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.

What is claimed is: 
     
         1 . A therapy management device, comprising:
 a display unit; and   a processor operatively coupled to the display unit, the processor configured to display one or more output related to an analyte level of an individual, the processor further configured to output in a superimposed manner a therapy related output over the displayed one or more outputs related to the analyte level of the individual.   
     
     
         2 . The device of  claim 1  wherein the output related to an analyte level of the individual includes a graphical display of a continuous monitored glucose level of the individual. 
     
     
         3 . The device of  claim 1  wherein the therapy related output includes one or more of an insulin action curve, insulin on board information, insulin sensitivity factor, carbohydrate action curve, or a current medication delivery profile information. 
     
     
         4 . The device of  claim 1  further including an insulin delivery unit, wherein the display unit is coupled to the insulin delivery unit. 
     
     
         5 . The device of  claim 1  further including an analyte monitoring unit, wherein the display unit is coupled to the analyte monitoring unit. 
     
     
         6 . A method, comprising:
 outputting one or more signals associated with a monitored analyte level of an individual;   determining one or more data associated with one or more therapy information related to the monitored analyte level; and   outputting in a superimposed manner the determined one or more data over the outputted one or more signals associated with the monitored analyte level.   
     
     
         7 . The method of  claim 6  wherein the output one or more signals includes one or more of a line graph, a bar graph, a 2-dimensional visual display, a three-dimensional visual display, an audible output, a vibratory output, a text notification or one or more combinations thereof. 
     
     
         8 . The method of  claim 6  wherein the determined one or more data is associated with a medication information for the therapy related to the monitored analyte level. 
     
     
         9 . The method of  claim 6  wherein the output one or more signals is associated with substantially real time continuously monitored glucose level of the individual. 
     
     
         10 . The method of  claim 6  wherein the determined one or more data output in the superimposed matter includes one or more of an insulin action curve, an insulin on board information, insulin sensitivity factor, carbohydrate action curve, or a current medication delivery profile information. 
     
     
         11 . The method of  claim 6  wherein the output one or more signals and the determined one or more data are substantially simultaneously displayed on a display unit. 
     
     
         12 . A therapy management device, comprising:
 a communication interface configured to receive one or more data associated with a monitored analyte level;   a processor coupled to the communication interface, the processor configured to detect or predict a predetermined rate of change or level based on the received one or more data associated with the monitored analyte level, wherein the processor is configured to disable one or more therapy related functions executable by a user when the detected predetermined rate of change deviates from a predefined threshold level. Prediction of a level or rate may occur through a fixed linear function, a curvilinear function, and/or in combination with other input values.   
     
     
         13 . The device of  claim 12  wherein the predetermined rate of change includes a decrease in the analyte level of the user. 
     
     
         14 . The device of  claim 12  wherein the one or more therapy related functions includes one or more medication or carbohydrate administration functions. 
     
     
         15 . The device of  claim 12  wherein the processor is configured to temporarily disable the one or more therapy related functions until the predicted or detected predetermined rate of change or level substantially falls within the predefined threshold level. 
     
     
         16 . The device of  claim 12  wherein the predefined threshold level includes a hypoglycemic condition, an impending hypoglycemic condition, a hyperglycemic condition or an impending hyperglycemic condition.