Latest Approval of Continuous Glucose Monitor

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The Juvenile Diabetes Research Foundation, the world's largest charitable funder of type 1 diabetes research, said that the Food and Drug Administration's approval of another continuous glucose monitor is an important step toward revolutionizing diabetes care and management. Continuous glucose monitors read glucose levels on a minute-by-minute basis using a small sensor inserted under the skin, which continuously transmits data to a hand-held device. The newly approved continuous glucose monitoring system is from Abbott Diabetes Care, part of Chicago-based Abbott Laboratories. It is the latest addition to an emerging market of similar devices approved by the FDA."Continuous glucose monitors offer a major breakthrough in diabetes care management," said Aaron Kowalski, PhD, Research Director for the JDRF Artificial Pancreas Project. "More choices are better for patients, and a competitive marketplace will encourage investment in new and even better generations of these products."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 percent of the day in normal range. The rest of the time, their glucose was either too high (which can lead to complications including eye, heart, kidney, and nerve disease), or too low (which can cause seizures, comas, and death). But studies have also found that patients who use continuous glucose sensors spent 26 percent more time in normal glucose range, and have statistically significant improvements in HbA1c levels, an important measure of longer-term glucose control.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, clinician adoption, and health insurance coverage of promising new diabetes technologies. These technologies include continuous glucose sensors as well as an artificial pancreas which would combine a glucose sensor with an insulin delivery device to automatically provide the right amount of insulin at the right time, like a healthy pancreas does in people without diabetes. Toward these goals, JDRF has funded a multi-million dollar research effort, which includes the world's largest clinical assessment of continuous glucose sensor use, which completed enrollment at ten U.S. sites last December, and a seven site international consortium of researchers developing and testing early, hospital-based versions of an artificial pancreas."We hope these independent, JDRF funded clinical trials will provide helpful information to regulators, clinicians, and health insurers so that we can ensure effective technologies are affordable and widely available to patients," said Cynthia Rice, Director of New Technology Access at JDRF. Click here for more on the JDRF Artificial Pancreas Project.JDRF is the leading charitable funder and advocate of type 1 (juvenile) diabetes research worldwide. 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 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 $1.16 billion to diabetes research, including more than $137 million in FY2007. In FY2007, the Foundation funded 700 centers, grants and fellowships in 20 countries. Leslie Schwartz, National Director of News Media Relations