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.
Department of Global Product Support, LifeScan, Inc., Milpitas, California 95035-6312, USA. jmahoney@lfsus.jnj.com
John J
JJ
Mahoney
John M
JM
Ellison
D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation* / Q000592:standards; D002138:Calibration; D005069:Evaluation Studies as Topic; D006801:Humans; D018579:Patient Selection; D012015:Reference Standards; D012107:Research Design; D018401:Sample Size
D001786:Blood Glucose