Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2015-07-31
2015-10-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Self-Monitoring of Glucose Blood Measurements
Self-Monitoring of Glucose Blood Measurements using the GlucoMe Glucose Monitoring Device and App
GlucoMe Glucose Monitoring Device
Perform a blood glucose test using the application and device
Interventions
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GlucoMe Glucose Monitoring Device
Perform a blood glucose test using the application and device
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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GlucoMe
INDUSTRY
Responsible Party
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Principal Investigators
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Ahava Stein
Role: STUDY_DIRECTOR
A. Stein Regulatory Affairs Consulting Ltd.
Other Identifiers
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Clin-001-00
Identifier Type: -
Identifier Source: org_study_id
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