Healthy.io Method Comparison & User Performance Study

Not Applicable

Completed

• Conditions: Kidney Failure; Urinary Tract Infection; Diabetes
• Interventions: Device: Dip.io Home Based Dipstick Analyzer; Device: ACON U500 Mission® U500 Urine Analyzer

• Registration Number: NCT02785445
• Lead Sponsor: Healthy.io Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2016-05-17
• Study First Submitted QC: 2016-05-24
• Study First Posted: 2016-05-27
• Primary Completion: 2017-06
• Status Verified: 2017-09
• Study Completion: 2017-09
• Last Update Submitted: 2017-09-07
• Last Update Posted: 2017-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 425

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All participants (single arm)	Dip.io Home Based Dipstick Analyzer	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.
All participants (single arm)	ACON U500 Mission® U500 Urine Analyzer	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Atlanta Center for Medical Research; 🇺🇸 Atlanta, Georgia, United States

AccuMed Research Associates; 🇺🇸 Garden City, New York, United States