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:

  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.

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

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Atlanta Center for Medical Research
    • New York
      • Garden City, New York, United States, 11530
        • AccuMed Research Associates

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:

  1. Subject is male or female, 18-80 years of age
  2. Subjects who are healthy or pregnant; or

  3. 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)
  4. Subject is capable and willing to provide informed consent.
  5. Subject has facility with both hands.
  6. Subject is capable and willing to adhere to the study procedures
  7. Subject is familiar with the use of a smartphone.

Exclusion Criteria:

  1. Subject has dementia.
  2. Subject has mental disorders.
  3. Subject is visually impaired (cannot read the user manual).
  4. Subject cannot collect urine in receptacle.
  5. 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.
Device: Dip.io Home Based Dipstick Analyzer
First intervention (assigned to the "All participants" arm).
Device: ACON U500 Mission® U500 Urine Analyzer
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

Healthy.io Ltd.

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.

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