CLSI Publishes New Guideline for Continuous Interstitial Glucose Monitoring.

WAYNE, Pa. -- Continuous interstitial glucose monitors (CGM) are medical devices that measure glucose in the interstitial fluid just under the skin. CGM offers the patients the potential of monitoring their glucose and managing insulin levels without repeated finger sticks. Because CGM offers the ability to report trends in glucose levels over time, the development of new evaluation methods for determining the accuracy of CGM devices is necessary. As more manufacturers develop CGM devices, consistent evaluation protocols become more important.

Clinical and Laboratory Standards Institute (CLSI) has recently published a new document, Performance Metrics for Continuous Interstitial Glucose Monitoring; Proposed Guideline (POCT5-P), which specifies requirements and recommendations for methods for determining analytical and clinical metrics of CGM.

David Klonoff, MD, FACP, Diabetes Technology Society, and chairholder of the CLSI subcommittee that developed the guideline, explains, "The POCT5-P document presents the use of CGM--how to present the data, how to compare the data between different continuous interstitial glucose monitors, and how to compare the data with spot blood testing. These guidelines should help save time and effort in developing new products by establishing for the manufacturers how the products must perform."

The guideline defines multiple aspects of analyzing CGM performance data including:

* point accuracy;

* trend accuracy;

* sensitivity and specificity;

* device stability;

* calibration;

* lag time; and

* trueness of measurement and device traceability.

For additional information on CLSI or for further information regarding this release, visit our website at http://www.clsi.org or call +610.688.0100.

CLSI, formerly NCCLS, is a global, nonprofit, membership-based organization dedicated to developing standards and guidelines for the health care 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.