SYSTEM AND METHOD FOR CREATING A PERSONALIZED TOOL PREDICTING A TIME COURSE OF BLOOD GLUCOSE AFFECT IN DIABETES MELLITUS

• US 20100145173A1
• Filed: 02/12/2008
• Published: 06/10/2010
• Est. Priority Date: 02/12/2008
• Status: Abandoned Application

• Current Assignee: Clifton A. Alferness, Gust H. Bardy
• Original Assignee: Clifton A. Alferness, Gust H. Bardy
• Inventors: Bardy, Gust H., Alferness, Clifton A.
• Application Number:
  US12/030,071
• Publication Number:
  US 20100145173A1
• Time in Patent Office: Days
• US Class Current: 600/365
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/60 relating to nutrition control, e.g. diets
• CPC Class Codes: G16H 40/60 for the operation of medical equipment or devices
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders

Abstract

A system and method for establishing a tool of blood glucose change for diabetes mellitus management in an individual patient is provided. Factors specific to a diabetic patient are determined. An insulin sensitivity for an insulin preparation for treatment of diabetes mellitus is identified. A carbohydrate sensitivity for a known quantity of carbohydrate is identified, which is measured postprandial after a fixed time period. A management tool for the diabetic patient is generated. A time course for a dose of the insulin preparation with an amplitude of change proportioned to the insulin sensitivity is mapped. A time course for an amount of carbohydrate with an amplitude of change proportioned to the carbohydrate sensitivity is mapped. The management tool is calibrated by aggregating feedback from testing of blood glucose into at least one of the insulin and the carbohydrate sensitivities.

Claims

1. A system for creating a personalized tool predicting a time course of blood glucose affect in diabetes mellitus, comprising:

stored information, comprising;

a substance whose introduction into a diabetic patient triggers a physiological effect relative to the diabetic patient'"'"'s blood glucose; and

a time course and an amplitude of change over which the physiological effect is expected to occur;

an analysis module configured to determine a factor specific to the physiological effect on the diabetic patient and to adjust the time course and the amplitude of change in relation to the diabetic patient-specific factor; and

a modeler module configured to model the physiological effect on a curve with the time course and the amplitude of change mapped as a function of a quantity of the substance.

2. A system according to claim 1, wherein a dosed insulin preparation is specified as the substance and an insulin sensitivity is specified as the factor, such that the affect of the substance comprises mediating transport of blood glucose into cells in proportion to the insulin sensitivity.

3. A system according to claim 2, wherein the stored information further comprises an insulin activity curve for the dosed insulin preparation comprising a time course and an amplitude of change applicable to a patient population, the system further comprising:

an evaluation module configured to identify the insulin sensitivity by taking a derivative of the rate of change of blood glucose over time for the dosed insulin preparation, wherein the insulin sensitivity is applied to the patient population insulin activity curve over a duration of action of the dosed insulin preparation.

4. A system according to claim 2, wherein the diabetic patient comprises a Type 1 diabetic and the dosed insulin preparation is required for inclusion in the stored information.

5. A system according to claim 1, wherein one of an antidiabetic medication and an oral medication is specified as the substance and a physiological reaction of the patient'"'"'s body to the medication is specified as the factor, such that the affect of the substance comprises triggering a hematological interaction with blood glucose as the physiological reaction.

6. A system according to claim 1, wherein carbohydrates are specified as the substance and a carbohydrate sensitivity is specified as the factor, such that the affect of the substance comprises causing a rise in blood glucose in proportion to the carbohydrate sensitivity.

7. A system according to claim 1, wherein the diabetic patient comprises a Type 2 diabetic, further comprising:

during an early stage of Type 2 diabetes, wherein the substance is omitted from the stored information;

during a middle stage of the Type 2 diabetes, wherein one of an antidiabetic medication and an oral medication is further specified as the substance and a physiological reaction of the patient'"'"'s body to the medication as the factor; and

during an end-stage of the Type 2 diabetes, wherein a dosed insulin preparation is further specified as the substance and an insulin sensitivity as the factor.

8. A method for creating a personalized tool predicting a time course of blood glucose affect in diabetes mellitus, comprising:

selecting a substance whose introduction into a diabetic patient triggers a physiological effect relative to the diabetic patient'"'"'s blood glucose;

determining a time course and an amplitude of change over which the physiological effect is expected to occur;

adjusting the time course and the amplitude of change in relation to a factor specific to the physiological effect on the diabetic patient; and

modeling the physiological effect on a curve with the time course and the amplitude of change mapped as a function of a quantity of the substance.

9. A method according to claim 8, further comprising:

specifying a dosed insulin preparation as the substance and an insulin sensitivity as the factor, wherein the affect of the substance comprises mediating transport of blood glucose into cells in proportion to the insulin sensitivity.

10. A method according to claim 9, further comprising:

identifying an insulin activity curve for the dosed insulin preparation comprising a time course and an amplitude of change applicable to a patient population;

determining the insulin sensitivity by taking a derivative of the rate of change of blood glucose over time for the dosed insulin preparation; and

applying the insulin sensitivity to the patient population insulin activity curve over a duration of action of the dosed insulin preparation.

11. A method according to claim 9, wherein the diabetic patient comprises a Type 1 diabetic, further comprising:

requiring inclusion of the dosed insulin preparation.

12. A method according to claim 8, further comprising:

specifying one of an antidiabetic medication and an oral medication as the substance and a physiological reaction of the patient'"'"'s body to the medication as the factor, wherein the affect of the substance comprises triggering a hematological interaction with blood glucose as the physiological reaction.

13. A method according to claim 8, further comprising:

specifying carbohydrates as the substance and a carbohydrate sensitivity as the factor, wherein the affect of the substance comprises causing a rise in blood glucose in proportion to the carbohydrate sensitivity.

14. A method according to claim 8, wherein the diabetic patient comprises a Type 2 diabetic, further comprising:

during an early stage of Type 2 diabetes, omitting the substance;

during a middle stage of the Type 2 diabetes, further specifying one of an antidiabetic medication and an oral medication as the substance and a physiological reaction of the patient'"'"'s body to the medication as the factor; and

during an end-stage of the Type 2 diabetes, further specifying a dosed insulin preparation as the substance and an insulin sensitivity as the factor.

15. A system for establishing a tool of blood glucose change for diabetes mellitus management in an individual patient, comprising:

a database comprising factors specific to a diabetic patient, comprising;

an insulin sensitivity for an insulin preparation for treatment of diabetes mellitus; and

a carbohydrate sensitivity for a known quantity of carbohydrate, which is measured postprandial after a fixed time period;

a modeler module configured to build a management tool for the diabetic patient, comprising;

a time course for a dose of the insulin preparation with an amplitude of change proportioned to the insulin sensitivity; and

a time course for an amount of carbohydrate with an amplitude of change proportioned to the carbohydrate sensitivity; and

a calibration module configured to calibrate the management tool by aggregating feedback from testing of blood glucose into at least one of the insulin and the carbohydrate sensitivities.

16. A system according to claim 15, wherein the database further comprises a population-based time course for a dose of the insulin preparation with an amplitude of change proportioned for a test patient population, the system further comprising:

an analysis module configured to apply the insulin sensitivity for a quantity comparable to the insulin preparation dose to the population-based time course.

17. A system according to claim 15, wherein the insulin sensitivity s is estimated by taking a first order derivative of a rate of change of blood glucose over time in accordance with:

$s=\int <br><br>\frac{<br><br>x}{<br><br>t}$

where x is glucose infusion rate and t is time.

18. A system according to claim 15, wherein the carbohydrate sensitivity is determined through ingestion of a standardized test meal comprising the known quantity of carbohydrate, the system further comprising:

a monitoring module configured to observe a baseline blood glucose and a peak blood glucose prior and postprandial to the standardized test meal; and

an analysis module configured to evaluate the baseline and the peak blood glucose levels to establish the carbohydrate sensitivity.

19. A system according to claim 15, further comprising:

a prediction module configured to forecast the blood glucose by application of the management tool predicated on at least one of a dose of the insulin preparation and ingestion of an amount of carbohydrate, wherein the blood glucose of the diabetic patient is observed as the feedback following actually taking the dose or postprandial to the ingestion.

20. A system according to claim 15, wherein the blood glucose is measured through one of extracorporeal and interstitial glucose testing

21. A method for establishing a tool of blood glucose change for diabetes mellitus management in an individual patient, comprising:

determining factors specific to a diabetic patient, comprising;

identifying an insulin sensitivity for an insulin preparation for treatment of diabetes mellitus; and

identifying a carbohydrate sensitivity for a known quantity of carbohydrate, which is measured postprandial after a fixed time period;

generating a management tool for the diabetic patient, comprising;

mapping, a time course for a dose of the insulin preparation with an amplitude of change proportioned to the insulin sensitivity; and

mapping a time course for an amount of carbohydrate with an amplitude of change proportioned to the carbohydrate sensitivity; and

calibrating the management tool by aggregating, feedback from testing, of blood glucose into at least one of the insulin and the carbohydrate sensitivities.

22. A method according to claim 21, further comprising:

referencing a population-based time course for a dose of the insulin preparation with an amplitude of change proportioned for a test patient population; and

applying the insulin sensitivity for a quantity comparable to the insulin preparation dose to the population-based time course.

23. A method according to claim 21, further comprising:

estimating the insulin sensitivity s by taking a first order derivative of a rate of change of blood glucose over time in accordance with;

$s=\int <br><br>\frac{<br><br>x}{<br><br>t}$

where x is glucose infusion rate and t is time.

24. A method according to claim 21, further comprising:

determining the carbohydrate sensitivity through ingestion of a standardized test meal comprising the known quantity of carbohydrate;

observing a baseline blood glucose and a peak blood glucose prior and postprandial to the standardized test meal; and

evaluating the baseline and the peak blood glucose levels to establish the carbohydrate sensitivity.

25. A method according to claim 21, further comprising:

forecasting the blood glucose by application of the management tool predicated on at least one of a dose of the insulin preparation and ingestion of an amount of carbohydrate; and

observing the blood glucose of the diabetic patient as the feedback following actually taking the dose or postprandial to the ingestion.

26. A method according to claim 21, further comprising:

measuring the blood glucose through one of extracorporeal and interstitial glucose testing.