METHOD AND CONTROL DEVICE FOR CONTROLLING THE ADMINISTRATION OF INSULIN TO A PATIENT

• US 20160089494A1
• Filed: 01/31/2014
• Published: 03/31/2016
• 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
• Granted Patent: US 10,525,199 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 (P) a target glucose level (T) is set and a controller (10) computes a recommended infusion rate (R) based on the target glucose level (T) and a measured glucose level (G) of a patient (P) for administering insulin to the patient (P). The controller (10) comprises a controller gain (K) for computing the recommended infusion rate (R). Herein, an insulin sensitivity (IS) of the patient (P) is determined by means of a mathematical model taking into account the measured glucose level (G) and an actual infusion rate (IR) of insulin administered to the patient (P) and, based on the insulin sensitivity (IS), the controller gain (K) of the controller (10) 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 based on the target glucose level and a measured glucose level of a patient for administering insulin to the patient, wherein the controller comprises a controller gain for computing the recommended infusion rate,

determining an insulin sensitivity of the patient by means of a mathematical model taking into account the measured glucose level and an actual infusion rate of insulin administered to the patient, and

determining, based on the insulin sensitivity the controller gain of the controller.

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 new insulin sensitivity and the controller computes the recommended infusion rate based on the current measured glucose level and the target glucose level using the newly set controller gain.

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 the controller gain is determined by associating the insulin sensitivity to a predefined insulin sensitivity class, wherein each insulin sensitivity class comprises 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.

7. The method according to claim 6, 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 newly determined insulin sensitivity class only if a predefined additional switch criterion is satisfied.

8. The method according to claim 6, wherein multiple insulin sensitivity classes are determined prior to administering insulin to a patient, wherein each insulin sensitivity class is defined by associated ranges of a stability parameter and a robustness parameter determined based on the insulin sensitivity.

9. The method according to claim 1, wherein the controller outputs the recommended infusion rate which is to be approved or modified by a nurse for administering insulin to the patient.

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

11. 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 the previously determined recommended infusion rate.

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

13. 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.

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

a model unit for determining an insulin sensitivity of the patient by means of a mathematical model taking into account 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.