StatStrip Glucose/Ketone Meter System Ketone Evaluation
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
The primary objectives of this study are:
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To assess the performance of the StatStrip Ketone assay in the hands of CLIA-Waived Point-of-Care users in at least three (3) distinct Point-of-Care clinical settings on venous, and capillary blood and compare the performance characteristics to a traceable laboratory reference method.
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To assess the Ease of Use of the StatStrip Glucose / Ketone Meter System in the hands of the intended CLIA-Waived Point-of-Care users. CLIA-Waived operators will be provided with all package-insert sheets, a Quick Reference Guide and Instructions for Use (IFU) Manual. No training, coaching, or prompting will be provided to the CLIA-Waived POC Users other than clarifying the protocol.
Study Design
Outcome Measures
Primary Outcome Measures
- Analytical verification of StatStrip glucose/ketone meter system - ketone comparison [20 days]
StatStrip ketone meter system, a point of care testing instrument is as effective as a reference laboratory method for ketone results in mmol/L
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult subjects (≥ 18 years old) with diabetes or suspected ketonemia.
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Adult subjects (≥ 18 years old) that are healthy.
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Subjects willing and able to consent to participating in the study.
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Subjects whose pre-screen ketone value, if performed, is deemed valuable to the study.
Exclusion Criteria:
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Subjects unable to consent to participating in the study.
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Subjects possessing a cognitive disorder or other condition, which, in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | South Florida Research Organization | Medley | Florida | United States | 33166 |
| 2 | Technical University of Munich - Diabetes Hospital | Munich | Germany | D-80333 | |
| 3 | Technical University of Munich - Emergency Reception | Munich | Germany | D-80333 |
Sponsors and Collaborators
- Nova Biomedical
- South Florida Research Organization
- Technical University of Munich - Diabetes Hospital
- Technical University of Munich - Emergency Reception
Investigators
- Principal Investigator: Jeremy Bleicher, MD, South Florida Research Organization
- Principal Investigator: Peter Luppa, Technical University of Munich - Diabetes Hospital
- Principal Investigator: Peter Luppa, Technical University of Munich - Emergency Reception
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NB21-SSK-NA-FDA