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 providing glycemic control, comprising:
 a drug administration system;   an analyte sensor; and   a data storage and controller module including a processor unit that receives analyte level information from the analyte sensor, executes a control algorithm to determine a rate of change of the analyte level and to compare the ratio of change of the analyte level to one or more threshold values, and determines a drug administration protocol based on the rate of change of the analyte level for execution by the drug administration system.   
     
     
         122 . The system of  121  wherein the data storage and controller unit receives patient specific data. 
     
     
         123 . The system of  claim 122  wherein the data includes information on food intake and exercise. 
     
     
         124 . The system of  claim 123  wherein the data storage and controller module includes a memory to store patient specific data. 
     
     
         125 . The system of  claim 124  wherein the memory stores the control algorithm that uses the stored patient specific data, and the processor unit executes the control algorithm to determine the rate of change of the analyte level. 
     
     
         126 . The system of  claim 121  wherein the analyte sensor is a periodic glucose sensing unit. 
     
     
         127 . The system of  claim 121  further including a memory unit that is formed to store 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 system of  claim 121  wherein the data storage and controller module and the drug administration system are integrated in a single device. 
     
     
         129 . The system of  claim 121  wherein the data storage and controller module wirelessly receives the analyte level information. 
     
     
         130 . The system of  claim 121  wherein the analyte includes glucose. 
     
     
         131 . The system of  claim 121  wherein the drug includes insulin. 
     
     
         132 . The system 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. 
     
     
         133 . The system of  claim 121  wherein the data storage and controller module modifies the drug administration protocol based on a subject's response to the drug. 
     
     
         134 . The system of  claim 133  wherein the response to the drug includes the subject's drug sensitivity curve. 
     
     
         135 . The system of  claim 133  wherein the drug administration system includes one or more of an internal infusion pump, an external infusion pump, a syringe injector or a transdermal delivery system. 
     
     
         136 . A system for providing glycemic control, comprising:
 means for delivering insulin;   means for determining an analyte level;   a data storage and controller module compares the analyte level to one or more threshold values to determine a drug administration protocol to be administered when the rate of change of the analyte level indicates an anticipated analyte level exceeding the one or more threshold values, and to transmit the drug administration protocol to the delivery means.