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Medtronic MiniMed Implantable Insulin Pump

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aventis U-400 Insulin
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

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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.

Sites / Locations

  • Johns Hopkins University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aventis U-400 Insulin

Arm Description

Outcomes

Primary Outcome Measures

Glucose Control as Assessed by Mean Glucose Levels

Secondary Outcome Measures

Full Information

First Posted
March 1, 2006
Last Updated
September 8, 2017
Sponsor
Johns Hopkins University
Collaborators
National Institutes of Health (NIH), Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT00298740
Brief Title
Medtronic MiniMed Implantable Insulin Pump
Official Title
Reimplantation of Subjects With Implantable Insulin Pump Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
February 2003 (Actual)
Primary Completion Date
September 24, 2009 (Actual)
Study Completion Date
September 24, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institutes of Health (NIH), Medtronic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aventis U-400 Insulin
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Aventis U-400 Insulin
Primary Outcome Measure Information:
Title
Glucose Control as Assessed by Mean Glucose Levels
Time Frame
End of study, approximately 5 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher D Saudek, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19885248
Citation
Witkowski CJ, Saudek C. The implantable peritoneal pump--a patient's perspective. J Diabetes Sci Technol. 2008 Jul;2(4):703-6. doi: 10.1177/193229680800200423.
Results Reference
background
PubMed Identifier
16800761
Citation
Moore KB, Saudek CD, Greene A, Dackiw A. Implantable insulin pump therapy: an unusual presentation of a catheter-related complication. Diabetes Technol Ther. 2006 Jun;8(3):397-401. doi: 10.1089/dia.2006.8.397.
Results Reference
background

Learn more about this trial

Medtronic MiniMed Implantable Insulin Pump

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