System coordinator and modular architecture for open-loop and closed-loop control of diabetes

Abstract

A structure, method, and computer program product for a diabetes control system provides, but is not limited thereto, the following: open-loop or closed-loop control of diabetes that adapts to individual physiologic characteristics and to the behavioral profile of each person. An exemplary aspect to this adaptation is biosystem (patient or subject) observation and modular control. Consequently, established is the fundamental architecture and the principal components for a modular system, which may include algorithmic observers of patients' behavior and metabolic state, as well as interacting control modules responsible for basal rate, insulin boluses, and hypoglycemia prevention.

1 - 9 . (canceled) 
     
     
         10 . A non-transitory computer readable medium, having stored thereon processor-executable instructions that when executed cause a processor to:
 receive metabolic measurement data;   generate metabolic state estimate data of a patient based on one or more of insulin pump data, exercise data, or meal data;   generate a total insulin infusion signal based on a computed output, the computed output including:
 an insulin infusion signal in response to the metabolic state estimate data; 
 a recommended meal insulin infusion signal in response to meal intake data; and/or 
 a recommended residual insulin infusion signal in response to glucose level excursion data, the glucose level excursion data being caused by non-meal occurrences; 
   wherein the computed output is based on one or more of the metabolic measurement data or the metabolic state estimate data of the patient; and   
       transmit the total insulin infusion signal to an insulin delivery device. 
     
     
         11 . The non-transitory computer readable medium of  claim 10 , wherein:
 the instructions cause the processor to generate the computed output.   
     
     
         12 . The non-transitory computer readable medium of  claim 10 , wherein:
 the instructions cause the processor to:
 transmit one or more of the metabolic measurement data or the metabolic state estimate data of the patient to a controller device, wherein the controller device generates the computed output; and 
 receive the computed output from the controller device to generate the total insulin infusion signal. 
   
     
     
         13 . The non-transitory computer readable medium of  claim 10 , wherein:
 the computed output includes:
 an insulin infusion signal in response to the metabolic state estimate data; 
 a recommended meal insulin infusion signal in response to meal intake data; and 
 a recommended residual insulin infusion signal in response to glucose level excursion data, the glucose level excursion data being caused by non-meal occurrences. 
   
     
     
         14 . The non-transitory computer readable medium of  claim 10 , wherein:
 the metabolic state estimate data of the patient is based on insulin pump data, exercise data, and meal data.   
     
     
         15 . The non-transitory computer readable medium of  claim 10 , wherein:
 the insulin delivery device is an insulin pump.   
     
     
         16 . The non-transitory computer readable medium of  claim 10 , wherein:
 the instructions cause the processor to transmit the total insulin infusion signal to the insulin delivery device via a closed loop control.   
     
     
         17 . The non-transitory computer readable medium of  claim 10 , wherein:
 the total insulin infusion signal is a control signal configured to cause the insulin delivery device to administer insulin.   
     
     
         18 . The non-transitory computer readable medium of  claim 10 , wherein:
 the instructions cause the processor to receive the one or more of insulin pump data, exercise data, or meal data from an external data source.   
     
     
         19 . The non-transitory computer readable medium of  claim 10 , wherein:
 the instructions cause the processor to receive the one or more of insulin pump data, exercise data, or meal data from a data acquisition controller.   
     
     
         20 . The non-transitory computer readable medium of  claim 10 , wherein:
 the computed output is further based on a vector of state estimate and/or a behavior profile.   
     
     
         21 . The non-transitory computer readable medium of  claim 20 , wherein:
 the vector of state estimate is based on data assessed at X times per hour, where 0<X≤7200; and   the behavioral profile is based on data assessed at X times per month, where 0<X≤60.   
     
     
         22 . An insulin delivery device, comprising:
 a processor configured to receive a signal from a computing environment, the computing environment including a non-transitory computer readable medium having instructions for causing the computing environment to:
 receive metabolic measurement data; 
 generate metabolic state estimate data of a patient based on one or more of insulin pump data, exercise data, or meal data; 
 generate a total insulin infusion signal based on a computed output, the computed output including:
 an insulin infusion signal in response to the metabolic state estimate data; 
 a recommended meal insulin infusion signal in response to meal intake data; and/or 
 a recommended residual insulin infusion signal in response to glucose level excursion data, the glucose level excursion data being caused by non-meal occurrences; 
 wherein the computed output is based on one or more of the metabolic measurement data or the metabolic state estimate data of the patient; and 
 
   transmit the total insulin infusion signal to the processor of the insulin delivery device; wherein the processor of the insulin delivery device administers insulin based on the total insulin infusion signal.   
     
     
         23 . The insulin delivery device of  claim 22 , wherein:
 the computed output includes:
 an insulin infusion signal in response to the metabolic state estimate data; 
 a recommended meal insulin infusion signal in response to meal intake data; and 
 a recommended residual insulin infusion signal in response to glucose level excursion data, the glucose level excursion data being caused by non-meal occurrences. 
   
     
     
         24 . The insulin delivery device of  claim 22 , wherein:
 the metabolic state estimate data of the patient is based on insulin pump data, exercise data, and meal data.   
     
     
         25 . The insulin delivery device of  claim 22 , wherein:
 the insulin delivery device is an insulin pump.   
     
     
         26 . The insulin delivery device of  claim 22 , wherein:
 the processor of the insulin delivery device is configured to receive the total insulin infusion signal via a closed loop control.   
     
     
         27 . The insulin delivery device of  claim 22 , wherein:
 the computed output is further based on a vector of state estimate and/or a behavior profile.   
     
     
         28 . The insulin delivery device of  claim 27 , wherein:
 the vector of state estimate is based on data assessed at X times per hour, where 0<X≤7200; and   the behavioral profile is based on data assessed at X times per month, where 0<X≤60.   
     
     
         29 . The insulin delivery device of  claim 22 , wherein:
 the processor of the insulin delivery device administers insulin by injecting an amount of insulin based on the total insulin infusion signal and/or adjusting an amount of insulin to be injected based on the total insulin infusion signal.