User Satisfaction Using the ADI Insulin Pump

This study has been completed.
Sponsor:
Information provided by:
NiliMedix
ClinicalTrials.gov Identifier:
NCT00797771
First received: November 23, 2008
Last updated: June 8, 2011
Last verified: June 2009

November 23, 2008
June 8, 2011
December 2008
November 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00797771 on ClinicalTrials.gov Archive Site
Number of severe hypoglycemic events [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
User Satisfaction Using the ADI Insulin Pump
Evaluation of 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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes
Device: "Adi" Insulin pump
insulin delivery will be defined by the physician
Experimental: A
"Adi" insulin pump users
Intervention: Device: "Adi" Insulin pump
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
January 2010
November 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00797771
NM-HU-01
No
Dr. Hanna Levy, NiliMedix
NiliMedix
Not Provided
Principal Investigator: Shlomit Shalitin, MD Schnieder Children's Medical Center Israel
NiliMedix
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP