Means and Method For Improved Glycemic Control For Diabetic Patients

• US 20160012204A1
• Filed: 09/22/2015
• Published: 01/14/2016
• Est. Priority Date: 09/11/2012
• Status: Active Grant

• Current Assignee: Aseko, Inc.
• Original Assignee: Aseko, Inc.
• Inventors: Booth, Robert C., Fischell, Robert E.
• Granted Patent: US 9,483,619 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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: G06F 3/04847 Interaction techniques to control parameter settings, e.g. interaction with sliders or dials
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• 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 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 20/60 relating to nutrition control, e.g. diets
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment
• CPC Class Codes: G16H 80/00 ICT specially adapted for facilitating communication between medical practitioners or patients, e.g. for collaborative diagnosis, therapy or health monitoring
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

A glycemic control system includes a physician processor, remote processor, and a portable telephone having a data input mechanism, a display, and an internal processor for bi-directional communication with the physician'"'"'s processor and the remote processor. A patient inputs data to the internal processor responsive to input from the physician'"'"'s processor and then transmits the information to the remote processor where an optimized number of units to be administered is sent back and displayed on the portable telephone.

Claims

1. A method comprising:

receiving, at data processing hardware, a current blood glucose measurement of a patient and a time period of the current blood glucose measurement from a blood glucose meter in communication with the data processing hardware;

obtaining, using the data processing hardware, blood glucose parameters for the patient from remote memory hardware in communication with the data processing hardware;

when the current blood glucose measurement is greater than a hyperglycemia blood glucose limit or less than a hypoglycemia blood glucose limit;

transmitting an out-of-range blood glucose alert from the data processing hardware to a computing device associated with an authorized medial professional; and

receiving, at the data processing hardware, one of hyperglycemia patient instructions or hypoglycemia patient instructions from the computing device associated with the authorized medial professional;

when the current blood glucose measurement exceeds a target blood glucose value that is greater than the hypoglycemia blood glucose limit and less than the hyperglycemia blood glucose limit, determining, using the data processing hardware, a correction dose based on the current blood glucose measurement and one or more of the blood glucose parameters;

when the time period of the current blood glucose measurement is a pre-meal time and a meal type associated with the pre-meal time is one of breakfast, lunch, dinner or snack;

obtaining, using the data processing hardware, a previous meal bolus administered by the patient for the associated meal type from the remote memory hardware;

obtaining, using the data processing hardware, a previous next scheduled blood glucose measurement from the remote memory hardware, the previous next scheduled blood glucose measurement resulting from the previous meal bolus administered by the patient; and

determining, using the data processing hardware, a current meal bolus based on the previous meal bolus and the previous next scheduled blood glucose measurement;

displaying the received hyperglycemia or hypoglycemia user instructions, the calculated correction dose and/or the calculated current meal bolus on a user interface in communication with the data processing hardware; and

storing the received hyperglycemia or hypoglycemia user instructions, the calculated correction dose and/or the calculated current meal bolus in the remote memory hardware.

2. The method of claim 1, further comprising, when the current blood glucose measurement is greater than the hyperglycemia blood glucose limit, determining, using the data processing hardware, the correction dose based on the current blood glucose measurement and the one or more of the blood glucose parameters.

3. The method of claim 2, wherein determining the correction dose comprises:

retrieving the target blood glucose value and an insulin sensitivity factor for the patient from the remote memory hardware; and

calculating the correction dose based on a function of the current blood glucose measurement, the target blood glucose value, and an insulin sensitivity factor for the patient obtained from the remote memory hardware.

4. The method of claim 1, wherein determining the current meal bolus comprises:

when the patient is on a fixed meal plan;

determining when the previous next scheduled blood glucose value is within a pre-configured range of values;

determining an adjustment factor by setting the adjustment factor to a pre-configured adjustment factor associated with the pre-configured range of values; and

calculating the current meal bolus by multiplying the previous meal bolus times the adjustment factor.

5. The method of claim 1, wherein determining the current meal bolus comprises:

when the patient is not on a fixed meal plan;

receiving an estimated number of carbohydrates to be ingested by the patient for the associated meal type;

obtaining a current carbohydrate to insulin ratio for the associated meal type; and

calculating the current meal bolus by dividing the estimated number of carbohydrates by the current carbohydrate-to-insulin ratio for the associated meal type.

6. The method of claim 5, wherein obtaining the current carbohydrate to insulin ratio for the associated meal type comprises:

retrieving a previous carbohydrate to insulin ratio for the associated meal type from the remote memory hardware, the previous carbohydrate to insulin ratio associated with the previous meal bolus;

determining when the previous next scheduled blood glucose value is within a pre-configured range of values;

determining an adjustment factor by setting the adjustment factor to a pre-configured adjustment factor associated with the pre-configured range of values; and

calculating the current carbohydrate to insulin ratio for the associated meal type by dividing the previous carbohydrate to insulin ratio by the adjustment factor.

7. The method of claim 1, further comprising when the time period of the current blood glucose measurement is the pre-meal time and the meal type associated with the pre-meal time is breakfast:

obtaining, using the data processing hardware, a previous mid-sleep blood glucose measurement and a previous breakfast blood glucose measurement of the patient;

determining, using the data processing hardware, an adjustment factor based on one of the previous mid-sleep blood glucose measurement or the previous breakfast blood glucose measurement; and

calculating, using the data processing hardware, a new basal dose by multiplying the previous basal dose times the adjustment factor.

8. The method of claim 7, wherein:

the adjustment factor is based on the previous mid-sleep blood glucose measurement when the previous mid-sleep blood glucose measurement is less than the previous breakfast blood glucose measurement;

or

the adjustment factor is based on the previous breakfast blood glucose measurement when the previous mid-sleep blood glucose measurement is greater than the previous breakfast blood glucose measurement.

9. The method of claim 7, further comprising:

displaying the calculated new basal dose on the user interface; and

storing the calculated new basal dose in the remote memory hardware.

10. The method of claim 1, further comprising:

determining, using the data processing hardware, whether the patient plans to exercise or has recently exercised; and

when the patient plans to exercise or has recently exercised and the current blood glucose measurement is less than the target blood glucose value;

determining, using the data processing hardware, a duration of the exercise planned by the patient or recently completed by the patient;

determining, using the data processing hardware, carbohydrate intake instructions for the patient including a predetermined amount of carbohydrates for the patient to ingest based on the duration of the exercise; and

transmitting the carbohydrate intake instructions to the user interface, the user instructions causing the user interface to display the predetermined amount of carbohydrates for the patient to ingest.

11. A system comprising:

a blood glucose meter measuring blood glucose measurements of a patient;

data processing hardware in communication with the glucometer, the data processing hardware;

receiving a current blood glucose measurement of the patient and a time period of the current blood glucose measurement from the blood glucose meter;

obtaining blood glucose parameters for the patient from remote memory hardware in communication with the data processing hardware;

when the current blood glucose measurement is greater than a hyperglycemia blood glucose limit or less than a hypoglycemia blood glucose limit;

transmitting an out-of-range blood glucose alert from the data processing hardware to a computing device associated with an authorized medial professional; and

receiving one of hyperglycemia patient instructions or hypoglycemia patient instructions from the computing device associated with the authorized medial professional;

when the current blood glucose measurement exceeds a target blood glucose value that is greater than the hypoglycemia blood glucose limit and less than the hyperglycemia blood glucose limit, determining a correction dose based on the current blood glucose measurement and one or more of the blood glucose parameters;

when the time period of the current blood glucose measurement is a pre-meal time and a meal type associated with the pre-meal time is one of breakfast, lunch, dinner or snack;

obtaining a previous meal bolus administered by the patient for the associated meal type from the remote memory hardware;

obtaining a previous next scheduled blood glucose measurement from the remote memory hardware, the previous next scheduled blood glucose measurement resulting from the previous meal bolus administered by the patient; and

determining a current meal bolus based on the previous meal bolus and the previous next scheduled blood glucose measurement; and

storing the received hyperglycemia or hypoglycemia user instructions, the calculated correction dose and/or the calculated current meal bolus in the remote memory hardware; and

a user interface in communication with the data processing hardware, the user interface displaying the hyperglycemia or hypoglycemia user instructions, the calculated correction dose and/or the calculated current meal bolus.

12. The system of claim 11, wherein the data processing hardware determines the correction dose based on the current blood glucose measurement and the one or more of the blood glucose parameters when the current blood glucose measurement is greater than the hyperglycemia blood glucose limit.

13. The system of claim 12, wherein the data processing hardware determines the correction dose by:

retrieving the target blood glucose value and an insulin sensitivity factor for the patient from the remote memory hardware; and

calculating the correction dose based on a function of the current blood glucose measurement, the target blood glucose value, and an insulin sensitivity factor for the patient obtained from the remote memory hardware.

14. The system of claim 11, wherein the data processing hardware determines the current meal bolus by:

when the patient is on a fixed meal plan;

determining when the previous next scheduled blood glucose value is within a pre-configured range of values;

determining an adjustment factor by setting the adjustment factor to a pre-configured adjustment factor associated with the pre-configured range of values; and

calculating the current meal bolus by multiplying the previous meal bolus times the adjustment factor.

15. The system of claim 11, wherein the data processing hardware determines the current meal bolus by:

when the patient is not on a fixed meal plan;

receiving an estimated number of carbohydrates to be ingested by the patient for the associated meal type;

obtaining a current carbohydrate to insulin ratio for the associated meal type; and

calculating the current meal bolus by dividing the estimated number of carbohydrates by the current carbohydrate-to-insulin ratio for the associated meal type.

16. The system of claim 15, wherein the data processing hardware obtains the current carbohydrate to insulin ratio for the associated meal type by:

retrieving a previous carbohydrate to insulin ratio for the associated meal type from the remote memory hardware, the previous carbohydrate to insulin ratio associated with the previous meal bolus;

determining when the previous next scheduled blood glucose value is within a pre-configured range of values;

determining an adjustment factor by setting the adjustment factor to a pre-configured adjustment factor associated with the pre-configured range of values; and

calculating the current carbohydrate to insulin ratio for the associated meal type by dividing the previous carbohydrate to insulin ratio by the adjustment factor.

17. The system of claim 11, wherein the data processing hardware:

when the time period of the current blood glucose measurement is the pre-meal time and the meal type associated with the pre-meal time is breakfast;

obtains a previous mid-sleep blood glucose measurement and a previous breakfast blood glucose measurement of the patient;

determines an adjustment factor based on one of the previous mid-sleep blood glucose measurement or the previous breakfast blood glucose measurement; and

calculates a new basal dose by multiplying the previous basal dose times the adjustment factor.

18. The system of claim 17, wherein the data processing hardware:

determines the adjustment factor based on the previous mid-sleep blood glucose measurement when the previous mid-sleep blood glucose measurement is less than the previous breakfast blood glucose measurement;

or

determines the adjustment factor based on the previous breakfast blood glucose measurement when the previous mid-sleep blood glucose measurement is greater than the previous breakfast blood glucose measurement.

19. The system of claim 17, wherein the data processing hardware:

stores the calculated new basal dose in the remote memory hardware; and

transmits the calculated new basal dose to the user interface, the calculated new basal dose received by the user interface causing the user interface to display the calculated new basal dose.

20. The system of claim 11, wherein the data processing hardware:

determines whether the patient plans to exercise or has recently exercised; and

when the patient plans to exercise or has recently exercised and the current blood glucose measurement is less than the target blood glucose value;

determines a duration of the exercise planned by the patient or recently completed by the patient;

determines carbohydrate intake instructions for the patient including a predetermined amount of carbohydrates for the patient to ingest based on the duration of the exercise; and

transmits the carbohydrate intake instructions to the user interface, the user instructions causing the user interface to display the predetermined amount of carbohydrates for the patient to ingest.

27. The system of claim 11, wherein the data processing hardware:

when the time period of the current blood glucose measurement is the pre-meal time and the meal type associated with the pre-meal time is breakfast;

obtains a previous mid-sleep blood glucose measurement and a previous breakfast blood glucose measurement of the patient;

determines an adjustment factor based on one of the previous mid-sleep blood glucose measurement or the previous breakfast blood glucose measurement; and

calculates a new basal dose by multiplying the previous basal dose times the adjustment factor.

28. The system of claim 27, wherein the data processing hardware:

determines the adjustment factor based on the previous mid-sleep blood glucose measurement when the previous mid-sleep blood glucose measurement is less than the previous breakfast blood glucose measurement;

or

determines the adjustment factor based on the previous breakfast blood glucose measurement when the previous mid-sleep blood glucose measurement is greater than the previous breakfast blood glucose measurement.

29. The system of claim 27, wherein the data processing hardware:

stores the calculated new basal dose in the remote memory hardware; and

transmits the calculated new basal dose to the user interface, the calculated new basal dose received by the user interface causing the user interface to display the calculated new basal dose.

21. A system comprising:

a blood glucose meter measuring blood glucose measurements of blood samples from a patient;

data processing hardware in communication with the glucometer, the data processing hardware;

receiving a current blood glucose measurement of the patient and a time period of the current blood glucose measurement from the blood glucose meter;

obtaining blood glucose parameters for the patient from remote memory hardware in communication with the data processing hardware;

when the time period of the current blood glucose measurement is a pre-meal time and a meal type associated with the pre-meal time is one of breakfast, lunch, dinner or snack;

obtaining a previous meal bolus dosage administered by the patient for the associated meal type and a previous next scheduled blood glucose measurement from the remote memory hardware, the previous next scheduled blood glucose measurement resulting from the previous meal bolus dosage administered by the patient; and

determining a current meal bolus dosage based on the previous meal bolus and the previous next scheduled blood glucose measurement;

calculating a prescribed number of units of insulin to control a blood glucose value of the patient, the calculated number of prescribed units of insulin comprising the current meal bolus dosage and a correction dosage, the correction dosage calculated as follows;

22. The system of claim 21, wherein the data processing hardware:

when the current blood glucose measurement is greater than a hyperglycemia blood glucose limit or less than a hypoglycemia blood glucose limit;

transmits an out-of-range blood glucose alert to a computing device associated with an authorized medial professional;

receives one of hyperglycemia patient instructions or hypoglycemia patient instructions from the computing device associated with the authorized medial professional;

stores the received hyperglycemia or hypoglycemia user instructions in the remote memory hardware; and

transmits the received hyperglycemia or hypoglycemia user instructions to the user interface, the hyperglycemia or hypoglycemia user instructions received by the user interface causing the user interface to display the hyperglycemia or hypoglycemia instructions.

23. The system of claim 22, wherein the hyperglycemia blood glucose limit is less than the first lower blood glucose limit and the hypoglycemia blood glucose limit is greater than the first upper blood glucose limit.

24. The system of claim 21, wherein the data processing hardware determines the current meal bolus dosage by:

when the patient is on a fixed meal plan;

determining when the previous next scheduled blood glucose value is within a pre-configured range of values;

determining an adjustment factor by setting the adjustment factor to a pre-configured adjustment factor associated with the pre-configured range of values; and

calculating the current meal bolus dosage by multiplying the previous meal bolus times the adjustment factor.

25. The system of claim 21, wherein the data processing hardware determines the current meal bolus dosage by:

when the patient is not on a fixed meal plan;

receiving an estimated number of carbohydrates to be ingested by the patient for the associated meal type;

obtaining a current carbohydrate to insulin ratio for the associated meal type; and

calculating the current meal bolus dosage by dividing the estimated number of carbohydrates by the current carbohydrate-to-insulin ratio for the associated meal type.

26. The system of claim 25, wherein the data processing hardware obtains the current carbohydrate to insulin ratio for the associated meal type by:

retrieving a previous carbohydrate to insulin ratio for the associated meal type from the remote memory hardware, the previous carbohydrate to insulin ratio associated with the previous meal bolus;

determining when the previous next scheduled blood glucose value is within a pre-configured range of values;

determining an adjustment factor by setting the adjustment factor to a pre-configured adjustment factor associated with the pre-configured range of values; and

calculating the current carbohydrate to insulin ratio for the associated meal type by dividing the previous carbohydrate to insulin ratio by the adjustment factor.

30. The system of claim 21, wherein the data processing hardware:

determines whether the patient plans to exercise or has recently exercised; and

when the patient plans to exercise or has recently exercised and the current blood glucose measurement is less than the target blood glucose value;

determines a duration of the exercise planned by the patient or recently completed by the patient;

determines carbohydrate intake instructions for the patient including a predetermined amount of carbohydrates for the patient to ingest based on the duration of the exercise; and

transmits the carbohydrate intake instructions to the user interface, the user instructions causing the user interface to display the predetermined amount of carbohydrates for the patient to ingest.