Evaluation of the Analytical Performance of ALLEGRO™ Instrument
NCT ID: NCT04096313
Last Updated: 2021-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
628 participants
OBSERVATIONAL
2020-03-25
2021-12-15
Brief Summary
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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
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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 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.
Conditions
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Keywords
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Study Design
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COHORT
OTHER
Interventions
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HbA1c, Lipids, UACR
compare diagnostic tests to reference methods
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Nova Biomedical
INDUSTRY
Responsible Party
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Principal Investigators
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Ronald Surowitz
Role: PRINCIPAL_INVESTIGATOR
Health Awareness, Inc
Allison Blomer, MA, MD
Role: PRINCIPAL_INVESTIGATOR
Health Awareness, Inc PSL
Jeremy Bleicher
Role: PRINCIPAL_INVESTIGATOR
South Florida Research Organization
Locations
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Health Awareness, Inc
Jupiter, Florida, United States
South Florida Research Organization
Medley, Florida, United States
Health Awareness, Inc PSL
Port Saint Lucie, Florida, United States
Countries
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Other Identifiers
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NB19-ALL-NA-FDA
Identifier Type: -
Identifier Source: org_study_id