Medtronic MiniMed Implantable Insulin Pump

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aventis U-400 Insulin

Device

Primary outcomes

Glucose Control as Assessed by Mean Glucose Levels

Time frame: End of study, approximately 5 years

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

Medtronic
National Institutes of Health (NIH)

Registry information

Official study title

Reimplantation of Subjects With Implantable Insulin Pump Therapy

Important dates

Study start: 2003
Primary completion: 2009
Study completion: 2009
First posted: Mar 3, 2006
Registry last updated: Sep 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed