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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05118061
Other study ID # NB21-SSK-NA-FDA
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 25, 2022
Est. completion date August 3, 2022

Study information

Verified date September 2022
Source Nova Biomedical
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 173
Est. completion date August 3, 2022
Est. primary completion date August 3, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Adult subjects (= 18 years old) with diabetes or suspected ketonemia. 2. Adult subjects (= 18 years old) that are healthy. 3. Subjects willing and able to consent to participating in the study. 4. Subjects whose pre-screen ketone value, if performed, is deemed valuable to the study. Exclusion Criteria: 1. Subjects unable to consent to participating in the study. 2. 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.

Study Design


Intervention

Diagnostic Test:
Ketone
compare diagnostic tests to reference methods

Locations

Country Name City State
Germany Technical University of Munich - Diabetes Hospital Munich
Germany Technical University of Munich - Emergency Reception Munich
United States South Florida Research Organization Medley Florida

Sponsors (2)

Lead Sponsor Collaborator
Nova Biomedical Ocean Wellness Center

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Analytical verification of StatStrip glucose/ketone meter system - ketone comparison StatStrip ketone meter system, a point of care testing instrument is as effective as a reference laboratory method for ketone results in mmol/L 20 days
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