Ketostix® and Keto-Diastix® Performance Study

Ascensia Diabetes Care

Status: Completed

Conditions: Urinalysis

Treatments: Device: Testing of self collected urine; Device: Labeling Evaluation; Device: Urine Control testing

Study type: Observational

Funder types: Industry

Identifiers

NCT06053593

GCA-PRO-2022-002-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

126 participants in 2 patient groups

Testing of Ketostix by Persons with Diabetes.

Description:

Each PWD will test Ketostix in their self-collected urine, complete a labeling evaluation, and test four urine control solutions.

Treatment:

Device: Labeling Evaluation

Device: Testing of self collected urine

Device: Urine Control testing

Testing of Keto-Diastix by Persons with Diabetes.

Description:

Each PWD will test Keto-Diastix in their self-collected urine, complete a labeling evaluation, and test four urine control solutions.

Treatment:

Device: Labeling Evaluation

Device: Testing of self collected urine

Device: Urine Control testing