Clinical trial NCT05144971: StatStrip A Glucose/Creatinine Meter System Lay User Study Evaluation
Official title: StatStrip A Glucose/Creatinine Meter System Lay User Study Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabete Mellitus
CKD
ESRD
Keywords: Diabetes
CKD
ESRD
POCT
Lead sponsor: Nova Biomedical
Sponsor class: INDUSTRY
Collaborators: name: Excellence Medical and Research
First posted: 2021-12-06
Enrollment: 175
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 150 to a maximum of 200 individual subjects (lay users) will be enrolled.

Subjects included in the study may be healthy, diabetic or having kidney diseases. The study will be conducted at one study site.

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 glucose/creatinine levels. The screening may be done by inspecting medical records.

Brief summary: The primary objective of this study is to assess the performance of the Nova StatStrip A Glucose/Creatinine Meter System in the hands of the subject (lay user) and compare the result to an accepted Glucose/Creatinine reference method in the hands of a trained technician.

Detailed description: To assess the performance of the StatStrip A Glucose/Creatinine assay in the hands of lay users on capillary whole blood obtained by finger stick and compare with the performance characteristics to a central laboratory traceable reference method.

To assess the Ease of Use of the StatStrip Glucose / Creatinine Meter System in the hands of the intended lay users. Lay users 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 lay users other than clarifying the protocol.

Eligibility criteria: Inclusion Criteria:

* Adult subjects (≥ 18 years old) with diabetes.
* Adult subjects (≥ 18 years old) with kidney diseases (CKD, ESRD) and/or in dialysis.
* Adult subjects (≥ 18 years old) that are healthy.
* Subjects willing to complete all study procedures.
* Subjects whose pre-screen glucose or creatinine medical history is deemed of value by the study site
* Subjects able to read, write, speak in English.

Exclusion Criteria:

* 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.
* Subjects taking prescription anticoagulants (such as Warfarin or Heparin) or has clotting problems that may prolong bleeding.
* Subjects having hemophilia or any other bleeding disorder.
* Subjects having an infection with a blood borne pathogen (e.g. HIV, hepatitis).
* Subjects working for a medical device or diagnostic company.

Primary outcomes:
measure: Nova StatStrip A Glucose/Creatinine Meter System
timeFrame: 20 days
Secondary outcomes:
Other outcomes:
Locations:
city: Miami Gardens
country: United States
facility: Excellence Medical Research
state: Florida
Study officials:
References: