User Satisfaction Using the ADI Insulin Pump

Diabetes Clinical Trial

Official title:

Evaluation of User Satisfaction Using the ADI Insulin Pump

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00797771
• Other study ID #: NM-HU-01
• Status: Completed
• Phase: N/A
• First received: November 23, 2008
• Last updated: June 8, 2011
• Start date: December 2008
• Est. completion date: January 2010

Study information

• Verified date: June 2009
• Source: NiliMedix
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes

Intervention

Device:
• "Adi" Insulin pump
insulin delivery will be defined by the physician

Locations

Country	Name	City	State
Israel	Schnieder Children's Medical Center	Petach-Tikva

Sponsors (1)

Lead Sponsor	Collaborator
NiliMedix

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of severe hypoglycemic events		during the study	Yes