Novo Nordisk, a global healthcare company focusing on diabetes care, has awarded a $1.5 million, three-year grant to create the Pediatric Diabetes Consortium (PDC), which is comprised of clinical centers at six major research facilities across the nation, according to a joint announcement by William V. Tamborlane, M.D., of Yale University School of Medicine and Yale-New Haven Children's Hospital, and Francine R. Kaufman, M.D., head of the Division of Endocrinology, Diabetes and Metabolism at Children's Hospital Los Angeles, co-chairs of the consortium.
In addition to Yale University in New Haven and Children's Hospital Los Angeles, the other members of the consortium are Stanford University, the Barbara Davis Center at the University of Colorado, Baylor University in Texas, and the University of Florida.
The consortium includes a coordinating center at the Jaeb Center for Health Research, a non-profit, freestanding center for clinical trials and epidemiologic research in Tampa, Fla., under the direction of Roy W. Beck, M.D., Ph.D., founder of the Jaeb Center.
"Although there are some interactions between the major pediatric diabetes programs in the United States, there is no formal structure for collaboration, sharing of information and development of joint research projects that utilize common outcome measures," said Dr. Kaufman, Distinguished Professor at the University of Southern California, with appointments at the Keck School of Medicine and the Annenberg School of Communication.
"As a result," said Dr. Tamborlane, professor and chief of Pediatric Endocrinology and Diabetes at Yale School of Medicine, "studies are often underpowered, repeated and difficult to compare."
According to Drs. Tamborlane and Kaufman, the PDC is being created to advance diabetes care and fundamentally change how the disease is treated in children. They say that it is imperative to determine how best to initiate insulin treatment in children at the time of diabetes diagnosis. Therefore, the PDC's initial aim will be to develop a study utilizing a database registry to assess treatment approaches for children and youth with new-onset type 1 diabetes.
"This project will be the first large consortium study to determine how diabetes is treated in children and youth with type 1 diabetes at leading pediatric diabetes centers in the United States," said Dr. Beck. "The consortium also will provide updated information regarding rates of severe hypoglycemia, serious adverse events, as well as evidence to direct future care and research."
"The Pediatric Diabetes Consortium is an important step in changing diabetes for people, specifically children, with type 1 diabetes," said Dr. Nathaniel Clark, senior medical advisor for diabetes at Novo Nordisk. "It will take the combined and shared knowledge of the health care community to improve the treatment of those with diabetes and ultimately to defeat the disease. The registry is a beginning step toward universal access to shared information about the current treatment of the disease, the first step in improving care."
According to Dr. Clark, the funding is part of Novo Nordisk's Changing Diabetes Leadership Initiative. The data from the consortium's study will be collected, collated and analyzed by the Coordinating Center. Writing teams will be established to prepare presentations at national and international research meetings, including descriptions of overall diabetes control during the first 12-24 months of treatment of diabetes, insulin regimens employed and their relationship with A1c levels, incidence of severe hypoglycemia and other adverse clinical events, impact of socioeconomic factors on clinical outcomes, and cost effectiveness analyses.
Following presentation and publication of the data gathered by the consortium, that data will be placed in the public domain and made available to other investigators.