Method and apparatus for glucose control and insulin dosing for diabetics

• US 7,651,845 B2
• Filed: 05/12/2005
• Issued: 01/26/2010
• Est. Priority Date: 05/13/2004
• Status: Active Grant

• Current Assignee: Regents of the University of California (University of California)
• Original Assignee: Regents of the University of California (University of California)
• Inventors: Doyle, Francis J. III, Jovanovic, Lois
• Primary Examiner(s): Saucier; Sandra
• Assistant Examiner(s): Singh; Satyendra K
• Application Number:
  US11/129,033
• Publication Number:
  US 20050272640A1
• Time in Patent Office: 1,720 Days
• Field of Search: None
• US Class Current: 435/14
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61K 38/28 Insulins
• CPC Class Codes: A61M 2005/1405 Patient controlled analgesia [PCA]
• CPC Class Codes: A61M 2005/14296 Pharmacokinetic models
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• 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 5/14276 specially adapted for implantation
• 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 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• 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

A computer implemented method and associated apparatus for the combined control of insulin bolus dosing and basal delivery for the goal of achieving normal glycemic response to meals, exercise, stressors, and other perturbations to blood glucose levels. A run-to-run algorithm is used to monitor blood glucose levels and adjust insulin delivery as conditions are varied.

Claims

1. A run-to-run control method of deriving the optimal dosage of insulin to provide both the basal insulin requirement and the meal-related insulin dosing of an individual having diabetes, comprising:

determining an insulin sensitivity matrix for said individual;

measuring a postprandial glucose response to at least one meal; and

estimating a preprandial dosage of insulin for a subsequent cycle'"'"'s corresponding meal based on said insulin sensitivity matrix of said individual and measured postprandial glucose response to the meal and preprandial dose of insulin for a current cycle;

wherein each element of said insulin sensitivity matrix is a function of one or more parameters affecting insulin needs of an individual pertaining to said individual;

wherein said one or more parameters is selected from the group consisting of physical stress, psychological stress, hormonal stress, activity, fitness, and weight;

wherein said insulin sensitivity matrix reflects a breadth of output responses in said individual as a function of changes in input; and

wherein dosage amount for a subsequent cycle is higher than, lower than, or the same as, dosage amount for a current cycle.

2. A method as recited in claim 1, wherein said insulin dosage comprises an insulin analog.

3. A method as recited in claim 1, wherein said dosage further comprises timing of said dosage of insulin.

4. A method as recited in claim 1, wherein maximum glucose levels following each meal are maintained within the normal glycemic range.

5. A method as recited in claim 1, wherein a subsequent cycle'"'"'s preprandial insulin dosages are corrected based on one or more meal-related postprandial glucose measurements from a previous cycle.

6. A method as recited in claim 5, wherein said dosage corrections incorporate at least one of the variables of time of day, carbohydrate content of a meal, preprandial glucose concentration and time since last meal bolus.

7. A method as recited in claim 1, further comprising:

repeating said estimating step through successive cycles until glucose levels converge to a predetermined target range.

8. A method as recited in claim 1, further comprising:

(a) measuring blood glucose level during a current cycle;

(b) estimating insulin dosage for said subsequent cycle as a function of said measured blood glucose level during said current cycle;

(c) administering said insulin dosage based on said estimate; and

repeating steps (a) through (c).

9. A method as recited in claim 1, wherein a cycle comprises a twenty-four hour period during which meals are ingested at variable times during the period.

10. A method as recited in claim 9, wherein more than three meals are ingested during the cycle.

11. A method as recited in claim 9, wherein fewer than three meals are ingested during the cycle.

12. A method as recited in claim 3, wherein said timing and amount of said insulin dosages provide an insulin dosing profile that is optimized over time.

13. A method as recited in claim 1, wherein said measuring step comprises at least one measurement of blood glucose levels from a sensor taken from the group of sensors consisting essentially of an implanted glucose sensor, an optical glucose sensor and a pin prick glucose sensor.

14. A method as recited in claim 13, wherein said parameter pertaining to said individual is selected from the group consisting of an exercise level and a degree of stress.

15. A method as recited in claim 14, wherein said exercise level parameter has mild, moderate or strenuous exercise levels.

16. A method as recited in claim 14, wherein said degree of stress parameter has mild, moderate or severe stress levels.

17. A method as recited in claim 1, wherein said estimating step is a function of said blood glucose level measurement, meal size and meal timing.

18. A method as recited in claim 1, wherein said estimating step is a function of said blood glucose level measurement, meal size, carbohydrate content, meal timing, and meal duration.

19. A method as recited in claim 18, wherein said parameter pertaining to said individual is selected from the group of stresses consisting essentially of physical stress, psychological stress or hormonal stress.

20. A method as recited in claim 1, wherein the preprandial dosage of insulin for a subsequent cycle'"'"'s meal is iteratively updated over time.

21. A method as recited in claim 20, wherein said dosage comprises insulin amount and timing of delivery.