Medtronic MiniMed Implantable Insulin Pump

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Device: Aventis U-400 Insulin

• Registration Number: NCT00298740
• Lead Sponsor: Johns Hopkins University

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.

Study Timeline

• Study Start: 2003-02
• Study First Submitted: 2006-03-01
• Study First Submitted QC: 2006-03-01
• Study First Posted: 2006-03-03
• Primary Completion: 2009-09-24
• Study Completion: 2009-09-24
• Results First Submitted: 2017-08-10
• Status Verified: 2017-09
• Results First Submitted QC: 2017-09-08
• Last Update Submitted: 2017-09-08
• Results First Posted: 2017-09-12
• Last Update Posted: 2017-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aventis U-400 Insulin	Aventis U-400 Insulin	-

Primary Outcome Measures

Name	Time	Method
Glucose Control as Assessed by Mean Glucose Levels	End of study, approximately 5 years

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States