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StatStrip Glucose/Ketone Meter System Ketone Evaluation

NCT05118061 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 173

Last updated 2022-09-30

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Ketone

compare diagnostic tests to reference methods

Sponsors & Collaborators

  • Ocean Wellness Center

    collaborator UNKNOWN

  • Nova Biomedical

    lead INDUSTRY

Principal Investigators

  • Jeremy Bleicher, MD · South Florida Research Organization

  • Peter Luppa · Technical University of Munich

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-25
Primary Completion
2022-08-03
Completion
2022-08-03
FDA Device
Yes

Countries

  • United States
  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05118061 on ClinicalTrials.gov