GLUCOME USABILITY STUDY
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Primary Endpoint
- Operating the GlucoMe device: obtaining a glucose reading and recording the results
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Self-Monitoring of Glucose Blood Measurements
Self-Monitoring of Glucose Blood Measurements using the GlucoMe Glucose Monitoring Device and App
Intervention: GlucoMe Glucose Monitoring Device (Device)
Outcomes
Primary Outcomes
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 Outcomes
- Documenting specific user errors and inefficiencies related to the use of the device and application(1 hour)
- Frequency of attempts to ask for assistance during the use of the device and application(1 hour)
- Participants' level of success in completing tasks related to the use of the device and application(1 hour)
- Time to completion of obtaining a glucose reading using the application and device(1 Hour)