Effects of Measurement Frequency on Analytical Quality Required for Glucose Measurements in Intensive Care Units: Assessments by Simulation Models

Abstract

Abstract BACKGROUND Total error allowances have been proposed for glucose meters used in tight-glucose-control (TGC) protocols. It is unclear whether these proposed quality specifications are appropriate for continuous glucose monitoring (CGM). METHODS We performed Monte Carlo simulations of patients on TGC protocols. To simulate use of glucose meters, measurements were made hourly. To simulate CGM, glucose measurements were made every 5 min. Glucose was measured with defined bias (varied from −20% to 20%) and imprecision (0% to 20% CV). The measured glucose concentrations were used to alter insulin infusion rates according to established treatment protocols. Changes in true glucose were calculated hourly on the basis of the insulin infusion rate, the modeled patient's insulin sensitivity, and a model of glucose homeostasis. We modeled 18 000 patients, equally divided between the hourly and every-5-min measurement schemas and distributed among 45 combinations of bias and imprecision and 2 treatment protocols. RESULTS With both treatment protocols and both measurement frequencies, higher measurement imprecision increased the rates of hypoglycemia and hyperglycemia and increased glycemic variability (SD). These adverse effects of measurement imprecision were lower at the higher measurement frequency. The rate of hypoglycemia at an imprecision (CV) of 5% with hourly measurements was similar to the rate of hypoglycemia at 10% CV when measurements were made every 5 min. With measurements every 5 min, imprecision up to 10% had minimal effects on hyperglycemia or glycemic variability. Effects of simulated analytical bias on glycemia were unaffected by measurement frequency. CONCLUSIONS Quality specifications for imprecision of glucose meters are not transferable to CGM.