Study of the Analytical Performance of ALLEGRO™ Instrument

Diabetes Clinical Trial

Official title:

Study of the Analytical Performance of ALLEGRO™ Instrument: Performance Evaluation of In Vitro Diagnostic Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04035044
• Other study ID #: 225107
• Status: Completed
• Start date: June 1, 2017
• Est. completion date: June 1, 2018

Study information

• Verified date: July 2019
• Source: Nova Biomedical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 1, 2018
• Est. primary completion date: May 31, 2018
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes

Locations

Country	Name	City	State
United Kingdom	C-TRIC	Derry

Sponsors (2)

Lead Sponsor	Collaborator
Nova Biomedical	C-TRIC

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analytical verification of Allegro - HbA1c comparison	Allegro™, a point of care testing instrument is as effective as a reference laboratory method for HbA1c blood results in mmol/mol	10 minutes
Primary	Analytical verification of Allegro - Cholesterol comparison	Allegro™, a point of care testing instrument is as effective as a reference laboratory method for Cholesterol blood results in mmol/L	10 minutes
Primary	Analytical verification of Allegro - HDL comparison	Allegro™, a point of care testing instrument is as effective as a reference laboratory method for HDL blood results in mmol/L	10 minutes
Primary	Analytical verification of Allegro - Triglycerides comparison	Allegro™, a point of care testing instrument is as effective as a reference laboratory method for Triglycerides blood results in mmol/L	10 minutes
Primary	Analytical verification of Allegro - Glucose comparison	Allegro™, a point of care testing instrument is as effective as a reference laboratory method for Glucose blood results in mmol/L	10 minutes
Primary	Analytical verification of Allegro - Creatinine comparison	Allegro™, a point of care testing instrument is as effective as a reference laboratory method for Creatinine blood results in mg/dL	10 minutes
Primary	Analytical verification of Allegro - Urine creatinine comparison	Allegro™, a point of care testing instrument is as effective as a reference laboratory method for Creatinine urine results in mg/dL	10 minutes
Primary	Analytical verification of Allegro - Urine Albumin comparison	Allegro™, a point of care testing instrument is as effective as a reference laboratory method for Albumin urine results in g/L	10 minutes