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NCT02785445 · ClinicalTrials.gov registry record · NA
Healthy.io Method Comparison & User Performance Study
A NA study of Diabetes and Kidney Failure, sponsored by Healthy.io.
- Completed
- Registry status
- NA
- Development phase
- 425
- Enrollment target
- 2
- Study locations
NCT02785445: Completed NA study of Diabetes and Kidney Failure, sponsored by Healthy.io.
NCT02785445 is a NA study of Diabetes and Kidney Failure that has completed, run by Healthy.io. The registered enrollment target is 425 participants, below the 3,027-participant average among 338 other Diabetes trials with a reported enrollment target (86% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02785445, a NA study of Diabetes and Kidney Failure, has completed, sponsored by Healthy.io.
- COMPLETED
- Registry status
- NA
- Development phase
- 425 participants
- Enrollment target
- 2
- Study locations
Study Summary
The objectives of the Healthy.io Method Comparison and User Performance Study are: 1. To evaluate the performance of Dip.io Device in comparison to the ACON U500 Mission® U500 Urine Analyzer. 2. To evaluate the user performance of Dip.io Device under actual use conditions (home environment) based on a user questionnaire and rating scale.
Primary Outcome
The primary objective of the study is to evaluate the exact agreement and the ±1 color block match of the Dip.io compared to the predicate device, for each analyte concentration (block).
Conditions Studied
Interventions
- DEVICE Dip.io Home Based Dipstick Analyzer
- DEVICE ACON U500 Mission® U500 Urine Analyzer
Study Locations (2)
Georgia
- Atlanta Center for Medical Research - Atlanta
New York
- AccuMed Research Associates - Garden City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 425 participants |
| Start Date | 2015-10 |
| Est. Completion | 2017-09 |
| Phase | NA |
What the finished NCT02785445 record still lists
NCT02785445 is an interventional study that assigns participants to a tested intervention. The registered 425 participants enrollment target is mid-sized for trials with a published cap, below the 3,027-participant average among 338 other Diabetes trials with a reported enrollment target (86% lower).
The record links to 3 conditions, with Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Dip.io Home Based Dipstick Analyzer is the first listed.
NCT02785445 reports a single indexed study location in Georgia, New York.
Frequently Asked Questions
What is clinical trial NCT02785445 about?
NCT02785445 is a clinical study titled "Healthy.io Method Comparison & User Performance Study". The objectives of the Healthy.io Method Comparison and User Performance Study are: 1. To evaluate the performance of Dip.io Device in comparison to the ACON U500 Mission® U500 Urine Analyzer. 2. To evaluate the user performance of Dip.io Device under actual use conditions (home environment) based o...
What is the current status of trial NCT02785445?
This trial is currently completed. It is a NA study. The enrollment target is 425 participants. The study started on 2015-10. Estimated completion is 2017-09.
What conditions does trial NCT02785445 study?
This clinical trial studies the following conditions: Diabetes, Kidney Failure, Urinary Tract Infection.
What interventions are being tested in trial NCT02785445?
The interventions under investigation include: Dip.io Home Based Dipstick Analyzer (DEVICE), ACON U500 Mission® U500 Urine Analyzer (DEVICE).
Who is sponsoring clinical trial NCT02785445?
This trial is sponsored by Healthy.io, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02785445 being conducted?
This trial has 2 study locations across Georgia, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes
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 NCT02785445's enrollment target sits among peer trials
425 81st of 338 higher than 257 of 338 other Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes 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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