title: Why the Diabetes Technology Society Surveillance Protocol for Glucose Meters Needs to Be Revised.
abstract: The Diabetes Technology Society surveillance protocol provides a seal of approval for a glucose meter if a sufficient number of a candidate glucose meter's results meet ISO 15197:2013 limits. The protocol provides clear details about how to conduct this study and analyze the data but has two flaws. There is no specification about the size of glucose meter errors that are outside of ISO limits. A meter that has a result in the E zone of a glucose meter error grid could receive the DTS seal of approval. In addition, the protocol uses the ISO standard, which could be considered a "state of the art" standard instead of an error grid, which is a clinical standard. Remedies for these problems are to replace the ISO standard with an error grid and to include requirements for errors found in C or higher zones of an error grid.
authors.affiliation: 1 Krouwer Consulting, Sherborn, MA, USA.
authors.forename: Jan S
authors.initials: JS
authors.lastname: Krouwer
mesh_terms: D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000378:metabolism*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation* / Q000592:standards; D003920:Diabetes Mellitus / Q000097:blood / Q000175:diagnosis*; D006801:Humans; D018670:Monitoring, Ambulatory / Q000295:instrumentation* / Q000592:standards; D017410:Practice Guidelines as Topic; D011237:Predictive Value of Tests; D015203:Reproducibility of Results; D013997:Time Factors
chemical_list: D015415:Biomarkers; D001786:Blood Glucose
keywords: DTS Surveillance Protocol; ISO 15197:2013; error grid; performance specifications