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GLUCOME USABILITY STUDY

Primary Purpose

Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
GlucoMe Glucose Monitoring Device
Sponsored by
GlucoMe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diabetes Mellitus, Type 1 focused on measuring Glucose blood measurements, glucometers ,audio communication

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject is male or female equal to or greater than 18 years of age.
  2. Subject is a potential candidate for purchasing the GlucoMe device (e.g., subjects diagnosed with diabetes type 1 or 2).
  3. Subject has facility with both hands.
  4. Subject monitors himself.
  5. Subject knows how to download and install apps.
  6. Subject is capable of understanding and is willing to sign informed consent.

Exclusion Criteria:

  1. Subject has dementia.
  2. Subject has mental disorders.
  3. Subject was diagnosed with diabetes other than type 1 or 2 (e.g. gestational diabetes, congenital diabetes, drug induced diabetes, etc.).
  4. Subject does not monitor himself.
  5. Subject is visually impaired.
  6. Subject cannot draw blood samples from fingertip.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    No Intervention

    Arm Label

    Self-Monitoring of Glucose Blood Measurements

    Arm Description

    Self-Monitoring of Glucose Blood Measurements using the GlucoMe Glucose Monitoring Device and App

    Outcomes

    Primary Outcome Measures

    Operating the GlucoMe device: obtaining a glucose reading and recording the results
    Using the device, with or without the user manual, all 20 subjects tested were able to complete device related tasks, including starting the application, operating the GlucoMe device and obtaining a glucose reading and recording the results, in a timeframe of up to 1 hour and with minimal attempts to ask for assistance; and Using the device and the user manual. Considering that the GlucoMe is a low risk device, and the probability of an occurrence and the severity of a failure are low, a success rate of 100% potential end user subjects passing may be considered acceptable for the over the counter use of the device. Any failures to complete the device related tasks and/or self-exclude from use of the device must be explained.

    Secondary Outcome Measures

    Time to completion of obtaining a glucose reading using the application and device
    The following measurable usability criteria for specific, critical steps, based on observer evaluation or user post-test questionnaire responses, will be assessed through analysis of the data following the study: Time-to-completion of task; Time to completion of obtaining a glucose reading using the application and device will be measured by the observer for both arms and will be analysed
    Frequency of attempts to ask for assistance during the use of the device and application
    Frequency of attempts to ask for assistance will be documented by the observer for both arms and will be analysed
    Participants' level of success in completing tasks related to the use of the device and application
    Numerical ratings describing the participants' level of success in completing tasks will be collected through user post-test questionnaire responses, for both arms and will be analysed
    Documenting specific user errors and inefficiencies related to the use of the device and application
    Qualitative information regarding specific user errors and inefficiencies will be collected through observer evaluation and user post-test questionnaire responses, for both arms and will be analysed

    Full Information

    First Posted
    June 23, 2015
    Last Updated
    September 17, 2020
    Sponsor
    GlucoMe
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02488278
    Brief Title
    GLUCOME USABILITY STUDY
    Official Title
    GLUCOME USABILITY STUDY
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    July 2015 (undefined)
    Primary Completion Date
    September 2015 (Actual)
    Study Completion Date
    October 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    GlucoMe

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The GlucoMe device, in its original packaging, along with the user manual and QuickStart guide will be provided to the patient in a simulated home use environment. The patient labeling will be in the format intended for distribution. Ten (10) subjects identified as potential end users of the GlucoMe device will receive the user manual. An additional ten (10) subjects also identified as potential end users of the GlucoMe device will NOT receive the user manual. All subjects will be provided with a pre-test and post-test questionnaire and a list of tasks to complete, including applying and operating the device. The observer and user post-test questionnaire will collect information regarding device use. The device's use will be compared with identified risks to determine if the percentage of failures is within the study protocol success criteria. Additionally, measurable usability criteria for specific, critical steps will be evaluated.
    Detailed Description
    Twenty (20) subjects identified as potential end users of the device will be recruited to the study and screened according to the study inclusion and exclusion criteria. Subjects will be asked to sign informed consent. The GlucoMe device, in its original packaging, along with the user manual and QuickStart guide will be provided to the patient in a simulated home-use environment. The patient labeling will be in the format intended for distribution. Ten (10) subjects identified as potential end users of the GlucoMe device will receive the user manual and QuickStart guide. An additional ten (10) subjects also identified as potential end users of the GlucoMe device will not receive the user manual, but will receive the QuickStart guide. All subjects will be provided with a pre-test and post-test questionnaire and a list of tasks to complete, including applying and operating the device. The observer examination and user post-test questionnaire will collect information regarding device use. The device's use will be compared with identified risks to determine if the percentage of failures is within the study protocol success criteria. Additionally, measurable usability criteria for specific, critical steps will be evaluated.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
    Keywords
    Glucose blood measurements, glucometers ,audio communication

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Self-Monitoring of Glucose Blood Measurements
    Arm Type
    No Intervention
    Arm Description
    Self-Monitoring of Glucose Blood Measurements using the GlucoMe Glucose Monitoring Device and App
    Intervention Type
    Device
    Intervention Name(s)
    GlucoMe Glucose Monitoring Device
    Intervention Description
    Perform a blood glucose test using the application and device
    Primary Outcome Measure Information:
    Title
    Operating the GlucoMe device: obtaining a glucose reading and recording the results
    Description
    Using the device, with or without the user manual, all 20 subjects tested were able to complete device related tasks, including starting the application, operating the GlucoMe device and obtaining a glucose reading and recording the results, in a timeframe of up to 1 hour and with minimal attempts to ask for assistance; and Using the device and the user manual. Considering that the GlucoMe is a low risk device, and the probability of an occurrence and the severity of a failure are low, a success rate of 100% potential end user subjects passing may be considered acceptable for the over the counter use of the device. Any failures to complete the device related tasks and/or self-exclude from use of the device must be explained.
    Time Frame
    1 Hour
    Secondary Outcome Measure Information:
    Title
    Time to completion of obtaining a glucose reading using the application and device
    Description
    The following measurable usability criteria for specific, critical steps, based on observer evaluation or user post-test questionnaire responses, will be assessed through analysis of the data following the study: Time-to-completion of task; Time to completion of obtaining a glucose reading using the application and device will be measured by the observer for both arms and will be analysed
    Time Frame
    1 Hour
    Title
    Frequency of attempts to ask for assistance during the use of the device and application
    Description
    Frequency of attempts to ask for assistance will be documented by the observer for both arms and will be analysed
    Time Frame
    1 hour
    Title
    Participants' level of success in completing tasks related to the use of the device and application
    Description
    Numerical ratings describing the participants' level of success in completing tasks will be collected through user post-test questionnaire responses, for both arms and will be analysed
    Time Frame
    1 hour
    Title
    Documenting specific user errors and inefficiencies related to the use of the device and application
    Description
    Qualitative information regarding specific user errors and inefficiencies will be collected through observer evaluation and user post-test questionnaire responses, for both arms and will be analysed
    Time Frame
    1 hour

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subject is male or female equal to or greater than 18 years of age. Subject is a potential candidate for purchasing the GlucoMe device (e.g., subjects diagnosed with diabetes type 1 or 2). Subject has facility with both hands. Subject monitors himself. Subject knows how to download and install apps. Subject is capable of understanding and is willing to sign informed consent. Exclusion Criteria: Subject has dementia. Subject has mental disorders. Subject was diagnosed with diabetes other than type 1 or 2 (e.g. gestational diabetes, congenital diabetes, drug induced diabetes, etc.). Subject does not monitor himself. Subject is visually impaired. Subject cannot draw blood samples from fingertip.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ahava Stein
    Organizational Affiliation
    A. Stein Regulatory Affairs Consulting Ltd.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    GLUCOME USABILITY STUDY

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