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 method for self diagnosis of a continuous analyte sensor, the method comprising:
 receiving a stream of sensor data from a continuous analyte sensor, the stream comprising at least one sensor data point;   converting the sensor data into calibrated data using a conversion function;   performing a self diagnostic test on the sensor data or the calibrated data to detect noise within the sensor data;   setting a suspended mode of operation of the continuous analyte sensor in response to a detection of noise within the sensor data, wherein the suspended mode comprises suspending display of data; and   measuring an amount of time a sensor has been in the suspended mode.   
     
     
         3 . The method of  claim 2 , wherein the step of performing a self diagnostic test comprises evaluating a rate of change of the calibrated data or a rate of change of the sensor data. 
     
     
         4 . The method of  claim 2 , wherein the step of setting a suspended mode of operation further comprises suspending conversion of sensor data. 
     
     
         5 . The method of  claim 4  wherein suspending conversion of sensor data includes suspending a continuous conversion of sensor data. 
     
     
         6 . The method of  claim 2 , wherein the step of performing a self diagnostic test comprises measuring one or more additional analytes. 
     
     
         7 . The method of  claim 6 , wherein the step of performing a self diagnostic test comprises measuring an oxygen concentration. 
     
     
         8 . The method of  claim 2 , wherein the step of performing a self diagnostic test comprises intermittently or continuously evaluating signal residuals. 
     
     
         9 . The method of  claim 8  wherein intermittently or continuously evaluating signal residuals includes comparing raw and filtered data to detect noise above a predetermined level. 
     
     
         10 . The method of  claim 2 , wherein the step of performing a self diagnostic test comprises performing pattern recognition. 
     
     
         11 . The method of  claim 2  wherein the step of performing a self diagnostic test comprises performing pattern recognition to identify noise associated with physiological conditions. 
     
     
         12 . The method of  claim 2 , wherein the step of performing a self diagnostic test comprises evaluating a clinical acceptability of the sensor data. 
     
     
         13 . The method of  claim 2 , wherein the step of performing a self diagnostic test comprises evaluating a clinical acceptability of the received additional sensor data. 
     
     
         14 . The method of  claim 2 , wherein the step of performing a self diagnostic test comprises detecting a signal associated with one or more interfering species on the sensor signal. 
     
     
         15 . The method of  claim 2 , wherein the step of performing a self diagnostic test comprises determining a number of times the self diagnostic test detects noise above the predetermined level. 
     
     
         16 . The method of  claim 2 , wherein the step of performing a self diagnostic test comprises maintaining a count comprising a number of times the self diagnostic test detects noise above the predetermined level. 
     
     
         17 . The method of  claim 16 , further comprising determining that a reset, failure or replacement of a sensor is required in response to the count exceeding a predetermined threshold. 
     
     
         18 . The method of  claim 17 , wherein the step of determining that a reset, failure or replacement of a sensor is required is in response to the count exceeding a predetermined threshold for a predetermined time period. 
     
     
         19 . The method of  claim 2 , further comprising setting a start up mode after the sensor has been in suspended mode for a predetermined time period. 
     
     
         20 . The method of  claim 2 , further comprising measuring an amount of time a sensor has been in the suspended mode. 
     
     
         21 . The method of  claim 20 , further comprising determining that a reset, failure or replacement of a sensor is required in response to the amount of time in suspended mode exceeding a threshold. 
     
     
         22 . The method of  claim 20 , further comprising requesting reference analyte data in response to the amount of time in suspended mode exceeding a threshold. 
     
     
         23 . The method of  claim 2 , wherein the suspended mode is continuously maintained until the self diagnostic test no longer detects noise above a predetermined level. 
     
     
         24 . The method of  claim 2 , further comprising setting a normal mode of operation when the self diagnostic test no longer detects noise above a predetermined level, wherein the normal mode comprises displaying calibrated analyte sensor data. 
     
     
         25 . The method of  claim 2 , wherein the suspended mode does not suspend conversion of the sensor data into calibrated data. 
     
     
         26 . The method of  claim 2 , wherein the calibration of the sensor comprises determining a conversion function.