Self Operating of the ADI Insulin Pump By Intended Users - A Usability Study

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00592241
• Date of registration: 17/12/2007
• Primary sponsor: NiliMedix
• Public title: Self Operating of the ADI Insulin Pump By Intended Users - A Usability Study
• Scientific title: Self Operating of the ADI Insulin Pump By Intended Users - A Usability Study
• Date of first enrolment: November 2007
• Target sample size: 30
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00592241
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Countries of recruitment

Israel

Contacts

• Name: Naim Shehadah, Prof.
• Affiliation: RAMBAM Medical Center, Haifa Israel

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- Major physical, motor, mental, behavioral, or psychiatric limitations.

- Concurrent additional major illness.

- Subject objects to the study protocol.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes Mellitus

Intervention(s)

Device: "Adi" Insulin Pump Usability

Primary Outcome(s)

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. [Time Frame: 4 hours]

Secondary Outcome(s)

Evaluate user's satisfaction. [Time Frame: 4 hours]

Secondary ID(s)

NM-UA-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors