User Satisfaction Using the ADI Insulin Pump

June 8, 2011 updated by: NiliMedix

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Petach-Tikva, Israel, 49202
        • Schnieder Children's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
"Adi" insulin pump users
Device: "Adi" Insulin pump
insulin delivery will be defined by the physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
End of study

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of severe hypoglycemic events
Time Frame: during the study
during the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NiliMedix

Investigators

  • Principal Investigator: Shlomit Shalitin, MD, Schnieder Children's Medical Center Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

November 23, 2008

First Submitted That Met QC Criteria

November 24, 2008

First Posted (Estimate)

November 25, 2008

Study Record Updates

Last Update Posted (Estimate)

June 9, 2011

Last Update Submitted That Met QC Criteria

June 8, 2011

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NM-HU-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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