Study Comparing Effectiveness of Intraperitoneal Insulin Administration to Subcutaneous Insulin Administration
Completed · Phase 3
Conditions studied: Type 1 Diabetes
In brief
The purpose of this study is to evaluate the effectiveness of insulin delivered in the peritoneum (abdomen)by an implantable pump in Type 1 diabetics.
Key facts
- Study ID
- NCT00211536
- Run by
- Medtronic MiniMed, Inc.
- People needed
- 107
- Starts
- 2002-06-01
- Expected to finish
- 2008-09-01
- Last updated by the study team
- 2011-09-21
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- The subject's insulin usage exceeds 66 units per day.
- Severe complications such as advanced autonomic neuropathy, legal blindness, or symptomatic cardiovascular disease as evidenced by a cardiovascular episode within the last six months
- Reside at or plan to travel to elevations above 8000 feet during the study period (commercial airline travel is acceptable)
- Subject who is pregnant, of childbearing potential or lactating and is neither surgically sterile, using contraceptives (devices, oral or implanted) nor other physician approved contraceptive
- The subject has any major concomitant disease or any physical or psychological disorder within the last five years, which might be considered life threatening, or which might confound the collection or interpretation of the study data
- The subject has previously enrolled in or participated in an investigational drug or device study within the preceding 4 weeks
- The subject has any condition that precludes him/her from completing the study requirements
- Has plans for activities which require them to go 25 feet below sea level
Where it is running
- Sansum Medical Research Institute — Santa Barbara, California, United States
- University of Colorado Health Sciences Center — Aurora, Colorado, United States
- Hellman & Rosen Endocrine Associates — North Kansas City, Missouri, United States
- Cleveland Clinic — Wooser, Ohio, United States
- Diabetes & Glandular Disease Clinic — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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