User Satisfaction Using the ADI Insulin Pump

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Device: "Adi" Insulin pump

• Registration Number: NCT00797771
• Lead Sponsor: NiliMedix

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-11-23
• Study First Submitted QC: 2008-11-24
• Study First Posted: 2008-11-25
• Study Start: 2008-12
• Status Verified: 2009-06
• Primary Completion: 2009-11
• Study Completion: 2010-01
• Last Update Submitted: 2011-06-08
• Last Update Posted: 2011-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	"Adi" Insulin pump	"Adi" insulin pump users

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Number of severe hypoglycemic events	during the study

Trial Locations

Locations (1)

Schnieder Children's Medical Center; 🇮🇱 Petach-Tikva, Israel