Medtronic MiniMed Implantable Insulin Pump
Reimplantation of Subjects With Implantable Insulin Pump Therapy
2 other identifiers
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2003
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2003
CompletedFirst Submitted
Initial submission to the registry
March 1, 2006
CompletedFirst Posted
Study publicly available on registry
March 3, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 24, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 24, 2009
CompletedResults Posted
Study results publicly available
September 12, 2017
CompletedSeptember 12, 2017
September 1, 2017
6.6 years
March 1, 2006
August 10, 2017
September 8, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Glucose Control as Assessed by Mean Glucose Levels
End of study, approximately 5 years
Study Arms (1)
Aventis U-400 Insulin
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- People with type 1 diabetes previously implanted with the MiniMed Implantable Pump model 2000 at Johns Hopkins may join this study.
You may not qualify if:
- Anyone not previously implanted with the MiniMed Implantable Pump model 2000 at Johns Hopkins.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johns Hopkins Universitylead
- National Institutes of Health (NIH)collaborator
- Medtroniccollaborator
Study Sites (1)
Johns Hopkins University
Baltimore, Maryland, 21287, United States
Related Publications (2)
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.
PMID: 19885248BACKGROUNDMoore 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.
PMID: 16800761BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Johns Hopkins ClinicalTrials.gov Program
- Organization
- Johns Hopkins University
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher D Saudek, MD
Johns Hopkins University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2006
First Posted
March 3, 2006
Study Start
February 1, 2003
Primary Completion
September 24, 2009
Study Completion
September 24, 2009
Last Updated
September 12, 2017
Results First Posted
September 12, 2017
Record last verified: 2017-09