Healthy.io Method Comparison & User Performance Study

Diabetes Clinical Trial

Official title:

A Comparative, Controlled Study to Evaluate the Clinical Accuracy and User Performance of the Dip Home-Based Dipstick Analyzer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02785445
• Other study ID #: CTP-Healthy.io-01/03
• Status: Completed
• Phase: N/A
• First received: May 17, 2016
• Last updated: September 7, 2017
• Start date: October 2015
• Est. completion date: September 2017

Study information

• Verified date: September 2017
• Source: Healthy.io Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 425
• Est. completion date: September 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Kidney Failure
• Renal Insufficiency
• Urinary Tract Infection
• Urinary Tract Infections

Intervention

Device:
• Dip.io Home Based Dipstick Analyzer
First intervention (assigned to the "All participants" arm).
• ACON U500 Mission® U500 Urine Analyzer
Second intervention (assigned to the "All participants" arm).

Locations

Country	Name	City	State
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	AccuMed Research Associates	Garden City	New York

Sponsors (1)

Lead Sponsor	Collaborator
Healthy.io Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exact and ±1 agreement to compared device	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).	Through study completion, an average of 1 month
Secondary	User performance	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.	Through study completion, an average of 1 month