Overview

This trial is active, not recruiting.

Condition type 1 diabetes
Treatment aventis u-400 insulin
Phase phase 2/phase 3
Sponsor Johns Hopkins University
Collaborator National Institutes of Health (NIH)
Start date February 2003
End date December 2011
Trial identifier NCT00298740, JHU, RR00052

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

Official title Reimplantation of Subjects With Implantable Insulin Pump Therapy
Principal investigator Christopher D Saudek, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2006.
Information provided to ClinicalTrials.gov by Johns Hopkins University.