Method and system for controlling a tuning factor due to sensor replacement for closed-loop controller in an artificial pancreas

• US 9,474,855 B2
• Filed: 10/04/2013
• Issued: 10/25/2016
• Est. Priority Date: 10/04/2013
• Status: Active Grant

• Current Assignee: LifeScan IP Holdings, LLC
• Original Assignee: Animas Corporation (Johnson & Johnson)
• Inventors: McCann, Thomas, Schaible, Thomas, Capurro, Jorge
• Primary Examiner(s): Riggs, II, Larry D
• Application Number:
  US14/046,880
• Publication Number:
  US 20150100038A1
• Time in Patent Office: 1,117 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/70 with testing or calibration facilities
• CPC Class Codes: A61M 2209/01 Remote controllers for specific apparatus
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

Described and illustrated is a system for management of diabetes that includes an infusion pump, glucose sensor and controller with a method programmed in the controller. The infusion pump is configured to deliver insulin. The glucose sensor senses glucose levels in the subject and provide output signals representative of the glucose levels in the subject. The controller is programmed receives signals from at least one of the glucose sensor and the pump and configured to issue signals to the pump to deliver an amount of insulin determined by a feedback controller that utilizes a model predictive control based on desired glucose levels, insulin amount delivered and measured glucose levels of the subject. The controller is also configured to deliver insulin using a tuning factor (R) for a model predictive controller in the microcontroller as a conservative setting otherwise the system maintains a current tuning factor (R) for the controller.

Claims

1. A method to control a system for management of diabetes using a model predictive controller having a tuning factor (R), the tuning factor (R) being adjustable between a conservative tuning factor and an aggressive tuning factor, the system comprising an infusion pump with a microcontroller to control the pump and receive data from at least one glucose sensor, and the method comprising:

measuring glucose level in the subject from the glucose sensor to provide at least one glucose measurement in each time interval in a series of discrete time intervals;

determining a change in an accuracy of the system, the determining comprising;

determining a reduction in the accuracy of the system responsive to the glucose sensor being replaced by a new glucose sensor within a predetermined time interval; and

determining an increase in the accuracy of the system responsive to a calibration of the glucose sensor;

setting the tuning factor (R) for the model predictive controller in the microcontroller as the conservative tuning factor responsive to determining the reduction in the accuracy of the system, or the aggressive tuning factor responsive to determining the increase in the accuracy of the system;

calculating an insulin amount for delivery by the microcontroller based on the model predictive controller that utilizes the tuning factor (R) so as to provide a calculated insulin amount to be delivered to the subject for one or more of the discrete time intervals; and

delivering via actuation of a pump by the microcontroller of the insulin amount determined from the calculating step.

2. The method of claim 1, in which the conservative tuning factor (R) comprises a value of about 500 and the predetermined time period comprises about 24 hours from a replacement of the glucose sensor with a new glucose sensor.

3. The method of claim 2, in which the tuning factor (R) comprises a value of about 10.

4. The method of claim 1, in which the tuning factor (R) comprises a value of about 1000.

5. The method of claim 1, in which the conservative setting of the tuning factor comprises a value of about 500.

6. The method of claim 1, in which tuning factor comprises any value from a first value that will cause the pump to have a quicker response in delivering the insulin to a second or conservative value that will cause the pump to have a slower response in delivering insulin and the conservative setting comprises the conservative value of the tuning factor.

7. The method of claim 1, in which the model predictive controller has an error weighing factor (Q) that is related to the tuning factor (R) where:

8. The method of claim 1, in which the at least one glucose sensor comprises a continuous glucose sensor and an episodic glucose meter.

9. A system for management of diabetes comprising:

an episodic glucose meter to measure blood glucose of a subject at discrete non-uniform time intervals and provide such episodic blood glucose level as a calibration;

a continuous glucose monitor to continuously measure glucose level of the subject at discrete generally uniform time intervals and provide the glucose level at each interval in the form of glucose measurement data;

an insulin infusion pump to deliver insulin;

a microcontroller using a model predictive controller having a tuning factor (R), the tuning factor (R) being adjustable between a conservative tuning factor and an aggressive tuning factor, the microcontroller being in communication with the pump, glucose meter and the glucose monitor in which the controller sets the tuning factor (R) to the conservative tuning factor for a predetermined time period after the continuous glucose monitor has been replaced with a new continuous glucose monitor, or to an aggressive tuning factor for the predetermined time period after the continuous glucose monitor has been calibrated, such that controller determines an insulin delivery rate for each time interval in the time interval index (k) from the model predictive control based on the tuning factor (R) and commands the pump to deliver insulin at the determined insulin delivery rate.

10. The system of claim 9, in which the conservative setting for the tuning factor (R) comprises a value of about 500.

11. The system of claim 9, in which the tuning factor (R) comprises a value of about 10.

12. The system of claim 9, in which the tuning factor (R) comprises a value of about 1000.

13. The system of claim 9, in which the model predictive controller has an error weighing factor (Q) that is related to the tuning factor (R) where:

14. The system of claim 9, in which the tuning factor comprises any value from a first value that will cause the pump to have a quicker response in delivering the insulin to a second or conservative value that will cause the pump to have a slower response in delivering insulin and the conservative setting comprises the conservative value of the tuning factor.

15. A method to control a system for management of diabetes using a model predictive controller having a tuning factor (R), the tuning factor (R) being adjustable between a conservative tuning factor and an aggressive tuning factor, the system comprising an infusion pump with a microcontroller to control the pump and receive data from at least one glucose sensor, and the method comprising:

measuring a glucose level in the subject from the glucose sensor to provide at least one glucose measurement in each time interval in a series of discrete time intervals;

determining a change in an accuracy of the system, the determining comprising;

determining a reduction in the accuracy of the system responsive to one or more of the glucose sensor being replaced by a new glucose sensor within a predetermined time interval, an increase in each successive sample following a calibration of the glucose sensor or a failure of the glucose sensor to report a glucose measurement; and

determining an increase in the accuracy of the system responsive to one or more of a calibration of the glucose sensor or a reestablishment of the glucose sensor reporting glucose measurements;

setting the tuning factor (R) for the model predictive controller in the microcontroller as the conservative tuning factor responsive to determining the reduction in the accuracy of the system, or the aggressive tuning factor responsive to determining the increase in the accuracy of the system;

calculating an insulin amount for delivery by the microcontroller based on a model predictive controller that utilizes the tuning factor (R) so as to provide a calculated insulin amount to be delivered to the subject for one or more of the discrete time intervals; and

delivering via actuation of a pump by the microcontroller of the insulin amount determined from the calculating step.