INTEGRATED CLOSED-LOOP MEDICATION DELIVERY WITH ERROR MODEL AND SAFETY CHECK
2 Assignments
0 Petitions
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.
-
Citations
65 Claims
-
1-35. -35. (canceled)
-
36. An integrated system for the delivery of medication to a patient, the system comprising:
-
a glucose sensor configured to provide a sensor glucose measurement signal representative of sensed glucose; a medication delivery device configured to deliver medication to a patient in response to control signals; and a controller programmed to receive the sensor glucose measurement signal and to provide a delivery control signal to the delivery device as a function of the received sensor glucose measurement signal in accordance with a control model and a glucose measurement error model; wherein the glucose measurement error model is derived from actual glucose sensor measurement data; wherein the controller is also programmed to adjust a value of the delivery control signal in accordance with a safety check, comprising at least one of; imposing a maximum infusion rate related to a basal rate depending on a current sensor glucose level, time since a previous meal, and carbohydrate content of a meal; shutting off medication delivery at a predetermined low sensor glucose value; and reducing medication delivery when sensor glucose is decreasing rapidly. - View Dependent Claims (37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50)
-
-
51. A method for delivering medication to a patient, the method comprising:
-
sensing glucose of a patient and providing sensed glucose measurement signals representative of sensed glucose; delivering medication to a patient in response to a delivery control signal; receiving the sensed glucose measurement signals and providing a delivery control signal as a function of the received sensed glucose measurement signals in accordance with a control model and a glucose measurement error model, wherein the glucose measurement error model is derived from actual glucose sensor measurement data; adjusting a value of the delivery control signal in accordance with a safety check, comprising at least one of; imposing a maximum infusion rate related to a basal rate depending on a current sensed glucose level, time since a previous meal, and carbohydrate content of a meal; shutting off medication delivery at a predetermined low sensed glucose value; and reducing medication delivery when sensed glucose is decreasing rapidly. - View Dependent Claims (52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65)
-
Specification