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 News Release - June 12, 2006

CLSI and the Diabetes Technology Society Announce a Joint Project to Develop a Guideline for Continuous Glucose Monitoring

Breakthrough Could Lead to the Accelerated Development of an Artificial Pancreas

WAYNE, Pa.--(HSMN NewsFeed)--June 12, 2006--Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) and the Diabetes Technology Society (DTS) announced today they would be working cooperatively on the development of a consensus guideline for continuous glucose monitoring.

The project was approved in late April during a meeting of the CLSI Chairholders Council. Since then a subcommittee on continuous glucose monitoring has been formed and approved and plans are underway to begin the first in a series of meetings.

Continuous glucose monitors (CGM) measure glucose in the interstitial fluid using devices attached to the skin. They offer the potential of managing insulin levels without the cost and discomfort of more traditional methods which require costly supplies and repeated painful fingersticks.

However, there is no current consensus on how to compare CGM devices, how to define the appropriate level of agreement given the time lag between blood and interstitial fluid levels, or how to display and interpret data. The guideline being co-developed by CLSI and DTS will address these issues by reaching consensus on how CGM data should be presented and compared between different devices and different glucose methodologies.

"The joint project being spearheaded by CLSI and DTS will play an important role in the development of new technology for people with diabetes," said Glen Fine Executive Vice President of Clinical and Laboratory Standards Institute. "It may even accelerate the development of an artificial pancreas by stimulating interest from industry in developing better continuous glucose monitoring products."

"We look forward to working with CLSI on this joint project. Continuous glucose monitoring is becoming established as an important management tool for diabetes, and this project will facilitate development of better continuous glucose monitors," said David Klonoff, M.D., President of Diabetes Technology Society.

For additional information on CLSI or for further information regarding this release, visit our website at or call 610.688.0100. For information on Diabetes Technology Society visit or call 1.650-357.7140.

CLSI is a global, nonprofit, membership-based organization dedicated to developing standards and guidelines for the healthcare and medical testing community. CLSI's unique consensus process facilitates the creation of standards and guidelines that are reliable, practical, and achievable for an effective quality system.

The Diabetes Technology Society (DTS) is a nonprofit organization devoted to the development of technology to help people with diabetes. DTS presents the Diabetes Technology Meeting and the Clinical Diabetes Technology Meeting and publishes the electronic peer-reviewed bimonthly Journal of Diabetes Science and Technology.

Source: Clinical and Laboratory Standards Institute

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