NCT05118061

StatStrip Glucose/Ketone Meter System Ketone Evaluation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 173 (actual)
• Sponsor: Nova Biomedical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

The primary objectives of this study are: 1. 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. 2. 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.

Conditions

• Diabetes Mellitus
• Ketosis, Diabetic

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Ketone	compare diagnostic tests to reference methods

Timeline

• Start date: 2022-05-25
• Primary completion: 2022-08-03
• Completion: 2022-08-03
• First posted: 2021-11-11
• Last updated: 2022-09-30

Locations

3 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated device study