Closed loop control system with safety parameters and methods

Abstract

Methods, system and devices for monitoring a plurality of parameters associated with a closed loop control operation including continuously monitoring a physiological condition and automatic administration of a medication, detecting an adverse condition associated with the monitored physiological condition or the medication administration deviating from a predetermined safety level of the closed loop control operation, and initiating a non-zero pre-programmed medication delivery rate are provided.

1 . A system comprising:
 an analyte monitoring device comprising an in vivo analyte sensor;   one or more processors; and   a memory operably coupled to the one or more processors and storing instructions that, when executed by the one or more processors, causes the one or more processors to:
 receive signal levels from the in vivo analyte sensor of the analyte monitoring device, the signal levels representative of analyte levels; 
 determine whether one or more of the signal levels are associated with a fault condition or potential fault condition of the analyte monitoring device; and 
 generate a notification on a user interface of a control unit in data communication with the analyte monitoring device based on the fault condition or the potential fault condition, wherein the notification comprises an alarm. 
   
     
     
         2 . The method of  claim 1 , wherein the one or more processors is electrically coupled to the control unit or the in vivo sensor. 
     
     
         3 . The system of  claim 1 , wherein the analyte levels are in vivo glucose levels. 
     
     
         4 . The system of  claim 1 , wherein the data communication is a Bluetooth enabled communication protocol. 
     
     
         5 . The system of  claim 1 , further comprising: prior to generation of the notification, the control unit is configured to generate an instruction to confirm the fault condition or the potential fault condition, and wherein the notification is generated if the fault condition or the potential fault condition is confirmed. 
     
     
         6 . The system of  claim 1 , wherein the fault condition or the potential fault condition comprises an analyte sensor malfunction. 
     
     
         7 . The system of  claim 1 , wherein the fault condition or the potential fault condition comprises analyte sensor malfunction. 
     
     
         8 . The system of  claim 1 , wherein the fault condition or the potential fault condition comprises analyte sensor dislodgment. 
     
     
         9 . The system of  claim 1 , wherein the fault condition or the potential fault condition comprises communication failure between the control unit and the analyte monitoring device. 
     
     
         10 . The system of  claim 1 , wherein the fault condition or the potential fault condition comprises a sensor signal loss, such that the control unit is not receiving the signal levels. 
     
     
         11 . The system of  claim 10 , wherein the notification on the user interface based on the fault condition or the potential fault condition is provided after 20 minutes have elapsed since the sensor signal loss. 
     
     
         12 . The system of  claim 1 , wherein the alarm is visual; audible; vibratory; or a combination of any of visual, audible, or vibratory. 
     
     
         13 . The system of  claim 1 , wherein the notification further comprises an instruction to perform a corrective action. 
     
     
         14 . The system of  claim 13 , wherein the instruction to perform the corrective action comprises an instruction to replace the analyte monitoring device. 
     
     
         15 . The system of  claim 13 , wherein the instruction to perform the corrective action comprises a recommendation to verify the analyte levels. 
     
     
         16 . The system of  claim 13 , wherein the instruction to perform the corrective action comprises a recommendation to modify a medication delivery rate. 
     
     
         17 . The system of  claim 13 , wherein the instruction to perform the corrective action comprises a recommendation to modify a medication delivery amount. 
     
     
         18 . The system of  claim 1 , further comprising a medication delivery device configured to deliver medication based on the received signal levels, wherein the medication delivery device is in data communication with the control unit. 
     
     
         19 . A system comprising:
 an analyte monitoring device comprising an in vivo analyte sensor;   one or more processors; and   a memory operably coupled to the one or more processors and storing instructions that, when executed by the one or more processors, causes the one or more processors to:
 receive signal levels from the in vivo analyte sensor of the analyte monitoring device, the signal levels representative of analyte levels; 
 determine whether one or more of the signal levels are associated with a fault condition or potential fault condition of the analyte monitoring device; and 
 generate a notification on a user interface of a control unit in data communication with the analyte monitoring device based on the fault condition or the potential fault condition, wherein the notification comprises an instruction to perform a corrective action. 
   
     
     
         20 . A method comprising:
 receiving, using one or more processors, signal levels from an in vivo analyte sensor of an analyte monitoring device, the signal levels representative of analyte levels;   determining, using the one or more processors, whether one or more of the signal levels are associated with a fault condition or potential fault condition of the analyte monitoring device; and   generating, using the one or more processors, a notification on a user interface of a control unit in data communication with the analyte monitoring device based on the fault condition or the potential fault condition, wherein the notification comprises an alarm.