Diabetes Mellitus, Kidney Diseases, Metabolic Disease
Conditions
Keywords
HbA1c, Lipids, UACR
Brief summary
To assess the performance of the Allegro in the hands of CLIA-Waived Point-of-Care users in at least three distinct Point-of-Care clinical settings and compare the performance characteristics to other accepted Point-of-Care methods and central laboratory reference methods. To assess the Ease of Use of the Allegro in the hands of the intended CLIA-Waived Point-of-Care users. CLIA-Waived operators will be provided with all package insert sheets, a Quick Reference Guide poster and Instructions for Use. No training, coaching, or prompting will be provided other than clarifying the protocol.
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 analyzer 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™ analyzer compared to laboratory analyses on capillary and venous whole blood samples and urine samples. Three hundred sixty (360) 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.
Interventions
DIAGNOSTIC_TESTHbA1c, Lipids, UACR
compare diagnostic tests to reference methods
Sponsors
Nova Biomedical
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* patients with ordered HbA1c, lipid profile, and UACr
Exclusion criteria
* pediatric
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analytical verification of Allegro - HbA1c comparison | 10 minutes | Allegro™, a point of care testing instrument is as effective as a reference laboratory method for HbA1c blood results in % (percentage) |
| Analytical verification of Allegro - Cholesterol comparison | 10 minutes | Allegro™, a point of care testing instrument is as effective as a reference laboratory method for Cholesterol blood results in mg/dL |
| Analytical verification of Allegro - HDL comparison | 10 minutes | Allegro™, a point of care testing instrument is as effective as a reference laboratory method for HDL Cholesterol blood results in mg/dL |
| Analytical verification of Allegro - Triglycerides comparison | 10 minutes | Allegro™, a point of care testing instrument is as effective as a reference laboratory method for Triglycerides blood results in mg/dL |
| Analytical verification of Allegro - Urine creatinine comparison | 10 minutes | Allegro™, a point of care testing instrument is as effective as a reference laboratory method for Creatinine urine results in mg/dL |
| Analytical verification of Allegro - Urine Albumin comparison | 10 minutes | Allegro™, a point of care testing instrument is as effective as a reference laboratory method for Albumin urine results in g/L |
Countries
United States
Outcome results
None listed