Accuracy Evaluation of Five Blood Glucose Monitoring Systems Obtained from the Pharmacy: A European Multicenter Study with 453 Subjects

Abstract

Background: This multicenter study was conducted to evaluate the performance of five recently introduced blood glucose (BG) monitoring (BGM) Ò [Bayer Vital GmbH, Leverkusen, Germany]) in a daily routine setting. All devices and strips were purchased from local regular distribution sources (pharmacies, four strip lots per device). The patients performed the finger prick and the glucose measurement on their own. In parallel, a healthcare professional performed the glucose assessment with the reference method (YSI 2300 Stat Plus). The primary objective was the comparison of the mean absolute relative differences (MARD). Secondary objectives were compliance with the International Organization for Standardization (ISO) accuracy criteria under these routine conditions and Clarke and Parkes Error Grid analyses. Results: MARD ranged from 4.9% (FreeStyle Lite) to 9.7% (OneTouch UltraEasy). The ISO 15197:2003 requirements were fulfilled by the FreeStyle Lite (98.8%), FreeStyle Freedom Lite (97.5%), and Accu-Chek Aviva (97.0%), but not by the Contour (92.4%) and OneTouch UltraEasy (91.1%). The number of values in Zone A of the Clarke Error Grid analysis was highest for the FreeStyle Lite (98.8%) and lowest for the OneTouch Ultra Easy (90.4%). Conclusions: FreeStyle Lite, FreeStyle Freedom Lite, and Accu-Chek Aviva performed very well in this study with devices and strips purchased through regular distribution channels, with the FreeStyle Lite achieving the lowest MARD in this investigation.

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

“…One study of test-strip accuracy compared 7 meters and tested 3 teststrip lots for each range and found that lot-to-lot variations were as high as 11% using the same meter (158). Another study found that the difference in bias between widely used BGM devices was as high as 4.8% (159). Underfilling the test strip can introduce errors >20% in some BGMs.…”

Clinical Implications and Economic Impact of Accuracy Differences among Commercially Available Blood Glucose Monitoring Systems

“…[10][11][12][13][14] Within the boundaries of this standard, meters can have very different performance profiles and error patterns.…”

“…This study investigated the measurement performance of five BGM systems independently obtained from pharmacies 10 and analyzed a total of 453 patients (T1DM or T2DM). Each patient was randomized to three out of the five meters.…”

“…Selection of this study as the meter-and-reference-BG paired points source was done as an example of the range of real-life error distribution in present-day BG meters. It is understood that results on a particular meter from different studies [10][11][12][13][14] may result in different performance outcomes. The comparative results in our analysis are meant to evaluate potential implications of accuracy differences using an empirical meter error distribution in lieu of an assumed error distribution (e.g.…”

Accuracy Evaluation of 19 Blood Glucose Monitoring Systems Manufactured in the Asia-Pacific Region: A Multicenter Study

“…To assure quality and provide valuable references for choosing reliable BG meters in the current market, accuracy evaluation of BGMs has been performed extensively by both manufactures and third-party institutions (ie, Institute for Diabetes Technology). [12][13][14] In the past 5 years, there were 21 and 15 large evaluations on the performance of BGMs manufactured in the regions of Europe and North America, respectively, [12][13][14][15][16][17][18][19][20] whereas only 5 studies mentioned a few BGMs manufactured in the Asia-Pacific region. [12][13][14]21,22 Not one single large data was published on BGMs manufactured in different regions of Asia.…”