Method and system for insulin management

• US 9,898,585 B2
• Filed: 10/27/2014
• Issued: 02/20/2018
• Est. Priority Date: 01/31/2014
• Status: Active Grant

• Current Assignee: Aseko, Inc.
• Original Assignee: Aseko, Inc.
• Inventors: Booth, Robert C., Hebblewhite, Harry
• Primary Examiner(s): Whaley, Pablo S
• Application Number:
  US14/524,756
• Publication Number:
  US 20150217054A1
• Time in Patent Office: 1,212 Days
• Field of Search: None
• 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. Each blood glucose measurement is separated by a time interval and includes a blood glucose time associated with a time of measuring the blood glucose measurement. The method also includes receiving patient information at the data processing device and selecting a subcutaneous insulin treatment for tube-fed patients from a collection of subcutaneous insulin treatments. The selection is based on the blood glucose measurements and the patient information. The subcutaneous insulin treatment program for tube-fed patients determines recommended insulin doses based on the blood glucose times. The method also includes executing, using the data processing device, the selected subcutaneous insulin treatment.

Claims

1. A method comprising:

receiving a blood glucose measurement of a patient at a data processing device from a glucometer in communication with the data processing device;

obtaining, by the data processing device, a blood glucose time associated with measuring the blood glucose measurement;

receiving patient information at the data processing device from a non-transitory computer-readable medium in communication with the data processing device, the patient information comprising recommended equal-boluses of insulin for administration to the patient at sequential time intervals throughout a day, the number of sequential time intervals comprising;

six sequential time intervals, each spaced four hours apart;

or

four sequential time intervals, each spaced six hours apart;

determining, by the data processing device, which of the sequential time intervals includes the blood glucose time for the blood glucose measurement of the patient;

determining, by the data processing device, for a given blood glucose time within a first sequential time interval of the four sequential time intervals or a second sequential time interval of the six sequential time intervals, a given blood glucose measurement that is within one of a plurality of target ranges of values, the plurality of target ranges of values comprising;

a first target range of values including blood glucose values less than a first configurable constant;

a second target range of values including blood glucose values greater than or equal to the first configurable constant and less than a low target blood glucose value of a target blood glucose range for the patient;

a third target range of values including blood glucose values greater than or equal to the low target blood glucose value and less than a high target blood glucose value of the target blood glucose range;

a fourth target range of values including blood glucose values greater than or equal to the high target blood glucose value and less than a second configurable constant;

a fifth target range of values including blood glucose values greater than or equal to the second configurable constant and less than a third configurable constant; and

a sixth target range of values including blood glucose values greater than or equal to the third configurable constant;

determining, by the data processing device, an adjustment factor for adjusting a value of recommended equal-boluses to the patient based on the corresponding target range of values and the given blood glucose measurement; and

retrieving, by the data processing device, a previous day'"'"'s value of recommended equal-boluses;

determining, by the data processing device, a new value of recommended equal-boluses by multiplying the adjustment factor times the previous day'"'"'s value of recommended equal-boluses, wherein the new value of recommended equal-boluses corresponds to an insulin dose of rapid-acting insulin or regular insulin to be administered to the patient at scheduled blood glucose measurements;

setting, by the data processing device, a timer for a next blood glucose measurement based on the sequential time intervals;

determining, by the data processing device, a correction bolus based on the blood glucose time by calculating;

CB_x=(BG−

BG_Target)/CF;

wherein CB is the correction bolus, BG is the blood glucose measurement, BG_Target is a target blood glucose value of the patient, and CF is a correction factor; and

administering the new value of recommended equal-boluses and the correction bolus to the patient by transmitting the new value of recommended equal-boluses and the correction insulin dose from the data processing device to a remote administration device comprising a doser configured to;

automatically set or dial in and administer a first number of units of insulin corresponding to the new value of the recommended equal-boluses to the patient at each of the sequential time intervals; and

automatically set or dial in and administer a second number of units of insulin corresponding to the correction bolus to the patient.

2. The method of claim 1, further comprising:

determining the correction factor using the data processing device by calculating;

CF=CFR/TDD

wherein CF is the correction factor, CFR is a constant determined from a statistical correlation, and TDD is total daily dose of insulin per day;

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

CB=(BG−

BG_Target)/CF

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

administering the pre-meal correction bolus by transmitting the pre-meal correction bolus from the data processing device to the remote administration device, the doser configured to automatically set or dial in a corresponding number of units of insulin for the pre-meal correction bolus and administer the corresponding number of units of insulin for the pre-meal correction bolus to the patient.

3. The method of claim 1, further comprising:

determining, using the data processing device, a post-prandial correction bolus by calculating;

4. The method of claim 3, further comprising:

receiving, at the data processing device, a half-life value of the rapid-acting insulin; and

determining, using the data processing device, the mean lifetime of the rapid-acting insulin by calculating;

iLifeRapid=Half-life*ln(2)

wherein iLifeRapid is the mean lifetime of the rapid-acting insulin and Half-life is a half-life value of the rapid-actin insulin.

5. 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; and

determining, using the data processing device, at least one bolus of insulin based on the Carbohydrate-to-Insulin Ratio.

6. The method of claim 1, further comprising, when the blood glucose time is within a second sequential time interval of the four sequential time intervals:

setting, using the data processing device, the blood glucose measurement as a governing blood glucose value;

determining, using the data processing device, a basal dose adjustment factor for adjusting a current day recommended basal dose based on the governing blood glucose value;

retrieving, using the data processing device, a previous day recommended basal dose;

determining, using the data processing device, the current day recommended basal dose by multiplying the basal dose adjustment factor times the previous day recommended basal dose, the current day recommended basal dose corresponding to an insulin dose of long-acting insulin; and

administering the current day recommended basal dose by transmitting the current day recommended basal dose from the data processing device to the remote administration device, the doser configured to automatically set or dial in a corresponding number of units of insulin for the current day recommended basal dose and administer the corresponding number of units of insulin for the current day recommended basal dose to the patient at a configurable frequency of one, two, or three times per day.

7. The method of claim 1, further comprising, when the blood glucose time is within a third sequential time interval of the six sequential time intervals:

setting, using the data processing device, the blood glucose measurement as a governing blood glucose value;

determining, using the data processing device, a basal dose adjustment factor for adjusting a current day recommended basal dose based on the governing blood glucose value;

retrieving, using the data processing device, a previous day recommended basal dose;

determining, using the data processing device, the current day recommended basal dose by multiplying the basal dose adjustment factor times the previous day recommended basal dose, the current day recommended basal dose corresponding to an insulin dose of long-acting insulin; and

administering the current day recommended basal dose by transmitting the current day recommended basal dose from the data processing device to the remote administration device, the doser configured to automatically set or dial in a corresponding number of units of insulin for the current day recommended basal dose and administer the corresponding number of units of insulin for the current day recommended basal dose to the patient at a configurable frequency of one, two, or three times per day.

8. A system comprising:

a glucometer configured to measure 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 a non-transitory computer-readable medium in communication with the data processing device, the data processing device configured to perform operations comprising;

receiving blood glucose measurements of a patient from the glucometer, each blood glucose measurement separated by a time interval and comprising a blood glucose time associated with a time of measuring the blood glucose measurement;

receiving patient information from the non-transitory computer-readable medium, the patient information comprising recommended equal-boluses of insulin for administration to the patient at sequential time intervals throughout a day, the number of sequential time intervals comprising;

six sequential time intervals, each spaced four hours apart;

or

four sequential time intervals, each spaced six hours apart;

determining which of the sequential time intervals includes the blood glucose time for the blood glucose measurement of the patient;

determining, for a given blood glucose time within a first sequential time interval of the four sequential time intervals or a second sequential time interval of the six sequential time intervals, a given blood glucose measurement that is within one of a plurality of target ranges of values, the plurality of target ranges of values comprising;

a first target range of values including blood glucose values less than a first configurable constant;

a second target range of values including blood glucose values greater than or equal to the first configurable constant and less than a low target blood glucose value of a target blood glucose range for the patient;

a third target range of values including blood glucose values greater than or equal to the low target blood glucose value and less than a high target blood glucose value of the target blood glucose range;

a fourth target range of values including blood glucose values greater than or equal to the high target blood glucose value and less than a second configurable constant;

a fifth target range of values including blood glucose values greater than or equal to the second configurable constant and less than a third configurable constant; and

a sixth target range of values including blood glucose values greater than or equal to the third configurable constant;

determining an adjustment factor for adjusting a value of recommended equal-boluses to the patient based on the corresponding target range of values and the given blood glucose measurement; and

retrieving a previous day'"'"'s value of recommended equal-boluses;

determining a new value of recommended equal-boluses by multiplying the adjustment factor times the previous day'"'"'s value of recommended equal-boluses, wherein the new value of recommended equal-boluses corresponds to an insulin dose of rapid-acting insulin or regular insulin to be administered to the patient at scheduled blood glucose measurements;

setting, by the data processing device, a timer for a next blood glucose measurement based on the sequential time intervals;

determining a correction bolus based on the blood glucose time by calculating;

CB_x=(BG−

BG_Target)/CF;

wherein CB is the correction bolus, BG is the blood glucose measurement, BG_Target is a target blood glucose value of the patient, and CF is a correction factor; and

administering the new value of recommended equal-boluses and the correction bolus to the patient by transmitting the new value of recommended equal-boluses and the correction insulin dose to a remote administration device comprising a doser configured to;

automatically set or dial in and administer a first number of units of insulin corresponding to the new value of the recommended equal-boluses to the patient at each of the sequential time intervals; and

automatically set or dial in and administer a second number of units of insulin corresponding to the correction bolus to the patient.

9. The system of claim 8, wherein the operations further comprise:

determining the correction factor by calculating;

CF=CFR/TDD

wherein CF is the correction factor, CFR is a constant determined from a statistical correlation, and TDD is total daily dose of insulin per day;

determining a pre-meal correction bolus by calculating;

CB=(BG−

BG_Target)/CF

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

administering the pre-meal correction bolus by transmitting the pre-meal correction bolus to the remote administration device, the doser configured to automatically set or dial in a corresponding number of units of insulin for the pre-meal correction bolus and administer the corresponding number of units of insulin for the pre-meal correction bolus to the patient.

10. The system of claim 8, wherein the operations further comprise:

determining a post-prandial correction bolus by calculating;

11. The system of claim 10, wherein the operations further comprise:

receiving a half-life value of the rapid-acting insulin; and

determining the mean lifetime of the rapid-acting insulin by calculating;

iLifeRapid=Half-life*ln(2)

wherein Half-life is a half-life value of the rapid-actin insulin.

12. The system of claim 8, wherein the operations further comprise:

determining 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; and

determining at least one bolus of insulin based on the Carbohydrate-to-Insulin Ratio.

13. The system of claim 8, wherein the operations further comprise, when the blood glucose time is within a second sequential time interval of the four sequential time intervals:

setting the blood glucose measurement as a governing blood glucose value;

determining a basal dose adjustment factor for adjusting a current day recommended basal dose based on the governing blood glucose value;

retrieving a previous day recommended basal dose;

determining the current day recommended basal dose by multiplying the basal dose adjustment factor times the previous day recommended basal dose, the current day recommended basal dose corresponding to an insulin dose of long-acting insulin; and

administering the current day recommended basal dose by transmitting the current day recommended basal dose to the remote administration device, the doser configured to automatically set or dial in a corresponding number of units of insulin for the current day recommended basal dose and administer the corresponding number of units of insulin for the current day recommended basal dose to the patient at a configurable frequency of one, two, or three times per day.

14. The system of claim 8, wherein the operations further comprise, when the blood glucose time is within a second sequential time interval of the six sequential time intervals:

setting the blood glucose measurement as a governing blood glucose value;

determining a basal dose adjustment factor for adjusting a current day recommended basal dose based on the governing blood glucose value;

retrieving a previous day recommended basal dose;

determining the current day recommended basal dose by multiplying the basal dose adjustment factor times the previous day recommended basal dose, the current day recommended basal dose corresponding to an insulin dose of long-acting insulin; and

administering the current day recommended basal dose by transmitting the current day recommended basal dose from to the remote administration device, the doser configured to automatically set or dial in a corresponding number of units of insulin for the current day recommended basal dose and administer the corresponding number of units of insulin for the current day recommended basal dose to the patient at a configurable frequency of one, two, or three times per day.