Clinical trial NCT00298740: Medtronic MiniMed Implantable Insulin Pump
Official title: Reimplantation of Subjects With Implantable Insulin Pump Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Medtronic
First posted: 2006-03-03
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Glucose Control as Assessed by Mean Glucose Levels
timeFrame: End of study, approximately 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Christopher D Saudek, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.