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GLUCOME USABILITY STUDY

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02488278
Recruitment Status : Withdrawn
First Posted : July 2, 2015
Last Update Posted : September 22, 2020
Sponsor:
Information provided by (Responsible Party):
GlucoMe

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Device: GlucoMe Glucose Monitoring Device Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: GLUCOME USABILITY STUDY
Study Start Date : July 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
Drug Information available for: Dextrose

Arm Intervention/treatment
No Intervention: Self-Monitoring of Glucose Blood Measurements
Self-Monitoring of Glucose Blood Measurements using the GlucoMe Glucose Monitoring Device and App
Device: GlucoMe Glucose Monitoring Device
Perform a blood glucose test using the application and device




Primary Outcome Measures :
  1. Operating the GlucoMe device: obtaining a glucose reading and recording the results [ Time Frame: 1 Hour ]
    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 :
  1. Time to completion of obtaining a glucose reading using the application and device [ Time Frame: 1 Hour ]

    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


  2. Frequency of attempts to ask for assistance during the use of the device and application [ Time Frame: 1 hour ]
    Frequency of attempts to ask for assistance will be documented by the observer for both arms and will be analysed

  3. Participants' level of success in completing tasks related to the use of the device and application [ Time Frame: 1 hour ]
    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

  4. Documenting specific user errors and inefficiencies related to the use of the device and application [ Time Frame: 1 hour ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02488278


Sponsors and Collaborators
GlucoMe
Investigators
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Study Director: Ahava Stein A. Stein Regulatory Affairs Consulting Ltd.
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Responsible Party: GlucoMe
ClinicalTrials.gov Identifier: NCT02488278    
Other Study ID Numbers: Clin-001-00
First Posted: July 2, 2015    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: September 2020
Keywords provided by GlucoMe:
Glucose blood measurements, glucometers ,audio communication
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases