Self Operating of the ADI Insulin Pump By Intended Users - A Usability Study
NCT ID: NCT00592241
Last Updated: 2008-04-08
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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COMPLETED
NA
30 participants
INTERVENTIONAL
2007-11-30
2007-12-31
Brief Summary
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Insulin pumps require extensive user interaction because it is critical for treatment. Avoidance of use-related risks that could harm the patient or impact the quality of the treatment is important. Testing for ease and accuracy of use is the only way to ensure that users can safely and effectively operate, install, and program and maintain the insulin pump device.
Detailed Description
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* Validate the safe and effective use while using the ADI Insulin Pump by intended users. This objective will be assessed by carrying out list of tasks (operating the device, programming the appropriate flow rate and volume-to-be-infused parameters, and reacting to hazard massages) independently and successfully.
* Evaluate user's satisfaction. Study Design Orientation, consent, and pre-test questionnaire Participants will receive a short, scripted verbal orientation explaining the purpose of the usability test.
Prior to any study related procedures participant will provide written informed consent.
Performance evaluation The performance evaluation will consist of a list of tasks that participants will attempt to complete. The tasks were designed to explore the usability concerns. Participants will be provided with the Adi Insulin Pump and the user manual.
All participants will be guided by the investigator how to use the ADI Insulin Pump independently, how to read and interpret the display readings, how to program the device including insulin Basal and Bolus settings as well as how to maintain the device. In addition, participants will be given sufficient time to read carefully the user manual.
After ensuring that the participant has perceived the directions for use he will be asked to operate the Adi Insulin Pump by performing list of tasks.
All tasks will be conducted by the participants independently. The investigator will not guide the subject during this phase- unless the subject asked him to.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
NONE
Study Groups
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A
Subject is diagnosed as a diabetic, or subject is parent/guardian of a diabetic child age under 18 years.
"Adi" Insulin Pump Usability
no intervention
Interventions
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"Adi" Insulin Pump Usability
no intervention
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject is diagnosed as a diabetic, or subject is parent/guardian of a diabetic child age under 18 years.
* Subject understands the study procedure.
* Subject is able to read the User Manual.
* Signed Informed Consent form
* Compliance with study requirements.
Exclusion Criteria
* Concurrent additional major illness.
* Subject objects to the study protocol.
18 Years
ALL
Yes
Sponsors
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NiliMedix
INDUSTRY
Responsible Party
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NiliMedix
Principal Investigators
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Naim Shehadah, Prof.
Role: PRINCIPAL_INVESTIGATOR
RAMBAM Medical Center, Haifa Israel
Locations
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RAMBAM Medical center
Haifa, , Israel
Countries
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Other Identifiers
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NM-UA-01
Identifier Type: -
Identifier Source: org_study_id