Ketostix® and Keto-Diastix® Performance Study

NCT06053593 | Completed FDA Device

• 1 other identifier: GCA-PRO-2022-002-01
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinalysis

Outcome Measures

Primary Outcomes (3)

• 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

• Labeling evaluation

  Number of Participants with Responses that are a 3,4, or 5 on a 5 point Likert Scale.

  Day 1

• Testing of Urine controls

  Number of Participants with Reponses that read within one color block.

  Day 1

Study Arms (2)

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; Device: Labeling Evaluation; Device: Urine Control testing

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; Device: Labeling Evaluation; Device: Urine Control testing

Interventions

Testing of self collected urine DEVICE

Each PWD will test their self-collected urine.

Testing of Keto-Diastix by Persons with Diabetes.; Testing of Ketostix by Persons with Diabetes.

Labeling Evaluation DEVICE

Each PWD will complete a labeling evaluation.

Testing of Keto-Diastix by Persons with Diabetes.; Testing of Ketostix by Persons with Diabetes.

Urine Control testing DEVICE

Each PWD will test four urine control solutions.

Testing of Keto-Diastix by Persons with Diabetes.; Testing of Ketostix by Persons with Diabetes.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Person with Diabetes.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ascensia Diabetes Care: lead

Study Sites (1)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Study Officials

• Robert H Christenson, PhD

  University of Maryland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: September 25, 2023
• Study Start: July 24, 2023
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)