Ketostix® and Keto-Diastix® Performance Study

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.

Study Overview

• Status: Completed
• Conditions: Urinalysis
• Intervention / Treatment: Device: Testing of self collected urine; Device: Labeling Evaluation; Device: Urine Control testing

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.

• Study Type: Observational
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Person with Diabetes.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Testing of Ketostix by Persons with Diabetes.; Each PWD will test Ketostix in their self-collected urine, complete a labeling evaluation, and test four urine control solutions.	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.
Testing of Keto-Diastix by Persons with Diabetes.; Each PWD will test Keto-Diastix in their self-collected urine, complete a labeling evaluation, and test four urine control solutions.	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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ascensia Diabetes Care
• Investigators: Principal Investigator: Robert H Christenson, PhD, University of Maryland

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2023
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: September 19, 2023
• First Submitted That Met QC Criteria: September 23, 2023
• First Posted (Actual): September 25, 2023

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: GCA-PRO-2022-002-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes