Model predictive method and system for controlling and supervising insulin infusion
First Claim
1. A method of optimizing delivery of insulin into a body of a user to cover a planned meal, the method comprising:
- (a) obtaining a carbohydrate count and a meal-type indicator for the meal;
(b) calculating an insulin bolus amount to cover the meal;
(c) generating a post-prandial glucose profile based on the carbohydrate count, the meal-type indicator and the calculated bolus amount; and
(d) determining whether the generated post-prandial glucose profile is acceptable.
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Abstract
A system and method for controlling and monitoring a diabetes-management system through the use of a model that predicts or estimates future dynamic states of glucose and insulin from variables such as insulin delivery or exogenous glucose appearance as well as inherent physiological parameters. The model predictive estimator can be used as an insulin bolus advisor to give an apriori estimate of postprandial glucose for a given insulin delivery profile administered with a known meal to optimize insulin delivery; as a supervisor to monitor the operation of the diabetes-management system; and as a model predictive controller to optimize the automated delivery of insulin into a user'"'"'s body to achieve a desired blood glucose profile or concentration. Open loop, closed-loop, and semi-closed loop embodiments of the invention utilize a mathematical metabolic model that includes a Minimal Model, a Pump Delivery to Plasma Insulin Model, and a Meal Appearance Rate Model.
648 Citations
32 Claims
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1. A method of optimizing delivery of insulin into a body of a user to cover a planned meal, the method comprising:
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(a) obtaining a carbohydrate count and a meal-type indicator for the meal; (b) calculating an insulin bolus amount to cover the meal; (c) generating a post-prandial glucose profile based on the carbohydrate count, the meal-type indicator and the calculated bolus amount; and (d) determining whether the generated post-prandial glucose profile is acceptable. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. A method of monitoring the operation of a diabetes-management system having a glucose sensor, a controller, and an insulin delivery pump, the method comprising:
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(a) storing historical meal information for meals consumed by a user, said meal information including a carbohydrate content and a meal-type indicator for each said meal; (b) storing historical insulin-delivery information including, for each instance of insulin delivery, an insulin amount and a delivery pattern; (c) generating a predicted glucose concentration profile by the controller based on the historical meal and insulin-delivery information; (d) generating a sensor glucose concentration profile based on periodic measurements obtained from the glucose sensor; and (e) determining whether, for a given point in time, the difference between the actual glucose concentration value and the predicted glucose concentration value is larger than a pre-determined error value. - View Dependent Claims (12, 13, 14, 15, 16, 17, 18, 19, 20)
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21. A method for optimizing the delivery of insulin into a body of a user so as to achieve a desired blood glucose concentration, the method comprising:
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(a) measuring the user'"'"'s current blood glucose concentration; (b) generating a pre-defined desired glucose concentration profile based on the current blood glucose concentration; (c) generating an insulin-delivery profile to achieve said desired concentration over a predetermined time period; (d) generating a predicted glucose concentration profile for said time period by a model predictive controller using the current glucose concentration and the generated insulin-delivery profile as inputs; (e) calculating a difference between the generated glucose concentration profile and the pre-defined glucose concentration profile; (f) iteratively repeating steps (a)-(e) and identifying an optimal insulin-delivery profile as the delivery profile that produces the minimal difference calculated in step (e); (g) delivering insulin to the user according to the optimal insulin-delivery profile for a pre-set period of time defining a time step; and (h) for the duration of the predetermined time period, repeating steps (a)-(g) every time step. - View Dependent Claims (22, 23, 24)
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25. An infusion pump for infusing insulin from a reservoir into a body of a user, the infusion pump comprising:
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a housing; a drive mechanism contained within the housing and operatively coupled to the reservoir to deliver insulin from the reservoir through a fluid path into the body of the user; and a controller contained within the housing and configured to optimize delivery of insulin into the body of the user to cover a planned meal by obtaining a carbohydrate count and a meal-type indicator for the meal, calculating an insulin amount to cover the meal, generating a post-prandial glucose profile based on the carbohydrate count, the meal-type indicator, and the calculated insulin amount, and determining whether the generated post-prandial glucose profile is acceptable. - View Dependent Claims (26, 27)
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28. An infusion pump for infusing insulin from a reservoir into a body of a user, the infusion pump operating in conjunction with a controller and a glucose sensor and comprising:
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a housing; a drive mechanism contained within the housing and operatively coupled to the reservoir to deliver insulin from the reservoir through a fluid path into the body of the user; and a controller contained within the housing and configured to monitor the operation of said infusion pump and glucose sensor by storing historical meal information for meals consumed by the user, said meal information including a carbohydrate content and a meal-type indicator for each said meal, storing historical insulin-delivery information including, for each instance of insulin delivery, an insulin amount and a delivery pattern, generating a predicted glucose concentration profile based on the historical meal and insulin-delivery information, generating a sensor glucose concentration profile based on periodic measurements obtained from the glucose sensor, and determining whether, for a given point in time, the difference between the actual glucose concentration value and the predicted glucose concentration value is larger than a pre-determined error value. - View Dependent Claims (29, 30)
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31. An infusion pump for infusing insulin from a reservoir into a body of a user, the infusion pump comprising:
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a housing; a drive mechanism contained within the housing and operatively coupled to the reservoir to deliver insulin from the reservoir through a fluid path into the body of the user; and a model predictive controller contained within the housing and configured to optimize the delivery of insulin into the user'"'"'s body so as to achieve a desired blood glucose concentration by measuring the user'"'"'s current blood glucose concentration, generating a pre-defined desired glucose concentration profile based on the current blood glucose concentration, generating an insulin-delivery profile to achieve said desired concentration over a predetermined time period, generating a predicted glucose concentration profile for said time period based on the current glucose concentration and the generated insulin-delivery profile, calculating a difference between the generated glucose concentration profile and the pre-defined glucose concentration profile, iteratively identifying an optimal insulin-delivery profile as the profile that minimizes said difference, and generating commands for the drive mechanism to deliver insulin to the user according to the optimal insulin-delivery profile for a pre-set period of time defining a time step. - View Dependent Claims (32)
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Specification