Call for Nominations
Performance Metrics for Continuous Interstitial Glucose Monitoring; Assessment of the Clinical Accuracy of Laboratory Tests Using Receiver Operation Characteristic (ROC) Plots

Clinical and Laboratory Standards Institute requests nominations for representatives to serve as subcommittee members on CLSI projects.  The project descriptions and specific qualifications needed are provided below: 

PROJECT:
Performance Metrics for Continuous Interstitial Glucose Monitoring

Description:
The use of self-management blood glucose devices (SMBG) or glucose meters has led to more normal glucose levels and lower risk of cardiovascular and long-term complications in both type I and type II diabetics. SMBG devices are typically used to test patient’s blood glucose levels one to four or more times a day in order to manage insulin dosages. Despite the ease of use of SMBG devices, many diabetics are not compliant with testing at the frequency recommended by their physicians because of the cost of testing supplies and the pain of repeated fingersticks. 

Continuous glucose monitors (CGM) are medical devices that measure glucose in the interstitial fluid just under the skin. CGM devices are attached to the skin by an adhesive patch and can be worn for up to several days. CGM offers the patients the potential of monitoring their glucose and managing insulin levels without repeated fingersticks. 

While guidelines exist for comparing SMBG devices to laboratory methodologies by analyzing differences between fingerstick capillary and venous blood levels collected at the same time, there is no current consensus on how to compare CGM devices, how to define good agreement given the time lag between blood and interstitial fluid levels, or even how to display and interpret the data produced by CGM in a common fashion. This standard will address these issues by reaching consensus on how CGM data should be presented and compared between devices and different glucose methodologies. Terminology will be defined for interstitial fluid glucose and its relationship to blood glucose levels, and the degree of agreement for acceptable technical performance will be defined to allow assessment of method comparability. Finally, this standard will present recommendations for clinical interpretation of CGM for utilization in patient care.

Table of Contents:
1. Scope
2. Introduction
3. Definitions/Acronyms
4. Physiology of blood and interstitial fluid
5. CGM – what it is and the data obtained
5.1. Frequency of measurement
5.2. Presentation of data
5.3. Technical performance – Comparability (accuracy) versus directionality (do CGM devices have to have the same accuracy given the added information from direction and magnitude of glucose change?)
6. CGM comparability of results – How is agreement measured and what are acceptable performance specifications?
7. Utilization of CGM in clinical management

Specific Expertise/Work Experience Needed:
* Clinicians, IVD manufacturers, regulatory personnel, or clinical laboratory staff familiar with diagnosis and management of diabetes
* US and EU regulatory expertise for data acquisition and analysis
* Statistician or equivalent for data analysis and display of data
* Experience with laboratory quality control and quality assurance
* Familiarity with previous or existing standards/guidelines

Review the objective of the project, and the requested volunteer expertise, and submit a nomination.

Extended Notice

PROJECT: 
(Revision of Approved Document) Assessment of the Clinical Accuracy of Laboratory Tests Using Receiver Operation Characteristic (ROC) Plots; Approved Guideline (GP10-A)

Description: 
GP10-A, which was reaffirmed in 2001, provides a protocol for evaluating the accuracy of a test to discriminate between two subclasses of subjects where there is some clinically relevant reason to separate them. In addition to the use of ROC plots, the importance of defining the question, selecting the sample group, and determining the “true” clinical state are emphasized.  In revising GP10 consideration will be given to expanding the guideline to address multiple analytes and changing the title to Assessment of the Clinical Accuracy of Diagnostic Tests Using Receiver Operation Characteristic (ROC) Plots.

Specific Expertise/Work Experience Needed: 
* Laboratorians with significant experience/expertise in performing and assuring quality of in vitro diagnostic assays.
* IVD manufacturers of clinical laboratory assay reagents and test systems
* Representatives of government agencies responsible for reviewing manufacturers' data for clearance or approval of clinical laboratory assay reagents and test systems.
* Statistical background and experience with ROC plots.

Review the objective of the project, and the requested volunteer expertise, and submit a nomination.

The deadline to submit the nominations, including a curriculum vitae and disclosure of interests form, is 1 May 2006.  Send to Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA 19087. [ return to top ]