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Completed

NCT Number: NCT02785445

Healthy.io Method Comparison & User Performance Study

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.

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Key information

Conditions

Urinary Tract Infection Diabetes Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Infections Kidney Diseases Kidney Failure Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Renal Insufficiency Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atlanta Center for Medical Research, Atlanta, Georgia, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is male or female, 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 (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)
  • 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
  • Subject is familiar with the use of a smartphone.

Exclusion criteria

  • Subject has dementia.
  • Subject has mental disorders.
  • Subject is visually impaired (cannot read the user manual).
  • Subject cannot collect urine in receptacle.
  • Any other reason that might preclude the subject from the study.

Treatment and study plan

Dip.io Home Based Dipstick Analyzer

Device

First intervention (assigned to the "All participants" arm).

ACON U500 Mission® U500 Urine Analyzer

Device

Second intervention (assigned to the "All participants" arm).

Primary outcomes

  1. Exact and ±1 agreement to compared device

    Time frame: 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 outcomes

  1. User performance

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Healthy.io Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 27, 2016
Registry last updated
Sep 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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