Diabetes management system with automatic basal and manual bolus insulin control

Abstract

Systems and methods for diabetes management with automatic basal and manual bolus insulin control are presented. An exemplary system includes a delivery device, a glucose sensor, and a controller. The delivery device delivers insulin and the glucose sensor measures glucose levels of the subject. A basal insulin dose is calculated using a model predictive control algorithm and physiological data of the subject including desired glucose levels, amounts of the delivered insulin and the measured glucose levels. A manual bolus insulin dose is initiated by the subject. The manual bolus insulin dose is modified based on one or both of the model predictive control algorithm and the physiological data of the subject. A total insulin dose is determined based on the modified manual bolus insulin dose and the calculated basal insulin dose, and delivered to the subject.

What is claimed is: 
     
         1 . A diabetes management system comprising:
 a delivery device for delivering insulin to a subject;   a glucose sensor for measuring glucose levels of the subject;   a bolus calculator into which a manual bolus insulin dose is initiated by the subject, the manual bolus insulin dose being determined by the bolus calculator as a function of a difference between a present glucose level of the subject, a glucose sensitivity of the subject, and an on-board insulin level of the subject; and   a controller configured to:
 receive glucose levels of the subject from the glucose sensor on a periodic basis, 
 automatically calculate a basal insulin dose using a model predictive control (MPC) algorithm and physiological data of the subject including desired glucose levels, amounts of the delivered insulin, and the measured glucose levels of the subject, 
 receive the manual bolus insulin dose determined by the bolus calculator, 
 modify the manual bolus insulin dose based on the physiological data, 
 determine a total insulin dose based on the modified manual bolus insulin dose and the calculated basal insulin dose, and 
 deliver the total insulin dose to the subject. 
   
     
     
         2 . The diabetes management system of  claim 1 , wherein the physiological data of the subject comprises a rate of glucose change of the subject and the modifying comprises reducing the manual bolus insulin dose to account for the rate of glucose change. 
     
     
         3 . The diabetes management system of  claim 1 , wherein the controller is further configured to detect hypoglycemic excursions of the subject and cancel the manual bolus insulin dose responsive to the detected hypoglycemic excursions. 
     
     
         4 . The diabetes management system of  claim 1 , wherein the modifying comprises overriding the manual bolus insulin dose determined by the bolus calculator. 
     
     
         5 . The diabetes management system of  claim 1 , wherein the bolus calculator calculates the manual bolus insulin dose to achieve a target glucose level. 
     
     
         6 . A diabetes management system with automatic basal and manual bolus insulin control, the diabetes management system comprising:
 a delivery device for delivering insulin to a subject;   a glucose sensor for measuring glucose levels of the subject;   a bolus calculator into which a manual bolus insulin dose is initiated by the subject, the manual bolus insulin dose being determined by the bolus calculator as a function of a difference between a present glucose level of the subject, a glucose sensitivity of the subject, and an on-board insulin level of the subject; and   a controller configured to:
 receive glucose levels of the subject from the glucose sensor on a periodic basis, 
 automatically calculate a basal insulin dose using a model predictive control (MPC) algorithm and physiological data of the subject including desired glucose levels, amounts of the delivered insulin and the measured glucose levels of the subject, 
 receive the manual bolus insulin dose determined by the bolus calculator, 
 modify the manual bolus insulin dose based on the MPC algorithm and physiological data of the subject. 
   
     
     
         7 . The diabetes management system of  claim 6 , wherein the controller is further configured to determine a total insulin dose based on the modified manual bolus insulin dose and the calculated basal insulin dose. 
     
     
         8 . The diabetes management system of  claim 6 , wherein the controller is further configured to command the delivery device to deliver the total insulin dose to the subject. 
     
     
         9 . The diabetes management system of  claim 6 , wherein the physiological data of the subject comprises a rate of glucose change of the subject and the modifying comprises reducing the manual bolus insulin dose to account for the rate of glucose change. 
     
     
         10 . The diabetes management system of  claim 6 , wherein the controller is further configured to detect hypoglycemic excursions of the subject and cancel the manual bolus insulin dose determined by the bolus calculator responsive to the detected hypoglycemic excursions. 
     
     
         11 . The diabetes management system of  claim 6 , wherein the modifying comprises overriding the manual bolus insulin dose determined by the bolus calculator. 
     
     
         12 . A method for managing diabetes using automatic basal and manual bolus insulin control in an artificial pancreas system having:
 a delivery device for delivering insulin to a subject, a glucose sensor for measuring glucose levels of the subject, a bolus calculator configured to determine a manual bolus insulin dose, and a controller, the method comprising the steps of:   using the controller, receiving glucose levels of the subject from the glucose sensor on a periodic basis;   using the controller, automatically calculating a basal insulin dose using a model predictive control (MPC) algorithm and physiological data of the subject including desired glucose levels, amounts of the delivered insulin and the measured glucose levels of the subject;   using the bolus calculator, determining a manual bolus insulin dose based on physiological data of the subject as a function of a difference between a present glucose level and the target glucose level, a glucose sensitivity of the subject, and the on-board level of insulin of the subject;   having the controller receive the determined manual bolus insulin dose from the bolus calculator; and   modifying the determined manual bolus insulin dose determined by the bolus calculator based on the MPC algorithm and physiological data of the subject;   determining a total insulin dose based on the modified manual bolus insulin dose and the calculated basal insulin dose; and   commanding the delivery device to deliver the total insulin dose to the subject.   
     
     
         13 . The method of  claim 12 , further comprising:
 using the MPC algorithm, determining whether there will be a near-future glycemic excursion of the subject based on the physiological data including rate of change of glucose, the near-future glycemic excursion being indicative of hypoglycemia; and   if a determination is made that there will be a near-future glycemic excursion indicative of hypoglycemia, then modifying the manual bolus insulin dose of the bolus calculator based on the predicted near-future glycemic excursion.   
     
     
         14 . The method of  claim 12 , wherein the modifying the manual bolus insulin dose comprises reducing or canceling the manual bolus insulin dose determined by the bolus calculator. 
     
     
         15 . The method of  claim 12 , wherein modifying the manual bolus insulin dose comprises calculating a function of a difference between a present glucose level of the subject and a target glucose level of the subject, a glucose sensitivity of the subject, and an on-board insulin level of the subject. 
     
     
         16 . The method of  claim 12 , wherein automatically calculating the basal insulin dose comprises using the MPC algorithm further based on a rate of glucose change of the subject, and the modifying comprises reducing the manual bolus insulin dose to account for the rate of glucose change. 
     
     
         17 . The method of  claim 12 , further comprising:
 detecting at least one hypoglycemic excursion of the subject using the MPC algorithm; and   canceling the manual bolus insulin dose responsive to the detected at least one hypoglycemic excursion.   
     
     
         18 . The method of  claim 12 , further comprising, calculating the manual bolus insulin dose to achieve a target glucose level using the bolus calculator.