Urinary Tract InfectionNCT02785445
Healthy.io Method Comparison & User Performance Study
A study testing Dip.io Home Based Dipstick Analyzer and ACON U500 Mission® U500 Urine Analyzer in people with Urinary Tract Infection and Kidney Failure, run by Healthy.io Ltd. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infection, Kidney Failure, Diabetes
- What is being tested?
- Dip.io Home Based Dipstick Analyzer and ACON U500 Mission® U500 Urine Analyzer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 425 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2015to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
AccuMed Research Associates
Garden City, New York, 11530
About this study
Official title: 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.
- Conditions
- Urinary Tract Infection, Kidney Failure, Diabetes
- Being tested
- Dip.io Home Based Dipstick Analyzer, ACON U500 Mission® U500 Urine Analyzer
- Medical subject headings
- Urinary Tract Infections, Renal Insufficiency, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dip.io Home Based Dipstick AnalyzerDevice
First intervention (assigned to the "All participants" arm).
ACON U500 Mission® U500 Urine AnalyzerDevice
Second intervention (assigned to the "All participants" arm).
| Study group | Role | What they receive |
|---|---|---|
| All participants (single arm) | Other | 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. Receives: Device: Dip.io Home Based Dipstick Analyzer; Device: ACON U500 Mission® U500 Urine Analyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Through study completion, an average of 1 month
Secondary outcomes (1)
User performance
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.
Measured: Through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study startOct 2015
- Primary completionJun 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 425 participants (actual)
Sponsor and investigators
- Lead sponsor
- Healthy.io Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02785445
- Sponsor's protocol ID
- CTP-Healthy.io-01/03
- Status last verified
- Sep 2017
- First submitted
- 17 May 2016
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative, Controlled Study to Evaluate the Clinical Accuracy and User Performance of the Dip Home-Based Dipstick Analyzer
- ClinicalTrials.gov ID
- NCT02785445
- Acronym / sponsor ID
- CTP-Healthy.io-01/03
- Conditions
- Urinary Tract Infection, Kidney Failure, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 425 participants (actual)
- Lead sponsor
- Healthy.io Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 27 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants (single arm) | Other | Device: Dip.io Home Based Dipstick Analyzer, Device: ACON U500 Mission® U500 Urine AnalyzerAll 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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):
- Subject is capable and willing to provide informed consent.
- Subject has facility with both hands.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dip.io Home Based Dipstick AnalyzerFirst intervention (assigned to the "All participants" arm). | Device | All participants (single arm) |
| ACON U500 Mission® U500 Urine AnalyzerSecond intervention (assigned to the "All participants" arm). | Device | All participants (single arm) |
Primary outcome
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).
1 secondary outcome
User performance
Time frame: Through study completion, an average of 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dip.io Home Based Dipstick Analyzer and ACON U500 Mission® U500 Urine Analyzer in people with Urinary Tract Infection and Kidney Failure, run by Healthy.io Ltd. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exact and ±1 agreement to compared device (time frame: Through study completion, an average of 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2017.