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Ketostix® and Keto-Diastix® Performance Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06053593
Recruitment Status : Enrolling by invitation
First Posted : September 25, 2023
Last Update Posted : September 25, 2023
Sponsor:
Information provided by (Responsible Party):
Ascensia Diabetes Care

Study Description
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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.

Condition or disease Intervention/treatment Phase
Urinalysis Device: Testing of self collected urine Device: Labeling Evaluation Device: Urine Control testing Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Ketostix® and Keto-Diastix® Performance Study
Actual Study Start Date : July 24, 2023
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
Experimental: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Testing of self collected urine [ Time Frame: Day 1 ]
    Number of Participants with results from self collected urine that are within one color block of reference analyzer

  2. Labeling evaluation [ Time Frame: Day 1 ]
    Number of Participants with Reponses that are a 3,4, or 5 on a 5 point Likert Scale.

  3. Testing of Urine controls [ Time Frame: Day 1 ]
    Number of Participants with Reponses that read within one color block.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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, Ganstrisin, Gantanol), nitrofurantinin (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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06053593


Locations
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United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Ascensia Diabetes Care
Investigators
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Principal Investigator: Robert H Christenson, PhD University of Maryland
More Information
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Responsible Party: Ascensia Diabetes Care
ClinicalTrials.gov Identifier: NCT06053593    
Other Study ID Numbers: GCA-PRO-2022-002-01
First Posted: September 25, 2023    Key Record Dates
Last Update Posted: September 25, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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