StatStrip Glucose/Ketone Meter System Ketone Evaluation

NCT05118061 | Completed FDA Device

• 1 other identifier: NB21-SSK-NA-FDA
• Study Type: observational
• Target: 173
• Locations: 2 countries
• Sites: 3

Brief 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

Diabetes Mellitus; Ketosis, Diabetic

Keywords

Ketone

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Ketone DIAGNOSTIC_TEST

compare diagnostic tests to reference methods

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adult subjects (≥ 18 years old) with diabetes or suspected ketonemia.
• Adult subjects (≥ 18 years old) that are healthy.
• Subjects willing and able to consent to participating in the study.
• Subjects whose pre-screen ketone value, if performed, is deemed valuable to the study.

You may not qualify if:

• Subjects unable to consent to participating in the study.
• 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.

Sponsors & Collaborators

• Nova Biomedical: lead
• Ocean Wellness Center: collaborator

Study Sites (3)

South Florida Research Organization

Medley, Florida, 33166, United States

Location

Technical University of Munich - Diabetes Hospital

Munich, D-80333, Germany

Location

Technical University of Munich - Emergency Reception

Munich, D-80333, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Ketoacidosis; Ketosis

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Acidosis; Acid-Base Imbalance; Diabetes Complications

Study Officials

• Jeremy Bleicher, MD

  South Florida Research Organization

  PRINCIPAL INVESTIGATOR

• Peter Luppa

  Technical University of Munich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: November 11, 2021
• Study Start: May 25, 2022
• Primary Completion: August 3, 2022
• Study Completion: August 3, 2022
• Last Updated: September 30, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); DE (2)