Manuel Eichenlaub, Delia Waldenmaier, Stephanie Wehrstedt, Stefan Pleus, Manuela Link, Nina Jendrike, Sükrü Öter, Cornelia Haug, Maren Schinz, Vincent Braunack-Mayer, Regula Schneider, Derek Brandt, Guido Freckmann
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引用次数: 0
Abstract
Background: The performance of continuous glucose monitoring (CGM) systems is difficult to compare due to different study designs and a lack of head-to-head studies. This study evaluated the performance of FreeStyle Libre 3 (FL3), Dexcom G7 (DG7), and Medtronic Simplera (MSP) against different comparator methods and during clinically relevant glycemic scenarios.
Method: Twenty-four adult participants with type 1 diabetes mellitus wore one sensor of each CGM system in parallel for up to 15 days. Sensors of DG7 and MSP were exchanged on days 5 and 8, respectively. Three 7-hour sessions with 15-minute comparator blood glucose-level measurements using YSI 2300 (YSI, venous), Cobas Integra (INT, venous), and Contour Next (CNX, capillary) were conducted on days 2, 5, and 15. Simultaneously, glucose-level excursions with transient hyperglycemia and hypoglycemia were induced according to a recently published testing procedure. The accuracy was evaluated using various metrics, including mean absolute relative differences (MARDs).
Results: Compared with YSI data, the MARDs of FL3, DG7, and MSP were 11.6%, 12.0%, and 11.6%, respectively. Relative to the INT data, the corresponding MARDs were 9.5%, 9.9%, and 13.9%, respectively, and compared with CNX data, MARDs were 9.7%, 10.1%, and 16.6%, respectively. Both FL3 and DG7 showed better accuracy in the normoglycemic and hyperglycemic range, while MSP performed better in the hypoglycemic range.
Conclusions: Performance results of all CGM systems varied depending on the comparator method. However, across comparators FL3 and DG7 tended to be more accurate compared with MSP. All CGM systems showed a lower accuracy compared with previous studies, emphasizing the need for comprehensive study design guidelines.
期刊介绍:
The Journal of Diabetes Science and Technology (JDST) is a bi-monthly, peer-reviewed scientific journal published by the Diabetes Technology Society. JDST covers scientific and clinical aspects of diabetes technology including glucose monitoring, insulin and metabolic peptide delivery, the artificial pancreas, digital health, precision medicine, social media, cybersecurity, software for modeling, physiologic monitoring, technology for managing obesity, and diagnostic tests of glycation. The journal also covers the development and use of mobile applications and wireless communication, as well as bioengineered tools such as MEMS, new biomaterials, and nanotechnology to develop new sensors. Articles in JDST cover both basic research and clinical applications of technologies being developed to help people with diabetes.