Insulin Management

• US 20150217053A1
• Filed: 10/09/2014
• Published: 08/06/2015
• Est. Priority Date: 01/31/2014
• Status: Active Grant

• Current Assignee: Glytec LLC (Aseko, Inc.)
• Original Assignee: Aseko, Inc.
• Inventors: Booth, Robert C., Hebblewhite, Harry
• Granted Patent: US 9,486,580 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 method comprising:

receiving blood glucose measurements on a computing device from a glucometer, the blood glucose measurements separated by a time interval; and

for each time interval;

determining, using the computing device, an intravenous insulin infusion rate based on the blood glucose measurements of the time interval;

determining, using the computing device, a blood glucose percentage drop based on the blood glucose measurements;

determining, using the computing device, a blood glucose drop rate based on the blood glucose measurements and the time interval;

decreasing the time interval between blood glucose measurements by the glucometer when the blood glucose percentage drop is greater than a threshold percentage drop;

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

sending the intravenous insulin infusion rate from the computing device to an insulin administration device.

2. The method of claim 1, further comprising setting the time interval between the blood glucose measurements by the glucometer to a default time interval or a minimum of:

a preconfigured hypoglycemia time interval when a current blood glucose measurement is less than a 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 a lower limit of a blood glucose target range and the blood glucose percentage drop is greater than a low blood glucose percentage drop limit;

or

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

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

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

or

a preconfigured meal bolus time interval when a meal bolus program is in operation;

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 method of claim 1, 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 method of claim 3, further comprising:

leaving the multiplier unchanged between time intervals when the current blood glucose measurement is greater than an upper limit of a blood glucose target range and a ratio of the current blood glucose measurement divided by a 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 of the blood glucose target 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 method of claim 4, wherein the constant K equals 60 mg/dl and the threshold ratio is 0.85.

6. The method of claim 4, further comprising dividing the multiplier by the change factor when the current blood glucose measurement is less than a lower limit of the blood glucose target range.

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

8. The method of claim 7, further comprising:

receiving, at the computing device, a number of estimated grams of carbohydrates for a meal;

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

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

determining, using the computing device, 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 computing device to the insulin administration device.

9. The method of claim 8, further comprising:

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, using the computing device, the total insulin rate for each meal time sub-interval in succession.

10. The method of claim 9, further comprising:

receiving, at the computing device, a number of actual grams of carbohydrates for the meal during a subsequent time interval after the first time interval;

determining, using the computing device, an actual meal bolus based on the number of actual grams of carbohydrates;

determining, using the computing device, 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, using the computing device, by subtracting a product of the estimated delivered meal bolus insulin rate and an actual delivery time from the actual meal bolus;

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

determining, using the computing device, 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 computing device to the insulin administration device.

11. The method of claim 10, further comprising decreasing the time interval to less than the default time interval for one or more meal time sub-intervals.

12. The method of claim 11, further comprising:

electronically displaying on a display in communication with the computing device a warning and blocking transition to a subcutaneous administration of insulin when the current blood glucose measurement is outside a stability target 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 method of claim 3, further comprising:

determining, using the computing device, 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, using the computing device, 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 computing device to a subcutaneous injection device or electronically displaying the recommended insulin doses on a display in communication with the computing device.

14. The method of claim 13, further comprising determining, using the computing device, 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 an upper limit of the blood glucose target range and BR_TRL is a lower limit of the blood glucose target range.

15. The method of claim 13, further comprising determining, using the computing device, 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.

16. 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 a computing device and non-transitory memory in communication with the computing device, the non-transitory memory storing instructions that when executed by the computing device cause the computing device to perform operations comprising;

receiving blood glucose measurements on a computing device from a glucometer, the blood glucose measurements separated by a time interval; and

for each time interval;

determining, using the computing device, an intravenous insulin infusion rate based on the blood glucose measurements of the time interval;

determining, using the computing device, a blood glucose percentage drop based on the blood glucose measurements;

determining, using the computing device, a blood glucose drop rate based on the blood glucose measurements and the time interval;

decreasing the time interval between blood glucose measurements by the glucometer when the blood glucose percentage drop is greater than a threshold percentage drop;

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

sending the intravenous insulin infusion rate from the computing device to the insulin administration device.

17. The system of claim 16, wherein the operations further comprise setting the time interval between the blood glucose measurements by the glucometer to a default time interval or a minimum of:

a preconfigured hypoglycemia time interval when a current blood glucose measurement is less than a 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 a lower limit of a blood glucose target range and the blood glucose percentage drop is greater than a low blood glucose percentage drop limit;

or

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

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

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

or

a preconfigured meal bolus time interval when a meal bolus program is in operation;

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.

18. The system of claim 16, 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;

19. The system of claim 18, wherein the operations further comprise:

leaving the multiplier unchanged between time intervals when the current blood glucose measurement is greater than an upper limit of a blood glucose target range and a ratio of the current blood glucose measurement divided by a 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 of the blood glucose target range and the ratio of the current blood glucose measurement divided by the previous blood glucose measurement is greater than the threshold ratio.

20. The system of claim 19, wherein the constant K equals 60 mg/dl and the threshold ratio is 0.85.

21. The system of claim 19, wherein the operations further comprise dividing the multiplier by the change factor when the current blood glucose measurement is less than a lower limit of the blood glucose target range.

22. The system of claim 18, wherein the operations further comprise, in response to receiving an indication of patient solid food consumption, increasing the intravenous insulin infusion rate and maintaining the multiplier unchanged for at least two time intervals.

23. The system of claim 22, wherein the operations further comprise:

receiving, at the computing device, a number of estimated grams of carbohydrates for a meal;

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

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

determining, using the computing device, 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 computing device to the insulin administration device.

24. The system of claim 23, 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, using the computing device, the total insulin rate for each meal time sub-interval in succession.

25. The system of claim 24, wherein the operations further comprise:

receiving, at the computing device, a number of actual grams of carbohydrates for the meal during a subsequent time interval after the first time interval;

determining, using the computing device, an actual meal bolus based on the number of actual grams of carbohydrates;

determining, using the computing device, 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, using the computing device, by subtracting a product of the estimated delivered meal bolus insulin rate and an actual delivery time from the actual meal bolus;

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

determining, using the computing device, 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 computing device to the insulin administration device.

26. The system of claim 25, wherein the operations further comprise decreasing the time interval to less than the default time interval for one or more meal time sub-intervals.

27. The system of claim 26, wherein the operations further comprise:

electronically displaying on a display in communication with the computing device a warning and blocking transition to a subcutaneous administration of insulin when the current blood glucose measurement is outside a stability target 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.

28. The system of claim 18, wherein the operations further comprise:

determining, using the computing device, 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, using the computing device, 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 computing device to a subcutaneous injection device or electronically displaying the recommended insulin doses on a display in communication with the computing device.

29. The system of claim 28, further comprising determining, using the computing device, 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 an upper limit of the blood glucose target range and BR_TRL is a lower limit of the blood glucose target range.

30. The system of claim 28, further comprising determining, using the computing device, 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.