Method and control device for controlling the administration of insulin to a patient

• US 10,525,199 B2
• Filed: 01/31/2014
• Issued: 01/07/2020
• Est. Priority Date: 06/21/2013
• Status: Active Grant

• Current Assignee: Fresenius Vial SAS (Else Kröner-Fresenius-Stiftung)
• Original Assignee: Fresenius Vial SAS (Else Kröner-Fresenius-Stiftung)
• Inventors: Guerrini, Alexandre
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): Ahmed, Tasnim Mehjabin
• Application Number:
  US14/890,665
• Publication Number:
  US 20160089494A1
• Time in Patent Office: 2,167 Days
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• 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
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders

Abstract

In a method for controlling the administration of insulin to a patient, a target glucose level is set and a controller computes a recommended infusion rate based on the target glucose level and a measured glucose level of a patient for administering insulin to the patient. The controller uses a controller gain for computing the recommended infusion rate. Herein, an insulin sensitivity of the patient is determined using a mathematical model taking into account the measured glucose level and an actual infusion rate of insulin administered to the patient and, based on the insulin sensitivity, the controller gain of the controller is determined. In this way a method for controlling the administration of insulin to a patient is provided which in a reliable, computationally efficient manner allows for maintaining a patient'"'"'s blood glucose level at or around a desired target glucose level.

Claims

1. A method for controlling the administration of insulin to a patient, comprising:

setting a target glucose level,

computing, using a controller, a recommended infusion rate for administering insulin to the patient based on the target glucose level and a measured glucose level of the patient determined using a sensor device, wherein the controller uses a controller gain for computing the recommended infusion rate,

determining an insulin sensitivity of the patient using a mathematical model based on the measured glucose level and an actual infusion rate of insulin administered to the patient,

determining, based on the insulin sensitivity, the controller gain of the controller, wherein the controller gain for computing the recommended infusion rate is determined by associating the insulin sensitivity to one of a plurality of predefined insulin sensitivity classes, each insulin sensitivity class having boundaries defined by measures of stability and robustness related to controller behavior and being associated with a predefined controller gain such that by associating the insulin sensitivity to an insulin sensitivity class, the controller gain is determined to be the controller gain of the associated insulin sensitivity class, wherein each insulin sensitivity class is defined by associated ranges of a stability parameter and a robustness parameter determined based on the insulin sensitivity, and

administering insulin at the recommended infusion rate to the patient using an infusion pump.

2. The method according to claim 1, wherein the controller computes the recommended infusion rate based on the target glucose level and the measured glucose level and in addition based on a glucose intake value of the patient.

3. The method according to claim 1, wherein the controller computes a proposed time for next measurement for measuring a glucose level of a patient.

4. The method according to claim 1, wherein the model is used to determine the insulin sensitivity of the patient anew for each measured glucose level, wherein the controller gain is set anew based on the insulin sensitivity of the patient determined anew for each measured glucose level and the controller computes the recommended infusion rate based on a current measured glucose level and a target glucose level using the controller gain set anew based on the insulin sensitivity of the patient determined anew for each measured glucose level.

5. The method according to claim 1, wherein the model is a PkPd model taking into account patient-specific parameters, the measured glucose level, the actual infusion rate and a glucose intake value and estimating the insulin sensitivity.

6. The method according to claim 1, wherein, if it is determined that for a time of measurement the insulin sensitivity is associated with a different insulin sensitivity class than for a previous time of measurement, the controller gain is set according to the insulin sensitivity class determined for the time of measurement only if a predefined additional switch criterion is satisfied.

7. The method according to claim 1, wherein multiple insulin sensitivity classes are determined prior to administering insulin to the patient.

8. The method according to claim 1, wherein the controller outputs the recommended infusion rate and awaits approval or modification of the recommended infusion rate by a nurse prior to administering insulin to the patient.

9. The method according to claim 1, wherein the controller is a PID controller.

10. The method according to claim 1, wherein the controller is defined by a PID controller equation having a proportional term, an integral term and a derivative term and further comprising a compliance term for taking into account, when determining a new recommended infusion rate, a deviation of the actual infusion rate from a previously determined recommended infusion rate.

11. The method according to claim 10, wherein the controller uses, as controller gain, a set of gains associated with the proportional term, the integral term and the derivative term of the PID controller equation.

12. The method according to claim 1, wherein the controller uses a saturation mechanism according to which the recommended infusion rate is limited to a range of allowable infusion rates.

13. The method according to claim 1, wherein determining the insulin sensitivity of the patient using a mathematical model occurs in real time, and associating the insulin sensitivity to a predefined insulin sensitivity class occurs in real time.

14. A control device for controlling the administration of insulin to a patient, comprising:

a target setting unit for setting a target glucose level,

a controller for computing a recommended infusion rate for administering insulin to the patient based on the target glucose level and a measured glucose level of the patient using a sensor device, wherein the controller uses a controller gain for computing the recommended infusion rate,

a model unit configured to determine an insulin sensitivity of the patient with a mathematical model based on the measured glucose level and an actual infusion rate of insulin administered to the patient and

an adaption unit for determining based on the insulin sensitivity, the controller gain of the controller, wherein the adaption unit is configured to determine the controller gain for computing the recommended infusion rate by associating the insulin sensitivity to one of a plurality of predefined insulin sensitivity classes, each insulin sensitivity class having boundaries defined by measures of stability and robustness related to controller behavior and being associated with a predefined controller gain such that by associating the insulin sensitivity to an insulin sensitivity class, the controller gain is determined to be the controller gain of the associated insulin sensitivity class, wherein each insulin sensitivity class is defined by associated ranges of a stability parameter and a robustness parameter determined based on the insulin sensitivity; and

an output connectable to an infusion pump for administering insulin at the recommended infusion rate to the patient to feed the infusion pump the recommended infusion rate.

15. The control device according to claim 14, wherein the mathematical model is a PkPd model.

16. The control device according to claim 14, wherein the model unit is configured to determine the insulin sensitivity of the patient with a mathematical model in real time, and the adaption unit associates the insulin sensitivity to a predefined insulin sensitivity class in real time.