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NCT05118061 · ClinicalTrials.gov registry record
StatStrip Glucose/Ketone Meter System Ketone Evaluation
A clinical trial, sponsored by Nova Biomedical.
- Completed
- Registry status
- 173
- Enrollment target
NCT05118061: Completed study, sponsored by Nova Biomedical.
NCT05118061 is a clinical trial that has completed, run by Nova Biomedical. The registered enrollment target is 173 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05118061 has completed, sponsored by Nova Biomedical.
- COMPLETED
- Registry status
- 173 participants
- Enrollment target
Study Summary
The Nova StatStrip Glucose / Ketone Meter System is a fast, simple, whole blood system that can be used to quantify both glucose and ketones using two distinct test strips. This Protocol will describe an evaluation of the system's Ketone performance only. Ketone testing methods that quantify beta-hydroxybutyrate (β-OHB), the predominant ketone body, are used for diagnosing and monitoring ketoacidosis, a life-threatening complication of hyperglycemia. The performance of the StatStrip Ketone test strip using the Nova StatStrip Glucose / Ketone Hospital Meter System on venous and capillary whole blood will be assessed.
Primary Outcome
StatStrip ketone meter system, a point of care testing instrument is as effective as a reference laboratory method for ketone results in mmol/L
Interventions
- DIAGNOSTIC_TEST Ketone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 173 participants |
| Start Date | 2022-05-25 |
| Est. Completion | 2022-08-03 |
What the finished NCT05118061 record still lists
NCT05118061 is an observational study that tracks outcomes without assigning an intervention. The registered 173 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Ketone is the first listed.
NCT05118061 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05118061 about?
NCT05118061 is a clinical study titled "StatStrip Glucose/Ketone Meter System Ketone Evaluation". The Nova StatStrip Glucose / Ketone Meter System is a fast, simple, whole blood system that can be used to quantify both glucose and ketones using two distinct test strips. This Protocol will describe an evaluation of the system's Ketone performance only. Ketone testing methods that quantify beta-hy...
What is the current status of trial NCT05118061?
This trial is currently completed. The enrollment target is 173 participants. The study started on 2022-05-25. Estimated completion is 2022-08-03.
What interventions are being tested in trial NCT05118061?
The interventions under investigation include: Ketone (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05118061?
This trial is sponsored by Nova Biomedical, which has 5 total clinical trials registered on ClinicalTrials.gov.
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