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 processing and displaying sensor data from a continuous analyte sensor, the method comprising:
 receiving sensor data from a continuous analyte sensor for a time period;   calculating a rate of change of the sensor data for the time period; and   displaying an arrow on a user interface that represents an amplitude and a direction of the rate of change of the sensor data for the time period.   
     
     
         3 . The method of  claim 2 , wherein the arrow has a rotational direction with at least 45 degrees of resolution. 
     
     
         4 . The method of  claim 2 , wherein the rotation of the arrow has a resolution of between about 1 degree and about 180 degrees. 
     
     
         5 . The method of  claim 2 , further comprising calibrating the sensor data to obtain calibrated sensor data, wherein the step of calculating a rate of change is performed on the calibrated sensor data. 
     
     
         6 . The method of  claim 2 , wherein the step of displaying comprises displaying a graphical representation of the sensor data and a numerical representation of the sensor data. 
     
     
         7 . The method of  claim 2 , wherein the step of displaying comprises displaying one or more clinical risk zones. 
     
     
         8 . The method of  claim 7 , wherein the clinical risk zone is represented by at least one of a line, a colored region, or a patterned region. 
     
     
         9 . The method of  claim 2 , wherein the step of displaying comprises displaying one or more target analyte values. 
     
     
         10 . The method of  claim 9 , further comprising determining a therapy recommendation associated with the one or more target analyte values, wherein the step of displaying comprises displaying a representation of the therapy recommendation. 
     
     
         11 . The method of  claim 2 , further comprising calibrating the sensor data, wherein the step of displaying comprises displaying a range of values representative of a variation of a calibrated sensor data value. 
     
     
         12 . The method of  claim 2 , wherein the step of displaying comprises displaying at least one of a predicted analyte value and a range of predicted analyte values. 
     
     
         13 . The method of  claim 2 , wherein the analyte sensor is a glucose sensor. 
     
     
         14 . A system for processing and displaying sensor data from a continuous analyte sensor, the system comprising:
 an input module configured to receive sensor data from a continuous analyte sensor for a time period; and   a processor module configured to calculate a rate of change of the sensor data for the time period, wherein the processor module is further configured to display an arrow on a user interface, wherein the arrow represents an amplitude and a direction of the rate of change of the sensor data for the time period.   
     
     
         15 . The system of  claim 14 , wherein the arrow has a rotational direction with at least 45 degrees of resolution. 
     
     
         16 . The system of  claim 14  wherein the rotation of the arrow has a resolution of between about 1 degree and about 180 degrees. 
     
     
         17 . The system of  claim 14 , wherein the processor module is further configured to calibrate the sensor data to obtain calibrated sensor data, wherein the rate of change calculation is performed on the calibrated sensor data. 
     
     
         18 . The system of  claim 14 , wherein the processor module is further configured to display a graphical representation of the sensor data and a numerical representation of the sensor data. 
     
     
         19 . The system of  claim 14 , wherein the processor module is further configured to display at least one clinical risk zone. 
     
     
         20 . The system of  claim 19 , wherein the clinical risk zone is represented by at least one of a line, a colored region, or a patterned region. 
     
     
         21 . The system of  claim 14 , wherein the processor module is configured to display one or more target analyte values. 
     
     
         22 . The system of  claim 21 , wherein the processor module is configured to determine a therapy recommendation associated with the one or more target analyte values, and wherein the processor module is further configured to display a representation of the therapy recommendation. 
     
     
         23 . The system of  claim 14 , wherein the processor module is further configured to calibrate the sensor data, and wherein the processor module is further configured to display a range of values representative of a variation of a calibrated sensor data value. 
     
     
         24 . The system of  claim 14 , wherein the processor module is further configured to display at least one of a predicted analyte value and a range of predicted analyte values. 
     
     
         25 . A method for processing and displaying sensor data from a continuous analyte sensor, the method comprising:
 receiving sensor data from a continuous analyte sensor for a time period; calibrating the sensor data;   calculating a rate of change of the sensor data for the time period; and   simultaneously displaying representations of first order, second order, and third order information associated with the calibrated sensor data.   
     
     
         26 . The method of  claim 25 , wherein the representation of first order calibrated sensor data comprises a numerical representation of the calibrated sensor data. 
     
     
         27 . The method of  claim 26 , wherein the representation of second order sensor data comprises an arrow on a user interface that represents an amplitude and a direction of the rate of change of the calibrated sensor data for the time period. 
     
     
         28 . The method of  claim 27 , wherein the arrow has a rotational direction with at least 45 degrees of resolution. 
     
     
         29 . The method of  claim 27 , wherein the arrow has a rotational direction with at least 180 degrees of resolution. 
     
     
         30 . The method of  claim 27 , wherein the representation of third order sensor data comprises a graphical representation of the calibrated sensor data for the time period. 
     
     
         31 . The method of  claim 25 , further comprising displaying a clinical risk zone. 
     
     
         32 . The method of  claim 25 , further comprising displaying one or more target analyte values. 
     
     
         33 . A method for processing and displaying sensor data from a continuous analyte sensor, the method comprising:
 receiving, with an electronic device, sensor data associated with a data stream from a continuous analyte sensor for a time period;   calculating a rate of change of sensor data; and   displaying to a user on a screen of the electronic device, a directional arrow indicative of both an amplitude of a rate of change of analyte concentration associated with sensor data for the time period and a direction of the rate of change.   
     
     
         34 . The method of  claim 33 , wherein the directional arrow has a rotational direction with at least about 45 degrees of resolution. 
     
     
         35 . The method of  claim 33  wherein the directional arrow has a rotational direction with at least about 180 degrees of resolution. 
     
     
         36 . The method of  claim 33 , wherein displaying comprises displaying one or more clinical risk zones. 
     
     
         37 . The method of  claim 33 , wherein displaying comprises displaying at least one of a predicted analyte value or a range of predicted analyte values. 
     
     
         38 . The method of  claim 33 , wherein sensor data comprises calibrated sensor data. 
     
     
         39 . The method of  claim 33 , further comprising calibrating sensor data to obtain calibrated sensor data, wherein the rate of change is associated with calibrated sensor data. 
     
     
         40 . The method of  claim 33 , wherein the continuous analyte sensor is a continuous glucose sensor. 
     
     
         41 . A method for processing and displaying sensor data from a continuous analyte sensor, the method comprising:
 receiving, with an electronic device, sensor data associated with a data stream from a continuous analyte sensor for a time period and a concentration measurement by a reference analyte monitor;   calculating a rate of change of sensor data for a time period; and   displaying to a user on a screen of the electronic device, a first output of sensor data displayed simultaneously with an analyte concentration target range, a second output of at least one analyte concentration measurement by the reference analyte monitor, and a third output of a directional arrow indicative of both an amplitude and a direction of a rate of change of analyte concentration associated with sensor data for the time period.   
     
     
         42 . The method of  claim 41 , wherein the directional arrow has a rotational direction with at least about 45 degrees of resolution. 
     
     
         43 . The method of  claim 41 , wherein the directional arrow has a rotational direction with at least about 180 degrees of resolution. 
     
     
         44 . The method of  claim 41 , wherein displaying the first output comprises displaying one or more clinical risk zones. 
     
     
         45 . The method of  claim 41 , wherein the target range is defined by a colored region. 
     
     
         46 . The method of  claim 41 , wherein the target range is represented by an upper boundary and a lower boundary. 
     
     
         47 . The method of  claim 46 , wherein the upper boundary and the lower boundary are user configurable. 
     
     
         48 . The method of  claim 41 , wherein displaying comprises displaying at least one of a predicted analyte value or a range of predicted analyte values. 
     
     
         49 . The method of  claim 41 , wherein sensor data comprises calibrated sensor data. 
     
     
         50 . The method of  claim 41 , further comprising calibrating sensor data to obtain calibrated sensor data, wherein the rate of change is associated with calibrated sensor data. 
     
     
         51 . The method of  claim 50 , further comprising updating calibration or recalibrating sensor data associated with a change in sensitivity. 
     
     
         52 . The method of  claim 50 , wherein calibrating sensor data comprises compensating for a time lag between the analyte concentration measured by the reference analyte monitor and sensor data from the continuous analyte sensor. 
     
     
         53 . The method of  claim 52 , wherein compensating comprises matching an analyte concentration measurement by the reference analyte monitor with sensor data obtained from about 5 minutes to about 20 minutes after the analyte concentration measurement by the reference analyte monitor. 
     
     
         54 . The method of  claim 41 , wherein the reference analyte monitor is physically attached to with the electronic device. 
     
     
         55 . The method of  claim 41 , wherein the first output and the second output are simultaneously displayed. 
     
     
         56 . The method of  claim 41 , further comprising:
 detecting an approaching clinical risk by performing an extrapolation of previous sensor data and performing a variation analysis; and   activating an alarm based at least in part on the approaching clinical risk.   
     
     
         57 . The method of  claim 56 , wherein activating the alarm comprises determining that a predicted potential analyte concentration is greater than a high threshold value or less than a low threshold value. 
     
     
         58 . The method of  claim 57 , wherein the high threshold value and the low threshold value are user configurable. 
     
     
         59 . The method of  claim 41 , wherein the continuous analyte sensor is a continuous glucose sensor. 
     
     
         60 . A system for processing and displaying sensor data from a continuous analyte sensor, the system comprising:
 means for receiving sensor data associated with a data stream from a continuous analyte sensor for a time period and a concentration measurement by a reference analyte monitor; and   means for calculating a rate of change of sensor data for a time period; and   means for displaying to a user on a screen of an electronic device, a first output of sensor data displayed simultaneously with an analyte concentration target range, a second output of at least one analyte concentration measurement by the reference analyte monitor, and a third output of a directional arrow indicative of both an amplitude and a direction of a rate of change of analyte concentration associated with sensor data for the time period.   
     
     
         61 . The system of  claim 60 , wherein the directional arrow has a rotational direction with at least about 45 degrees of resolution. 
     
     
         62 . The system of  claim 60 , wherein the directional arrow has a rotational direction with at least about 180 degrees of resolution. 
     
     
         63 . The system of  claim 60 , wherein the means for displaying the first output comprises means for displaying one or more clinical risk zones. 
     
     
         64 . The system of  claim 60 , wherein the target range is defined by a colored region. 
     
     
         65 . The system of  claim 60 , wherein the target range is represented by an upper boundary and a lower boundary. 
     
     
         66 . The system of  claim 65 , wherein the upper boundary and the lower boundary arc user configurable. 
     
     
         67 . The system of  claim 66 , wherein the means for displaying comprises means for displaying at least one of a predicted analyte value or a range of predicted analyte values. 
     
     
         68 . The system of  claim 60 , wherein sensor data comprises calibrated sensor data. 
     
     
         69 . The system of  claim 60 , further comprising means for calibrating sensor data to obtain calibrated sensor data, wherein the rate of change is associated with calibrated sensor data. 
     
     
         70 . The system of  claim 69 , further comprising means for updating calibration or recalibrating sensor data associated with a change in sensitivity. 
     
     
         71 . The system of  claim 69 , wherein the means for calibrating sensor data comprises means for compensating for a time lag between the analyte concentration measured by the reference analyte monitor and sensor data from the continuous analyte sensor. 
     
     
         72 . The system of  claim 71 , wherein the means for compensating comprises means for matching an analyte concentration measurement by the reference analyte monitor with sensor data obtained from about 5 minutes to about 20 minutes after the analyte concentration measurement by the reference analyte monitor. 
     
     
         73 . The system of  claim 60 , wherein the reference analyte monitor is physically attached to the electronic device. 
     
     
         74 . The system of  claim 60 , wherein the first output and the second output are simultaneously displayed. 
     
     
         75 . The system of  claim 60 , further comprising:
 means for detecting an approaching clinical risk by performing an extrapolation of previous sensor data and performing a variation analysis; and   means for activating an alarm based at least in part on the approaching clinical risk.   
     
     
         76 . The system of  claim 75 , wherein the means for activating the alarm comprises means for determining that a predicted potential analyte concentration is greater than a high threshold value or less than a low threshold value. 
     
     
         77 . The system of  claim 76 , wherein the high threshold value and the low threshold value are user configurable. 
     
     
         78 . The system of  claim 60 , wherein the continuous analyte sensor is a continuous glucose sensor.