Journal of diabetes science and technology · 2025
Performance of Three Continuous Glucose Monitoring Systems in Adults With Type 1 Diabetes.
СтатьяСравнительное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Eichenlaub Manuel, Waldenmaier Delia, Wehrstedt Stephanie, Pleus Stefan, Link Manuela, Jendrike Nina, Öter Sükrü, Haug Cornelia, Schinz Maren, Braunack-Mayer Vincent, Schneider Regula, Brandt Derek, Freckmann Guido
Аннотация
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.
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.