Study of the Analytical Performance of ALLEGRO™ Instrument
Study of the Analytical Performance of ALLEGRO™ Instrument: Performance Evaluation of In Vitro Diagnostic Device
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Blood and urine tests are used in the assessment of diabetes and to guide clinical management. In the traditional model of care, blood samples are taken from patients at the clinic and are sent to the laboratory for analysis and the results may not be available for a number of hours/days after the clinic visit.
A new analyser has been developed (Allegro™) which allows the tests to be undertaken at the clinic, with the results available in a few minutes. This means that patients can get immediate feedback and that the doctors/nurses can adjust treatment before the patient leaves the clinic. It is obviously important that this analyser performs to a similar degree of accuracy to the laboratory analyses.
The aim of this research study is to assess the accuracy of the Allegro™ analyser compared to laboratory analyses on finger prick capillary blood samples and urine samples. Fifty (50) patients with diabetes will be invited to give a venous blood sample, finger prick capillary blood sample and urine sample. The venous blood sample, finger prick capillary blood sample and urine sample will be analysed by both the Allegro™ analyser and laboratory analyses and the results compared. The Allegro™ results will not be used in the management of the patients' diabetes.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Derry, Storbritannia, BT476SB
- C-TRIC
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Diabetes patients attending Altnagelvin Area Hospital Clinics or primary care in Western Trust area aged 18-80 years of age
Exclusion Criteria:
- Patients who are less than 18 years or over 80 years of age
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Analytisk verifisering av Allegro - Urin kreatinin sammenligning
Tidsramme: 10 minutter
|
Allegro™, et testinstrument for behandlingspunkt er like effektivt som en referanselaboratoriemetode for kreatinin-urinresultater i mg/dL
|
10 minutter
|
|
Analytisk verifisering av Allegro - Urin Albumin sammenligning
Tidsramme: 10 minutter
|
Allegro™, et testinstrument for behandlingspunkt er like effektivt som en referanselaboratoriemetode for albuminurinresultater i g/L
|
10 minutter
|
|
Analytical verification of Allegro - HbA1c comparison
Tidsramme: 10 minutes
|
Allegro™, a point of care testing instrument is as effective as a reference laboratory method for HbA1c blood results in mmol/mol
|
10 minutes
|
|
Analytical verification of Allegro - Cholesterol comparison
Tidsramme: 10 minutes
|
Allegro™, a point of care testing instrument is as effective as a reference laboratory method for Cholesterol blood results in mmol/L
|
10 minutes
|
|
Analytical verification of Allegro - HDL comparison
Tidsramme: 10 minutes
|
Allegro™, a point of care testing instrument is as effective as a reference laboratory method for HDL blood results in mmol/L
|
10 minutes
|
|
Analytical verification of Allegro - Triglycerides comparison
Tidsramme: 10 minutes
|
Allegro™, a point of care testing instrument is as effective as a reference laboratory method for Triglycerides blood results in mmol/L
|
10 minutes
|
|
Analytical verification of Allegro - Glucose comparison
Tidsramme: 10 minutes
|
Allegro™, a point of care testing instrument is as effective as a reference laboratory method for Glucose blood results in mmol/L
|
10 minutes
|
|
Analytical verification of Allegro - Creatinine comparison
Tidsramme: 10 minutes
|
Allegro™, a point of care testing instrument is as effective as a reference laboratory method for Creatinine blood results in mg/dL
|
10 minutes
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Bogdan Milojkovic, PhD, Nova Biomedical
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 225107
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
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