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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
  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. 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.

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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:

Primary Outcome Measures:
  • Glucose Control as Assessed by Mean Glucose Levels [ Time Frame: End of study, approximately 5 years ]

Enrollment: 12
Actual Study Start Date: February 2003
Study Completion Date: September 24, 2009
Primary Completion Date: September 24, 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aventis U-400 Insulin Device: Aventis U-400 Insulin

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00298740


Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
National Institutes of Health (NIH)
Medtronic
Investigators
Principal Investigator: Christopher D Saudek, MD Johns Hopkins University
  More Information

Publications:
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00298740     History of Changes
Other Study ID Numbers: 03-05-01-08
RR00052
First Submitted: March 1, 2006
First Posted: March 3, 2006
Results First Submitted: August 10, 2017
Results First Posted: September 12, 2017
Last Update Posted: September 12, 2017
Last Verified: September 2017

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

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs


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