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 method comprising:
 receiving analyte level information;   executing a control algorithm to determine a rate of change of the analyte level;   comparing the rate of change of the analyte level to one or more threshold values; and   determining a drug administration protocol based on the rate of change of the analyte level.   
     
     
         122 . The method of  claim 121  including receiving patient specific data. 
     
     
         123 . The method of  claim 122  wherein the data includes information on food intake and exercise. 
     
     
         124 . The method of  claim 123  including storing patient specific data. 
     
     
         125 . The method of  claim 124  including:
 storing the control algorithm that uses the stored patient specific data; and   executing the control algorithm to determine the rate of change of the analyte level.   
     
     
         126 . The method of  claim 121  including periodically detecting the analyte level. 
     
     
         127 . The method of  claim 121  including storing the control algorithm and data, the data including analyte level information, the rate of change of the analyte levels, the one or more threshold values, and the drug administration protocol. 
     
     
         128 . The method of  claim 121  wirelessly receiving the analyte level information. 
     
     
         129 . The method of  claim 121  wherein the analyte includes glucose. 
     
     
         130 . The method of  claim 121  wherein the drug includes insulin. 
     
     
         131 . The method of  claim 121  wherein the one or more threshold values are associated with one or more of a hyperglycemic condition, hypoglycemic condition, an impending hyperglycemic condition, or an impending hypoglycemic condition. 
     
     
         132 . The method of  claim 121  including modifying the drug administration protocol based on a subject's response to the drug. 
     
     
         133 . The method of  claim 132  wherein the response to the drug includes the subject's drug sensitivity curve.