Blood glucose control system

• US 10,188,795 B2
• Filed: 12/15/2016
• Issued: 01/29/2019
• Est. Priority Date: 10/31/2010
• Status: Active Grant

• Current Assignee: The General Hospital Corporation (Mass General Brigham, Inc.), Trustees of Boston University
• Original Assignee: The General Hospital Corporation (Mass General Brigham, Inc.), Trustees of Boston University
• Inventors: El-Khatib, Firas, Damiano, Edward, Russell, Steven J.
• Primary Examiner(s): SCHMIDT, EMILY LOUISE
• Application Number:
  US15/380,516
• Publication Number:
  US 20170095612A1
• Time in Patent Office: 775 Days
• CPC Class Codes: A61M 2005/1402 Priming
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2202/07 Proteins
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• 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 5/14248 of the skin patch type
• 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 20/13 delivered from dispensers
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

Techniques are used for adaptation of drug-administration parameters that control insulin delivery in a blood glucose control system. One technique provides long-term adaptation of a nominal basal infusion rate, adapting to longer-term changes in a patient'"'"'s needs due to growth, illness, hormonal fluctuations, physical activity, aging, etc. Another technique provides adaptation of priming dose size at mealtimes for overall better glycemic control and also adapting to longer-term changes in a patient'"'"'s needs. Adaptation calculations use a receding-horizon window of recent values of the adapted parameter. Doses of a counter-regulatory agent (e.g., glucagon) may also be delivered in response to information about estimated accumulation of exogenously infused insulin (subcutaneously, intramuscularly, intraperitoneally, or intravenously) and/or the effect insulin might have on glucose levels (blood glucose concentration or interstitial fluid glucose concentration).

Claims

1. A sensor-driven glucose control system, comprising:

an insulin delivery device operative in response to an insulin dose control signal to infuse insulin into the subject; and

a controller operative to generate the insulin dose control signal by;

(1) continually administering priming doses of insulin at respective times, each priming dose being of a respective amount and having a prescribed interval of action;

(2) receiving information regarding total amounts of insulin administered during the prescribed intervals of action, each total amount including an aggregation of total doses administered in response to a glucose level signal; and

(3) automatically adapting the amounts of the priming doses in response to a mathematical relationship, over respective periods each spanning multiple prescribed intervals of action, between the amounts of the priming doses and the total amounts of insulin administered during the prescribed intervals of action.

2. A sensor-driven glucose control system according to claim 1, wherein the mathematical relationship includes a target ratio of the amount of each priming dose to the total amount of insulin administered in each prescribed interval of action.

3. A sensor-driven glucose control system according to claim 2, wherein the target ratio has different values over respective time periods of a day, or over different prescribed intervals of action, or both.

4. A sensor-driven glucose control system according to claim 3, wherein the time periods have a regularity associated with timing of food consumption.

5. A sensor-driven glucose control system according to claim 1, wherein each period is defined by a receding-horizon time window extending back from a present time by a predetermined amount of time.

6. A sensor-driven glucose control system according to claim 1, being an autonomous or semi-autonomous control system in which the controller includes a corrective insulin controller that generates the insulin dose control signal in response to the glucose level signal to administer corrective doses of insulin so as to regulate the glucose level signal.

7. A sensor-driven glucose control system according to claim 1, further comprising a counter-regulatory agent delivery device operative to infuse a counter-regulatory agent into the subject in response to a counter-regulatory agent dose control signal, and wherein the controller is operative to generate the counter-regulatory agent dose control signal by performing a calculation generating (1) a raw dose control value based on the glucose level signal, and (2) the counter-regulatory agent dose control signal as a modification of the raw dose control value based on an estimation of an effect of insulin infused into the subject by the insulin delivery device.

8. A method of operating a controller for a sensor-driven glucose control system including an insulin delivery device operative in response to an insulin dose control signal to infuse insulin into the subject, comprising:

generating the insulin dose control signal to continually administer priming doses of insulin at respective times, each priming dose being of a respective amount and having a prescribed interval of action;

receiving information regarding total amounts of insulin administered during the prescribed intervals of action, each total amount including an aggregation of total doses administered in response to a glucose level signal; and

automatically adapting the amounts of the priming doses in response to a mathematical relationship, over respective periods each spanning multiple prescribed intervals of action, between the amounts of the priming doses and the total amounts of insulin administered during the prescribed intervals of action.

9. A method according to claim 8, wherein the mathematical relationship includes a target ratio of the amount of each priming dose to the total amount of insulin administered in each prescribed interval of action.

10. A method according to claim 9, wherein the target ratio has different values over respective time periods of a day, or over different prescribed intervals of action, or both.

11. A method according to claim 10, wherein the time periods have a regularity associated with timing of food consumption.

12. A method according to claim 8, wherein each period is defined by a receding-horizon time window extending back from a present time by a predetermined amount of time.

13. A method according to claim 8, wherein the sensor-driven glucose control system is an autonomous or semi-autonomous control system in which the controller includes a corrective insulin controller that generates the insulin dose control signal in response to the glucose level signal to administer corrective doses of insulin so as to regulate the glucose level signal.

14. A method according to claim 8, wherein the sensor-driven glucose control system further includes a counter-regulatory agent delivery device operative to infuse a counter-regulatory agent into the subject in response to a counter-regulatory agent dose control signal, and wherein the method further includes generating the counter-regulatory agent dose control signal by performing a calculation generating (1) a raw dose control value based on the glucose level signal, and (2) the counter-regulatory agent dose control signal as a modification of the raw dose control value based on an estimation of an effect of insulin infused into the subject by the insulin delivery device.