Diabetes, Kidney Failure, Urinary Tract Infection
Conditions
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.
Interventions
DEVICEDip.io Home Based Dipstick Analyzer
First intervention (assigned to the All participants arm).
DEVICEACON U500 Mission® U500 Urine Analyzer
Second intervention (assigned to the All participants arm).
Sponsors
Healthy.io Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exact and ±1 agreement to compared device | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| User performance | 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. |
Countries
United States
Outcome results
None listed