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Completed

NCT Number: NCT02910674

Dario Blood Glucose Monitoring System - Android Devices User Performance Study Report

The purpose of this study is to evaluate the accuracy of the Dario Blood Glucose Monitoring System as compared to a reference method (Yellow Springs Instrument 2300 STAT Plus) and to evaluate the usability of the device when used by laypersons.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

13 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barbara Davis Center

Aurora, Colorado, 80045, United States

About this study

The objectives for this study are to evaluate the blood glucose level results obtained from the subject's fingertip using the Dario Blood Glucose Monitoring System paired with a reference device from one of three Android smart mobile device families as compared to the results from the Yellow Springs Instrument 2300 STAT Plus. The usability of the Dario Blood Glucose Monitoring System when paired with a reference device from one of three Android smart mobile device families and used by laypersons is also evaluated.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subject has Type 1 or Type II diabetes
  • Subject speaks and reads English proficiently
  • Subject is able and agrees to sign the informed consent form (minor subjects must be accompanied by a parent or legal guardian to provide consent for their participation in the study)

Exclusion criteria

  • Subject has medical training or works in the field of blood glucose monitoring systems.
  • Subject is critically ill.
  • Subject has an impairment that prevents him/her from following the study procedures.
  • Subject has any condition that the Principal Investigator believes may interfere in the subject's participation in the study.
  • Hematocrit levels outside the range of 20%-60%.

Treatment and study plan

Dario Blood Glucose Monitoring System

Device

Accuracy with usability assessment

Primary outcomes

  1. Accuracy of Glucose Concentrations (%)

    Time frame: 1 Day

    Accuracy acceptability is defined as follows:

    Ninety-five percent (95%) of the individual glucose results shall fall within +/-15 mg/dL of the results of the Dario's measurement at glucose concentrations < 75 mg/dL and within +/- 20% at glucose concentrations greater than or equal to 75 mg/dL.

    The accuracy of the Dario Blood Glucose Monitoring System when used with Android operating system smart mobile devices was assessed against the Yellow Springs Instrument 2300 STAT Plus.

  2. Average Rank of the Indication of "How Would Rate Your Success in Operating Dario BGMS"

    Time frame: 1 Day

    Using a scale of 1-5 where 1-completely fails, 2-unsuccessful, 3-Partially successful, 4-successful, 5-very successful.

    Average rank of 3.5 ('average'/'successful') or above in question #2 - How would you rate your success in operating Dario™ BGMS?

  3. Average Rank of the Indication of "How Easy Was it to Operate the Dario™ BGMS on the First Time?"

    Time frame: 1 Day

    Using a scale of 1-5 where 1-very hard, 2-hard, 3-average, 4-easy, 5-very easy.

    An average rank of 3 ('average') or above in question #3 - How easy was it to operate the Dario™ BGMS on the first time?

  4. Percent of Participants Responding 'YES' on the Question "Did You Successfully Obtain Measurement Result Using the Dario™ BGMS?"

    Time frame: 1 Day

    The acceptance criteria for this question is: at least ninety percent (90%) need to answer 'Yes' on question #1 - Did you successfully obtain measurement result using the Dario™ BGMS?

    100% of subjects (102 of 102) answered "Yes" to this question.

Sponsors and collaborators

Lead sponsor

LabStyle Innovations Ltd.

Industry

Registry information

Official study title

Dario Blood Glucose Monitoring System - Android Devices User Performance

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Sep 22, 2016
Registry last updated
Apr 13, 2021

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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