Integrated closed-loop medication delivery with error model and safety check
First Claim
1. An integrated system for the delivery of medication to a patient, the system comprising:
- a controller programmed to receive a sensor glucose measurement signal, to provide a delivery control signal to a medication delivery device as a function of the received sensor glucose measurement signal in accordance with a control model and a glucose measurement error model, and to adjust a value of the delivery control signal in accordance with safety checks, wherein the safety checks;
impose a maximum infusion rate related to a basal rate, the maximum infusion rate being dependent on a current sensor glucose level, time since a previous meal, and carbohydrate content of a meal; and
cap the medication infusion to a pre-programmed basal rate in response to an inference of an occlusion of the medication delivery device.
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Accused Products
Abstract
A closed-loop system for insulin infusion overnight uses a model predictive control algorithm (“MPC”). Used with the MPC is a glucose measurement error model which was derived from actual glucose sensor error data. That sensor error data included both a sensor artifacts component, including dropouts, and a persistent error component, including calibration error, all of which was obtained experimentally from living subjects. The MPC algorithm advised on insulin infusion every fifteen minutes. Sensor glucose input to the MPC was obtained by combining model-calculated, noise-free interstitial glucose with experimentally-derived transient and persistent sensor artifacts associated with the FreeStyle Navigator® Continuous Glucose Monitor System (“FSN”). The incidence of severe and significant hypoglycemia reduced 2300- and 200-fold, respectively, during simulated overnight closed-loop control with the MPC algorithm using the glucose measurement error model suggesting that the continuous glucose monitoring technologies facilitate safe closed-loop insulin delivery.
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Citations
30 Claims
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1. An integrated system for the delivery of medication to a patient, the system comprising:
a controller programmed to receive a sensor glucose measurement signal, to provide a delivery control signal to a medication delivery device as a function of the received sensor glucose measurement signal in accordance with a control model and a glucose measurement error model, and to adjust a value of the delivery control signal in accordance with safety checks, wherein the safety checks; impose a maximum infusion rate related to a basal rate, the maximum infusion rate being dependent on a current sensor glucose level, time since a previous meal, and carbohydrate content of a meal; and cap the medication infusion to a pre-programmed basal rate in response to an inference of an occlusion of the medication delivery device. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15)
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16. A method for delivering medication to a patient, the method comprising:
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receiving a sensed glucose measurement signal and providing a delivery control signal as a function of the received sensed glucose measurement signal in accordance with a control model and a glucose measurement error model; and adjusting a value of the delivery control signal in accordance with safety checks that cause; the imposing of a maximum infusion rate related to a basal rate, the maximum infusion rate being dependent on a current sensor glucose level, time since a previous meal, and carbohydrate content of a meal; and the capping of the medication infusion to a pre-programmed basal rate if a medication delivery device occlusion is inferred. - View Dependent Claims (17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30)
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Specification