User Satisfaction Using the ADI Insulin Pump
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00797771|
Recruitment Status : Completed
First Posted : November 25, 2008
Last Update Posted : June 9, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes||Device: "Adi" Insulin pump||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of User Satisfaction Using the ADI Insulin Pump|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||January 2010|
"Adi" insulin pump users
Device: "Adi" Insulin pump
insulin delivery will be defined by the physician
- 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 ]
- Number of severe hypoglycemic events [ Time Frame: during the study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00797771
|Schnieder Children's Medical Center|
|Petach-Tikva, Israel, 49202|
|Principal Investigator:||Shlomit Shalitin, MD||Schnieder Children's Medical Center Israel|