Insulin Management

• US 20170007761A1
• Filed: 09/22/2016
• Published: 01/12/2017
• Est. Priority Date: 01/31/2014
• Status: Active Grant

• Current Assignee: Aseko, Inc.
• Original Assignee: Aseko, Inc.
• Inventors: Booth, Robert C, Hebblewhite, Harry
• Granted Patent: US 9,604,002 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 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61M 2005/14296 Pharmacokinetic models
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• 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 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2230/201 Glucose concentration
• 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: G16H 10/00 ICT specially adapted for the handling or processing of patient-related medical or healthcare data for medical reports G16H15/00; for therapies or health-improving plans G16H20/00; for the handling or processing of medical images G16H30/00
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A method of managing insulin includes receiving blood glucose measurements on a computing device from a glucometer. The blood glucose measurements are separated by a time interval. The method includes determining, using the computing device, an insulin dose rate based on the blood glucose measurements and determining a blood glucose drop rate based on the blood glucose measurements and the time interval. The method also includes determining a blood glucose percentage drop based on the blood glucose measurements. The method includes decreasing the time interval between blood glucose measurements by the glucometer when the blood glucose drop rate is greater than a threshold drop rate, and decreasing the time interval between blood glucose measurements by the glucometer when the blood glucose percentage drop is greater than a threshold percentage drop.

Claims

1. A system comprising:

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

an insulin administration device; and

a dosing controller in communication with the glucometer and the insulin administration device, the dosing controller including data processing hardware and non-transitory memory in communication with the data processing hardware, the non-transitory memory storing instructions that when executed by the data processing hardware cause the data processing hardware to perform operations comprising;

receiving blood glucose measurements for a patient from the glucometer, the blood glucose measurements comprising a current blood glucose measurement measured at a current time and a previous blood glucose measurement measured at a previous time earlier than the current time, wherein an elapsed time between the current time and the previous time defines a current time interval;

determining an intravenous insulin infusion rate based on the current blood glucose measurement and the previous blood glucose measurement;

determining a blood glucose percentage drop based on the current blood glucose measurement and the previous blood glucose measurement;

determining a blood glucose drop rate based on the current blood glucose measurement, the previous blood glucose measurement, and the current time interval;

determining a next time interval from the current time until a next time of a next scheduled blood glucose measurement for the patient based on the current blood glucose measurement, the next time interval comprising a shorter duration of time than the current time interval when;

the blood glucose percentage drop is greater than a threshold percentage drop;

or

the blood glucose drop rate is greater than a threshold drop rate; and

sending the intravenous insulin infusion rate from the data processing hardware to the insulin administration device in communication with the data processing hardware, and when the insulin administration device receives the intravenous insulin infusion rate, the insulin administration device configured to administer insulin to the patient intravenously using the intravenous insulin infusion rate.

2. The system of claim 1, wherein the operations further comprise:

obtaining patient information from the non-transitory memory, the patient information comprising;

a target blood glucose range for the patient 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 threshold hypoglycemia blood glucose value for the patient, the threshold hypoglycemia blood glucose value less than the lower limit blood glucose value of the target blood glucose range;

a low blood glucose percentage drop limit for the patient when the current blood glucose measurement is less than the lower limit blood glucose value of the target blood glucose range;

a regular blood glucose percentage drop limit for the patient when the current blood glucose measurement is greater than or equal to the lower limit blood glucose value of the target blood glucose range;

a blood glucose drop rate limit for the patient; and

a stable time period comprising a recommended duration of time required for the current blood glucose measurement within the target blood glucose range to determine a blood glucose concentration for the patient is stable in the target blood glucose range,

wherein determining the next time interval comprises setting the next time interval to a default time interval or one;

a preconfigured hypoglycemia time interval when the current blood glucose measurement is less than the threshold hypoglycemia blood glucose value;

a preconfigured short time interval when;

the current blood glucose measurement is greater than the threshold hypoglycemia blood glucose value and less than the lower limit blood glucose value of the target blood glucose range and the blood glucose percentage drop is greater than the low blood glucose percentage drop limit;

or

the current blood glucose measurement is greater than or equal to the lower limit blood glucose value of the target blood glucose range and the blood glucose percentage drop is greater than the regular blood glucose percentage drop limit;

a preconfigured blood glucose drop rate time interval when the blood glucose drop rate is greater than the blood glucose drop rate limit;

a preconfigured long time interval when the current blood glucose measurement has been within the blood glucose target range for a duration of time greater than the stable time period;

or

a preconfigured meal bolus time interval when a meal bolus program is in operation, and

wherein the hypoglycemia time interval is less than the short time interval, the short time interval is less than the blood glucose drop rate time interval, the blood glucose drop rate time interval is less than the long time interval, and the meal bolus time interval is less than the long time interval.

3. The system of claim 2, wherein determining the intravenous insulin infusion rate comprises calculating:

IIR=(BG−

K)*M

wherein IIR is the intravenous insulin infusion rate, BG is the current blood glucose measurement, K is a constant, and M is a multiplier,

wherein determining the blood glucose percentage drop comprises calculating;

4. The system of claim 3, wherein the operations further comprise:

leaving the multiplier unchanged between time intervals when the current blood glucose measurement is greater than the upper limit blood glucose value of the target blood glucose range and a ratio of the current blood glucose measurement divided by the previous blood glucose measurement is less than or equal to a threshold ratio; and

multiplying the multiplier by a change factor when the current blood glucose measurement is greater than the upper limit blood glucose value of the target blood glucose range and the ratio of the current blood glucose measurement divided by the previous blood glucose measurement is greater than the threshold ratio.

5. The system of claim 4, wherein the constant K equals 60 mg/dl and the threshold ratio is 0.85.

6. The system of claim 4, wherein the operations further comprise dividing the multiplier by the change factor when the current blood glucose measurement is less than the lower limit blood glucose value of the target blood glucose range.

7. The system of claim 3, wherein, in response to receiving an indication of patient solid food consumption, the operations further comprise increasing the intravenous insulin infusion rate and maintaining the multiplier unchanged for at least two time intervals.

8. The system of claim 7, wherein the operations further comprise:

receiving a number of estimated grams of carbohydrates for a meal;

determining an estimated meal bolus in units of insulin based on the number of estimated grams of carbohydrates and a carbohydrate-insulin-ratio;

determining an estimated meal bolus insulin rate, based on the estimated meal bolus, an available delivery time, and a configurable constant;

determining a total insulin rate as a sum of the intravenous insulin rate and the estimated meal bolus insulin rate; and

sending the total insulin rate from the data processing hardware to the insulin administration device.

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

dividing a total meal time into meal time sub-intervals, a first meal time sub-interval starting with a pre-meal blood glucose measurement before receiving the indication of patient solid food consumption; and

determining the total insulin rate for each meal time sub-interval in succession.

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

receiving a number of actual grams of carbohydrates for the meal during a subsequent meal time sub-interval after the first meal time sub-interval;

determining an actual meal bolus based on the number of actual grams of carbohydrates;

determining an estimated delivered meal bolus by multiplying the estimated meal bolus rate by an elapsed delivery time;

determining a remaining meal bolus in units of insulin by subtracting a product of the estimated delivered meal bolus insulin rate and an actual delivery time from the actual meal bolus;

determining a revised meal bolus insulin rate as the remaining meal bolus divided by a time remaining in the total meal time;

determining a revised total insulin rate as a sum of the intravenous insulin rate and the revised meal bolus insulin rate; and

sending the revised total insulin rate from the data processing hardware to the insulin administration device.

11. The system of claim 10, wherein one or more of the meal time sub-intervals comprise a shorter duration of time than the default time interval.

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

electronically displaying on a display in communication with the data processing hardware a warning and blocking transition to a subcutaneous administration of insulin when the current blood glucose measurement is outside a stability target range included within the obtained patient information, the stability target range comprising a wider range of blood glucose values than the range of blood glucose values associated with the target blood glucose range; and

electronically displaying on the display a warning when the current blood glucose measurement is within the stability target range for less than a threshold stability period of time.

13. The system of claim 3, wherein the operations further comprise:

determining a total daily dose of insulin based on the multiplier when the current blood glucose measurement is within a stability target range for a threshold stability period of time;

determining recommended insulin doses comprising a daily basal insulin and a daily meal insulin for subcutaneous therapy as an apportioning of the total daily dose of insulin, wherein the daily basal insulin is half of the total daily dose of insulin and the daily meal insulin is half of the total daily dose of insulin; and

sending the recommended insulin doses from the data processing hardware to a subcutaneous injection device or electronically displaying the recommended insulin doses on a display in communication with the data processing hardware.

14. The system of claim 13, further comprising determining the total daily dose of insulin by calculating:

TDD=(BG_Target−

K)*(M_Trans)*24

wherein TDD is the total daily dose of insulin, M_Trans is a current multiplier at a moment of initiation of a process of a transition to subcutaneous insulin treatment; and

BG_Target is determined by calculating;

BG_Target=(BR_TRH+BR_TRL)/2

wherein BR_TRH is the upper limit blood glucose value of the blood glucose target range and BR_TRL is the lower limit blood glucose value of the target blood glucose range.

15. The system of claim 13, further comprising determining the total daily dose of insulin as a function of a patient body weight by calculating:

TDD=0.5*Weight

wherein TDD is the total daily dose of insulin and Weight is a patient body weight in kilograms.