NCT05144971

StatStrip A Glucose/Creatinine Meter System Lay User Study Evaluation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 175 (actual)
• Sponsor: Nova Biomedical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diabete Mellitus
• CKD
• ESRD

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Glucose, Creatinine	Compare diagnostic tests to reference methods

Timeline

• Start date: 2021-10-28
• Primary completion: 2021-12-03
• Completion: 2021-12-03
• First posted: 2021-12-06
• Last updated: 2022-09-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study