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Diabetes Clinical Trials

Bringing Research to the Patient

Our clinical trials offer participants the opportunity to play an active role in their own healthcare, and to access potential new treatments before they are widely available. These studies provide important information to advance medical care and are crucial to finding a definitive cure for diabetes.   

After a promising new treatment is developed in our laboratory and its safety and effectiveness is carefully tested in the pre-clinical setting, clinical investigators obtain the University of Miami's Institutional Review Board (IRB) approval to conduct diabetes clinical trials in patients.  Participants receive high-quality care and related study medications throughout the trial at no cost. 

Islet Transplant Clinical Trials

Though progress has been substantial, islet cell transplantation remains an experimental procedure. Islet transplant studies at the DRI will continue to focus on improving the safety, long-term function and success of cell replacement therapies. 
 
Our Clinical Cell Transplant Program has active protocols that will:

  • Assess the safety and effectiveness of new drugs to prevent rejection.
  • Assess the safety and effectiveness of other agents to improve islet engraftment and increase islet mass after transplantation.
  • Assess the safety and effectiveness of co-transplanting selected immune cells to improve graft acceptance and promote long-term cell function.
  • Identify markers that indicate early islet loss so we can develop intervention strategies to sustain islet function.
  • Assess the safety and effectiveness of alternative transplant sites.

We’re actively screening individuals for participation in the following studies:

>> Pilot Clinical Trial to Test a New Site for a BioHub Platform

For additional information on the trials and/or eligibility criteria, please call 305-243-5321 or send an email. You can also print out and complete the Islet Transplantation Generic Screening form and fax it to 305-243-1058.

The DRI collaborates with other researchers through the Clinical Islet Transplantation Consortium, a network of clinical centers and a data coordinating center established in 2004 to conduct studies of islet transplantation in patients with type 1 diabetes. 

We also are screening individuals for:


Type 1 Diabetes TrialNet

TrialNet is an international consortium of investigators focusing on research to prevent type 1 diabetes. Our goals are to:

  • Identify strategies to prevent the onset of diabetes in those at risk
  • Halt the progression of diabetes in newly-diagnosed patients
  • Enhance the long-term success of cellular therapies and other methods aimed at curing diabetes.

Funded by the National Institute of Health (NIH), this program enables researchers around the world to collaborate on numerous studies aimed at the preservation of insulin-producing cells in persons at-risk for developing type 1 diabetes and in persons recently diagnosed with type 1.

Several researchers at the DRI are involved in this study, including the Study Chair, Dr. Jay Skyler. This research invites relatives of people with type 1 diabetes to undergo a simple blood test to determine if there are antibodies present in the blood that indicate a risk for development of type 1 diabetes. If antibodies are identified, further testing will be done to determine the degree of that individual’s risk and, if found eligible, they will then be asked to participate in one of the currently available prevention trials.

If you would like more information about Type 1 Diabetes TrialNet and its active studies, please contact us or visit the TrialNet Web site.

Immunogenetics

This DRI program is focused on understanding how genetic and immunological factors play a role in the development of type 1 diabetes and, by contrast, how certain genetic and immunological factors may actually afford protection from diabetes.  

Integrating the studies of genetics and immunology of human diabetes, our investigators are uncovering ways to interfere with the immune cells that attack the insulin producing cells in the pancreas resulting in diabetes. This is a critical factor for both preventing and curing diabetes, since the immune cells that caused diabetes in the first place might be reactivated and damage the transplanted insulin-producing cells. 

Making the Decision 

Participating in a clinical trial for diabetes or any other disease is an important personal decision. To learn more about what’s involved, the National Institutes of Health answers Frequently Asked Questions about clinical trials on its web site.  In addition, it is often helpful to talk to a physician, family members, or friends about deciding to join a trial.

Karla Edge has been insulin-free for 6 years and has a Reason to Believe in a cure for diabetes.
Karla Edge has been living insulin free for more than eight years after having an islet cell transplant at the DRI. At the time of this video, Karla was off of insulin for more than six years.    Watch her story>>

 

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