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 .- 120 . (canceled) 
     
     
         121 . A system for monitoring glucose concentration in a biological sample of a host, the system comprising:
 a continuous glucose sensor that produces a data stream indicative of a host's glucose concentration, wherein the continuous glucose sensor comprises a sensing region and a sensing membrane located over the sensing region;   an integrated receiver that receives the data stream from the continuous glucose sensor, wherein the integrated receiver comprises a housing, and wherein the housing comprises:
 a processor module comprising programming to process the data stream received from glucose sensor; 
 a single point glucose monitor adapted to receive a biological sample from the host and measure the concentration of glucose in the sample, wherein electronics associated with the single point monitor are non-releasably located on the housing, wherein the single point glucose monitor further comprises a sensing region and a sensing membrane located over the sensing region; and 
   wherein the processor module further comprises programming to calibrate the data stream using the glucose concentration measured by the single point glucose monitor.   
     
     
         122 . The system of  claim 121 , wherein the continuous glucose sensor comprises an electrochemical cell that measures the glucose concentration. 
     
     
         123 . The system of  claim 122 , wherein the single point glucose monitor comprises an electrochemical cell that measures a concentration of glucose in the sample. 
     
     
         124 . The system of  claim 121 , wherein the integrated receiver further comprises a user interface for displaying glucose concentration data from the continuous glucose sensor and the single point glucose monitor. 
     
     
         125 . The system of  claim 121 , wherein the sensing membrane of each of the continuous sensor and the single point monitor comprise an enzyme domain, and wherein the enzyme domain of the sensing membrane of the continuous sensor and the enzyme domain of the sensing membrane of the single point monitor are substantially similar. 
     
     
         126 . The system of  claim 121 , wherein the continuous glucose sensor and the single point glucose monitor use similar measurement technologies, and wherein the similar measurement technologies used for both the continuous glucose sensor and the single point glucose monitor comprise the same technology selected from the group consisting of enzymatic, chemical, and/or electrochemical technologies. 
     
     
         127 . The system of  claim 121 , wherein the sensing membrane of the single point glucose monitor comprises one or more domains and/or layers that are the same as one or more domains and/or layers of the sensing membrane of the continuous glucose sensor. 
     
     
         128 . The system of  claim 127 , wherein an enzyme domain of the sensing membrane of the continuous glucose sensor and an enzyme domain of the sensing membrane of the single point glucose monitor comprise same materials. 
     
     
         129 . The system of  claim 127 , wherein the sensing membrane of the single point glucose monitor comprises two or more domains and/or layers that are the same as two or more domains and/or layers of the sensing membrane of the continuous glucose sensor. 
     
     
         130 . The system of  claim 129 , wherein the sensing membrane of the single point glucose monitor comprises three or more domains and/or layers that are the same as three or more domains and/or layers of the sensing membrane continuous glucose sensor. 
     
     
         131 . The system of  claim 121 , wherein the sensing membrane of the single point glucose monitor comprises two or more materials that are the same as two or more materials of the sensing membrane of the continuous glucose sensor. 
     
     
         132 . The system of  claim 131 , wherein the sensing membrane of the single point glucose monitor comprises three or more materials that are the same as three or more materials of the sensing membrane of the continuous glucose sensor. 
     
     
         133 . The system of  claim 121 , wherein the sensing region and/or the sensing membrane of the single point glucose monitor is located on a test strip configured to be releasably received by the single point glucose monitor. 
     
     
         134 . The system of  claim 121 , wherein the sensing membrane comprises an enzyme. 
     
     
         135 . A method for calibrating a continuous glucose sensor within an integrated receiver housing comprising a processor module comprising programming to process a data stream received from a continuous glucose sensor and a single point glucose monitor adapted to receive a biological sample from the host and measure the concentration of glucose in the sample, wherein each of the continuous sensor and the single point monitor comprise a sensing region comprising a sensing membrane, the method comprising:
 continually receiving a data stream in the integrated receiver housing from a continuous glucose sensor;   measuring a glucose concentration of a biological sample using a single point glucose monitor, wherein electronics associated with the single point glucose monitor are non-releasably located on the integrated receiver housing; and   calibrating the data stream within the integrated receiver using the glucose concentration measured by the single point glucose monitor.   
     
     
         136 . The method of  claim 135 , further comprising the step of: displaying the glucose concentration measured by the single point glucose monitor. 
     
     
         137 . The method of  claim 135 , further comprising the step of: displaying a calibrated data stream. 
     
     
         138 . The method of  claim 135 , wherein the sensing membrane of each of the continuous sensor and the single point monitor comprise an enzyme domain, and wherein the enzyme domain of the sensing membrane of the continuous sensor and the enzyme domain of the sensing membrane of the single point monitor are substantially similar. 
     
     
         139 . The method of  claim 135 , wherein the continuous glucose sensor and the single point glucose monitor use similar measurement technologies, and wherein the similar measurement technologies used for both the continuous glucose sensor and the single point glucose monitor comprise the same technology selected from the group consisting of enzymatic, chemical, physical, and/or electrochemical. 
     
     
         140 . The method of  claim 136 , wherein the sensing membrane of the single point glucose monitor comprises one or more domains and/or layers that are the same as one or more domains and/or layers of the sensing membrane of the continuous glucose sensor. 
     
     
         141 . The method of  claim 140 , wherein an enzyme domain of the sensing membrane of the continuous glucose sensor and an enzyme domain of the sensing membrane of the single point glucose monitor comprise same materials. 
     
     
         142 . The method of  claim 140 , wherein the sensing membrane of the single point glucose monitor comprises two or more domains and/or layers that are the same as two or more domains and/or layers of the sensing membrane of the continuous glucose sensor. 
     
     
         143 . The method of  claim 142 , wherein the sensing membrane of the single point glucose monitor comprises three or more domains and/or layers that are the same as three or more domains and/or layers of the sensing membrane continuous glucose sensor. 
     
     
         144 . The method of  claim 135 , wherein the sensing membrane of the single point glucose monitor comprises two or more materials and/or layers that are the same as two or more materials of the sensing membrane of the continuous glucose sensor. 
     
     
         145 . The method of  claim 144 , wherein the sensing membrane of the single point glucose monitor comprises three or more materials and/or layers that are the same as three or more materials of the sensing membrane of the continuous glucose sensor. 
     
     
         146 . The method of  claim 135 , wherein the sensing region and/or the sensing membrane of the single point glucose monitor is located on a test strip configured to be releasably received by the single point glucose monitor. 
     
     
         147 . A system for calibrating a continuous glucose sensor data, the system comprising:
 an integrated receiver comprising an integrated receiver housing, wherein the integrated receiver housing comprises:
 a single point glucose monitor integral with the housing and adapted to measure a glucose concentration in a biological sample; 
 a receiver for receiving a data stream from a continuous glucose sensor; 
 a processor module comprising programming to calibrate the data stream from a continuous glucose sensor using the glucose concentration measured from the single point glucose monitor, wherein each of the continuous sensor and the single point monitor comprise a sensing region comprising a sensing membrane, wherein the sensing membrane of the single point glucose monitor comprises one or more domains and/or layers that are the same as one or more domains and/or layers of the sensing membrane of the continuous glucose sensor. 
   
     
     
         148 . The system of  claim 147 , wherein an enzyme domain of the sensing membrane of the continuous glucose sensor and an enzyme domain of the sensing membrane of the single point glucose monitor comprise same materials. 
     
     
         149 . The system of  claim 147 , wherein the sensing membrane of the single point glucose monitor comprises two or more domains and/or layers that are the same as two or more domains and/or layers of the sensing membrane of the continuous glucose sensor. 
     
     
         150 . The system of  claim 149 , wherein the sensing membrane of the single point glucose monitor comprises three or more domains and/or layers that are the same as three or more domains and/or layers of the sensing membrane continuous glucose sensor. 
     
     
         151 . The system of  claim 147 , further comprising a continuous glucose sensor, wherein the continuous glucose sensor produces a data stream indicative of a glucose concentration in a host, and wherein the continuous glucose sensor further comprises an electrochemical cell configured to measure the glucose concentration. 
     
     
         152 . The system of  claim 151 , wherein the single point glucose monitor comprises an electrochemical cell configured to measure the glucose concentration in the biological sample. 
     
     
         153 . The system of  claim 151 , further comprising a user interface configured to display glucose data from at least one of the continuous glucose sensor and the single point glucose monitor. 
     
     
         154 . The system of  claim 147 , wherein the single point glucose monitor comprises at least two electrodes, wherein the sensing region of the single point glucose monitor is located within the integrated receiver. 
     
     
         155 . The system of  claim 147 , wherein the sensing membrane of the single point glucose monitor comprises two or more materials that are the same as two or more materials of the sensing membrane of the continuous glucose sensor. 
     
     
         156 . The system of  claim 155 , wherein the sensing membrane of the single point glucose monitor comprises three or more materials that are the same as three or more materials of the sensing membrane of the continuous glucose sensor. 
     
     
         157 . The system of  claim 147 , wherein the sensing region and/or the sensing membrane of the single point glucose monitor is located on a test strip configured to be releasably received by the single point glucose monitor. 
     
     
         158 . The system of  claim 147 , wherein the sensing membrane comprises an enzyme. 
     
     
         159 . A system for calibrating a continuous glucose sensor data, the system comprising:
 an integrated receiver comprising an integrated receiver housing, wherein the integrated receiver housing comprises:
 a single point glucose monitor integral with the housing and adapted to measure a glucose concentration in a biological sample; 
 a receiver for receiving a data stream from a continuous glucose sensor; 
 a processor module comprising programming to calibrate the data stream from a continuous glucose sensor using the glucose concentration measured from the single point glucose monitor, wherein each of the continuous sensor and the single point monitor comprise a sensing region comprising a sensing membrane, wherein the sensing membrane of the single point glucose monitor comprises two or more materials that are the same as two or more materials of the sensing membrane of the continuous glucose sensor. 
   
     
     
         160 . The system of  claim 159 , wherein the sensing membrane of the single point glucose monitor comprises three or more materials that are the same as three or more materials of the sensing membrane of the continuous glucose sensor. 
     
     
         161 . The system of  claim 159 , further comprising a continuous glucose sensor, wherein the continuous glucose sensor produces a data stream indicative of a glucose concentration in a host, and wherein the continuous glucose sensor further comprises an electrochemical cell configured to measure the glucose concentration. 
     
     
         162 . The system of  claim 159 , wherein the single point glucose monitor comprises an electrochemical cell configured to measure the glucose concentration in the biological sample. 
     
     
         163 . The system of  claim 159 , further comprising a user interface configured to display glucose data from at least one of the continuous glucose sensor and the single point glucose monitor. 
     
     
         164 . The system of  claim 159 , wherein the single point glucose monitor comprises at least two electrodes, wherein the sensing region of the single point glucose monitor is located within the integrated receiver. 
     
     
         165 . The system of  claim 159 , wherein the sensing membrane of the single point glucose monitor comprises one or more domains and/or layers that are the same as one or more domains and/or layers of the sensing membrane of the continuous glucose sensor. 
     
     
         166 . The system of  claim 165 , wherein an enzyme domain of the sensing membrane of the continuous glucose sensor and an enzyme domain of the sensing membrane of the single point glucose monitor comprise same materials. 
     
     
         167 . The system of  claim 165 , wherein the sensing membrane of the single point glucose monitor comprises two or more domains and/or layers that are the same as two or more domains and/or layers of the sensing membrane of the continuous glucose sensor. 
     
     
         168 . The system of  claim 167 , wherein the sensing membrane of the single point glucose monitor comprises three or more domains and/or layers that are the same as three or more domains and/or layers of the sensing membrane continuous glucose sensor. 
     
     
         169 . The system of  claim 159 , wherein the sensing region and/or the sensing membrane of the single point glucose monitor is located on a test strip configured to be releasably received by the single point glucose monitor. 
     
     
         170 . The system of  claim 159 , wherein the single point glucose monitor is integrally formed within the housing. 
     
     
         171 . The system of  claim 159 , wherein the sensing membrane comprises an enzyme. 
     
     
         172 . A system for monitoring glucose concentration in a biological sample of a host, the system comprising:
 a continuous glucose sensor that produces a data stream indicative of a host's glucose concentration, wherein the continuous glucose sensor comprises a sensing region and a sensing membrane located over the sensing region;   an integrated receiver that receives the data stream from the continuous glucose sensor, wherein the integrated receiver comprises a housing, and wherein the housing comprises:
 a processor module comprising programming to process the data stream received from glucose sensor; and 
 a single point glucose monitor adapted to receive a biological sample from the host and measure the concentration of glucose in the sample, wherein the single point monitor is non-releasably located on the housing, wherein the single point glucose monitor comprises a sensing region and a sensing membrane located over the sensing region; 
 wherein the processor module further comprises programming to calibrate the data stream using the glucose concentration measured by the single point glucose monitor. 
   
     
     
         173 . The system of  claim 172 , wherein the continuous glucose sensor comprises an electrochemical cell that measures the glucose concentration. 
     
     
         174 . The system of  claim 173 , wherein the single point glucose monitor comprises an electrochemical cell that measures a concentration of glucose in the sample. 
     
     
         175 . The system of  claim 171 , wherein the integrated receiver further comprises a user interface for displaying glucose concentration data from the continuous glucose sensor and the single point glucose monitor. 
     
     
         176 . The system of  claim 171 , wherein the sensing membrane of each of the continuous sensor and the single point monitor comprise an enzyme domain, and wherein the enzyme domain of the sensing membrane of the continuous sensor and the enzyme domain of the sensing membrane of the single point monitor are substantially similar. 
     
     
         177 . The system of  claim 171 , wherein the continuous glucose sensor and the single point glucose monitor use similar measurement technologies, and wherein the similar measurement technologies used for both the continuous glucose sensor and the single point glucose monitor comprise the same technology selected from the group consisting of enzymatic, chemical, and/or electrochemical technologies. 
     
     
         178 . The system of  claim 171 , wherein the sensing membrane of the single point glucose monitor comprises one or more domains and/or layers that are the same as one or more domains and/or layers of the sensing membrane of the continuous glucose sensor. 
     
     
         179 . The system of  claim 177 , wherein an enzyme domain of the sensing membrane of the continuous glucose sensor and an enzyme domain of the sensing membrane of the single point glucose monitor comprise same materials. 
     
     
         180 . The system of  claim 177 , wherein the sensing membrane of the single point glucose monitor comprises two or more domains and/or layers that are the same as two or more domains and/or layers of the sensing membrane of the continuous glucose sensor. 
     
     
         181 . The system of  claim 179 , wherein the sensing membrane of the single point glucose monitor comprises three or more domains and/or layers that are the same as three or more domains and/or layers of the sensing membrane continuous glucose sensor. 
     
     
         182 . The system of  claim 171 , wherein the sensing membrane of the single point glucose monitor comprises two or more materials and/or layers that are the same as two or more materials of the sensing membrane of the continuous glucose sensor. 
     
     
         183 . The system of  claim 181 , wherein the sensing membrane of the single point glucose monitor comprises three or more materials and/or layers that are the same as three or more materials of the sensing membrane of the continuous glucose sensor. 
     
     
         184 . The system of  claim 171 , wherein the sensing region and/or the sensing membrane of the single point glucose monitor is located on a test strip configured to be releasably received by the single point glucose monitor. 
     
     
         185 . A method for calibrating a continuous glucose sensor within an integrated receiver housing comprising a processor module comprising programming to process a data stream received from a continuous glucose sensor and a single point glucose monitor adapted to receive a biological sample from the host and measure the concentration of glucose in the sample, wherein each of the continuous sensor and the single point monitor comprise a sensing region comprising a sensing membrane, the method comprising:
 continually receiving a data stream in the integrated receiver housing from a continuous glucose sensor;   measuring a glucose concentration of a biological sample using a single point glucose monitor non-releasably located on the integrated receiver housing; and   calibrating the data stream within the integrated receiver using the glucose concentration measured by the single point glucose monitor.   
     
     
         186 . The method of  claim 184 , further comprising the step of: displaying the glucose concentration measured by the single point glucose monitor. 
     
     
         187 . The method of  claim 184 , further comprising the step of: displaying a calibrated data stream. 
     
     
         188 . The method of  claim 184 , wherein the sensing membrane of each of the continuous sensor and the single point monitor comprise an enzyme domain, and wherein the enzyme domain of the sensing membrane of the continuous sensor and the enzyme domain of the sensing membrane of the single point monitor are substantially similar. 
     
     
         189 . The method of  claim 184 , wherein the continuous glucose sensor and the single point glucose monitor use similar measurement technologies, and wherein the similar measurement technologies used for both the continuous glucose sensor and the single point glucose monitor comprise the same technology selected from the group consisting of enzymatic, chemical, and/or electrochemical technologies. 
     
     
         190 . The method of  claim 184 , wherein the sensing membrane of the single point glucose monitor comprises one or more domains and/or layers that are the same as one or more domains and/or layers of the sensing membrane of the continuous glucose sensor. 
     
     
         191 . The method of  claim 189 , wherein an enzyme domain of the sensing membrane of the continuous glucose sensor and an enzyme domain of the sensing membrane of the single point glucose monitor comprise same materials. 
     
     
         192 . The method of  claim 189 , wherein the sensing membrane of the single point glucose monitor comprises two or more domains and/or layers that are the same as two or more domains and/or layers of the sensing membrane of the continuous glucose sensor. 
     
     
         193 . The method of  claim 191 , wherein the sensing membrane of the single point glucose monitor comprises three or more domains and/or layers that are the same as three or more domains and/or layers of the sensing membrane continuous glucose sensor. 
     
     
         194 . The method of  claim 184 , wherein the sensing membrane of the single point glucose monitor comprises two or more materials and/or layers that are the same as two or more materials of the sensing membrane of the continuous glucose sensor. 
     
     
         195 . The method of  claim 193 , wherein the sensing membrane of the single point glucose monitor comprises three or more materials and/or layers that are the same as three or more materials of the sensing membrane of the continuous glucose sensor. 
     
     
         196 . The method of  claim 184 , wherein the sensing region and/or the sensing membrane of the single point glucose monitor is located on a test strip configured to be releasably received by the single point glucose monitor. 
     
     
         197 . A system for calibrating a continuous glucose sensor data, the system comprising:
 an integrated receiver comprising an integrated receiver housing, wherein the integrated receiver housing comprises:
 a single point glucose monitor integrally formed within the housing and adapted to measure a glucose concentration in a biological sample; 
 a receiver for receiving a data stream from a continuous glucose sensor; 
 a processor module comprising programming to calibrate the data stream from a continuous glucose sensor using the glucose concentration measured from the single point glucose monitor, wherein each of the continuous sensor and the single point monitor comprise a sensing region comprising a sensing membrane, wherein the sensing membrane of the single point glucose monitor comprises one or more domains and/or layers that are the same as one or more domains and/or layers of the sensing membrane of the continuous glucose sensor. 
   
     
     
         198 . The system of  claim 196 , wherein an enzyme domain of the sensing membrane of the continuous glucose sensor and an enzyme domain of the sensing membrane of the single point glucose monitor comprise same materials. 
     
     
         199 . The system of  claim 196 , wherein the sensing membrane of the single point glucose monitor comprises two or more domains and/or layers that are the same as two or more domains and/or layers of the sensing membrane of the continuous glucose sensor. 
     
     
         200 . The system of  claim 198 , wherein the sensing membrane of the single point glucose monitor comprises three or more domains and/or layers that are the same as three or more domains and/or layers of the sensing membrane continuous glucose sensor. 
     
     
         201 . The system of  claim 196 , further comprising a continuous glucose sensor, wherein the continuous glucose sensor produces a data stream indicative of a glucose concentration in a host, and wherein the continuous glucose sensor further comprises an electrochemical cell configured to measure the glucose concentration. 
     
     
         202 . The system of  claim 196 , wherein the single point glucose monitor comprises an electrochemical cell configured to measure the glucose concentration in the biological sample. 
     
     
         203 . The system of  claim 196 , further comprising a user interface configured to display glucose data from at least one of the continuous glucose sensor and the single point glucose monitor. 
     
     
         204 . The system of  claim 196 , wherein the single point glucose monitor comprises at least two electrodes, wherein the sensing region of the single point glucose monitor is located within the integrated receiver. 
     
     
         205 . The system of  claim 196 , wherein the sensing membrane of the single point glucose monitor comprises two or more materials and/or layers that are the same as two or more materials of the sensing membrane of the continuous glucose sensor. 
     
     
         206 . The system of  claim 204 , wherein the sensing membrane of the single point glucose monitor comprises three or more materials and/or layers that are the same as three or more materials of the sensing membrane of the continuous glucose sensor. 
     
     
         207 . The system of  claim 196 , wherein the sensing region and/or the sensing membrane of the single point glucose monitor is located on a test strip configured to be releasably received by the single point glucose monitor. 
     
     
         208 . A system for calibrating a continuous glucose sensor data, the system comprising:
 an integrated receiver comprising an integrated receiver housing, wherein the integrated receiver housing comprises:
 a single point glucose monitor integrally formed within the housing and adapted to measure a glucose concentration in a biological sample; 
 a receiver for receiving a data stream from a continuous glucose sensor; 
 a processor module comprising programming to calibrate the data stream from a continuous glucose sensor using the glucose concentration measured from the single point glucose monitor, wherein each of the continuous sensor and the single point monitor comprise a sensing region comprising a sensing membrane, wherein the sensing membrane of the single point glucose monitor comprises two or more materials and/or layers that are the same as two or more materials of the sensing membrane of the continuous glucose sensor. 
   
     
     
         209 . The system of  claim 207 , wherein the sensing membrane of the single point glucose monitor comprises three or more materials and/or layers that are the same as three or more materials of the sensing membrane of the continuous glucose sensor. 
     
     
         210 . The system of  claim 207 , further comprising a continuous glucose sensor, wherein the continuous glucose sensor produces a data stream indicative of a glucose concentration in a host, and wherein the continuous glucose sensor further comprises an electrochemical cell configured to measure the glucose concentration. 
     
     
         211 . The system of  claim 207 , wherein the single point glucose monitor comprises an electrochemical cell configured to measure the glucose concentration in the biological sample. 
     
     
         212 . The system of  claim 207 , further comprising a user interface configured to display glucose data from at least one of the continuous glucose sensor and the single point glucose monitor. 
     
     
         213 . The system of  claim 207 , wherein the single point glucose monitor comprises at least two electrodes, wherein the sensing region of the single point glucose monitor is located within the integrated receiver. 
     
     
         214 . The system of  claim 207 , wherein the sensing membrane of the single point glucose monitor comprises one or more domains and/or layers that are the same as one or more domains and/or layers of the sensing membrane of the continuous glucose sensor. 
     
     
         215 . The system of  claim 213 , wherein an enzyme domain of the sensing membrane of the continuous glucose sensor and an enzyme domain of the sensing membrane of the single point glucose monitor comprise same materials. 
     
     
         216 . The system of  claim 213 , wherein the sensing membrane of the single point glucose monitor comprises two or more domains and/or layers that are the same as two or more domains and/or layers of the sensing membrane of the continuous glucose sensor. 
     
     
         217 . The system of  claim 215 , wherein the sensing membrane of the single point glucose monitor comprises three or more domains and/or layers that are the same as three or more domains and/or layers of the sensing membrane continuous glucose sensor. 
     
     
         218 . The system of  claim 207 , wherein the sensing region and/or the sensing membrane of the single point glucose monitor is located on a test strip configured to be releasably received by the single point glucose monitor.