Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2008-12-31
2010-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A
"Adi" insulin pump users
"Adi" Insulin pump
insulin delivery will be defined by the physician
Interventions
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"Adi" Insulin pump
insulin delivery will be defined by the physician
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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NiliMedix
INDUSTRY
Responsible Party
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NiliMedix
Principal Investigators
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Shlomit Shalitin, MD
Role: PRINCIPAL_INVESTIGATOR
Schnieder Children's Medical Center Israel
Locations
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Schnieder Children's Medical Center
Petah Tikva, , Israel
Countries
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Other Identifiers
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NM-HU-01
Identifier Type: -
Identifier Source: org_study_id
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