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Ketostix® and Keto-Diastix® Performance Study

NCT06053593 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 126

Last updated 2024-03-29

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Ascensia Diabetes Care

    lead INDUSTRY

Principal Investigators

  • Robert H Christenson, PhD · University of Maryland

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-24
Primary Completion
2023-11-30
Completion
2023-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06053593 on ClinicalTrials.gov