Means and method for improved glycemic control for diabetic patients

• US 9,483,619 B2
• Filed: 09/22/2015
• Issued: 11/01/2016
• Est. Priority Date: 09/11/2012
• Status: Active Grant

• Current Assignee: Glytec LLC (Aseko, Inc.)
• Original Assignee: Aseko, Inc.
• Inventors: Booth, Robert C., Fischell, Robert E.
• Primary Examiner(s): SOREY, ROBERT A
• Application Number:
  US14/861,427
• Publication Number:
  US 20160012204A1
• Time in Patent Office: 406 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
• 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 user device controlled by the patient and in communication with the data processing hardware, wherein the user device;

receives the current blood glucose measurement and the time period of the current blood glucose measurement from a blood glucose meter in communication with the user device; and

transmits the current blood glucose measurement of the patient and the time period of the current blood glucose measurement to the data processing hardware;

in response to receiving the current blood glucose measurement from the user device, obtaining, by the data processing hardware, blood glucose parameters for the patient from remote memory hardware locationally removed from the data processing hardware and in communication with the data processing hardware, the blood glucose parameters input to the remote memory hardware by a medical professional computing device associated with an authorized medical professional and include a hyperglycemia blood glucose limit, a hypoglycemia blood glucose limit, a target blood glucose range defined by upper and lower blood glucose limits, and an insulin sensitivity factor for the patient;

comparing, by the data processing hardware, the current blood glucose measurement to the obtained blood glucose parameters for the patient;

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

transmitting an out-of-range blood glucose alert from the data processing hardware to the medical professional computing device;

receiving, at the data processing hardware, one of hyperglycemia patient instructions when the current blood glucose measurement is greater than the hyperglycemia blood glucose limit or hypoglycemia patient instructions when the current blood glucose measurement is less than the hypoglycemia blood glucose limit from the medical professional computing device;

transmitting the received one of the hyperglycemia patient instructions or the hypoglycemia patient instructions from the data processing hardware to the user device, the hyperglycemia patient instructions or the hypoglycemia patient instructions when received by the user device, causing a user interface executing on the user device to display the hyperglycemia patient instructions or the hypoglycemia patient instructions; and

storing the received one of the hyperglycemia patient instructions or the hypoglycemia patient instructions in the remote memory hardware;

when the current blood glucose measurement exceeds a midpoint of the target blood glucose range that is greater than the hypoglycemia blood glucose limit and less than the hyperglycemia blood glucose limit;

determining, by the data processing hardware, a correction dose based on a function of the current blood glucose measurement, the mid-point of the target blood glucose range and the insulin sensitivity factor, the correction dose calculated as follows;

2. The method of claim 1, further comprising:

determining whether the current blood glucose measurement is greater than the hyperglycemia blood glucose limit; and

when the current blood glucose measurement is greater than the hyperglycemia blood glucose limit, determining, by the data processing hardware, the correction dose based on the function of the current blood glucose measurement, the mid-point of the target blood glucose range and the insulin sensitivity factor.

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

determining whether or not the patient is on a fixed meal plan; and

when the patient is on the 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.

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

determining whether or not the patient is on a fixed meal plan; and

when the patient is not on the 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.

5. The method of claim 4, 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.

6. 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, by the data processing hardware, a previous mid-sleep blood glucose measurement and a previous breakfast blood glucose measurement of the patient;

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

7. The method of claim 6, 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.

8. The method of claim 6, further comprising:

transmitting the calculated new basal dose to the user device, the calculated new basal dose when received by the user device, causing the user interface executing on the user device to display the calculated new basal dose; and

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

9. The method of claim 1, further comprising:

determining, by 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 mid-point of the target blood glucose range;

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

determining, by 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 device, the user instructions when received by the user device, causing the user interface executing on the user device to display the predetermined amount of carbohydrates for the patient to ingest.

10. A system comprising:

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

a user device controlled by the patient and in communication with the blood glucose meter, the user device receiving a current blood glucose measurement of the patient and a time period of the current blood glucose measurement from the blood glucose meter;

data processing hardware in communication with the user device, the data processing hardware;

receiving, after the user device receives the current blood glucose measurement and the time period of the blood glucose measurement from the blood glucose meter, the current blood glucose measurement of the patient and the time period of the current blood glucose measurement from the user device;

in response to receiving the current blood glucose measurement from the user device, obtaining blood glucose parameters for the patient from remote memory hardware locationally removed from the data processing hardware and in communication with the data processing hardware, the blood glucose parameters input to the remote memory hardware by a medical professional computing device associated with an authorized medical professional and including a hyperglycemia blood glucose limit, a hypoglycemia blood glucose limit, a target blood glucose range defined by upper and lower blood glucose limits, and an insulin sensitivity factor for the patient;

comparing the current blood glucose measurement to the obtained blood glucose measurements for the patient;

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

transmitting an out-of-range blood glucose alert from the data processing hardware to the medical professional computing device; and

receiving one of hyperglycemia patient instructions when the current blood glucose measurement is greater than the hyperglycemia blood glucose limit or hypoglycemia patient instructions when the current blood glucose measurement is less than the hypoglycemia blood glucose limit from the medical professional computing device;

transmitting the received one of the hyperglycemia patient instructions or the hypoglycemia patient instructions from the data processing hardware to the user device, the hyperglycemia patient instructions or the hypoglycemia patient instructions when received by the user device, causing a user interface executing on the user device to display the hyperglycemia patient or the hypoglycemia patient instructions; and

storing the received one of the hyperglycemia patient instructions or the hypoglycemia patient instructions in the remote memory hardware;

when the current blood glucose measurement exceeds a midpoint of the target blood glucose range that is greater than the hypoglycemia blood glucose limit and less than the hyperglycemia blood glucose limit;

determining a correction dose based on a function of the current blood glucose measurement, the mid-point of the target blood glucose range and the insulin sensitivity factor, the correction dose calculated as follows;

11. The system of claim 10, wherein the data processing hardware:

determines whether the current blood glucose measurement is greater than the hyperglycemia blood glucose limit; and

when the current blood glucose measurement is greater than the hyperglycemia blood glucose limit, determines the correction dose based on the function of the current blood glucose measurement, the mid-point of the target blood glucose range and the insulin sensitivity factor.

12. The system of claim 10, wherein the data processing hardware determines the current meal bolus by:

determining whether or not the patient is on a fixed meal plan; and

when the patient is on the 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.

13. The system of claim 10, wherein the data processing hardware determines the current meal bolus by:

determining whether or not the patient is on a fixed meal plan; and

when the patient is not on the 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.

14. The system of claim 13, 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.

15. The system of claim 10, 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.

16. The system of claim 15, 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.

17. The system of claim 15, 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 device, the calculated new basal dose when received by the user device, causing the user interface executing on the user device to display the calculated new basal dose.

18. The system of claim 10, 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 mid-point of the target blood glucose range;

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 device, the user instructions when received by the user device, causing the user interface executing on the user device to display the predetermined amount of carbohydrates for the patient to ingest.

19. The system of claim 10, 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.

20. The system of claim 19, 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.

21. The system of claim 19, 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 device, the calculated new basal dose when received by the user device, causing the user interface executing on the user device to display the calculated new basal dose.

22. A system comprising:

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

a user device controlled by the patient and in communication with the blood glucose meter, the user device receiving a current blood glucose measurement of the patient and a time period of the current blood glucose measurement from the blood glucose meter;

data processing hardware in communication with the user device, the data processing hardware;

receiving, after the user device receives the current blood glucose measurement and the time period of the blood glucose measurement from the blood glucose meter, the current blood glucose measurement of the patient and the time period of the current blood glucose measurement from the user device;

in response to receiving the current blood glucose measurement from the user device, obtaining blood glucose parameters for the patient from remote memory hardware locationally removed from the data processing hardware and in communication with the data processing hardware, the blood glucose parameters input to the remote memory hardware by a medical professional computing device associated with an authorized medical professional and including a hyperglycemia blood glucose limit, a hypoglycemia blood glucose limit, a target blood glucose range defined by first upper and lower blood glucose limits, and an insulin sensitivity value for the patient;

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

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 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;

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

compares the current blood glucose measurement to the hyperglycemia blood glucose limit and the hypoglycemia blood glucose limit;

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

transmits an out-of-range blood glucose alert to the medical professional computing device;

receives one of hyperglycemia patient instructions when the current blood glucose measurement is greater than the hyperglycemia blood glucose limit or hypoglycemia patient instructions when the current blood glucose measurement is less than the hypoglycemia blood glucose limit from the medical professional computing device;

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

transmits the received one of the hyperglycemia or hypoglycemia user instructions to the user device, the hyperglycemia or hypoglycemia user instructions when received by the user device, causing the user interface executing on the user device to display the hyperglycemia or hypoglycemia instructions.

24. 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.

25. The system of claim 22, wherein the data processing hardware determines the current meal bolus dosage by:

determining whether the patient is on a fixed meal plan; and

when the patient is on the 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.

26. The system of claim 22, wherein the data processing hardware determines the current meal bolus dosage by:

determining whether the patient is on a fixed meal plan; and

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.

27. The system of claim 26, 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.

28. The system of claim 22, 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 mid-point of the target blood glucose range;

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 device, the user instructions when received by the user device, causing the user interface executing on the user device to display the predetermined amount of carbohydrates for the patient to ingest.