StatStrip A Glucose/Creatinine Meter System Lay User Study Evaluation

NCT05144971 | Completed FDA Device

• 1 other identifier: NB21-SSA-NA-LAY-FDA
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabete Mellitus; CKD; ESRD

Keywords

Diabetes; CKD; ESRD; POCT

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Glucose, Creatinine DIAGNOSTIC_TEST

Compare diagnostic tests to reference methods

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nova Biomedical: lead
• Excellence Medical and Research: collaborator

Study Sites (1)

Excellence Medical Research

Miami Gardens, Florida, 33169, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 6, 2021
• Study Start: October 28, 2021
• Primary Completion: December 3, 2021
• Study Completion: December 3, 2021
• Last Updated: September 28, 2022

Record last verified: 2022-09

Locations

US (1)