Healthy.io Method Comparison & User Performance Study

Healthy.io

Status: Completed

Conditions: Kidney Failure; Diabetes; Urinary Tract Infection

Treatments: Device: ACON U500 Mission® U500 Urine Analyzer; Device: Dip.io Home Based Dipstick Analyzer

Study type: Interventional

Funder types: Industry

Identifiers

NCT02785445

CTP-Healthy.io-01/03

Details and patient eligibility

About

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.

Enrollment: 425 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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425 participants in 1 patient group

All participants (single arm)

Other group

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.

Treatment:

Device: ACON U500 Mission® U500 Urine Analyzer

Device: Dip.io Home Based Dipstick Analyzer