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 method of adaptive diabetes control by a diabetes control system, the method comprising:
 receiving a first glucose input reflective of glucose sample processing by a continuous glucose monitor (CGM) sensor;   receiving a first insulin delivery command, the first insulin delivery command representing a most recent command to an insulin pump relative to a time of the first glucose input;   computing, in a first control function, a first reference insulin infusion based on the first glucose input, the first insulin delivery command, and a first profile descriptive of a statistical insulin utilization;   computing, in a second control function, a first residual insulin infusion based on the first glucose input and a second profile descriptive that is at least a function of time of day;   computing, in a third control function, a first meal-accommodation insulin infusion based on a third profile of a meal behavior; and   determining a first total insulin infusion based on the first reference insulin infusion, the first residual insulin infusion, and the first meal-accommodation insulin infusion.   
     
     
         11 . The method of  claim 10 , comprising the diabetes control system:
 commanding the insulin pump to deliver the determined first total insulin infusion via a second insulin delivery command.   
     
     
         12 . The method of  claim 11 , wherein the diabetes control system is external to the insulin pump and the commanding comprises:
 sending the second insulin delivery command to the insulin pump over a wireless communications channel.   
     
     
         13 . The method of  claim 11 , wherein the computing a first residual insulin infusion comprises:
 managing, in the second control function, a blood glucose excursion not accounted for by the third control function.   
     
     
         14 . The method of  claim 11 , comprising, by the diabetes control system:
 estimating, in the third control function, a first glucose excursion from a target due to at least one of a meal or a response to a meal; and   estimating, based on the estimated first glucose excursion, a second glucose excursion from the target that is not due to the at least one of a meal or a response to a meal,   wherein the first residual insulin infusion is computed based on the estimated second glucose excursion.   
     
     
         15 . The method of  claim 11 , wherein the first reference insulin infusion comprises:
 a suggested basal delivery, the first residual insulin infusion compensating the suggested basal delivery either upward to correct hyperglycemia or downward to reduce a likelihood of hypoglycemia.   
     
     
         16 . The method of  claim 11 , the method comprising, by the diabetes control system:
 receiving a second glucose input reflective of glucose sample processing by the CGM sensor;   receiving the second insulin delivery command, the received second insulin delivery command representing a most recent command to the insulin pump relative to a time of the second glucose input;   computing, in the first control function, a second reference insulin infusion based on the second glucose input, the received second insulin delivery command, and the first profile descriptive of the statistical insulin utilization;   computing, in the second control function, a second residual insulin infusion based on the second glucose input and the second profile descriptive that is at least a function of time of day;   computing, in the third control function, a second meal-accommodation insulin infusion based on the third profile of meal behavior;   determining a second total insulin infusion based on the second reference insulin infusion, the second residual insulin infusion, and the second meal-accommodation insulin infusion; and   commanding the insulin pump to deliver the determined second total insulin via a third insulin delivery command.   
     
     
         17 . The method of  claim 11 , comprising the diabetes control system:
 assessing at least one of the first profile, the second profile, or the third profile and, subsequent to the assessing:   receiving a second glucose input reflective of glucose sample processing by the CGM sensor;   receiving the second insulin delivery command, the received second insulin delivery command representing a most recent command to the insulin pump relative to a time of the second glucose input;   computing, in the first control function, a second reference insulin infusion based on the second glucose input, the received second insulin delivery command, and the first profile descriptive statistical insulin utilization;   computing, in the second control function, a second residual insulin infusion based on the second glucose input and the second profile descriptive that is at least a function of time of day;   computing, in the third control function, a second meal-accommodation insulin infusion based on the third profile of the meal behavior;   determining a second total insulin infusion based on the second reference insulin infusion, the second residual insulin infusion, and the second meal-accommodation insulin infusion; and   commanding the insulin pump to deliver the determined second total insulin infusion via a third insulin delivery command.   
     
     
         18 . The method of  claim 11 , wherein the first residual insulin infusion is computed via at least one of the following:
 a model predictive control (MPC) technique;   a dynamic model of interactions of a glucose target and residual insulin;   a linear quadratic Gaussian (LQG) control methodology;   a learning model predictive control (LMPC) methodology; and/or   a proportional-integral-derivative (PID) control methodology.   
     
     
         19 . The method of  claim 10 , comprising the diabetes control system:
 assessing the first profile, the second profile, and the third profile at least monthly.   
     
     
         20 . A system for diabetes control, the system comprising:
 at least one processor; and   memory having control logic stored thereon that is executable by the at least one processor to perform operations including:
 receiving a first glucose input reflective of glucose sample processing by a continuous glucose monitor (CGM) sensor configured for a patient; 
 receiving a first insulin delivery command, the first insulin delivery command representing a most recent command to an insulin pump relative to a time of the first glucose input; 
 computing, in a first control function, a first reference insulin infusion based on the first glucose input, the first insulin delivery command, and a first profile descriptive of a statistical insulin utilization; 
 computing, in a second control function, a first residual insulin infusion based on the first glucose input and a second profile descriptive that is at least a function of time of day; 
 computing, in a third control function, a first meal-accommodation insulin infusion based on a third profile of meal behavior; and 
 determining a first total insulin infusion based on the first reference insulin infusion, the first residual insulin infusion, and the first meal-accommodation insulin infusion. 
   
     
     
         21 . The system of  claim 20 , wherein the operations comprise:
 commanding the insulin pump to deliver the determined first total insulin infusion via a second insulin delivery command.   
     
     
         22 . The system of  claim 21 , wherein the computing a first residual insulin infusion comprises:
 managing, in the second control function, a blood glucose excursion not accounted for by the third control function.   
     
     
         23 . The system of  claim 21 , wherein the operations comprise:
 estimating, in the third control function, a first glucose excursion from a target due to at least one of a meal or a response to a meal; and   estimating, based on the estimated first glucose excursion, a second glucose excursion from the target that is not due to the at least one of a meal or a response to a meal,   wherein the first residual insulin infusion is computed based on the estimated second glucose excursion.   
     
     
         24 . The system of  claim 21 , wherein the first reference insulin infusion includes a suggested basal delivery, the first residual insulin infusion compensating the suggested basal delivery either upward to correct hyperglycemia or downward to reduce a likelihood of hypoglycemia. 
     
     
         25 . The system of  claim 21 , wherein the operations comprise:
 receiving a second glucose input reflective of glucose sample processing by the CGM sensor;   receiving the second insulin delivery command, the received second insulin delivery command representing a most recent command to the insulin pump relative to a time of the second glucose input;   computing, in the first control function, a second reference insulin infusion based on the second glucose input, the received second insulin delivery command, and the first profile descriptive of the statistical insulin utilization;   computing, in the second control function, a second residual insulin infusion based on the second glucose input and the second profile descriptive that is at least a function of time of day;   computing, in the third control function, a second meal-accommodation insulin infusion based on the third profile of the meal behavior;   determining a second total insulin infusion based on the second reference insulin infusion, the second residual insulin infusion, and the second meal-accommodation insulin infusion; and   commanding the insulin pump to deliver the determined second total insulin infusion via a third insulin delivery command.   
     
     
         26 . The system of  claim 21 , wherein the operations comprise:
 assessing at least one of the first profile, the second profile, or the third profile and, subsequent to the assessing:   receiving a second glucose input reflective of glucose sample processing by the CGM sensor;   receiving the second insulin delivery command, the received second insulin delivery command representing a most recent command to the insulin pump   relative to a time of the second glucose input;   computing, in the first control function, a second reference insulin infusion based on the second glucose input, the received second insulin delivery command, and the first profile descriptive of the statistical insulin utilization;   computing, in the second control function, a second residual insulin infusion based on the second glucose input and the second profile descriptive of the patient at least a function of time of day;   computing, in the third control function, a second meal-accommodation insulin infusion based on the third profile of the meal behavior;   determining a second total insulin infusion based on the second reference insulin infusion, the second residual insulin infusion, and the second meal-accommodation insulin infusion; and   commanding the insulin pump to deliver the determined second total insulin infusion via a third insulin delivery command.   
     
     
         27 . The system of  claim 21 , wherein the operations comprise:
 assessing the first profile, the second profile, and the third profile at least monthly.   
     
     
         28 . The system of  claim 21 , wherein the system is a personal device comprising:
 a display and an interface for wireless communication, and the operations comprise:
 sending the second insulin delivery command to the insulin pump via the interface for wireless communication. 
   
     
     
         29 . The system of  claim 21 , wherein the system is a personal device comprising:
 a display and an interface for cellular communication.   
     
     
         30 . A computer-program product having a non-transitory computer-usable medium with computer program logic stored thereon, the computer program logic being configured to be executed to perform operations comprising:
 receiving a first glucose input reflective of glucose sample processing by a continuous glucose monitor (CGM) sensor configured for a patient;   receiving a first insulin delivery command, the first insulin delivery command representing a most recent command to an insulin pump relative to a time of the first glucose input;   computing, in a first control function, a first reference insulin infusion based on the first glucose input, the first insulin delivery command, and a first profile descriptive of a statistical insulin utilization;   computing, in a second control function, a first residual insulin infusion based on the first glucose input and a second profile descriptive that is at least a function of time of day;   computing, in a third control function, a first meal-accommodation insulin infusion based on a third profile of meal behavior; and   determining a first total insulin infusion based on the first reference insulin infusion, the first residual insulin infusion, and the first meal-accommodation insulin infusion.   
     
     
         31 . The computer-program product of  claim 30 , wherein the operations comprise:
 commanding the insulin pump to deliver the determined first total insulin via a second insulin delivery command.   
     
     
         32 . The computer-program product of  claim 22 , wherein the computing a first residual insulin infusion comprises:
 managing, in the second control function, a blood glucose excursion not accounted for by the third control function.   
     
     
         33 . The computer-program product of  claim 31 , wherein the operations comprise:
 estimating, in the third control function, a first glucose excursion from a target due to at least one of a meal or a response to a meal; and   estimating, based on the estimated first glucose excursion, a second glucose excursion from the target that is not due to the at least one of a meal or a response to a meal,   wherein the first residual insulin infusion is computed based on the estimated second glucose excursion.   
     
     
         34 . The computer-program product of  claim 31 , wherein the first reference insulin infusion comprises:
 a suggested basal delivery, the first residual insulin infusion compensating the suggested basal delivery either upward to correct hyperglycemia or downward to reduce a likelihood of hypoglycemia.   
     
     
         35 . The computer-program product of  claim 31 , wherein the operations comprise:
 receiving a second glucose input reflective of glucose sample processing by the CGM sensor;   receiving the second insulin delivery command, the received second insulin delivery command representing a most recent command to the insulin pump relative to a time of the second glucose input;   computing, in the first control function, a second reference insulin infusion based on the second glucose input, the received second insulin delivery command, and the first profile descriptive of the statistical insulin utilization;   computing, in the second control function, a second residual insulin infusion based on the second glucose input and the second profile descriptive that is at least a function of time of day;   computing, in the third control function, a second meal-accommodation insulin infusion based on the third profile of the meal behavior;   determining a second total insulin infusion based on the second reference insulin infusion, the second residual insulin infusion, and the second meal-accommodation insulin infusion; and   commanding the insulin pump to deliver the determined second total insulin infusion via a third insulin delivery command.   
     
     
         36 . The computer-program product of  claim 31 , wherein the operations comprise:
 assessing at least one of the first profile, the second profile, or the third profile and, subsequent to the assessing:   receiving a second glucose input reflective of glucose sample processing by the CGM sensor;   receiving the second insulin delivery command, the received second insulin delivery command representing a most recent command to the insulin pump relative to a time of the second glucose input;   computing, in the first control function, a second reference insulin infusion based on the second glucose input, the received second insulin delivery command, and the first profile descriptive of the statistical insulin utilization;   computing, in the second control function, a second residual insulin infusion based on the second glucose input and the second profile descriptive that is at least a function of time of day;   computing, in the third control function, a second meal-accommodation insulin infusion based on the third profile of the meal behavior;   determining a second total insulin infusion based on the second reference insulin infusion, the second residual insulin infusion, and the second meal-accommodation insulin infusion; and   commanding the insulin pump to deliver the determined second total insulin infusion to the patient via a third insulin delivery command.   
     
     
         37 . The computer-program product of  claim 31 , wherein the operations comprise:
 assessing the first profile, the second profile, and the third profile at least monthly.   
     
     
         38 . The computer-program product of  claim 31 , wherein the computer program logic is implemented on a personal device having a display and an interface for wireless communication, and the operations comprise:
 sending the second insulin delivery command to the insulin pump via the interface for wireless communication.   
     
     
         39 . The computer-program product of  claim 31 , wherein the computer program logic is implemented on a personal device having a display and an interface for cellular communication.