StatStrip A Glucose/Creatinine Meter System Lay User Study Evaluation

ESRD Clinical Trial

Official title:

StatStrip A Glucose/Creatinine Meter System Lay User Study Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05144971
• Other study ID #: NB21-SSA-NA-LAY-FDA
• Status: Completed
• Start date: October 28, 2021
• Est. completion date: December 3, 2021

Study information

• Verified date: September 2022
• Source: Nova Biomedical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: December 3, 2021
• Est. primary completion date: December 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• CKD
• Diabete Mellitus
• Diabetes Mellitus
• ESRD

Intervention

Diagnostic Test:
• Glucose, Creatinine
Compare diagnostic tests to reference methods

Locations

Country	Name	City	State
United States	Excellence Medical Research	Miami Gardens	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Nova Biomedical	Excellence Medical and Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nova StatStrip A Glucose/Creatinine Meter System	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.; The two parameters for the outcome measure in this study are glucose and creatinine. The unit of measure for glucose and creatinine is mg/dL and mmol/L, respectively.	20 days