Healthy.io Method Comparison & User Performance Study
September 7, 2017 updated by: Healthy.io Ltd.
A Comparative, Controlled Study to Evaluate the Clinical Accuracy and User Performance of the Dip Home-Based Dipstick Analyzer
The objectives of the Healthy.io Method Comparison and User Performance Study are:
- To evaluate the performance of Dip.io Device in comparison to the ACON U500 Mission® U500 Urine Analyzer.
- To evaluate the user performance of Dip.io Device under actual use conditions (home environment) based on a user questionnaire and rating scale.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
425
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30331
- Atlanta Center for Medical Research
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New York
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Garden City, New York, United States, 11530
- AccuMed Research Associates
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
OTHER: All participants (single arm)
All 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.
|
First intervention (assigned to the "All participants" arm).
Second intervention (assigned to the "All participants" arm).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exact and ±1 agreement to compared device
Time Frame: Through study completion, an average of 1 month
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
User performance
Time Frame: Through study completion, an average of 1 month
|
All subjects tested should be able to complete device related tasks. The healthcare professionals also recorded their assessment of each subject's use of the new device. The subjects and healthcare inputs were recorded using study questionnaires. |
Through study completion, an average of 1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2015
Primary Completion (ACTUAL)
June 1, 2017
Study Completion (ACTUAL)
September 1, 2017
Study Registration Dates
First Submitted
May 17, 2016
First Submitted That Met QC Criteria
May 24, 2016
First Posted (ESTIMATE)
May 27, 2016
Study Record Updates
Last Update Posted (ACTUAL)
September 11, 2017
Last Update Submitted That Met QC Criteria
September 7, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTP-Healthy.io-01/03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.