StatStrip A Glucose/Creatinine Meter System Lay User Study Evaluation

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.

Study Overview

• Status: Completed
• Conditions: ESRD; Diabete Mellitus; CKD
• Intervention / Treatment: Diagnostic test: Glucose, Creatinine

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 Type: Observational
• Enrollment (Actual): 175

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami Gardens, Florida, United States, 33169
      • Excellence Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Nova Biomedical
• Collaborators: Excellence Medical and Research

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2021
• Primary Completion (Actual): December 3, 2021
• Study Completion (Actual): December 3, 2021

Study Registration Dates

• First Submitted: November 22, 2021
• First Submitted That Met QC Criteria: November 22, 2021
• First Posted (Actual): December 6, 2021

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Diabetes; CKD; ESRD; POCT
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: NB21-SSA-NA-LAY-FDA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes