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NCT04096313 · ClinicalTrials.gov registry record
Evaluation of the Analytical Performance of ALLEGRO™ Instrument
A clinical trial of Diabetes Mellitus and Kidney Diseases, sponsored by Nova Biomedical.
- Completed
- Registry status
- 628
- Enrollment target
- 3
- Study locations
NCT04096313: Completed study of Diabetes Mellitus and Kidney Diseases, sponsored by Nova Biomedical.
NCT04096313 is a study of Diabetes Mellitus and Kidney Diseases that has completed, run by Nova Biomedical. The registered enrollment target is 628 participants, below the 1,864-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (66% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04096313, a study of Diabetes Mellitus and Kidney Diseases, has completed, sponsored by Nova Biomedical.
- COMPLETED
- Registry status
- 628 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
Allegro™, a point of care testing instrument is as effective as a reference laboratory method for HbA1c blood results in % (percentage)
Conditions Studied
Interventions
- DIAGNOSTIC_TEST HbA1c, Lipids, UACR
Study Locations (3)
Florida
- Health Awareness, Inc - Jupiter
- South Florida Research Organization - Medley
- Health Awareness, Inc PSL - Port Saint Lucie
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 628 participants |
| Start Date | 2020-03-25 |
| Est. Completion | 2021-12-15 |
What the finished NCT04096313 record still lists
NCT04096313 is an observational study that tracks outcomes without assigning an intervention. The registered 628 participants enrollment target is mid-sized for trials with a published cap, below the 1,864-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (66% lower).
The record links to 3 conditions, with Diabetes Mellitus appearing as the primary indexed condition, and to 1 intervention - of which HbA1c, Lipids, UACR is the first listed.
NCT04096313 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT04096313 about?
NCT04096313 is a clinical study titled "Evaluation of the Analytical Performance of ALLEGRO™ Instrument". 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...
What is the current status of trial NCT04096313?
This trial is currently completed. The enrollment target is 628 participants. The study started on 2020-03-25. Estimated completion is 2021-12-15.
What conditions does trial NCT04096313 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Kidney Diseases, Metabolic Disease.
What interventions are being tested in trial NCT04096313?
The interventions under investigation include: HbA1c, Lipids, UACR (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04096313?
This trial is sponsored by Nova Biomedical, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04096313 being conducted?
This trial has 3 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04096313's enrollment target sits among peer trials
628 38th of 208 higher than 171 of 208 other Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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