Medtronic MiniMed Implantable Insulin Pump
Recruitment status was Active, not recruiting
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Reimplantation of Subjects With Implantable Insulin Pump Therapy|
|Study Start Date:||February 2003|
|Estimated Study Completion Date:||December 2011|
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.
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Christopher D Saudek, MD||Johns Hopkins University|