Clinical trial NCT05118061: StatStrip Glucose/Ketone Meter System Ketone Evaluation
Official title: StatStrip Glucose/Ketone Meter System Ketone Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Ketosis, Diabetic
Keywords: Ketone
Lead sponsor: Nova Biomedical
Sponsor class: INDUSTRY
Collaborators: name: Ocean Wellness Center
First posted: 2021-11-11
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Analytical verification of StatStrip glucose/ketone meter system - ketone comparison
timeFrame: 20 days
Secondary outcomes:
Other outcomes:
Locations:
city: Medley
country: United States
facility: South Florida Research Organization
state: Florida
city: Munich
country: Germany
facility: Technical University of Munich - Diabetes Hospital
city: Munich
country: Germany
facility: Technical University of Munich - Emergency Reception
Study officials:
affiliation: South Florida Research Organization
name: Jeremy Bleicher, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Technical University of Munich
name: Peter Luppa
role: PRINCIPAL_INVESTIGATOR
References: