title: The surveillance error grid.
abstract: Currently used error grids for assessing clinical accuracy of blood glucose monitors are based on out-of-date medical practices. Error grids have not been widely embraced by regulatory agencies for clearance of monitors, but this type of tool could be useful for surveillance of the performance of cleared products. Diabetes Technology Society together with representatives from the Food and Drug Administration, the American Diabetes Association, the Endocrine Society, and the Association for the Advancement of Medical Instrumentation, and representatives of academia, industry, and government, have developed a new error grid, called the surveillance error grid (SEG) as a tool to assess the degree of clinical risk from inaccurate blood glucose (BG) monitors. A total of 206 diabetes clinicians were surveyed about the clinical risk of errors of measured BG levels by a monitor. The impact of such errors on 4 patient scenarios was surveyed. Each monitor/reference data pair was scored and color-coded on a graph per its average risk rating. Using modeled data representative of the accuracy of contemporary meters, the relationships between clinical risk and monitor error were calculated for the Clarke error grid (CEG), Parkes error grid (PEG), and SEG. SEG action boundaries were consistent across scenarios, regardless of whether the patient was type 1 or type 2 or using insulin or not. No significant differences were noted between responses of adult/pediatric or 4 types of clinicians. Although small specific differences in risk boundaries between US and non-US clinicians were noted, the panel felt they did not justify separate grids for these 2 types of clinicians. The data points of the SEG were classified in 15 zones according to their assigned level of risk, which allowed for comparisons with the classic CEG and PEG. Modeled glucose monitor data with realistic self-monitoring of blood glucose errors derived from meter testing experiments plotted on the SEG when compared to the data plotted on the CEG and PEG produced risk estimates that were more granular and reflective of a continuously increasing risk scale. The SEG is a modern metric for clinical risk assessments of BG monitor errors that assigns a unique risk score to each monitor data point when compared to a reference value. The SEG allows the clinical accuracy of a BG monitor to be portrayed in many ways, including as the percentages of data points falling into custom-defined risk zones. For modeled data the SEG, compared with the CEG and PEG, allows greater precision for quantifying risk, especially when the risks are low. This tool will be useful to allow regulators and manufacturers to monitor and evaluate glucose monitor performance in their surveillance programs.
authors.affiliation: Mills-Peninsula Health Services, San Mateo, CA, USA dklonoff@diabetestechnology.org.
authors.forename: David C
authors.initials: DC
authors.lastname: Klonoff
authors.affiliation: US Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Courtney
authors.initials: C
authors.lastname: Lias
authors.affiliation: Walter Reed National Military Medical Center, Bethesda, MD, USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Vigersky
authors.affiliation: University of Virginia, Charlottesville, VA, USA.
authors.forename: William
authors.initials: W
authors.lastname: Clarke
authors.affiliation: Joan Lee Parkes Consulting Inc, Bristol, IN, USA.
authors.forename: Joan Lee
authors.initials: JL
authors.lastname: Parkes
authors.affiliation: National Institutes of Health, Bethesda, MD, USA.
authors.forename: David B
authors.initials: DB
authors.lastname: Sacks
authors.affiliation: University of North Carolina, Chapel Hill, NC, USA.
authors.forename: M Sue
authors.initials: MS
authors.lastname: Kirkman
authors.affiliation: University of Virginia, Charlottesville, VA, USA.
authors.forename: Boris
authors.initials: B
authors.lastname: Kovatchev
mesh_terms: D000328:Adult; D000367:Age Factors; D000465:Algorithms; D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000706:statistics & numerical data*; D002648:Child; D032921:Consensus; D003920:Diabetes Mellitus / Q000097:blood; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy; D019538:Health Care Surveys; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D015203:Reproducibility of Results; D018570:Risk Assessment
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents
keywords: accuracy; blood glucose; error grid; monitor; surveillance