Insulin Management

• US 20150217055A1
• Filed: 10/27/2014
• Published: 08/06/2015
• Est. Priority Date: 01/31/2014
• Status: Active Grant

• Current Assignee: Aseko, Inc.
• Original Assignee: Aseko, Inc.
• Inventors: Hebblewhite, Harry, Booth, Robert C
• Granted Patent: US 9,233,204 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/14296 Pharmacokinetic models
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3327 Measuring
• CPC Class Codes: A61M 2205/35 Communication
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/507 Head Mounted Displays [HMD]
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/14 Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• 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: A61P 3/10 : for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: G16H 10/40 : for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• 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 80/00 : ICT specially adapted for facilitating communication between medical practitioners or patients, e.g. for collaborative diagnosis, therapy or health monitoring

Abstract

A method of administering insulin includes receiving blood glucose measurements of a patient at a data processing device from a glucometer. The blood glucose measurements are separated by a time interval. The method also includes receiving patient information at the data processing device and selecting a subcutaneous insulin treatment from a collection of subcutaneous insulin treatments. The selection is based on the blood glucose measurements and the patient information. The selection includes one or more of a subcutaneous standard program, a subcutaneous program without meal boluses, a meal-by-meat subcutaneous program without carbohydrate counting, a meal-by-meal subcutaneous program with carbohydrate counting, and a subcutaneous program for non-diabetic patients. The method also includes executing, using the data processing device, the selected subcutaneous insulin treatment.

Claims

1. A method comprising:

receiving blood glucose measurements of a patient at a data processing device from a glucometer, the blood glucose measurements separated by a time interval;

receiving patient information at the data processing device;

selecting, using the data processing device, a subcutaneous insulin treatment from a collection of subcutaneous insulin treatments based on the blood glucose measurements and the patient information, the selected subcutaneous insulin treatment includes one or more of a subcutaneous standard program, a subcutaneous program without meal boluses, a meal-by-meal subcutaneous program without carbohydrate counting, a meal-by-meal subcutaneous program with carbohydrate counting, and a subcutaneous program for non-diabetic patients, the subcutaneous standard program comprising;

determining a blood glucose type of the received blood glucose measurement using the data processing device; and

determining a correction insulin dose based on the blood glucose type using the data processing device by calculating;

CB_x=(BG_x−

BG_Target)/CF;

wherein CB_x is the correction dose based on blood glucose type X, BG_x is the blood glucose measurement, BG_Target is a target blood glucose value of a patient, and CF is a correction factor; and

executing, using the data processing device, the selected subcutaneous insulin treatment.

2. The method of claim 1, further comprising:

determining a pre-meal correction bolus using the data processing device by calculating;

CB=(BG−

BG_Target)/CF;

wherein CB is the pre-meal correction bolus, BG is the blood glucose measurement, and BG_Target is a target blood glucose of the patient.

3. The method of claim 1, further comprising:

receiving, at the data processing device, a governing blood glucose value; and

determining, using the data processing device, an adjustment factor based on the received governing blood glucose value.

4. The method of claim 3, wherein determining the adjustment factor comprises:

determining when the governing blood glucose value is within a threshold range of values; and

setting the adjustment factor to a preconfigured adjustment factor associated with the threshold range of values.

5. The method of claim 3, wherein determining the adjustment factor comprises:

determining the governing blood glucose value is within one of multiple pre-configured ranges of values; and

setting the adjustment factor to a pre-configured adjustment factor associated with the pre-configured range of values that includes the governing blood glucose value.

6. The method of claim 1, further comprising determining, using the data processing device, a Carbohydrate-to-Insulin Ratio based on the adjustment factor by calculating:

CIR=(CIR_Previous)/AF;

wherein CIR is the Carbohydrate-to-Insulin Ratio, CIR_Previous is a previously determined Carbohydrate-to-Insulin Ratio, and AF is the adjustment factor.

7. The method of claim 1, wherein the blood glucose type is associated with a blood glucose time associated with a time of measuring the blood glucose measurement, the blood glucose type selected from the group consisting of:

a pre-breakfast blood glucose measurement, a pre-lunch blood glucose measurement, a pre-dinner blood glucose measurement, a bedtime blood glucose measurement, a midsleep blood glucose measurement and a miscellaneous blood glucose measurement.

8. The method of claim 1, further comprising:

determining, using the data processing device, if a breakfast blood glucose measurement has been received at the data processing device from the glucometer; and

when the breakfast blood glucose measurement has been received;

selecting, using the data processing device, a governing blood glucose as a lesser one of a previous midsleep blood glucose measurement or the breakfast blood glucose measurement;

determining, using the data processing device, an adjustment factor for adjusting a current day'"'"'s recommended basal dose based on the selected governing blood glucose measurement;

retrieving, by the data processing device, a previous day'"'"'s bed time recommended basal dose; and

determining, by the data processing device, the current day'"'"'s recommended basal dose by multiplying the adjustment factor times the previous day'"'"'s bed time recommended basal dose, the current day'"'"'s recommended basal dose corresponding to an insulin dose of long-acting insulin to be administered to the patient at a configurable frequency of one, two, or three times per day.

9. The method of claim 8, further comprising, when the breakfast blood glucose measurement has not been received:

blocking, using the data processing device, a basal dose recommendation; and

transmitting a warning from the data processing device to a display in communication with the data processing device, the warning indicating the blocked basal dose recommendation.

10. The method of claim 1, further comprising:

receiving, at the data processing device, a breakfast blood glucose measurement from the glucometer;

selecting, using the data processing device, a governing blood glucose as one of a previous midsleep blood glucose measurement and the received breakfast blood glucose measurement;

determining, using the data processing device, an adjustment factor for adjusting a current day'"'"'s recommended basal dose based on the selected governing blood glucose measurement;

retrieving, by the data processing device, a previous day'"'"'s bed time recommended basal dose; and

determining, by the data processing device, the current day'"'"'s recommended basal dose by multiplying the adjustment factor times the previous day'"'"'s bed time recommended basal dose, the current day'"'"'s recommended basal dose corresponding to an insulin dose of long-acting insulin to be administered to the patient at a configurable frequency of one, two, or three times per day;

wherein the governing blood glucose is selected as the previous midsleep blood glucose measurement when the previous midsleep blood glucose measurement is less than the breakfast blood glucose measurement; and

wherein the governing blood glucose is selected as the breakfast blood glucose measurement when the breakfast blood glucose measurement is less than the previous midsleep blood glucose measurement unless the previous midsleep blood glucose measurement was accompanied by a correction insulin dose exceeding three units of insulin, and an elapsed time between the correction insulin dose and the breakfast blood glucose measurement is less than three hours

11. The method of claim 1, further comprising, when the determined blood glucose type is one of a breakfast blood glucose measurement, a lunch blood glucose measurement, or a dinner blood glucose measurement:

after a subsequent blood glucose measurement associated with a subsequent blood glucose type is received, determining, using the data processing device, an adjustment factor for adjusting a next day'"'"'s recommended meal bolus at a time of day associated with the determined blood glucose type based upon the subsequent blood glucose measurement; and

determining, by the data processing device, the next day'"'"'s recommended meal bolus at the time of day associated with the determined blood glucose type by multiplying the current day'"'"'s recommended meal bolus associated with the determined blood glucose type times the adjustment factor.

12. The method of claim 1, wherein the subcutaneous program for non-diabetic patients comprises:

for each blood glucose measurement received by the data processing device from the glucometer that is less than or equal to a threshold value;

determining, using the data processing device, new currently-recommended insulin doses by multiplying all currently-recommended insulin doses by a dose reduction factor comprising a value less than one; and

recalculating, using the data processing device, a total daily dose of insulin as a sum of all the new currently-recommended insulin doses.

13. The method of claim 1, wherein the subcutaneous meal-by-meal without carb-counting program comprises:

determining, using the data processing device, a recommended meal bolus for use throughout the day; and

for each meal, adjusting the meal bolus, using the data processing device, by multiplying an immediately previous recommended meal bolus times an adjustment factor governed by a blood glucose measurement received after an immediately previous meal associated with the immediately previous recommended meal bolus.

14. The method of claim 1, wherein the subcutaneous meal-by-meal with carb-counting program comprises:

determining, using the data processing device, a carbohydrate-insulin ratio for use throughout the day; and

for each meal, adjusting the carbohydrate-insulin ratio, using the data processing device, by dividing an immediately previous carbohydrate-insulin ratio associated with an immediately previous meal by an adjustment factor governed by a blood glucose measurement received after the immediately previous meal.

15. The method of claim 1, further comprising transmitting the selected subcutaneous insulin treatment to an administration device in communication with the data processing device, the administration device comprising:

a doser; and

an administration computing device in communication with the doser, the administration computing device, when executing the selected subcutaneous insulin treatment, causing the doser to administer insulin specified by the selected subcutaneous insulin treatment.

16. A system comprising:

a glucometer measuring blood glucose measurements separated by a time interval; and

a dosing controller in communication with the glucometer, the dosing controller including a data processing device and non-transitory memory in communication with the data processing device, the dosing controller;

receiving blood glucose measurements of a patient from the glucometer;

receiving patient information; and

selecting a subcutaneous insulin treatment from a collection of subcutaneous insulin treatments based on the blood glucose measurements and the patient information, the selected subcutaneous insulin treatment includes one or more of a subcutaneous standard program, a subcutaneous program without meal boluses, a meal-by-meal subcutaneous program without carbohydrate counting, a meal-by-meal subcutaneous program with carbohydrate counting, and a subcutaneous program for non-diabetic patients, wherein during the standard subcutaneous program, the dosing controller;

determines a blood glucose type of the received blood glucose measurement; and

determines a correction insulin dose based on the blood glucose type by calculating;

CB_x=(BG_x−

BG_Target)/CF;

wherein CB_x is the correction dose based on blood glucose type X, BG_x is the blood glucose measurement, BG_Target is a target blood glucose value of a patient, and CF is a correction factor; and

executing the selected subcutaneous insulin treatment.

17. The system of claim 16, wherein the dosing controller determines a pre-meal correction bolus by calculating:

CB=(BG−

CBG_Target)/CF

wherein BG is the blood glucose measurement, and BG_Target is a target blood glucose of the patient.

18. The system of claim 16, wherein the dosing controller:

receives a governing blood glucose value; and

determines an adjustment factor based on the received governing blood glucose value.

19. The system of claim 16, wherein the dosing controller:

receives a governing blood glucose value;

determines the governing blood glucose value is within a threshold range of values; and

sets an adjustment factor to a preconfigured adjustment factor based on the threshold range of values.

20. The system of claim 16, wherein the dosing controller:

receives a governing blood glucose value;

determines the governing blood glucose value is within one of multiple pre-configured ranges of values; and

sets an adjustment factor to a pre-configured adjustment factor associated with the pre-configured range of values that includes the governing blood glucose value.

21. The system of claim 16, wherein the dosing controller determines a Carbohydrate-to-Insulin Ratio based on the adjustment factor by calculating:

CIR=(CIR_Previous)/AF;

wherein CIR is the Carbohydrate-to-Insulin Ratio, CIR_Previous is a previously determined Carbohydrate-to-Insulin Ratio, and AF is the adjustment factor.

22. The system of claim 16, wherein the blood glucose type is associated with a blood glucose time associated with a time of measuring the blood glucose measurement, the blood glucose type selected from the group consisting of a:

midsleep blood glucose measurement, a pre-breakfast blood glucose measurement, a pre-lunch blood glucose measurement, a pre-dinner blood glucose measurement, and a bedtime blood glucose measurement wherein the midsleep, pre-breakfast, pre-lunch, pre-dinner, and bedtime blood glucose measurements are scheduled in a daily repetitive rotational order.

23. The system of claim 16, wherein the dosing controller:

determines if a pre-breakfast blood glucose measurement has been received at data processing device from the glucometer; and

when the pre-breakfast blood glucose measurement has been received;

selects a governing blood glucose as a lesser one of a previous midsleep blood glucose measurement or the pre-breakfast blood glucose measurement;

determines an adjustment factor for adjusting a current day'"'"'s recommended basal dose based on the selected governing blood glucose measurement;

retrieves a previous day'"'"'s bed time recommended basal dose; and

determines the current day'"'"'s recommended basal dose by multiplying the adjustment factor times the previous day'"'"'s bed time recommended basal dose, the current day'"'"'s recommended basal dose corresponding to an insulin dose of long-acting insulin to be administered to the patient at a configurable frequency of one, two, or three times per day.

24. The method of claim 23, wherein the dosing controller, when the pre-breakfast blood glucose measurement has not been received:

blocks a basal dose recommendation; and

transmits a warning to a display in communication with the dosing controller, the warning indicating the pre-breakfast blood glucose measurement has not been received and the blocked basal dose recommendation.

25. The system of claim 16, wherein the dosing controller:

receives a pre-breakfast blood glucose measurement from the glucometer;

selects a governing blood glucose as one of a previous midsleep blood glucose measurement or the received pre-breakfast blood glucose measurement;

determines an adjustment factor for adjusting a current day'"'"'s recommended basal dose based on the selected governing blood glucose measurement;

retrieves a previous day'"'"'s bed time recommended basal dose; and

determines the current day'"'"'s recommended basal dose by multiplying the adjustment factor times the previous day'"'"'s bed time recommended basal dose, the current day'"'"'s recommended basal dose corresponding to an insulin dose of long-acting insulin to be administered to the patient at a configurable frequency of one, two, or three times per day;

wherein the governing blood glucose is selected as the previous midsleep blood glucose measurement when the previous midsleep blood glucose measurement is less than the pre-breakfast blood glucose measurement; and

wherein the governing blood glucose is selected as the pre-breakfast blood glucose measurement when the breakfast blood glucose measurement is less than the previous midsleep blood glucose measurement unless the previous midsleep blood glucose measurement was accompanied by a correction insulin dose exceeding three units of insulin and an elapsed time between the correction insulin dose and the pre-breakfast blood glucose measurement is less than three hours.

26. The system of claim 16, wherein the dosing controller, when the determined blood glucose type is one of a pre-breakfast blood glucose measurement, a pre-lunch blood glucose measurement, or a pre-dinner blood glucose measurement:

after a subsequent blood glucose measurement associated with a subsequent blood glucose type is received, determines an adjustment factor for adjusting a next day'"'"'s recommended meal bolus for the determined blood glucose type governed by the blood glucose measurement for the subsequent blood glucose type; and

determines the next day'"'"'s recommended meal bolus at the time of day associated with the determined blood glucose type by multiplying the current day'"'"'s recommended meal bolus associated with the determined blood glucose type times the adjustment factor.

27. The system of claim 16, wherein during the subcutaneous program for non-diabetic patients, the dosing controller:

for each blood glucose measurement received by the dosing controller from the glucometer that is less than or equal to a threshold value;

determines new currently-recommended insulin doses by multiplying all currently-recommended insulin doses by a dose reduction factor comprising a value less than one; and

recalculates a total daily dose of insulin as a sum of all the new currently recommended insulin doses.

28. The system of claim 16, wherein during the subcutaneous meal-by-meat without carb-counting program, the dosing controller:

determines a recommended meal bolus for use throughout the day; and

for each meal, adjusts the meal bolus by multiplying an immediately previous recommended meal bolus times an adjustment factor governed by a blood glucose measurement received after an immediately previous meal associated with the immediately previous recommended meal bolus.

29. The system of claim 16, wherein during the subcutaneous meat-by-meal with carb-counting program, the dosing controller:

determines a carbohydrate-insulin ratio for use throughout the day;

for each meal, adjusts the carbohydrate-insulin ratio by dividing an immediately previous carbohydrate-insulin ratio associated with an immediately previous meal by an adjustment factor governed by a blood glucose measurement received after the immediately previous meal;

for an amount of carbohydrates associated with each meal, determines a recommended meal bolus for each meal by dividing the associated amount of carbohydrates by the associated adjusted carbohydrate-insulin ratio.

30. The system of claim 16, wherein the dosing controller transmits the selected subcutaneous insulin treatment to an administration device in communication with the dosing controller, the administration device comprising:

a doser; and

an administration computing device in communication with the doser, the administration computing device, when executing the selected subcutaneous insulin treatment, causing the doser to administer insulin specified by the selected subcutaneous insulin treatment.