NCT06053593

Ketostix® and Keto-Diastix® Performance Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 126 (actual)
• Sponsor: Ascensia Diabetes Care · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinalysis

Interventions

Type	Name	Description
DEVICE	Testing of self collected urine	Each PWD will test their self-collected urine.
DEVICE	Labeling Evaluation	Each PWD will complete a labeling evaluation.
DEVICE	Urine Control testing	Each PWD will test four urine control solutions.

Timeline

• Start date: 2023-07-24
• Primary completion: 2023-11-30
• Completion: 2023-11-30
• First posted: 2023-09-25
• Last updated: 2024-03-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study