User Satisfaction Using the ADI Insulin Pump
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of User Satisfaction Using the ADI Insulin Pump|
- User satisfaction regarding the "Adi" pump functioning will be evaluated by questionnaire. The questionnaire will be administrated during the last study visit [ Time Frame: End of study ] [ Designated as safety issue: No ]
- Number of severe hypoglycemic events [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2008|
|Study Completion Date:||January 2010|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
"Adi" insulin pump users
Device: "Adi" Insulin pump
insulin delivery will be defined by the physician
Please refer to this study by its ClinicalTrials.gov identifier: NCT00797771
|Schnieder Children's Medical Center|
|Petach-Tikva, Israel, 49202|
|Principal Investigator:||Shlomit Shalitin, MD||Schnieder Children's Medical Center Israel|