StatStrip A Glucose/Creatinine Meter System Lay User Study Evaluation

Completed

• Conditions: CKD; ESRD; Diabete Mellitus

• Registration Number: NCT05144971
• Lead Sponsor: Nova Biomedical

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.

Study Timeline

• Study Start: 2021-10-28
• Study First Submitted: 2021-11-22
• Study First Submitted QC: 2021-11-22
• Primary Completion: 2021-12-03
• Study Completion: 2021-12-03
• Study First Posted: 2021-12-06
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-27
• Last Update Posted: 2022-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Nova StatStrip A Glucose/Creatinine Meter System	20 days	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.

Trial Locations

Locations (1)

Excellence Medical Research; 🇺🇸 Miami Gardens, Florida, United States