StatStrip Glucose/Ketone Meter System Ketone Evaluation

Diabetes Mellitus Clinical Trial

Official title:

StatStrip Glucose/Ketone Meter System Ketone Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05118061
• Other study ID #: NB21-SSK-NA-FDA
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Ketoacidosis
• Ketosis, Diabetic

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