Kalman Filter Based On-Off Switch for Insulin Pump

• US 20140221966A1
• Filed: 02/07/2014
• Published: 08/07/2014
• Est. Priority Date: 02/07/2013
• Status: Active Grant

• Current Assignee: Rensselaer Polytechnic Institute, Board of Trustees of the Leland Stanford Junior University (Stanford Management Co.)
• Original Assignee: Rensselaer Polytechnic Institute, Board of Trustees of the Leland Stanford Junior University (Stanford Management Co.), Regents of the University of California (University of California), The Board of Regents of the University of Colorado (University of Colorado System)
• Inventors: Buckingham, Bruce A., Bequette, B. Wayne, Cameron, Fraser, Wilson, Darrell M., Chase, H. Peter, Doyle, Francis J. III, Stenerson, Matthew
• Granted Patent: US 9,227,014 B2
• Time in Patent Office: Days
• US Class Current: 604/504
• CPC Class Codes: A61M 2005/14296 Pharmacokinetic models
• CPC Class Codes: A61M 2205/332 Force measuring means
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/06 Heartbeat rate only
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 2230/63 Motion, e.g. physical activity
• 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

Techniques for controlling an insulin pump include determining values for parameters selected from a group including a first prediction time horizon, a predicted glucose threshold (Goff) for turning the insulin pump off, a maximum shut off time within a time window, and duration of the time window. A safety rule is determined based on the maximum shut off time within the duration. Glucose readings are collected up to a current time. An expected current glucose value G and glucose temporal rate of change are determined based only on the glucose readings and a Kalman filter configured for noisy glucose readings. A glucose level (Gh1) is predicted for a future time that is the prediction time horizon after the current time. A command is issued to shut off the insulin pump if it is determined both that Gh1 is less than Goff and that the safety rule is satisfied.

Claims

1. A non-transitory computer-readable medium carrying one or more sequences of instructions, wherein execution of the one or more sequences of instructions by one or more processors causes an apparatus to:

determine values for a plurality of parameters for an automatic on-off switch for an insulin pump configured to inject insulin into a subject, wherein the plurality of parameters are selected from a group of parameters comprising a first prediction time horizon (H1), a first predicted glucose threshold (Goff) for turning the insulin pump off, a maximum shut off time within a first time window, and duration of the first time window;

determine a first safety rule based at least in part on the maximum shut off time within the first time window and the duration of the first time window;

collect a plurality of glucose readings of a glucose level in a bloodstream of the subject up to a current time;

determine an expected current glucose value G and expected current glucose temporal rate of change dG/dt based only on the plurality of glucose readings and a Kalman filter configured for noisy glucose readings of the glucose level in the bloodstream of the subject;

predict a glucose level (Gh1) for a first future time that is the first prediction time horizon after the current time; and

issue a command to shut off the insulin pump if it is determined both that the predicted glucose level (Gh1) is less than Goff and that the safety rule is satisfied.

2. A non-transitory computer-readable medium as recited in claim 1, wherein:

the group of parameters further comprises a second predicted glucose threshold (Gon) for turning the insulin pump on, and a constant basal rate for the insulin pump when the insulin pump is on; and

the apparatus is further configured to issue a command to turn on the insulin pump at the constant basal rate if it is determined both that the predicted glucose level (Gh1) is more than Gon and that the insulin pump is currently turned off.

3. A non-transitory computer-readable medium as recited in claim 1, wherein:

the group of parameters further comprises a different second prediction time horizon, a predicted glucose threshold (Gon) for turning the insulin pump on, and a constant basal rate for the insulin pump when the insulin pump is on; and

the apparatus is further configured to;

predict a different glucose level (Gh2) for a different second future time that is the second prediction time horizon (H2) after the current time; and

issue a command to turn on the insulin pump at the constant basal rate if it is determined both that the different predicted glucose level (Gh2) is more than Gon and that the insulin pump is currently turned off.

4. A non-transitory computer-readable medium as recited in claim 1, wherein:

the group of parameters further comprises a maximum shut off time within a second time window and a duration of the second time window; and

to determine the first safety rule further comprises to determine the first safety rule based at least in part on the maximum shut off time within the second time window and the duration of the second time window.

5. A non-transitory computer-readable medium as recited in claim 1, wherein:

the group of parameters further comprises at least one of an initial variability of glucose readings, or initial variability in time rate of change of glucose, or a steady state variability of glucose values; and

the Kalman filter is based at least in part on at least one of the values for the initial variability of glucose readings, or the initial variability in time rate of change of glucose, or the steady state variability of glucose values.

6. A non-transitory computer-readable medium as recited in claim 1, wherein:

the group of parameters further comprises at least one of a default glucose value, or a prior multiplier, or a sensor dropout time; and

the Kalman filter is based at least in part on at least one of the values for the default glucose value, or the prior multiplier, or the sensor dropout time.

7. A non-transitory computer-readable medium as recited in claim 1, wherein:

the group of parameters further comprises a current activity level (Aoff) for turning the insulin pump off and a current glucose threshold (Ga) for turning the insulin pump off during activity; and

the apparatus is further configured to

collect a reading of activity level at the current time, and

issue a command to shut off the insulin pump if it is determined both that the reading of activity level is more than Aoff and that the expected current glucose value G is less than Ga.

8. A non-transitory computer-readable medium as recited in claim 7, wherein the current glucose threshold (Ga) for turning the insulin pump off during activity is in about 180 milligrams per deciliter.

9. A non-transitory computer-readable medium as recited in claim 1, wherein

the group of parameters further comprises a danger current glucose threshold (Gd) for turning off the insulin pump;

and

the safety rule is not satisfied if the expected current glucose value G is less than Gd.

10. A non-transitory computer-readable medium as recited in claim 1, wherein the first prediction time horizon H1 is in a range from about 50 minutes to about 90 minutes.

11. A non-transitory computer-readable medium as recited in claim 1, wherein the first predicted glucose threshold (Goff) is in a range from about 70 milligram per deciliter to about 90 milligrams per deciliter.

12. A non-transitory computer-readable medium as recited in claim 2, wherein the second predicted glucose threshold (Gon) is in a range from about 90 milligram per deciliter to about 110 milligrams per deciliter.

13. An apparatus comprising:

at least one processor; and

at least one memory including one or more sequences of instructions,

the at least one memory and the one or more sequences of instructions configured to, with the at least one processor, cause the apparatus to perform at least the following,

determining values for a plurality of parameters for an automatic on-off switch for an insulin pump configured to inject insulin into a subject, wherein the plurality of parameters are selected from a group of parameters comprising a first prediction time horizon, a predicted glucose threshold (Goff) for turning the insulin pump off, a maximum shut off time within a first time window, and duration of the first time window;

determining a first safety rule based at least in part on the maximum shut off time within the first time window and the duration of the first time window;

collecting a plurality of glucose readings of a glucose level in a bloodstream of a subject up to a current time;

determining an expected current glucose value G and expected current glucose temporal rate of change dG/dt based only on the plurality of glucose readings and a Kalman filter configured for noisy glucose readings of the glucose level in the bloodstream of the subject;

predicting a glucose level (Gh1) for a first future time that is the first prediction time horizon (H1) after the current time; and

issuing a command to shut off the insulin pump if it is determined both that the predicted glucose level (Gh1) is less than Goff and that the safety rule is satisfied.

14. A method for operating an insulin pump, comprising:

determining values for a plurality of parameters for an automatic on-off switch for an insulin pump configured to inject insulin into a subject, wherein the plurality of parameters are selected from a group of parameters comprising a first prediction time horizon, a predicted glucose threshold (Goff) for turning the insulin pump off, a maximum shut off time within a first time window, and duration of the first time window;

determining a first safety rule based at least in part on the maximum shut off time within the first time window and the duration of the first time window;

collecting a plurality of glucose readings of a glucose level in a bloodstream of a subject up to a current time;

determining an expected current glucose value G and expected current glucose temporal rate of change dG/dt based only on the plurality of glucose readings and a Kalman filter configured for noisy glucose readings of the glucose level in the bloodstream of the subject;

predicting a glucose level (Gh1) for a first future time that is the first prediction time horizon after the current time; and

issuing a command to shut off the insulin pump if it is determined both that the predicted glucose level (Gh1) is less than Goff and that the safety rule is satisfied.

15. A system for operating an insulin pump, comprising:

means for determining values for a plurality of parameters for an automatic on-off switch for an insulin pump configured to inject insulin into a subject, wherein the plurality of parameters are selected from a group of parameters comprising a first prediction time horizon, a predicted glucose threshold (Goff) for turning the insulin pump off, a maximum shut off time within a first time window, and duration of the first time window;

means for determining a first safety rule based at least in part on the maximum shut off time within the first time window and the duration of the first time window;

means for collecting a plurality of glucose readings of a glucose level in a bloodstream of a subject up to a current time;

means for determining an expected current glucose value G and expected current glucose temporal rate of change dG/dt based only on the plurality of glucose readings and a Kalman filter configured for noisy glucose readings of the glucose level in the bloodstream of the subject;

means for predicting a glucose level (Gh1) for a first future time that is the first prediction time horizon after the current time; and

means for issuing a command to shut off the insulin pump if it is determined both that the predicted glucose level (Gh1) is less than Goff and that the safety rule is satisfied.

16. A system as recited in claim 15, further comprising:

means for determining a current activity level of the subject; and

means for issuing a command to shut off the insulin pump if it is determined both that the current activity level exceeds a threshold value (Aoff), and that a second predicted glucose level (Gha) at a second time horizon (ha) after the current time is less than an glucose activity level threshold (Ga).

17. A non-transitory computer-readable medium carrying one or more sequences of instructions, wherein execution of the one or more sequences of instructions by one or more processors causes an apparatus to:

determine values for a plurality of parameters for an automatic on-off switch for an insulin pump configured to inject insulin into a subject, wherein the plurality of parameters are selected from a group of parameters comprising a first prediction time horizon (H1), a first predicted glucose threshold (Goff) for turning the insulin pump off;

collect a plurality of glucose readings of a glucose level in a bloodstream of the subject up to a current time;

determine an expected current glucose value G and expected current glucose temporal rate of change dG/dt based only on the plurality of glucose readings and a Kalman filter configured for noisy glucose readings of the glucose level in the bloodstream of the subject;

predict a glucose level (Gh1) for a first future time that is the first prediction time horizon after the current time; and

issue a command to shut off the insulin pump if it is determined that the predicted glucose level (Gh1) is less than Goff.