In clinical studies of the FreeStyle Libre System, an evaluation tool used was a Consensus Error Grid (CEG), a scatter chart divided into 5 performance zones. For the FreeStyle Libre system, 99.9% of the readings fell within the two desirable zones of the grid (Zones A and B) for adults, and 100% of the readings fell within the two desirable zones of the grid (Zones A and B) for pediatrics. Results in Zones A and B have no effect on the clinical action (clinical accuracy) or the action would have little effect on the clinical outcome.*
*Data on File, Abbott Diabetes Care Inc, FreeStyle Libre 2 System Performance Data Sheet.