User Satisfaction Using the ADI Insulin Pump
Evaluation of User Satisfaction Using the ADI Insulin Pump
1 other identifier
interventional
20
1 country
1
Brief Summary
Approximately 250,000 people worldwide are currently being treated with an insulin pump. This number is growing dramatically as these devices become smaller and more user-friendly. Insulin pumps allow for tight metabolic control and lifestyle flexibility while minimizing the number of hypoglycemic events. The NiliMedix ADI Insulin Pump is an ambulatory, battery operated, rate programmable micro- infusion pump, designed for continuous delivery of insulin. A custom reservoir is driven by the pressure of insulin within it to deliver preset basal profiles and patient programmed bolus of insulin through custom infusion sets, into subcutaneous tissue. This type of device requires extensive user interaction and education in order to ensure its safety. This study was designed to test the independent home-use of the NiliMedix ADI Insulin Pump, and to evaluate user's satisfaction.
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
Started Dec 2008
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
First Submitted
Initial submission to the registry
November 23, 2008
CompletedFirst Posted
Study publicly available on registry
November 25, 2008
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedJune 9, 2011
June 1, 2009
11 months
November 23, 2008
June 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
User satisfaction regarding the "Adi" pump functioning will be evaluated by questionnaire. The questionnaire will be administrated during the last study visit
End of study
Secondary Outcomes (1)
Number of severe hypoglycemic events
during the study
Study Arms (1)
A
EXPERIMENTAL"Adi" insulin pump users
Interventions
Eligibility Criteria
You may qualify if:
- Male/female age 18 years and up.
- Subject is diagnosed as Type 1 Diabetes.
- Pump Users for at least 6 months
- HbA1c: less than 8.5%
- Capable of reading pump screens in English.
- Subject understands the study procedure.
- Subject is willing to sign the informed consent form and comply with the study requirements.
You may not qualify if:
- Major physical, motor, mental, behavioral, or psychiatric limitations.
- Subject experienced a severe hypoglycemic episode that led to hospitalization during the last 6 months.
- Subject experienced an episode of Ketoacidosis during the last 6 months, while using an insulin pump.
- Concurrent additional major illness.
- Subject objects to the study protocol.
- Physician objection
- Concurrent participation in other study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NiliMedixlead
Study Sites (1)
Schnieder Children's Medical Center
Petah Tikva, 49202, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shlomit Shalitin, MD
Schnieder Children's Medical Center Israel
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 23, 2008
First Posted
November 25, 2008
Study Start
December 1, 2008
Primary Completion
November 1, 2009
Study Completion
January 1, 2010
Last Updated
June 9, 2011
Record last verified: 2009-06