JDRF Rocky Mountain Juvenile Diabetes Foundation Rocky Mountain Chapter Denver Colorado
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Juvenile Diabetes Research Foundation Awards Research Grants to
Dr. Peter Chase of The University of Colorado


Grants are Part of JDRF's $6 Million Research Initiative to Investigate Benefits of Technology that Controls Glucose Levels in Diabetics

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 around the world to participate in the JDRF Artificial Pancreas Project, which will 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.

Among the researchers named was H. Peter Chase, M.D. of the Barbara Davis Center for Childhood Diabetes in Aurora, Colorado. He will lead a team, including Dr. Rosanna Fiallo-Scharer, which will participate in both of the two research initiatives that comprise the JDRF Artificial Pancreas Project: the Continuous Glucose Sensor Human Clinical Trial and the Artificial Pancreas Consortium.

Continuous Glucose Sensor Human Clinical Trial

Drs. Chase and Fiallo-Scharer will be part of this large, multi-site clinical trial, which will compare health outcomes of people who use continuous glucose sensors to those who do not, to quantify the benefits of these devices.

Continuous glucose sensors 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 also tell a patient whether their 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 University of Colorado will be one of nine research centers in the clinical trial, each using the same clinical protocol. The variety of patient populations at 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. Data will also be collected to assess the economic costs and benefits of sensor use over the next 12 months.

Other research sites include Joslin Diabetes Center, Boston, Mass.; Kaiser Permanente Southern California, Pasadena, Calif.; Nemours Children's Clinic, Jacksonville, Fla.; Roybal Community Health Center/University of Southern California, Los Angeles, Calif.; Stanford University, Stanford, Calif.; University of Iowa Carver College of Medicine, Iowa City, Iowa; Yale University, New Haven, Conn.; and the University of Washington, Seattle, Wash.

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 Pritzker School of Medicine to analyze and model the short- and long-term costs and benefits of patients using sensors.

Artificial Pancreas Consortium:

Dr. Chase will be part of this multi-site research consortium, which will aim to speed and optimize the development of a closed-loop system (or artificial pancreas). This mechanical system will integrate a real-time glucose sensor and an insulin delivery system. The 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.

The consortium will work to develop various computer "algorithms" to communicate between the glucose sensors and insulin pumps. It 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, as well as 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 everyday life settings, such as home or school.

In addition to the University of Colorado, other recent centers include Yale University, New Haven, Conn.; Cambridge University, Cambridge, England, UK; Sansum Diabetes Research Institute, Santa Barbara, Calif.; Stanford University, Stanford, Calif.; and the University of Virginia, Charlottesville, VA.

JDRF's Artificial Pancreas Project

To expedite the availability of 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.

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 disease - measuring their blood glucose an average of nine times a day - spent 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.

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 are suffering from severe and even deadly complications. The development of an artificial pancreas can revolutionize diabetes care because it carries the potential of eliminating these complications and easing the tremendous burden of diabetes."

"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."

Though JDRF is funding the Artificial Pancreas Project 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.

The JDRF was founded in 1970 by the parents of children with juvenile diabetes - a disease that strikes children suddenly, makes them insulin dependent for life, and carries the constant threat of devastating complications. Since inception, JDRF has provided more than $1 billion to diabetes research worldwide. More than 80 percent of JDRF's expenditures directly support research and education about research. JDRF's mission is constant: to find a cure for diabetes and its complications through the support of research.

Addie, age 9<br>diagnosed at age 6 "If I could be or do anything in the world, I would find a cure for diabetes. That would be the best thing ever...or fly!"

Addie, age 9
diagnosed at age 6
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