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StatStrip A Glucose/Creatinine Meter System Lay User Study Evaluation 175

Completato
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La sperimentazione clinica NCT05144971 è stata uno studio osservazionale per Diabete mellito, CKD (Malattia renale cronica), IRC (Insufficienza renale cronica), attualmente completato. Avviato il 28 ottobre 2021, prevedeva di arruolare 175 partecipanti. Sotto la guida di Nova Biomedical, si è concluso il 3 dicembre 2021. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 28 settembre 2022.
Sommario breve
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.
Descrizione dettagliata
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 shee...

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Titolo ufficiale

StatStrip A Glucose/Creatinine Meter System Lay User Study Evaluation

Patologie
Diabete mellitoCKD (Malattia renale cronica)IRC (Insufficienza renale cronica)
Altri ID dello studio
  • NB21-SSA-NA-LAY-FDA
Numero NCT
NCT05144971
Data di inizio (effettiva)
2021-10-28
Ultimo aggiornamento pubblicato
2022-09-28
Data di completamento (stimata)
2021-12-03
Arruolamento (previsto)
175
Tipo di studio
Osservazionale
Stato
Completato
Parole chiave
Diabetes
CKD
ESRD
POCT
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
N.D.
Glucose, Creatinine
Compare diagnostic tests to reference methods
Esito primario
Misure di esitoDescrizione della misuraArco temporale
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
Criteri di eleggibilità

Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
Accetta volontari sani
Sì
  • 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.

  • 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.
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Excellence Medical and Research logoExcellence Medical and Research
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1 Centri dello studio in 1 paesi

Florida

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