search
Back to results

Healthy.io Method Comparison & User Performance Study

Primary Purpose

Urinary Tract Infection, Kidney Failure, Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dip.io Home Based Dipstick Analyzer
ACON U500 Mission® U500 Urine Analyzer
Sponsored by
Healthy.io Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Urinary Tract Infection

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Atlanta Center for Medical Research
  • AccuMed Research Associates

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

All participants (single arm)

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

First Posted
May 17, 2016
Last Updated
September 7, 2017
Sponsor
Healthy.io Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT02785445
Brief Title
Healthy.io Method Comparison & User Performance Study
Official Title
A Comparative, Controlled Study to Evaluate the Clinical Accuracy and User Performance of the Dip Home-Based Dipstick Analyzer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Healthy.io Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection, Kidney Failure, Diabetes

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
425 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All participants (single arm)
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Dip.io Home Based Dipstick Analyzer
Intervention Description
First intervention (assigned to the "All participants" arm).
Intervention Type
Device
Intervention Name(s)
ACON U500 Mission® U500 Urine Analyzer
Intervention Description
Second intervention (assigned to the "All participants" arm).
Primary Outcome Measure Information:
Title
Exact and ±1 agreement to compared device
Description
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).
Time Frame
Through study completion, an average of 1 month
Secondary Outcome Measure Information:
Title
User performance
Description
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.
Time Frame
Through study completion, an average of 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
AccuMed Research Associates
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Healthy.io Method Comparison & User Performance Study

We'll reach out to this number within 24 hrs