Analyte Monitoring Device and Methods of Use

Abstract

An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor has, for example, a substrate, a recessed channel formed in the substrate, and conductive material disposed in the recessed channel to form a working electrode. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte. The analyte monitor may also be part of a drug delivery system to alter the level of the analyte based on the data obtained using the sensor.

1 . (canceled) 
     
     
         2 . A system for measurement of an analyte concentration, the system comprising:
 an implantable sensor configured to measure in vivo a signal indicative of an analyte concentration in a host, wherein the sensor further comprises a membrane located over the sensor;   a processor configured to process sensor data; and   a user interface configured to display information corresponding to sensor data;
 wherein, over a sensor session length of from 3 to 7 days, the system is configured to: 
 provide a level of accuracy corresponding to a first mean absolute relative difference value, wherein one or more reference measurements used to calculate the first mean absolute relative difference are determined by analysis of blood; and 
 provide a level of accuracy corresponding to a second mean absolute relative difference value, wherein one or more reference measurements used to calculate the second mean absolute relative difference are determined by analysis of blood; and 
 wherein the first mean absolute relative difference value is less than or equal to the second mean absolute relative difference value. 
   
     
     
         3 . The system of  claim 2 , wherein the membrane comprises a layer configured to reduce a flux of the analyte. 
     
     
         4 . The system of  claim 3 , wherein the layer comprises a polymer comprising polyurethane. 
     
     
         5 . The system of  claim 3 , wherein the layer comprises a hydrophobic portion and a hydrophilic portion. 
     
     
         6 . The system of  claim 2 , wherein the membrane comprises an enzyme configured to react with the analyte. 
     
     
         7 . The system of  claim 2 , wherein the sensor comprises an electrode configured to oxidize a measured species that is a product of an enzyme-catalyzed reaction with the analyte, whereby the signal is generated.