Healthy.io Method Comparison & User Performance Study
A Comparative, Controlled Study to Evaluate the Clinical Accuracy and User Performance of the Dip Home-Based Dipstick Analyzer
1 other identifier
interventional
425
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2015
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 17, 2016
CompletedFirst Posted
Study publicly available on registry
May 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedSeptember 11, 2017
September 1, 2017
1.7 years
May 17, 2016
September 7, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Exact and ±1 agreement to compared device
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).
Through study completion, an average of 1 month
Secondary Outcomes (1)
User performance
Through study completion, an average of 1 month
Study Arms (1)
All participants (single arm)
OTHERAll study participants once enrolled into the study were asked to collect their midstream urine in the designated device urine cups. The urine sample was then tested sequentially; first by the Dip.io Home Based Dipstick Analyzer (first intervention) and by the ACON U500 Mission® U500 Urine Analyzer (comparative device - second intervention). Part of the participants (100 out of 302) were asked to perform the Dip.io urine test by themselves for the user performance evaluation.
Interventions
First intervention (assigned to the "All participants" arm).
Second intervention (assigned to the "All participants" arm).
Eligibility Criteria
You may qualify if:
- Subject is male or female, 18-80 years of age
- Subjects who are healthy or pregnant; or
- Subjects diagnosed with a disease that normally represents itself with an abnormal concentration of one of the following urine analytes; Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Leukocytes, and Nitrite (examples of such diseases include the following):
- diabetes Type I, Type II, or gestational diabetes (Type III) or,
- urinary tract infection (UTI)
- heart disease
- kidney disease
- liver disease
- pregnant women with preeclampsia, gestational diabetes or UTI
- any pathological findings which might be identified by the urine test (according to the physician discretion)
- Subject is capable and willing to provide informed consent.
- Subject has facility with both hands.
- Subject is capable and willing to adhere to the study procedures
- Subject is familiar with the use of a smartphone.
You may not qualify if:
- Subject has dementia.
- Subject has mental disorders.
- Subject is visually impaired (cannot read the user manual).
- Subject cannot collect urine in receptacle.
- Any other reason that might preclude the subject from the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Healthy.io Ltd.lead
Study Sites (2)
Atlanta Center for Medical Research
Atlanta, Georgia, 30331, United States
AccuMed Research Associates
Garden City, New York, 11530, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2016
First Posted
May 27, 2016
Study Start
October 1, 2015
Primary Completion
June 1, 2017
Study Completion
September 1, 2017
Last Updated
September 11, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will not share