Self Operating of the ADI Insulin Pump By Intended Users - A Usability Study
1 other identifier
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus
Started Nov 2007
Shorter than P25 for not_applicable diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 17, 2007
CompletedFirst Posted
Study publicly available on registry
January 14, 2008
CompletedApril 8, 2008
December 1, 2007
1 month
December 17, 2007
April 6, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Validate safety while using the ADI Insulin Pump by intended users. This objective will be assessed by independently and successfully carrying out a list of tasks.
4 hours
Secondary Outcomes (1)
Evaluate user's satisfaction.
4 hours
Study Arms (1)
A
NO INTERVENTIONSubject is diagnosed as a diabetic, or subject is parent/guardian of a diabetic child age under 18 years.
Interventions
Eligibility Criteria
You may qualify if:
- Male/female age 18 years and up.
- 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.
You may not qualify if:
- Major physical, motor, mental, behavioral, or psychiatric limitations.
- Concurrent additional major illness.
- Subject objects to the study protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NiliMedixlead
Study Sites (1)
RAMBAM Medical center
Haifa, 34636, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Naim Shehadah, Prof.
RAMBAM Medical Center, Haifa Israel
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 17, 2007
First Posted
January 14, 2008
Study Start
November 1, 2007
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
April 8, 2008
Record last verified: 2007-12