Clinical trial NCT06053593: Ketostix® and Keto-Diastix® Performance Study
Official title: Ketostix® and Keto-Diastix® Performance Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinalysis
Lead sponsor: Ascensia Diabetes Care
Sponsor class: INDUSTRY
First posted: 2023-09-25
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Person with Diabetes.

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 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.

Eligibility criteria: 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, 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).

Primary outcomes:
measure: Testing of self collected urine
timeFrame: Day 1
measure: Labeling evaluation
timeFrame: Day 1
measure: Testing of Urine controls
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
Study officials:
affiliation: University of Maryland
name: Robert H Christenson, PhD
role: PRINCIPAL_INVESTIGATOR
References: