UrinalysisNCT06053593
Ketostix® and Keto-Diastix® Performance Study
An observational study of Urinalysis, run by Ascensia Diabetes Care at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinalysis
- What is being tested?
- Testing of self collected urine and Labeling Evaluation
- Type of treatment
- Medical device
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2023to 30 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Person with Diabetes.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this 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.
Read the detailed description
Persons with Diabetes (PWDs), at minimum of (n=120) will successfully collect their urine and test with two Ascensia strip products.
- 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.
- 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.
- Demonstrate that persons with diabetes (PWDs) can successfully test urinalysis control solutions.
- Conditions
- Urinalysis
- Being tested
- Testing of self collected urine, Labeling Evaluation, Urine Control testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testing of self collected urineDevice
Each PWD will test their self-collected urine.
Labeling EvaluationDevice
Each PWD will complete a labeling evaluation.
Urine Control testingDevice
Each PWD will test four urine control solutions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Testing of self collected urine; Device: Labeling Evaluation; Device: Urine Control testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Testing of self collected urine
Number of Participants with results from self collected urine that are within one color block of reference analyzer
Measured: Day 1
Labeling evaluation
Number of Participants with Responses that are a 3,4, or 5 on a 5 point Likert Scale.
Measured: Day 1
Testing of Urine controls
Number of Participants with Reponses that read within one color block.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start24 Jul 2023
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrinalysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascensia Diabetes Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert H Christenson, PhD, Principal investigator, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06053593
- Sponsor's protocol ID
- GCA-PRO-2022-002-01
- Status last verified
- Mar 2024
- First submitted
- 19 Sep 2023
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketostix® and Keto-Diastix® Performance Study
- ClinicalTrials.gov ID
- NCT06053593
- Acronym / sponsor ID
- GCA-PRO-2022-002-01
- Conditions
- Urinalysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Ascensia Diabetes CareIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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.
- Demonstrate that persons with diabetes (PWDs) can successfully test urinalysis control solutions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Testing of Ketostix by Persons with Diabetes. | – | Device: Testing of self collected urine, Device: Labeling Evaluation, Device: Urine Control testingEach PWD will test Ketostix in their self-collected urine, complete a labeling evaluation, and test four urine control solutions. |
| Testing of Keto-Diastix by Persons with Diabetes. | – | Device: Testing of self collected urine, Device: Labeling Evaluation, Device: Urine Control testingEach PWD will test Keto-Diastix in their self-collected urine, complete a labeling evaluation, and test four urine control solutions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Person with Diabetes.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testing of self collected urineEach PWD will test their self-collected urine. | Device | Testing of Keto-Diastix by Persons with Diabetes., Testing of Ketostix by Persons with Diabetes. |
| Labeling EvaluationEach PWD will complete a labeling evaluation. | Device | Testing of Keto-Diastix by Persons with Diabetes., Testing of Ketostix by Persons with Diabetes. |
| Urine Control testingEach PWD will test four urine control solutions. | Device | Testing of Keto-Diastix by Persons with Diabetes., Testing of Ketostix by Persons with Diabetes. |
Primary outcome
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
Labeling evaluation
Time frame: Day 1
Number of Participants with Responses that are a 3,4, or 5 on a 5 point Likert Scale.
Testing of Urine controls
Time frame: Day 1
Number of Participants with Reponses that read within one color block.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert H Christenson, PhD principal investigator
University of Maryland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinalysis, run by Ascensia Diabetes Care at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Testing of self collected urine (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2024.