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Medtronic MiniMed Implantable Insulin Pump

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2006 by Johns Hopkins University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00298740
First received: March 1, 2006
Last updated: NA
Last verified: February 2006
History: No changes posted

March 1, 2006
March 1, 2006
February 2003
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No Changes Posted
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Medtronic MiniMed Implantable Insulin Pump
Reimplantation of Subjects With Implantable Insulin Pump Therapy

This research is being done to find out whether subjects previously treated with the implantable insulin pump (IIP) therapy, and now taking insulin by injection, will benefit from re-implantation of IIP. We will see if IIP causes more stable control of blood sugar, with fewer highs and lows. People with type 1 diabetes previously implanted with the MiniMed Implantable Pump (MIP) model 2000 at Johns Hopkins may join this study.

If you join the study and choose to have a new pump implanted, the study is expected to last 12-15 months for each person, and you will continue to be followed, with 3-monthly refills and research visits for as long as the pump lasts, until you choose to withdraw, until the FDA approves the pump for regular care, or until the company stops supporting the pump. During the first 12-15 months of the study, there will be an estimated 13 clinic visits and one hospital stay for 2-3 days. The data collection visits will take about 30 minutes, and a continuous glucose monitor will be started. You will have a brief visit 3-4 days later to drop off the monitor. After this phase of the research, you will still be cared for with the implanted pump, having visits for refills and tests every 3 months. This long-term follow up will last until you choose to withdraw, the pump malfunctions, the FDA approves the pump for regular care, or the company no longer supports the pump. If you are no longer taking part in the study, we will have the pump removed from your body.

Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 1 Diabetes
Device: Aventis U-400 Insulin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
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December 2011
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Inclusion Criteria:

  • People with type 1 diabetes previously implanted with the MiniMed Implantable Pump model 2000 at Johns Hopkins may join this study.

Exclusion Criteria:

  • Anyone not previously implanted with the MiniMed Implantable Pump model 2000 at Johns Hopkins.
Both
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Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00298740
JHU, RR00052
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Johns Hopkins University
National Institutes of Health (NIH)
Principal Investigator: Christopher D Saudek, MD Johns Hopkins University
Johns Hopkins University
February 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP