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.
Mahoney
John J
JJ
Department of Global Product Support, LifeScan, Inc., Milpitas, California 95035-6312, USA. jmahoney@lfsus.jnj.com
Ellison
John M
JM
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