Medtronic MiniMed Implantable Insulin Pump

Type 1 Diabetes Clinical Trial

Official title:

Reimplantation of Subjects With Implantable Insulin Pump Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00298740
• Other study ID #: 03-05-01-08
• Secondary ID: RR00052
• Status: Completed
• Phase: N/A
• First received: March 1, 2006
• Last updated: September 8, 2017
• Start date: February 2003
• Est. completion date: September 24, 2009

Study information

• Verified date: September 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 24, 2009
• Est. primary completion date: September 24, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Type 1 Diabetes

Intervention

Device:
• Aventis U-400 Insulin

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	Medtronic, National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

Witkowski CJ, Saudek C. The implantable peritoneal pump--a patient's perspective. J Diabetes Sci Technol. 2008 Jul;2(4):703-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose Control as Assessed by Mean Glucose Levels		End of study, approximately 5 years