Glossary Term Name
This is a placeholder for glossary term definitions.
Media Contact:
Peter Cleary, National Manager, JDRF Media Relations
Phone: (212) 479-7553
E-mail: pcleary@jdrf.org
New York, NY, September 12, 2006 - The Juvenile Diabetes Research Foundation (JDRF), the world's largest charitable funder of type 1 diabetes research, announced today that it has funded leading researchers from around the world to assess new diabetes technologies and help accelerate their availability for patients. The first year's funding for this multi-year research program exceeds $5.5 million.
"We believe that the new continuous glucose sensors will dramatically improve the ability of people with type 1 diabetes to control the wide fluctuations of glucose levels that, over time, lead to severe complications like heart attacks, kidney failure, amputations, and blindness," said Dr. Richard Insel, JDRF's Executive Vice President of Research. "These grants will help us better understand and quantify the benefits of technology-enabled glucose control, and take a big step towards an artificial pancreas."
JDRF has made its Artificial Pancreas Project a priority because research confirms that current diabetes technology is inadequate: some studies have found that even patients who aggressively manage their diseasemeasuring their blood glucose an average of nine times a dayspent less than 30% of the day in normal range. The rest of the time, their blood sugar levels were either too high or too low.
A closed-loop artificial pancreas is a mechanical system that will integrate a real-time glucose sensor and an insulin delivery system. This technology will enable a person with diabetes to maintain normal glucose and HbA1c levels by automatically providing the right amount of insulin at the right time, just as the pancreas does in people without the disease.
According to Dr. Aaron Kowalski, Director of Strategic Research Projects for JDRF, "When a person has type 1 diabetes, maintaining an acceptable blood sugar level is a constant struggle. Tight control is very difficult for most, and as a result diabetes patients run the risk of developing severe and even deadly complications. The artificial pancreas will revolutionize diabetes care because it carries the potential of eliminating these complications and easing the tremendous burden of diabetes."
In order to expedite the availability of this rapidly emerging technology for people with type 1 diabetes, JDRF launched the JDRF Artificial Pancreas Project in late 2005. Through research and advocacy, the JDRF project aims to speed regulatory approval, health insurance coverage, and clinician adoption of promising new artificial pancreas technologies.
The research announced today includes:
* Continuous Glucose Sensor Human Clinical Trial: This large, multi-
site clinical trial will compare health outcomes -- such as HbA1c levels
and avoidance of hypoglycemia -- of people who use continuous glucose
sensors to those who do not, to quantify the benefits of these devices.
The trial will enroll both children and adults with type 1 diabetes and will
collect data to assess the economic costs and benefits of sensor use
over the next 12 months.
* Artificial Pancreas Consortium: This multi-site research consortium
will work collaboratively to research potential algorithms for a closed-
loop system that links continuous glucose sensors and insulin pumps
to automatically dispense insulin to patients with type 1 diabetes.
Though JDRF is funding this research independently, it is working with government agencies to accelerate the availability of these technologies to people with diabetes. In the last six months, 68 U.S. Senators and 244 U.S. Representatives signed a letter highlighting the promise of these technologies, the U.S. Food and Drug Administration said an artificial pancreas "could revolutionize diabetes care and management" and included it on its "Critical Path Opportunities List," and the U.S. Centers for Medicare and Medicaid Services held an expert panel to advise on future research using these technologies in the Medicare population. JDRF commends this leadership by the Congress and the Department of Health and Human Services regarding this emerging technology.
Continuous Glucose Sensor Clinical Trial
Continuous glucose monitors read glucose levels on a minute-by-minute basis using a small sensor that is inserted under the skin and continuously transmits data to a hand-held device. These devices not only provide actual glucose readings, but tell a patient whether a glucose level is trending upwards or downward. Patients can adjust insulin dosing and carbohydrate intake to maintain control of blood sugar levels. Research has found that patients using continuous glucose sensors spend 26% more time in normal glucose range, and have statistically significant improvements in HbA1c levels.
The Continuous Glucose Sensor Human Clinical Trial will invite nine research centers each using the same clinical protocol. These sites will test the effectiveness of sensors in various populations (including children and adults of various ethnic and socioeconomic groups) and different health care settings (including specialty diabetes care, managed care, and publicly funded clinics). The trial will specifically investigate whether continuous glucose sensors have a direct impact on better glycemic control, reduced HbA1c levels, and hypoglycemia. But it will also explore the impact of sensors on other aspects of diabetes care, such as quality of life issues, for the children using the devices, as well as their parents. The selected researchers include:
* Joslin Diabetes Center, Boston, Mass. Howard Wolpert, M.D.
* Joslin Diabetes Center, Boston, Mass. Lori Laffel, M.D.
* Kaiser Permanente Southern California, Pasadena, Calif.
Jean M. Lawrence, Sc.D., M.P.H.
* Nemours Children's Clinic, Jacksonville, Fla. Tim Wysocki, Ph.D.
* Roybal Community Health Center/Univ. Southern Calif., Los Angeles,
Calif. Anne Peters, M.D.
* Stanford University, Stanford, Calif. Bruce Buckingham, M.D.
* University of Colorado, Barbara Davis Center, Aurora, Colo.
Peter Chase, M.D.
* University of Iowa Carver College of Medicine, Iowa City, Iowa
Eva Tsalikian, M.D.
* University of Washington, Seattle, Wash. Irl Hirsch M.D.
* Yale University, New Haven, Conn. William Tamborlane, M.D.
The Jaeb Center in Tampa Florida, led by Roy Beck, M.D., Ph.D., will serve as the trial's coordinating center. Michael O'Grady, Ph.D., of the National Opinion Research Center, will serve as the trial's lead economic researcher, working with Elbert Huang, M.D., M.P.H., of the University of Chicago's Pritzker School of Medicine to analyze and model the short- and long-term costs and benefits of patients using sensors.
Artificial Pancreas Consortium
The Artificial Pancreas Consortium will aim to speed and optimize the process of linking continuous glucose sensors and insulin pumps, including the development of various computer "algorithms" to communicate between the two devices. This team will also investigate the safety and efficiency of the technology such as whether insulin pumps can be shut off automatically during potentially severe hypoglycemic episodes. Studies will include children and adults with type 1 diabetes. While the initial research will take place in hospital based clinical settings, the goal of the initiative is to eventually test artificial pancreas systems in every day life settings such as home or school. Researchers include:
* Cambridge University, Cambridge, England, UK Roman Hovorka, Ph.D.
* Sansum Diabetes Research Institute, Santa Barbara, Calif.
Lois Jovanovic, M.D.
* Stanford University, Stanford, Calif. Bruce Buckingham, M.D.
* University of Colorado, Boulder, Colo. Peter Chase, M.D.
* University of Virginia, Charlottesville, Va. Boris Kovatchev, Ph.D.
* Yale University, New Haven, Conn. Stuart Weinzimer, M.D.
About JDRF
JDRF is a leader in setting the agenda for diabetes research worldwide, and is the largest charitable funder and advocate of type 1 research. The mission of JDRF is to find a cure for diabetes and its complications through the support of research. Type 1 diabetes is a disease which strikes children and adults suddenly and requires multiple injections of insulin daily or a continuous infusion of insulin through a pump. Insulin, however, is not a cure for diabetes, nor does it prevent its eventual and devastating complications which may include kidney failure, blindness, heart disease, stroke, and amputation.
Since its founding in 1970 by parents of children with type 1 diabetes, JDRF has awarded more than $1.4 billion to diabetes research, including more than $100 million last year.
For more information, please visit http://www.jdrf.org/
