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 . A method for managing diabetes of a patient, comprising:
 receiving metabolic measurement data and metabolic state estimate data of a patient at a system coordinator controller device;   routing the received data to one or more activated controller devices selectively activated by the system coordinator controller device for diabetes management of the patient, wherein the selectively activated controller devices include a daily profile controller device configured to compute a reference insulin infusion signal in response to at least a metabolic state estimate of the patient, a meal controller device configured to compute a recommended meal insulin infusion signal in response to data relating to intake of a meal by the patient, and a compensation control to target controller device configured to compute a recommended residual insulin infusion signal in response to data relating to glucose level excursions of the patient caused by non-meal occurrences; and   receiving and monitoring at a supervision controller device the insulin infusion signals from the activated controller devices and non-activated controller devices;   adjusting the insulin infusion signals in accordance with a total insulin infusion amount in dependence on a number of activated controller devices to produce an adjusted total insulin infusion signal, wherein the supervision controller device is configured to send the adjusted total insulin infusion signal to the patient as a suggestion, in an open loop control mode, and send the adjusted total insulin infusion signal to an insulin infusion pump in a closed loop control mode in order for the insulin infusion pump to administer insulin based on the adjusted total insulin infusion signal; and   receiving at a data acquisition controller device continuous glucose monitoring data, insulin pump data, exercise data, and meal data from external data sources, wherein the data acquisition controller device is configured to output data to the system coordinator controller device, such that the system coordinator controller receives the output data in addition to the received metabolic measurement data and the metabolic state estimate data.   
     
     
         2 . The method of  claim 1 , wherein the data outputted by the data acquisition controller device includes:
 a single, processed glucose sample at a specific time, a history of glucose samples up to a specific time, or a statistic computed from glucose samples up to a specific time;   a most recent actual insulin pump command, a history of recent insulin pump commands up to a specific time, or a statistic computed from recent commands;   exercise process data at the specific time; and   meal data at the specific time.   
     
     
         3 . The method of  claim 2 , comprising:
 receiving by at least one observer controller device the data outputted by the data acquisition controller device; and   compute by the at least one observer controller device said metabolic measurement data and metabolic state estimate data.   
     
     
         4 . The method of  claim 3 , wherein the metabolic measurement data includes at least one of continuous glucose measurements and insulin measurements. 
     
     
         5 . The method of  claim 3 , wherein the metabolic state estimate data includes at least one of meal data, exercise data, insulin infusion data, glucagon infusion data, and hypoglycemia treatment data. 
     
     
         6 . The method of  claim 3 , comprising:
 receiving at the supervision controller device data from the at least one observer controller device and the controller devices;   determining from the received data whether a predefined increased risk of hypoglycemia or hyperglycemia exists, to reduce or discontinue a suggested insulin infusion when the predefined increased risk of hypoglycemia is determined to exist; and   notifying a user when the predefined increased risk of hyperglycemia is determined to exist.   
     
     
         7 . The method of  claim 3 , comprising:
 receiving at a short term observer controller device data X times per hour, where 0<X≤7200, wherein the at least one observer controller device includes the short term observer controller device; and   outputting at least one of a vector of estimates of metabolic states of an individual, a single, processed glucose sample at a specific time, a history of glucose samples up to a specific time, or a statistic computed from glucose samples up to a specific time.   
     
     
         8 . The method of  claim 3 , comprising:
 assessing at a long term observer controller device a patient profile X times per month, where 0<X≤60, wherein the at least one observer controller device includes the long term observer controller device; and   outputting at least one of a daily profile of an individual's meal behavior as a function of the time of day, a daily profile of the individual's exercise behavior as a function of the time of day; and a daily profile of the individual's utilization of insulin as a function of the time of day.   
     
     
         9 . The method of  claim 1 , comprising:
 determining a reference insulin infusion signal once per day at the daily profile controller device;   determining at the compensation control to target controller device a recommended residual insulin infusion signal every fifteen to thirty minutes; and   determining at the meal controller device a recommended meal insulin infusion signal every several hours.