Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2025-12-17 @ 2:39 PM
Study NCT ID:
NCT06053593
Status:
None
Last Update Posted:
2024-03-29 00:00:00
First Post:
2023-09-19 00:00:00
Brief Title:
Ketostix® and Keto-Diastix® Performance Study
Sponsor:
Ascensia Diabetes Care
Organization:
Ascensia Diabetes Care
Study Overview
Official Title:
Ketostix® and Keto-Diastix® Performance Study
Status:
None
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
Persons with Diabetes PWDs at minimum of n120 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 3Neutral 2Disagree 3Strongly Disagree
3 Demonstrate that persons with diabetes PWDs can successfully test urinalysis control solutions
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 3Neutral 2Disagree 3Strongly Disagree
3 Demonstrate that persons with diabetes PWDs can successfully test urinalysis control solutions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None