Dip Home-Based Dipstick Analyzer Performance Evaluation

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

The Dip Home-Based Dipstick Analyzer (henceforth HBDA) is composed of a kit and a smartphone application. The device will be provided to the subject in a simulated home-use environment. All subjects will be asked to complete the urine test by following the application guidance, including providing a urine sample and scanning the urine strip after placing it on the Color-Board. The user will also complete a questionnaire to collect information regarding the use of the HBDA device. Following the usability test performed by the lay user, the subject's urine sample will be tested by the professional user using the comparator device. The use of the HBDA device will be evaluated for accuracy and identified risks. Additionally, measurable usability criteria for specific, critical steps will be evaluated.

Study Overview

• Status: Completed
• Conditions: Urine Detectable Acute and Chronic Diseases
• Intervention / Treatment: Device: Experimental: Dip Home-Based Dipstick Analyzer

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Atlanta Center for Medical Research
  • Massachusetts
    • Methuen, Massachusetts, United States, 01844
      • ActivMed Practices & Research, Inc.
  • New York
    • Garden City, New York, United States, 11530
      • AccuMed Research Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men and women 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Dip Home-Based Dipstick Analyzer; The Dip Home-Based Dipstick Analyzer is a prescription, in-vitro diagnostic, home use device, which qualitatively and semi-quantitatively measures 10 urine analytes. The device combines a urine stick kit with an easy to use smartphone application using an image recognition algorithm. Results of the experimental HBDA device will be compared to the results of the predicate device tested by a professional user

Device: Experimental: Dip Home-Based Dipstick Analyzer; Dip Home-Based Dipstick Analyzer The Dip Home-Based Dipstick Analyzer is a prescription, in-vitro diagnostic, home use device, which qualitatively and semi-quantitatively measures 10 urine analytes. The device combines a urine stick kit with an easy to use smartphone application using an image recognition algorithm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of the % agreement of the Dip HBDA, tested by the lay user, as compared to a comparator device, tested by a professional user.	11 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluation of the Dip HBDA usability success rate, by potential lay users under actual use conditions	11 months

Collaborators and Investigators

• Sponsor: Healthy.io Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2018
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: July 1, 2020
• First Submitted That Met QC Criteria: July 7, 2020
• First Posted (Actual): July 10, 2020

Study Record Updates

• Last Update Posted (Actual): July 10, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: Protocol CTP-Healthy.io-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes