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
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes
Device: Aventis U-400 Insulin
Phase 2
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Study Start Date: February 2003
Estimated Study Completion Date: December 2011
Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00298740

Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Christopher D Saudek, MD Johns Hopkins University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00298740     History of Changes
Other Study ID Numbers: JHU, RR00052
Study First Received: March 1, 2006
Last Updated: March 1, 2006
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014