CKD, Diabete Mellitus, ESRD
Conditions
Keywords
Diabetes, CKD, ESRD, POCT
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.
Interventions
DIAGNOSTIC_TESTGlucose, Creatinine
Compare diagnostic tests to reference methods
Sponsors
Excellence Medical and Research
Nova Biomedical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed