User Satisfaction Using the ADI Insulin Pump

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of User Satisfaction Using the ADI Insulin Pump

Conditions
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Diabetes

Intervention / Treatment
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* Device: Adi Insulin pump


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Adi insulin pump users | Device: Adi Insulin pump<br>* insulin delivery will be defined by the physician<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of severe hypoglycemic events |  | during the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insulin delivery