People at risk for type 1 diabetes and those newly diagnosed will soon be able to join clinical trials testing promising new approaches to prevention and treatment. With the formation of Type 1 Diabetes TrialNet, a collaborative network of clinical centers, experts in diabetes and immunology, specialized laboratories and other facilities will be solely dedicated to testing new approaches to understanding, preventing, and treating type 1 diabetes. Recruitment for the first trials is planned for the fall of 2003.
The goal of the prevention trials is to stop or delay the immune destruction of the insulin-producing beta cells of the pancreas in people at risk for type 1 diabetes, an autoimmune disease. Treatment trials will try to preserve remaining beta cells in people with new onset type 1 diabetes. Research has already shown that, even after a diagnosis of type 1 diabetes, the immune system continues to destroy beta cells, making blood glucose harder and harder to control for many people.
"TrialNet will expedite the application of discoveries in basic research to therapies that benefit people with type 1 diabetes and those at risk," said study chair Dr. Jay Skyler of the University of Miami. "From earlier studies, we've learned a great deal about the antibody markers for type 1 diabetes risk and how the level of risk can be assessed for individuals. We've also seen progress in understanding the autoimmune process that leads to type 1 diabetes, and recent studies suggest that process can be modulated or arrested," added Dr. Skyler, who oversaw the two clinical trials of the Diabetes Prevention Trial Type 1 (DPT-1).
Neither DPT-1's low-dose insulin injection trial in people at high risk, which ended in 2001, nor its oral insulin trial in people at moderate risk, which ended in 2003, were able to slow or prevent the development of type 1 diabetes.
TrialNet investigators are currently developing protocols for several other agents that have shown promise in earlier studies. Before participating centers can begin enrolling patients, protocols must be approved by local institutional review boards and an NIH Data Safety Monitoring Board, which reviews each study for safety and scientific soundness and monitors its progress.
"The Juvenile Diabetes Research Foundation International enthusiastically supports TrialNet," said Dr. Robert Goldstein, JDRF's Chief Scientific Officer. The JDRF recently funded four international sites that are participating in the network.
"Mounting individual trials for prevention of type 1 diabetes is a challenging, costly endeavor. This network provides a stable, efficient, cost-effective system for identifying people at risk for type 1 diabetes and testing the ability of promising new agents to prevent the disease," said Dr. Allen Spiegel, director of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). TrialNet is funded by the NIDDK, the National Institute of Child Health and Human Development, and the National Institute of Allergy and Infectious Diseases, all parts of the National Institutes of Health under the Department of Health and Human Services. The JDRF and the American Diabetes Association also support the initiative.
The network currently consists of 18 clinical centers in the U.S., Canada, Europe, and Australia. For more information, call 1-800-HALT-DM1 (1-800-425-8361).
TrialNet Centers
Children's Hospital of Los Angeles
Los Angeles, CA
1-888-835-3761
Stanford University Medical Center
Stanford, CA
1-877-232-5182
University of California San Francisco
San Francisco, CA
415-514-3730
Barbara Davis Center for Childhood Diabetes, University of Colorado
Denver, CO
1-800-572-3992
University of Florida
Gainesville, FL
1-800-749-7424 Ext. 334-0857
University of Miami
Miami, FL
305-243-3781
Indiana University
Indianapolis, IN
1-866-230-8486
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Joslin Diabetes Center
Boston, MA
1-800-242-5836
University of Minnesota
Minneapolis, MN
1-800-688-5252 ext.58944
Columbia University
Naomi Berrie Diabetes Center
New York, NY
212-851-5449
University of Pittsburgh
Pittsburgh, PA
412-692-5210
University of Texas Southwestern
Dallas, TX
214-648-4844
Benaroya Research Institute
Virgina Mason Medical Center
Seattle, WA
1-800-888-4187
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International Sites
Hospital for Sick Children
Toronto, CANADA
1-866-699-1899
San Raffaele University
Hospital and Scientific Institute
Milan, ITALY 20132
+39-02-2643 4714
University of Turku,
Department of Pediatrics
Kiinamyllynkatu 4-8
FIN-20520 Turku
FINLAND
+358-2-313 0000
University of Bristol
Southmead Hospital
Bristol, UK BS10 5NB
+44-117-959 5337
Walter and Eliza Hall Institute of Medical Research
Royal Melbourne Hospital
Burnet Clinical Research Unit
Victoria 3050 AUSTRALIA
(+613) 9345 2460
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