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Healthy.io Method Comparison & User Performance Study | Clinical Trials | Clareo Health

COMPLETEDNA

Healthy.io Method Comparison & User Performance Study

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

NCT02785445•Healthy.io Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

ALL

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 more criteria

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.

Locations (2)

Atlanta Center for Medical Research

Atlanta, Georgia, United States

AccuMed Research Associates

Garden City, New York, United States

Key Dates

Start Date

October 1, 2015

Primary Completion Date

June 1, 2017

Completion Date

September 1, 2017

Last Updated

September 11, 2017

Enrollment

425

ACTUAL participants

Conditions

Urinary Tract InfectionKidney FailureDiabetes

Interventions

Dip.io Home Based Dipstick Analyzer

DEVICE

ACON U500 Mission® U500 Urine Analyzer

DEVICE

Genetic Studies of Insulin and Diabetes

NCT00001987

Diabetes MellitusSevere Insulin Resistance

View study

RECRUITINGNA

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 11, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Healthy.io Method Comparison & User Performance Study

Inclusion Criteria

Exclusion Criteria

Genetic Studies of Insulin and Diabetes

Feasibility of a Tailored Online Self-compassion Intervention

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