The Accuracy and Efficacy of the Dexcom G4 Platinum Continuous Glucose Monitoring System

Abstract

Background: The purpose of this study was to evaluate the accuracy and efficacy of Dexcom G4 Platinum CGM System. Methods: Seventy-two subjects enrolled at 4 US centers; 61% were male; 83% had T1DM and17% had T2DM. Subjects wore at least 1 system for up to 7 days. Subjects participated in a total of 36 hours in the clinic to contribute YSI reference glucose measurements with venous blood draws every 15 minutes on study Day 1, Day 4, and Day 7. Results:The overall mean absolute relative difference (ARD) versus YSI was 13% with a median of 10%. Precision ARD was 9% ± 4% between 2 sensors with a 7% coefficient of variation. The mean ARD versus SMBG was 14% with a median of 11%. One hundred two (94%) sensors lasted 7 days and the systems displayed 97% of their expected glucose readings in average. The time spent in low CGM readings during nighttime hours decreased from the first night use to the 6th night (P < .001) with a small difference in average CGM glucose from 147 ± 40 mg/dL to 166 ± 62 mg/dL. There were no serious adverse events or infectious complications reported. Conclusions:The study showed the Dexcom G4 Platinum CGM System is one of the most accurate CGMs. The significant reduction in nocturnal time spent in a hypoglycemic state observed during this study suggests that a longer term study of CGM use, especially nocturnal use, could be beneficial for patients with hypoglycemia unawareness.

Continuous Glucose Monitoring: A Review of Successes, Challenges, and Opportunities

“…W hen continuous glucose monitoring (CGM) first became commercially available in the year 2000 its measurement error was more than -20%. 1 Today, overall measurement error has been reduced by twofold (-10%), [2][3][4][5] and accuracy continues to improve. Size, weight, complexity, and cost of CGM sensors/devices have decreased, whereas the duration of use, specificity, user-friendliness, user interface and displays, data management, and software for data analysis have improved.…”

Performance of a new real‐time continuous glucose monitoring system: A multicenter pilot study

“…The commonly used methods for evaluating the accuracy of a CGM system include bias analysis, agreement analysis and error grid analysis (EGA) [5][6][7][8] . There are three major producers of commercial CGM systems: Medtronic MiniMed (Northridge, California, USA), Dexcom (San Diego, California, USA) and Abbott Diabetes Care (Alameda, California, USA), and numerous clinical trials were carried out to investigate the performance of these CGM systems [9][10][11][12] . Furthermore, there were articles that compared the performance of these CGM systems head-to-head [13][14][15] .…”

Role of continuous glucose monitoring in the management of glycogen storage disorders

“…This finding is reassuring as there has long been concerns about reliability of CGMS readings, especially in the lower ranges. Newer CGMS such as the one used in this study have greater accuracy and smaller measurement errors compared to its predecessors as a result of continued clinical research into the performance of CGMS from the time of its introduction in the early 2000s (Damiano et al 2014;Nakamura and Balo 2015). We hope that findings from this study will help to establish CGMS as a standard of care in the management of GSD as it has been in T1DM.…”

“…As a result, most CGMS require calibration with a capillary blood glucose measurement once or twice daily. Attempts are ongoing to improve the accuracy of CGMS readings, especially around low blood glucose values with the advent of newer devices (Laffel 2016;Kovatchev 2015;Nakamura and Balo 2015;Damiano et al 2014;Klonoff et al 2017).…”