StatStrip A Glucose/Creatinine Meter System Lay User Study Evaluation

Nova Biomedical

Status: Completed

Conditions: ESRD; CKD; Diabete Mellitus

Treatments: Diagnostic Test: Glucose, Creatinine

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05144971

NB21-SSA-NA-LAY-FDA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 175 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.