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 . A sensor control unit comprising:
 a housing adapted for placement on skin and adapted to receive a portion of an electrochemical sensor having a plurality of contact pads;   a plurality of conductive contacts disposed on the housing and configured for coupling to the plurality of contact pads on the sensor; and   a transmitter disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor.   
     
     
         2 - 120 . (canceled) 
     
     
         121 . A method for analyzing data from an analyte sensor, the method comprising:
 receiving data from the analyte sensor, the data comprising at least one sensor data point;   receiving reference data from a reference analyte monitor, the reference data comprising at least one reference data point; and   determining an acceptability of the sensor data or the reference data by subjecting the reference data and substantially time-corresponding sensor data to a boundary test utilizing boundaries.   
     
     
         122 . The method of  claim 121 , wherein the boundaries are derived from prior information. 
     
     
         123 . The method of  claim 122 , wherein the prior information comprises information obtained from at least one of in vivo testing of at least one analyte sensor and in vivo use of at least one analyte sensor. 
     
     
         124 . The method of  claim 121 , further comprising a step of determining acceptability of the reference data, wherein a positive determination of acceptability is determined when the reference data and substantially time-corresponding sensor data fall within the boundaries of the boundary test. 
     
     
         125 . The method of  claim 124 , further comprising using the reference data for calibration of the analyte sensor in response to a positive determination of acceptability. 
     
     
         126 . The method of  claim 124 , further comprising requesting additional reference data in response to a negative determination of acceptability. 
     
     
         127 . The method of  claim 126 , further comprising determining acceptability of the additional reference data, wherein a positive determination of acceptability is determined when the additional reference data and substantially time-corresponding sensor data fall within the boundaries of the boundary test. 
     
     
         128 . The method of  claim 127 , further comprising using the additional reference data for calibration of the analyte sensor in response to a positive determination of acceptability of the additional reference data. 
     
     
         129 . The method of  claim 127 , further comprising using the reference data for calibration of the analyte sensor if the additional reference data substantially corresponds to the reference data. 
     
     
         130 . A system for analyzing data from an analyte sensor, the system comprising:
 a sensor data receiving module configured to receive sensor data from the analyte sensor, the sensor data comprising at least one sensor data point;   a reference data receiving module configured to receive reference data from a reference analyte monitor, the reference data comprising at least one reference data point; and   a processor module configured to determine an acceptability of the sensor data or the reference data by subjecting the reference data and substantially time-corresponding sensor data to a boundary test utilizing boundaries.   
     
     
         131 . The system of  claim 130 , wherein the boundaries are derived from prior information. 
     
     
         132 . The system of  claim 131 , wherein the prior information comprises information obtained from at least one of in vivo testing of at least one analyte sensor and in vivo use of at least one analyte sensor. 
     
     
         133 . The system of  claim 130 , wherein the processor module is configured to determine an acceptability of the reference data, wherein a positive determination of acceptability is determined when the reference data and substantially time-corresponding sensor data fall within the boundaries of the boundary test. 
     
     
         134 . The system of  claim 133 , wherein the processor module is configured to use the reference data for calibration of the analyte sensor in response to a positive determination of acceptability. 
     
     
         135 . The system of  claim 133 , wherein the processor module is configured to request additional reference data in response to a negative determination of acceptability. 
     
     
         136 . The system of  claim 135 , wherein the processor module is configured to determine acceptability of the additional reference data, wherein a positive determination of acceptability is determined when the additional reference data and substantially time-corresponding sensor data fall within the boundaries of the boundary test. 
     
     
         137 . The system of  claim 136 , wherein the processor module is configured to use the additional reference data for calibration of the analyte sensor in response to a positive determination of acceptability of the additional reference data. 
     
     
         138 . The system of  claim 136 , wherein the processor module is configured to use the reference data for calibration of the analyte sensor if the additional reference data substantially corresponds to the reference data. 
     
     
         139 . A system for analyzing data from an analyte sensor, the system comprising:
 a sensor data receiving module configured to receive sensor data from the analyte sensor, the sensor data comprising at least one sensor data point;   a reference data receiving module configured to receive reference data from a reference analyte monitor, the reference data comprising at least one reference data point; and   a processor module configured to perform outlier detection on the reference data or the sensor data, wherein the processor module is further configured to calibrate the analyte sensor.   
     
     
         140 . The system of  claim 139 , wherein the processor module is configured to calibrate the analyte sensor after the system has successfully passed outlier detection. 
     
     
         141 . The system of  claim 139 , wherein outlier detection comprises comparing reference data and time-corresponding sensor data to a boundary test. 
     
     
         142 . The system of  claim 139 , wherein the processor module is configured to detect noise in the sensor signal. 
     
     
         143 . The system of  claim 142 , wherein the processor module is configured to calibrate the analyte sensor only when noise is substantially not detected in the sensor signal.