System for administering insulin boluses to a patient

• US 10,811,133 B2
• Filed: 08/22/2018
• Issued: 10/20/2020
• 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:
  US16/109,508
• Publication Number:
  US 20180366217A1
• Time in Patent Office: 790 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 dosing controller for administering insulin. The dosing controller includes a data processing device and non-transitory memory in communication with the data processing device. The dosing controller receives blood glucose measurements of a patient from the glucometer, receives patient information, selects a subcutaneous insulin treatment from a collection of subcutaneous insulin treatments based on the blood glucose measurements and the patient information, and executes the selected subcutaneous insulin treatment. 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.

Claims

1. A system comprising:

a dose administering system having a doser and a patient display;

a screen;

a data processing device in communication with the patient display and the screen; and

a non-transitory computer-readable medium in communication with the data processing device, the non-transitory computer-readable medium storing instructions that when executed on the data processing device cause the data processing device to perform operations comprising;

determining a total daily dose (TDD) of insulin for a current day based on all basal doses and bolus doses of insulin administered to a patient on an immediately previous day;

receiving sequential blood glucose measurements of the patient, the sequential blood glucose measurements comprising a current blood glucose measurement measured at a current time and one or more previous blood glucose measurements measured before the current time;

executing a subcutaneous treatment program configured to display a graphical user interface on the screen in communication with the data processing device, wherein the subcutaneous treatment program is configured to;

display, in the graphical user interface, a patient information input window and a blood glucose information window; and

receive, in the patient information input window, patient information comprising;

a target blood glucose range for the patient, the target blood glucose range comprising a range of blood glucose values between and including a lower limit blood glucose value and an upper limit blood glucose value greater than the lower limit blood glucose value;

a specified number of consecutive blood glucose measurements of the patient within the target blood glucose range to determine a blood glucose concentration for the patient is stable in the target blood glucose range; and

recommended boluses of insulin for administration to the patient at sequential time intervals throughout a day, wherein a value for the recommended boluses of insulin is based on the determined TDD of insulin for the current day;

determining that the current blood glucose measurement and the one or more previous blood glucose measurements equal the specified number of consecutive blood glucose measurements within the target blood glucose range;

determining a time interval from the current time until a next time of a next scheduled blood glucose measurement for the patient based on the determination that the current blood glucose measurement and the one or more previous blood glucose measurements equal the specified number of consecutive blood glucose measurements within the target blood glucose range, the time interval comprising a duration of time that is longer than a default time interval, wherein the subcutaneous treatment program is further configured to;

display, in the graphical user interface, a countdown timer set for a duration of time equal to the determined time interval to indicate a remaining time until the next time of the next scheduled blood glucose measurement for the patient; and

display, in the graphical user interface, a blood glucose due message at the end of the determined time interval indicating that the next scheduled blood glucose measurement for the patient is due;

determining a correction bolus based on the current time by calculating;

CB_x=(BG−

BG_Target)/CF;

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

administering the recommended boluses and the correction bolus to the patient by transmitting the recommended boluses and the correction bolus from the data processing device to the dose administering system having the doser and the patient display at the sequential time interval that includes the current time for the current blood glucose measurement of the patient, the patient display configured to display a first number of units of insulin corresponding to a value of the recommended boluses and a second number of units of insulin corresponding to the correction bolus and trigger administration of the first number of units of insulin and the second number of units of insulin to the patient.

2. The system of claim 1, wherein the recommended boluses comprise recommended equal-boluses and the number of sequential time intervals comprises:

six sequential time intervals, each spaced four hours apart;

or

four sequential time intervals, each spaced six hours apart.

3. The system of claim 2, wherein the current time for the current blood glucose measurement of the patient is within one of:

a second sequential time interval, a third sequential time interval, a fourth sequential time interval, a fifth sequential time interval, or a sixth sequential time interval of the six sequential time intervals;

or

a first sequential time interval, a third sequential time interval, or a fourth sequential time interval of the four sequential time intervals.

4. The system of claim 2, wherein the operations further comprise:

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;

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;

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; and

transmitting the new value of recommended equal-boluses from the data processing device to the patient display at the sequential time intervals, the patient display configured to display a third number of units of insulin corresponding to the new value of recommended equal-boluses and trigger administration of the third number of units of insulin to the patient at each of the sequential time intervals.

5. The system of claim 4, wherein the plurality of target ranges of values comprises:

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.

6. The system of claim 2, wherein the operations further comprise:

determining for a given blood glucose time within a second sequential time interval of the four sequential time intervals or a third 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;

determining a basal dose adjustment factor for adjusting a current day recommended basal dose for administration to the patient based on the corresponding target range of values and the given blood glucose measurement;

retrieving a previous day recommended basal dose;

determining a new value of the current day recommended basal dose by multiplying the basal adjustment factor times the previous day recommended basal dose; and

transmitting the value of the current day'"'"'s recommended basal dose from the data processing device to the patient display, the patient display configured to display a third number of units of insulin corresponding to the value of the current day'"'"'s recommended basal dose and trigger administration of the third number of units of insulin to the patient at a configurable frequency of one, two, or three times per day.

7. The system of claim 1, wherein determining the correction bolus further comprises:

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

CF=CFR/TDD

wherein CF is the correction factor and CFR is a constant determined from a statistical correlation.

8. The system of claim 1, wherein the value for the recommended boluses of insulin is based on a bolus percentage of the TDD of insulin for the current day.