The Accuracy of Point-of-Care Glucose Measurements

Abstract

Control of blood glucose (BG) in an acceptable range is a major therapy target for diabetes patients in both the hospital and outpatient environments. This review focuses on the state of point-of-care (POC) glucose monitoring and the accuracy of the measurement devices. The accuracy of the POC glucose monitor depends on device methodology and other factors, including sample source and collection and patient characteristics. Patient parameters capable of influencing measurements include variations in pH, blood oxygen, hematocrit, changes in microcirculation, and vasopressor therapy. These elements alone or when combined can significantly impact BG measurement accuracy with POC glucose monitoring devices (POCGMDs). In general, currently available POCGMDs exhibit the greatest accuracy within the range of physiological glucose levels but become less reliable at the lower and higher ranges of BG levels. This issue raises serious safety concerns and the importance of understanding the limitations of POCGMDs. This review will discuss potential interferences and shortcomings of the current POCGMDs and stress when these may impact the reliability of POCGMDs for clinical decision-making.

American Association Of Clinical Endocrinologists And American College Of Endocrinology 2016 Outpatient Glucose Monitoring Consensus Statement

“…Since it is only recently that any devices have even approached such performance, regulatory criteria for device approval have been more pragmatic, focusing on the hazards of incorrect readings (e.g., suboptimal treatment decisions, including improper adjustments in medication dosage, potentially increasing the frequency of both hypoglycemia and hyperglycemia) (58). Accuracy, ergonomics, and ease of use of blood glucose meters have improved dramatically over time (124)(125)(126), and the accuracy of CGM is beginning to approach that of BGM devices (113,114,(127)(128)(129)(130). However, a clinically significant variation in accuracy and precision persists among currently marketed GM devices.…”

Analytic Evaluation of a New Glucose Meter System in 15 Different Critical Care Settings

“…The analytic performance of this meter appears to exceed any of those described in a review of 43 studies of glucose meter accuracy. 25 Moreover, the performance of the Roche meter appears to be similar or superior to that of the blood gas analyzer used in the original study of Van den Berghe and coauthors. 6 That device had day-to-day imprecision (coefficients of variation) of 2.79% and 3.49% at mean glucose concentrations of 92 and 220 mg/dl (from Bouilon via personal email to David E. Bruns, March 1, 2002).…”

Performance of Point-of-Care Diagnostics for Glucose, Lactate, and Hemoglobin in the Management of Severe Malaria in a Resource-Constrained Hospital in Uganda

“…The OneTouch device may be a less sensitive method for detecting hypoglycemia, which may lead to underrecognition of clinically significant hypoglycemia, which was previously documented with other point-of-care glucose sensors. 18 Upward adjustment of a treatment threshold (e.g., to~5 mmol/L) based on the instrument bias might be considered and would have captured all cases of hypoglycemia in our series. Previous studies comparing the i-STAT glucose 12 and the One Touch Ultra instruments 3,6,8 to reference standards have generally shown a high level of accuracy and tighter precision than suggested by our findings, perhaps related to greater variability under field conditions of either or both instruments.…”