Visual Abstract
Continuous glucose monitors (CGMs) are increasingly becoming indispensable in everyday diabetes management. This study assessed the accuracy of the new GlucoMen Day® CGM (Waveform Cascade, launched by A. Menarini Diagnostics) by comparing it to a laboratory reference instrument and a self-monitoring blood glucose (SMBG) device. Eight individuals with type 1 diabetes (3 females, age 41.6 ± 13.3 years, BMI 28.0 ± 6.1 kg/m2, HbA1c 55.6 ± 12.2 mmol/mol, diabetes duration 13.9 ± 6.5 years) spent 14 days at home simultaneously wearing two CGMs in the abdominal subcutaneous adipose tissue while also performing a minimum of five SMBG measurements (GlucoMen Day® Meter, A. Menarini Diagnostics, IT) per day. On days four and ten of sensor wear, the participants underwent a 5-hour meal and insulin challenge at the research center. The plasma glucose concentration was determined in 20-min intervals with a laboratory reference instrument (YSI 2300 Stat Plus, Yellow Springs, OH). The CGM accuracy was assessed by calculating the mean absolute relative difference (MARD) and by performing the consensus error grid analysis (CEG). The overall MARDs calculated for YSI and SMBG were 9.7 % and 13.1 %, respectively. The CEG analysis showed that 98% of all data points were in the clinically acceptable zones A and B. The study data indicate that the CGM accuracy meets the current clinical requirements for state-of-the-art continuous glucose monitors.
A. Simic: None. M. T. Taucher: None. D. A. Hochfellner: None. T. Poettler: None. F. Aberer: None. J. K. Mader: Advisory Panel; Self; Becton, Dickinson and Company, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Medtronic, Roche Diabetes Care, Speaker's Bureau; Self; Abbott Diabetes, Novo Nordisk A/S, Roche Diabetes Care, Sanofi, Stock/Shareholder; Self; decide Clinical Software GmbH.
A. Menarini Diagnostics
