Assessing glucose monitor performance--a standardized approach.

Background: Glucose monitor evaluations must be carefully designed and executed in order to control protocol-specific bias and random patient interferences. Although published guidelines and recommendations exist, investigators rarely incorporate consensus standards or quality guidelines into glucose monitor evaluation studies.

Methods: We performed a literature search for "best practice" quality guidelines for conducting and reporting glucose monitor evaluation studies. These guidelines included: Standards for Reporting Diagnostic Accuracy (STARD); Clinical and Laboratory Standards Institute (CLSI) C30-A2 and EP9-A2; U.S. Food and Drug Administration (FDA); International Federation of Clinical Chemistry (IFCC); Netherlands Organization for Applied Scientific Research (TNO); U.K. Medicines and Healthcare products Regulatory Agency (MHRA); Scandinavian evaluation of laboratory equipment for primary health care (SKUP); National Standard of the People's Republic of China (China GB/T 19634); and International Standards Organization (ISO 15197).

Results: We constructed a checklist that outlines a standardized approach to glucose monitor evaluations, along with associated references applicable to international standards and consensus recommendations. We expect that the checklist could be used as the basis for a protocol that is (1) evidence-based, (2) scientifically defensible, and (3) sufficiently descriptive to allow for test and result reproducibility.

Conclusions: We propose a standardized 14-step checklist that facilitates the incorporation of international consensus standards, quality guidelines, and acceptance criteria into the design and reporting of glucose monitor evaluation protocols.