Sensor readings show minimal variance in performance
Consensus Error Grid Analysis evaluating CGM accuracy with regard to clinical decisions. CGM errors are translated into the potential clinical consequences of the errors.4 Data are plotted vs YSI reference in the scatterplot, and the error grid is divided into zones, with Zone A representing the greatest accuracy:
Zone A: No effect on clinical action (considered clinically accurate)
Zone B: Altered clinical action, but no or little effect on clinical outcome
Zone C: Altered clinical action—likely to affect clinical outcome
Zone D: Altered clinical action—could have significant medical risk
Zone E: Altered clinical action—could have dangerous consequences
YSI Reference (mg/dL).
N=17,477 paired data points.
93.3% of glucose results within Zone A.
*Data based on the number of patients assigned to each manufacturer based on last filled prescription in US Retail Pharmacy and DME.
†Based on FDA iCGM special controls.
‡MARD (mean absolute relative difference) is compared to reference YSI (Yellow Springs Instrument) values.
References: 1. FreeStyle Libre 2 system User’s Manual. 2. iCGM Special Controls. Accessed Sept 2021. https://www.accessdata.fda.gov/cdrh_docs/pdf17/DEN170088.pdf 3. Data on file. Abbott Diabetes Care. 4. Parkes JL, Slatin SL, Pardo S, Ginsberg BH. A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose. Diabetes Care. 2000;23(8):1143-1148.
ADC-21508 v2.0 09/21