Analyte Monitoring System and Method

Abstract

Devices and methods for monitoring an analyte are provided. Embodiments include continuous analyte sensors having a high degree of accuracy.

1 . An analyte monitoring system, comprising:
 an analyte sensor configured to detect one or more analyte levels of a patient;   a transmitter unit operatively coupled to the analyte sensor, the transmitter unit configured to transmit one or more signals associated with the detected one or more analyte levels; and   a receiver unit configured to receive the transmitted one or more signals associated with the detected one or more analyte levels;
 wherein the accuracy of the detected one or more analyte levels relied upon to make a clinically relevant decision is established without using a blood glucose measurement. 
   
     
     
         2 . The system of  claim 1  where clinically relevant decision includes healthcare decision. 
     
     
         3 . The system of  claim 1  wherein the clinically relevant decision includes a bolus amount determination. 
     
     
         4 . The system of  claim 1  wherein the blood glucose measurement includes a confirmatory blood glucose measurement. 
     
     
         5 . The system of  claim 1  wherein the detected one or more analyte level is calibrated. 
     
     
         6 . The system of  claim 1  wherein the detected one or more analyte levels is calibrated using single point calibration. 
     
     
         7 . The system of  claim 1  wherein the transmitter unit is configured to wirelessly transmit the one or more signals to the receiver unit. 
     
     
         8 . The system of  claim 1 , wherein the analyte sensor has at least about 85% of its paired data points within zone A and at least about 95% of its paired data points within zone A and zone B of the Clarke Error Grid.