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Medtronic MiniMed Implantable Insulin Pump

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00298740
First Posted: March 3, 2006
Last Update Posted: September 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
Medtronic
Information provided by (Responsible Party):
Johns Hopkins University
March 1, 2006
March 3, 2006
August 10, 2017
September 12, 2017
September 12, 2017
February 2003
September 24, 2009   (Final data collection date for primary outcome measure)
Glucose Control as Assessed by Mean Glucose Levels [ Time Frame: End of study, approximately 5 years ]
Not Provided
Complete list of historical versions of study NCT00298740 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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. The investigators 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 the participant joins the study and chooses to have a new pump implanted, the study is expected to last 12-15 months for each participant, and each participant will continue to be followed, with 3-monthly refills and research visits for as long as the pump lasts, until the participant chooses 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. The participants will have a brief visit 3-4 days later to drop off the monitor. After this phase of the research, the participants 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 the participants choose to withdraw, the pump malfunctions, the FDA approves the pump for regular care, or the company no longer supports the pump. If the participants are no longer taking part in the study, the investigators will have the pump removed from their body.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Type 1 Diabetes
Device: Aventis U-400 Insulin
Experimental: Aventis U-400 Insulin
Intervention: Device: Aventis U-400 Insulin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
September 24, 2009
September 24, 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00298740
03-05-01-08
RR00052
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Not Provided
Johns Hopkins University
Johns Hopkins University
  • National Institutes of Health (NIH)
  • Medtronic
Principal Investigator: Christopher D Saudek, MD Johns Hopkins University
Johns Hopkins University
September 2017

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