Study of the Analytical Performance of ALLEGRO™ Instrument

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |