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-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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Ketosis, Diabetic
• Intervention / Treatment: Diagnostic test: Ketone

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.

• Study Type: Observational
• Enrollment (Actual): 173

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany, D-80333
    • Technical University of Munich - Diabetes Hospital
  • Munich, Germany, D-80333
    • Technical University of Munich - Emergency Reception
• United States
  • Florida
    • Medley, Florida, United States, 33166
      • South Florida Research Organization

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

a minimum of 360 to a maximum of 500 individual subjects will be enrolled to test both capillary and venous whole blood. Subjects included in the study may be healthy, diabetic or suspected of ketonemia. The study will be conducted in at least three (3) separate study sites, with each site targeting 120 patients up to 200 patients.

Adult subjects (≥ 18 years old) of both genders will be included in this study.

Potential subjects may be screened prior to testing to assess their baseline ketone levels. The screening may be done by inspecting medical records, fingerstick ketone testing or urine dipstick testing. Each site shall follow their own specified procedures and protocols for the screening test method, if applicable.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Nova Biomedical
• Collaborators: Ocean Wellness Center
• 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 record dates

Study Major Dates

• Study Start (Actual): May 25, 2022
• Primary Completion (Actual): August 3, 2022
• Study Completion (Actual): August 3, 2022

Study Registration Dates

• First Submitted: July 28, 2021
• First Submitted That Met QC Criteria: November 1, 2021
• First Posted (Actual): November 11, 2021

Study Record Updates

• Last Update Posted (Actual): September 30, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Ketone
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Acid-Base Imbalance; Acidosis; Ketosis; Diabetic Ketoacidosis
• Other Study ID Numbers: NB21-SSK-NA-FDA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes