Clinical trial NCT04035044: Study of the Analytical Performance of ALLEGRO™ Instrument
Official title: Study of the Analytical Performance of ALLEGRO™ Instrument: Performance Evaluation of In Vitro Diagnostic Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Lead sponsor: Nova Biomedical
Sponsor class: INDUSTRY
Collaborators: name: C-TRIC
First posted: 2019-07-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fifty(50) patients with diabetes will be recruited from Diabetes Clinics, WHSCT or from patients attending primary care diabetes services.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Analytical verification of Allegro - HbA1c comparison
timeFrame: 10 minutes
measure: Analytical verification of Allegro - Cholesterol comparison
timeFrame: 10 minutes
measure: Analytical verification of Allegro - HDL comparison
timeFrame: 10 minutes
measure: Analytical verification of Allegro - Triglycerides comparison
timeFrame: 10 minutes
measure: Analytical verification of Allegro - Glucose comparison
timeFrame: 10 minutes
measure: Analytical verification of Allegro - Creatinine comparison
timeFrame: 10 minutes
measure: Analytical verification of Allegro - Urine creatinine comparison
timeFrame: 10 minutes
measure: Analytical verification of Allegro - Urine Albumin comparison
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Derry
country: United Kingdom
facility: C-TRIC
Study officials:
affiliation: Nova Biomedical
name: Bogdan Milojkovic, PhD
role: STUDY_DIRECTOR
References: