Method and apparatus for providing data processing and control in a medical communication system

Abstract

Methods and apparatus for providing data processing and control for use in a medical communication system are provided.

What is claimed is: 
     
         1 . A method of determining glucose information, comprising:
 receiving, at a receiving device, a current signal associated with a monitored glucose level from an in vivo glucose sensor by a communication protocol;   retrieving a plurality of stored signals associated with the monitored glucose level over a predetermined time interval of at least 10 minutes;   estimating glucose trend information of the monitored glucose level based on the retrieved plurality of stored signals and the current signal;   displaying a current glucose level based on the current signal;   displaying a function related to the estimated trend information to a user, wherein the function comprises a projection based at least in part on the estimated trend information; and   disabling the display of the function related to the estimated trend information if the trend information exceeds a predetermined tolerance range.   
     
     
         2 . The method of  claim 1 , further comprising determining one or more of the plurality of stored signals and the current signal as invalid. 
     
     
         3 . The method of  claim 2 , wherein the estimating glucose trend information includes determining the glucose trend information based on the retrieved plurality of stored signals and the current signal that are not determined to be invalid. 
     
     
         4 . The method of  claim 1 , wherein the estimating glucose trend information includes determining a rate of change of the retrieved plurality of stored signals and the current signal. 
     
     
         5 . The method of  claim 4 , wherein the estimating glucose trend information includes determining an uncertainty measure of the rate of change of the retrieved plurality of stored signals and current signal. 
     
     
         6 . The method of  claim 5 , wherein the disabling the display of the function related to the estimated trend information further comprises comparing the rate of change to a predetermined threshold, and disabling the display of the function related to the estimated trend information if the threshold is exceeded. 
     
     
         7 . The method of  claim 6 , wherein the predetermined threshold comprises a rate variance. 
     
     
         8 . The method of  claim 7 , wherein the rate variance comprises 3. 
     
     
         9 . The method of  claim 1 , further comprising updating the trend information based on the retrieved plurality of stored signals and at least the current signal. 
     
     
         10 . The method of  claim 1 , wherein the predetermined time interval comprises 30 minutes. 
     
     
         11 . The method of  claim 1 , wherein each of the retrieved plurality of stored signals and the current signal includes a corresponding calibration parameter comprising a sensitivity. 
     
     
         12 . A glucose monitoring system, comprising:
 a glucose sensor comprising an ex vivo portion configured to reside above a skin surface of a user and an in vivo portion configured to reside below the skin surface and in contact with interstitial fluid of the user, the in vivo portion including a working electrode and a reference electrode, and configured to generate electrical signals associated with the glucose level in the interstitial fluid of the user, and   a receiving device, comprising:
 a display, 
 one or more processors; and 
 a memory operatively coupled to the one or more processors for storing instructions which, when executed cause the one or more processors to:
 receive a current signal associated with a monitored glucose level from the glucose sensor; 
 retrieve from the memory a plurality of stored signals associated with the monitored glucose level over a predetermined time interval of at least 10 minutes; 
 estimate glucose trend information of the monitored glucose level based on the retrieved plurality of stored signals and the current signal; 
 display, on the display, a current glucose level based on the current signal; 
 display, on the display, a function related to the estimated trend information to a user, wherein the function comprises a projection based at least in part on the estimated trend information; and 
 disable the display of the function related to the estimated trend information if the trend information exceeds a predetermined tolerance range. 
 
   
     
     
         13 . The system of  claim 12 , wherein the instructions are further configured to cause the one or more processors to estimate glucose trend information by determining a rate of change of the retrieved plurality of stored signals and the current signal. 
     
     
         14 . The system of  claim 13 , wherein the instructions are further configured to cause the one or more processors to estimate glucose trend information by determining an uncertainty measure of the rate of change of the retrieved plurality of stored signals and current signal. 
     
     
         15 . The system of  claim 14 , wherein the instructions are further configured to cause the one or more processors to disable the display of the function related to the estimated trend information by comparing the rate of change to a predetermined threshold, and disabling the display of the function related to the estimated trend information if the threshold is exceeded. 
     
     
         16 . The system of  claim 15 , wherein the predetermined threshold comprises a rate variance. 
     
     
         17 . The system of  claim 12 , wherein the predetermined time interval comprises 30 minutes. 
     
     
         18 . A glucose monitoring system, comprising:
 a glucose sensor comprising an ex vivo portion configured to reside above a skin surface of a user and an in vivo portion configured to reside below the skin surface and in contact with interstitial fluid of the user, the in vivo portion including a working electrode and a reference electrode, and configured to generate electrical signals associated with the glucose level in the interstitial fluid of the user;   one or more processors; and   a memory operatively coupled to the one or more processors for storing instructions which, when executed cause the one or more processors to:
 monitor the electrical signals generated by the glucose sensor for an adverse data condition occurrence upon detection of insertion of the in vivo portion of the sensor for a predetermined period of time, wherein the adverse data condition occurrence comprises one or more of a persistent low sensor signal for a predefined time period and a sensor condition; 
 monitor a glucose level; and 
 display the glucose level and information associated with a rate of change of the glucose level to a user; and 
 temporarily disable the display of the information associated with the rate of change until the electrical signals generated by the glucose sensor are within a predetermined acceptable tolerance range. 
   
     
     
         19 . The glucose monitoring system of  claim 18 , wherein the instructions are further configured to cause the one or more processors to generate a notification to the user when the adverse data condition occurrence exceeds a predetermined number of occurrences during a predefined time period. 
     
     
         20 . The glucose monitoring system of  claim 19 , wherein the instructions are further configured to cause the one or more processors to accept one or more verifications by the user responsive to the notification. 
     
     
         21 . A method of determining glucose information, comprising:
 receiving a signal associated with a monitored glucose level from a transcutaneous glucose sensor;   retrieving a predetermined number of stored signals associated with the monitored glucose level;   determining a rate of change estimate of the monitored glucose level based on the received signal associated with the monitored glucose level and the retrieved predetermined number of stored signals;   calculating an uncertainty measure associated with the determined rate of change estimate;   determining if the uncertainty measure exceeds a tolerance range; and   temporarily disabling an output function associated with the rate of change determination related to the monitored glucose level, wherein the output function is a glucose level trend indicator.   
     
     
         22 . The method of  claim 21 , wherein glucose level trend indicator is a visual trend arrow. 
     
     
         23 . The method of  claim 21 , wherein the tolerance range is predetermined. 
     
     
         24 . The method of  claim 21 , wherein the tolerance range is dynamic. 
     
     
         25 . The method of  claim 21 , wherein the determining if the uncertainty measure exceeds a tolerance range comprises comparing the number of stored signals that are corrupt to a threshold level. 
     
     
         26 . The method of  claim 21 , wherein the determining if the uncertainty measure exceeds a tolerance range comprises comparing the number of stored signals that are missing to a threshold. 
     
     
         27 . The method of  claim 21 , wherein the determining if the uncertainty measure exceeds a tolerance range comprises comparing the rate of acceleration or deceleration of the monitored glucose level to a threshold. 
     
     
         28 . The method of  claim 21 , wherein receiving the signal is performed at least substantially in real time. 
     
     
         29 . The method of  claim 21 , wherein each of the predetermined number of stored signals and the received signal associated with the monitored glucose level are temporally separated by approximately one minute or less. 
     
     
         30 . A device for determining glucose information, comprising:
 a glucose sensor comprising an ex vivo portion configured to reside above a skin surface of a user and an in vivo portion configured to reside below the skin surface and in contact with interstitial fluid of the user, the in vivo portion including a working electrode and a reference electrode, and configured to generate electrical signals associated with the glucose level in the interstitial fluid of the user;   one or more processors;   a memory storing instructions which, when executed by the one or more processors, cause the one or more processors to:
 receive a current signal associated with a monitored glucose level from the glucose sensor; 
 retrieve stored signals associated with the monitored glucose level; 
 determine a rate of change estimate of the monitored glucose level based on the received signal associated with the monitored glucose level and the retrieved predetermined number of stored signals; 
 calculate an uncertainty measure associated with the determined rate of change estimate; 
 determine if the uncertainty measure exceeds a tolerance range; and 
 temporarily disable an output function associated with the rate of change determination related to the monitored glucose level, wherein the output function is a glucose level trend indicator; and 
 a display unit operatively coupled to the data processing unit to display the glucose level trend indicator. 
   
     
     
         31 . The apparatus of  claim 30 , wherein each of the predetermined number of stored signals and the received signal associated with the monitored glucose level are temporally separated by a predetermined time period. 
     
     
         32 . The apparatus of  claim 30 , further including a communication unit operatively coupled to the data processing unit, wherein the predetermined time period includes a data transmission rate of the communication unit. 
     
     
         33 . The apparatus of  claim 32 , wherein the communication unit is configured for wireless communication. 
     
     
         34 . The apparatus of  claim 30 , further comprising a sensor code with a preassigned sensitivity. 
     
     
         35 . The apparatus of  claim 30 , wherein the apparatus is configured to detect sensor insertion. 
     
     
         36 . The apparatus of  claim 35 , wherein the apparatus is configured to initiate a sensor expiration timer upon detecting sensor insertion. 
     
     
         37 . The apparatus of  claim 30 , further comprising a first and a second temperature sensor. 
     
     
         38 . The apparatus of  claim 30 , wherein the transcutaneous glucose sensor comprises a plurality of electrodes. 
     
     
         39 . The apparatus of  claim 38 , wherein the plurality of electrodes includes a working electrode comprising a glucose-responsive enzyme disposed on the working electrode. 
     
     
         40 . A method comprising:
 receiving sensor data corresponding to a monitored glucose level from a glucose sensor, at least a portion of the glucose sensor being positioned in contact with a fluid under a skin layer;   monitoring for an adverse data condition occurrence associated with the glucose sensor based on the sensor data, wherein the adverse data condition occurrence is associated with an inaccurate glucose level received from the glucose sensor;   generating a notification configured to be provided to a user when the adverse data condition occurrence exceeds a predetermined threshold during a time period; and   displaying the notification on a display of a receiving device.   
     
     
         41 . The method of  claim 41 , further comprising detecting the portion of the glucose sensor is positioned in contact with a fluid under a skin layer. 
     
     
         42 . The method of  claim 41 , wherein the adverse data condition occurrence comprises a persistent low glucose level. 
     
     
         43 . The method of  claim 41 , wherein the inaccurate glucose level received from the glucose sensor indicates that the glucose sensor is improperly positioned. 
     
     
         44 . The method of  claim 41 , wherein the inaccurate glucose level received from the glucose sensor indicates that the glucose sensor is defective. 
     
     
         45 . The method of  claim 41 , wherein the time period is between 1 to 24 hours. 
     
     
         46 . The method of  claim 41 , wherein the notification instructs the user to replace the glucose sensor. 
     
     
         47 . The method of  claim 41 , wherein the notification instructs the user to perform one or more troubleshooting steps. 
     
     
         48 . The method of  claim 47 , wherein the one or more troubleshooting steps comprise verifying that a transmitter unit is in proper contact with the glucose sensor, and verifying that the glucose sensor is properly inserted and positioned. 
     
     
         49 . The method of  claim 41 , wherein the notification comprises at least one of an auditory, vibratory, or visual alarm. 
     
     
         50 . A system, comprising:
 a glucose sensor comprising an ex vivo portion configured to reside above a skin surface of a user and an in vivo portion configured to reside below the skin surface and in contact with interstitial fluid of the user, the in vivo portion including a working electrode and a reference electrode, and configured to generate electrical signals associated with the glucose level in the interstitial fluid of the user; and   a receiving device, comprising:
 a display; 
 one or more processors; and 
 at least one memory storing instructions which, when executed by the one or more processors, cause the receiving device to: 
 receive sensor data corresponding to a monitored glucose level from the glucose sensor; 
 monitor for an adverse data condition occurrence associated with the glucose sensor based on the sensor data, wherein the adverse data condition occurrence is associated with an inaccurate glucose level received from the glucose sensor; 
 generate a notification configured to be provided to a user when the adverse data condition occurrence exceeds a predetermined threshold during a time period; and 
   display the notification on a display of a receiving device.   
     
     
         51 . The system of  claim 50 , wherein the memory storing instructions which, when executed by the one or more processors, cause the receiving device to:
 detect a portion of the glucose sensor being positioned in contact with a fluid under a skin layer.   
     
     
         52 . The system of  claim 51 , wherein the adverse data condition occurrence comprises a persistent low glucose level. 
     
     
         53 . The system of  claim 52 , wherein the inaccurate glucose level received from the glucose sensor indicates that the glucose sensor is improperly positioned. 
     
     
         54 . The system of  claim 52 , wherein the inaccurate glucose level received from the glucose sensor indicates that the glucose sensor is defective. 
     
     
         55 . The system of  claim 50 , wherein the time period is between 1 to 24 hours. 
     
     
         56 . The system of  claim 50 , wherein the notification instructs the user to replace the glucose sensor. 
     
     
         57 . The system of  claim 50 , wherein the notification instructs the user to perform one or more troubleshooting steps. 
     
     
         58 . The system of  claim 57 , wherein the one or more troubleshooting steps comprise verifying that a transmitter unit is in proper contact with the glucose sensor, and verifying that the glucose sensor is properly inserted and positioned. 
     
     
         59 . The system of  claim 50 , wherein the notification comprises at least one of an auditory, vibratory, or visual alarm. 
     
     
         60 . The system of  claim 50 , wherein the adverse data condition occurrence further includes a data quality identifier associated with an adverse data condition.