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
  Purpose

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 Intervention
Diabetes
Device: "Adi" Insulin pump

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by NiliMedix:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Number of severe hypoglycemic events [ Time Frame: during the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: December 2008
Study Completion Date: January 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
"Adi" insulin pump users
Device: "Adi" Insulin pump
insulin delivery will be defined by the physician

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00797771

Locations
Israel
Schnieder Children's Medical Center
Petach-Tikva, Israel, 49202
Sponsors and Collaborators
NiliMedix
Investigators
Principal Investigator: Shlomit Shalitin, MD Schnieder Children's Medical Center Israel
  More Information

No publications provided

Responsible Party: Dr. Hanna Levy, NiliMedix
ClinicalTrials.gov Identifier: NCT00797771     History of Changes
Other Study ID Numbers: NM-HU-01
Study First Received: November 23, 2008
Last Updated: June 8, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by NiliMedix:
Insulin delivery

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014