Healthy.io Method Comparison & User Performance Study

NCT ID: NCT02785445

Last Updated: 2017-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 425 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2017-09-30

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.

Conditions

Urinary Tract Infection; Kidney Failure; Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Dip.io Home Based Dipstick Analyzer

Intervention Type: DEVICE

First intervention (assigned to the "All participants" arm).

ACON U500 Mission® U500 Urine Analyzer

Intervention Type: DEVICE

Second intervention (assigned to the "All participants" arm).

Interventions

Dip.io Home Based Dipstick Analyzer

First intervention (assigned to the "All participants" arm).

Intervention Type: DEVICE

ACON U500 Mission® U500 Urine Analyzer

Second intervention (assigned to the "All participants" arm).

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Healthy.io Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Atlanta Center for Medical Research

Atlanta, Georgia, United States

AccuMed Research Associates

Garden City, New York, United States

Countries

United States

Other Identifiers

CTP-Healthy.io-01/03

Identifier Type: -

Identifier Source: org_study_id