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Withdrawn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
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
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.
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
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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