Diabetes Mellitus Clinical Trial
Official title:
Self Operating of the ADI Insulin Pump By Intended Users - A Usability Study
Diabetes mellitus (DM) is a multisystem disease with both biochemical and anatomical
consequences. Insulin pump therapy (continuous subcutaneous insulin infusion [CSII]) is an
attractive way of treating patients with diabetes. The NiliMedix ADI Insulin Pump is an
ambulatory, battery operated, rate programmable micro infusion pump, designed for continuous
delivery of insulin.
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.
This usability study was designed in order to test independent home use and device interface
effectiveness of the NiliMedix Adi Insulin Pump, in order to validate safe and effective use
by intended users. The study objectives are as following:
- 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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
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