Healthy.io Method Comparison & User Performance Study

Completed · Not applicable

Conditions studied: Urinary Tract Infection, Kidney Failure, Diabetes

In brief

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.

Key facts

Study ID

NCT02785445

Run by

Healthy.io Ltd.

People needed

425

Starts

2015-10-01

Expected to finish

2017-09-01

Last updated by the study team

2017-09-11

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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