Method and system to handle manual boluses or meal events for closed-loop controllers

• US 9,757,510 B2
• Filed: 06/29/2012
• Issued: 09/12/2017
• Est. Priority Date: 06/29/2012
• Status: Active Grant

• Current Assignee: JDRF International
• Original Assignee: Animas Corporation (Johnson & Johnson)
• Inventors: Finan, Daniel
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): LEGETTE, TIFFANY
• Application Number:
  US13/539,056
• Publication Number:
  US 20140005633A1
• Time in Patent Office: 1,901 Days
• Field of Search: 6048901, 604 48, 604 65- 67, 604503-504, 604506
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2209/01 Remote controllers for specific apparatus
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the 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
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

Abstract

Described and illustrated is a diabetes management system that includes an infusion pump, glucose sensor and controller with a method programmed into the controller. The infusion pump is configured to deliver insulin to a subject. The glucose sensor is configured to sense glucose levels in the subject and provide output signals representative of the glucose levels in the subject. The controller is programmed to receive 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 and also configured to deliver at least the basal amount of insulin whenever the subject has initiated a manual bolus of insulin and a sensed or measured glucose level is at least a first threshold within a first duration of time.

Claims

1. A diabetes management system comprising:

an infusion pump configured to deliver insulin to a subject;

a glucose sensor configured to sense glucose levels in the subject and provide output signals representative of the glucose levels in the subject; and

a controller that receives signals from at least one of the glucose sensor and the infusion pump, the controller configured to calculate a basal insulin rate and issue signals to the infusion pump to deliver an amount of insulin determined by a feedback controller that utilizes a model predictive control of the subject based on desired glucose levels, insulin amount delivered, and measured glucose levels of the subject, the controller being further configured to determine whether;

(a) the subject has initiated a manual bolus of insulin using the infusion pump within a first duration, and (b) a sensed or measured glucose level from the glucose sensor is at least a first threshold wherein the controller is configured to set a first lower insulin-infusion constraint if the controller determines that the subject has initiated the manual bolus of insulin within the first duration and the glucose level is at least equal to or greater than a first predetermined threshold, the first lower insulin-infusion constraint being equal to the calculated basal insulin rate and to set a lower second infusion constraint of zero if the controller determines that the subject has activated the manual bolus within the duration of time and the glucose level is not greater than or equal to the predetermined threshold and in which the model predictive control determines the amount of insulin to deliver based on either the first or second infusion constraint and wherein model predictive control is continually maintained by the system.

2. The system of claim 1, in which the first threshold comprises about 120 milligrams of glucose per deciliter of blood and the first duration comprises about 45 minutes.

3. The system of claim 2, in which the glucose sensor comprises at least one of an episodic glucose sensor and a continuous glucose sensor.

4. A method to manage diabetes of a subject with an infusion pump, controller, and at least one glucose sensor, the method comprising:

measuring glucose level in the subject from the at least one glucose sensor to provide a plurality of glucose measurements;

calculating a basal insulin rate by the controller for delivery by an insulin pump based on a model predictive controller that utilizes the plurality of glucose measurements to predict a trend of the glucose level from estimates of a metabolic state of the subject so as to provide a calculated insulin amount relative to the calculated basal insulin rate to be delivered to the subject over a predetermined interval;

determining, using the model predictive controller, whether the subject initiated a manual bolus using the insulin pump, while the measured glucose level is at least a first glucose threshold within a first time period;

if the subject has initiated a manual bolus while the measured glucose is at least a first glucose threshold within the first time period, then using the model predictive controller, constraining insulin delivery to be proceeded for delivery at a first lower infusion constraint equal to the calculated basal insulin rate; and

if the subject initiated the manual bolus within the duration of time and the measured glucose level is not greater than or equal to the predetermined threshold, using the model predictive controller to constrain insulin delivery to a second lower infusion constraint which is equal to zero,

wherein the model predictive controller determines the insulin delivery.

6. The method of one of claim 4 or 5, in which the first glucose threshold comprises a glucose concentration of any concentration from about 80 mg of glucose per deciliter of blood to about 180 mg of glucose per deciliter of blood.

7. The method of claim 6, in which the first time period comprises a duration of any value from about 15 minutes to two hours.

8. The method according to one of claim 4 or claim 5, in which the predetermined interval comprises an interval selected from a group consisting essentially of 1 minute, 3, minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes and combinations thereof.

9. The method according to one of claim 4 or claim 5, in which the glucose sensor comprises at least one of an episodic glucose sensor and a continuous glucose sensor.

10. The method according to one of claim 4 or claim 5, in which the calculating further comprises recursively determining an estimate of a metabolic state of the subject from approximately real-time measurements of the glucose levels in the subject.

5. A method to manage diabetes of a subject with an infusion pump, controller, and at least one glucose sensor, the method comprising:

measuring glucose level in the subject from the glucose sensor to provide a plurality of glucose measurements;

calculating a basal insulin rate for delivery of insulin to the subject based on a model predictive controller that utilizes the plurality of glucose measurements to predict a trend of the glucose level from estimates of a metabolic state of the subject so as to provide a calculated insulin amount to be delivered to the subject over a predetermined interval;

determining using the model predictive controller whether (a) the subject initiated a manual bolus using the infusion pump with (b) the measured glucose level being at a level of at least a first glucose threshold within a first time period;

in the event the subject initiated a manual bolus using the infusion pump and the measured glucose level is at a level of least the first glucose threshold within the first time period and using the model predictive controller, constraining the infusion pump to proceed with minimum delivery of insulin by the infusion pump at a first infusion constraint equal to the calculated basal insulin rate;

in the event the determining is false and using the model predictive controller, limiting the infusion pump to deliver at a second lower infusion constraint of approximately zero rate;

calculating insulin dosing with the model predictive controller based on the constraining and limiting steps; and

commanding the pump to deliver insulin dosing calculated by the calculating step.