Clinical trial NCT02488278: GLUCOME USABILITY STUDY
Official title: GLUCOME USABILITY STUDY
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Keywords: Glucose blood measurements, glucometers ,audio communication
Lead sponsor: GlucoMe
Sponsor class: INDUSTRY
First posted: 2015-07-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility 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.

Primary outcomes:
measure: Operating the GlucoMe device: obtaining a glucose reading and recording the results
timeFrame: 1 Hour
Secondary outcomes:
measure: Time to completion of obtaining a glucose reading using the application and device
timeFrame: 1 Hour
measure: Frequency of attempts to ask for assistance during the use of the device and application
timeFrame: 1 hour
measure: Participants' level of success in completing tasks related to the use of the device and application
timeFrame: 1 hour
measure: Documenting specific user errors and inefficiencies related to the use of the device and application
timeFrame: 1 hour
Other outcomes:
Locations:
Study officials:
affiliation: A. Stein Regulatory Affairs Consulting Ltd.
name: Ahava Stein
role: STUDY_DIRECTOR
References: