Status:
COMPLETED
Evaluation of the Analytical Performance of ALLEGRO™ Instrument
Lead Sponsor:
Nova Biomedical
Conditions:
Diabetes Mellitus
Kidney Diseases
Eligibility:
All Genders
18+ years
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...
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...
Eligibility Criteria
Inclusion
- patients with ordered HbA1c, lipid profile, and UACr
Exclusion
- pediatric
Key Trial Info
Start Date :
March 25 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 15 2021
Estimated Enrollment :
628 Patients enrolled
Trial Details
Trial ID
NCT04096313
Start Date
March 25 2020
End Date
December 15 2021
Last Update
December 16 2021
Active Locations (3)
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1
Health Awareness, Inc
Jupiter, Florida, United States, 33458
2
South Florida Research Organization
Medley, Florida, United States, 33166
3
Health Awareness, Inc PSL
Port Saint Lucie, Florida, United States, 34952