br>* Each PWD will test four urine control solutions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Testing of self collected urine | Number of Participants with results from self collected urine that are within one color block of reference analyzer | Day 1 | 
| Labeling evaluation | Number of Participants with Reponses that are a 3,4, or 5 on a 5 point Likert Scale. | Day 1 | 
| Testing of Urine controls | Number of Participants with Reponses that read within one color block. | Day 1 |