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| Name | Class |
|---|---|
| C-TRIC | UNKNOWN |
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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.
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.
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Fifty(50) patients with diabetes will be recruited from Diabetes Clinics, WHSCT or from patients attending primary care diabetes services.
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| Name | Affiliation | Role |
|---|---|---|
| Bogdan Milojkovic, PhD | Nova Biomedical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| C-TRIC | Londonderry | BT476SB | United Kingdom |
No plan to share IPD
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 18, 2016 | Jul 9, 2019 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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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 |