Status:
COMPLETED
Ketostix® and Keto-Diastix® Performance Study
Lead Sponsor:
Ascensia Diabetes Care
Conditions:
Urinalysis
Eligibility:
All Genders
18+ years
Brief Summary
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
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 Instr...
Eligibility Criteria
Inclusion
- 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
- 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, Gantrisin, Gantanol), nitrofurantoin (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).
Key Trial Info
Start Date :
July 24 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 30 2023
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT06053593
Start Date
July 24 2023
End Date
November 30 2023
Last Update
March 29 2024
Active Locations (1)
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1
University of Maryland
Baltimore, Maryland, United States, 21201