StatStrip A Glucose/Creatinine Meter System Lay User Study Evaluation

Study Overview
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Brief Summary
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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
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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.

Official Title
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StatStrip A Glucose/Creatinine Meter System Lay User Study Evaluation

Conditions
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CKD, Diabete Mellitus, ESRD

Intervention / Treatment
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* Diagnostic Test: Glucose, Creatinine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Glucose, Creatinine|Compare diagnostic tests to reference methods|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, CKD, ESRD, POCT