Ketostix® and Keto-Diastix® Performance Study

Urinalysis Clinical Trial

Official title:

Ketostix® and Keto-Diastix® Performance Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06053593
• Other study ID #: GCA-PRO-2022-002-01
• Status: Completed
• Start date: July 24, 2023
• Est. completion date: November 30, 2023

Study information

• Verified date: March 2024
• Source: Ascensia Diabetes Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Urinalysis

Intervention

Device:
• Testing of self collected urine
Each PWD will test their self-collected urine.
• Labeling Evaluation
Each PWD will complete a labeling evaluation.
• Urine Control testing
Each PWD will test four urine control solutions.

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Ascensia Diabetes Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Labeling evaluation	Number of Participants with Responses that are a 3,4, or 5 on a 5 point Likert Scale.	Day 1
Primary	Testing of Urine controls	Number of Participants with Reponses that read within one color block.	Day 1