CLSI Publishes Approved Guideline For Continuous Interstitial Glucose Monitoring

Main Category: Diabetes
Also Included In: Medical Devices / Diagnostics
Article Date: 30 Jan 2009 - 8:00 PDT

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Clinical and Laboratory Standards Institute (CLSI) recently published Performance Metrics for Continuous Interstitial Glucose Monitoring; Approved Guideline (POCT05-A) , which provides recommendations for methods for determining analytical and clinical metrics of continuous interstitial glucose monitors (CGM).

CGM are medical devices that measure glucose in the interstitial fluid just under the skin. CGM offer patients the potential of monitoring their glucose and managing insulin levels without repeated fingersticks. CGM technology has the potential to revolutionize diabetes management by providing real-time information not only about current glucose level, but also about time-dependent characteristics of glucose fluctuation, in particular about the short-term or instantaneous glucose rate and direction of change.

As more manufacturers develop CGM devices, consistent evaluation protocols become more important. Arleen Pinkos, MT(ASCP), US Food and Drug Administration (FDA) Center for Devices/Radiological Health, an advisor to the committee that developed the document, says, "POCT05-A provides an excellent framework for product developers, manufacturers, and the FDA. Using the consensus process to agree on the basic concepts and elements that impact the safety and effectiveness of CGM creates a foundation of understanding among stakeholders. These devices are unique in terms of both the volume and types of information they provide, and this makes it important to agree on the metrics for characterizing and evaluating them."

Pinkos adds, "Voluntary guidelines, such as POCT05-A, are valuable tools. They save time by creating a level of expectation for both manufacturers and the FDA. Those expectations help to define what information manufacturers should include in a marketing application to the FDA, and what information the FDA needs to assess the scientific and clinical aspects of the device."

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

- point accuracy;
- trend accuracy;
- sensitivity and specificity;
- device stability;
- calibration;
- lag time; and
- device traceability.

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.

http://www.clsi.org

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