System and method for optimizing insulin dosages for diabetic subjects

• US 9,897,565 B1
• Filed: 09/11/2012
• Issued: 02/20/2018
• Est. Priority Date: 09/11/2012
• Status: Active Grant

• Current Assignee: Aseko, Inc.
• Original Assignee: Aseko, Inc.
• Inventors: Booth, Robert C.
• Primary Examiner(s): Whaley, Pablo S
• Application Number:
  US13/610,287
• Time in Patent Office: 1,988 Days
• Field of Search: None
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: G01N 27/3271 Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood amperometry per se G01N27/49; aspects concerning the enzyme reagent C12Q1/001
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• 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 and system for optimizing insulin dosages for diabetic subjects which includes a processor for calculating basal and bolus dosages to be recommended for meal types including breakfast, lunch, dinner, snack, or at miscellaneous times. The bolus calculations are specifically directed to time periods which are taken from either pre-meal, post-meal, bedtime, mid-sleep or miscellaneous times. The processor calculates an optimized bolus for a specific time period and meal type based upon prior basal dosages, prior blood glucose doses, hypoglycemia thresholds, mid-point of target ranges, and subject insulin sensitivity factors. A display is provided to the subject for sensing the optimized insulin dosage recommended at a specific time period and for a specific meal type.

Claims

1. A method comprising:

receiving, at a system processor, a current blood glucose measurement of a patient from a blood glucose meter in communication with the system processor;

obtaining, by the system processor, a blood glucose time period associated with a time of measuring the current blood glucose measurement;

retrieving, by the system processor, a hypoglycemia threshold and a target blood glucose range for the patient from remote memory hardware associated with a remote processor locationally removed from the system processor and in communication with the system processor, the hypoglycemia threshold and the target blood glucose range inputted to the remote memory hardware by the remote processor;

comparing, by the system processor, the current blood glucose measurement to the hypoglycemia threshold and a mid-point of the target blood glucose range greater than the hypoglycemia threshold;

when the current blood glucose measurement is less than the hypoglycemia threshold, determining, by the system processor, one of;

a recommend dosage of oral glucose for oral ingestion by the patient;

a recommended dosage of glucagon for administration to the patient;

or

a recommended dosage of saline and insulin for intravenous insertion to the patient;

when the current blood glucose measurement is greater than the hypoglycemia threshold and the mid-point of the target blood glucose range;

retrieving, by the system processor, an insulin sensitivity factor for the patient from the remote memory hardware, the insulin sensitivity factor inputted to the remote memory hardware by the remote processor;

calculating, by the system processor, a correction dose based on a function of the current blood glucose measurement, the mid-point of the target blood glucose range, and the insulin sensitivity factor;

administering the calculated correction dose to the patient by transmitting the calculated correction dose from the system processor to a dose administering system having a patient display configured to display the calculated correction dose and trigger administration of the calculated correction dose to the patient; and

storing the calculated correction dose in the remote memory hardware;

determining whether the blood glucose time period of the current blood glucose measurement is within a pre-meal time period before the patient consumes food or other nutrients;

when the blood glucose time period of the current blood glucose measurement is not within the pre-meal time period, calculating, by the system processor, the correction dose based on the function of the current blood glucose measurement, the mid-point of the target blood glucose range, and the insulin sensitivity factor; and

when the blood glucose time period of the current blood glucose measurement is within the pre-meal time;

determining whether a meal type associated with the pre-meal time period of the blood glucose time period is one of breakfast, lunch, dinner, or snack;

calculating, by the system processor, a meal bolus for the patient when the meal type associated with the pre-meal time period of the blood glucose time period is one of breakfast, lunch, dinner, or snack; and

when the meal type associated with the pre-meal time period of the blood glucose time period is breakfast;

retrieving, by the system processor, a previous day basal dose that was administered to the patient, a previous mid-sleep blood glucose measurement of the patient, and a previous breakfast blood glucose measurement of the patient from the remote memory hardware;

determining, by the system processor, whether the lesser one of the previous mid-sleep blood glucose measurement or the previous breakfast blood glucose measurement is within one of multiple pre-configured ranges of values;

setting, by the system processor, an adjustment factor to a preconfigured adjustment factor associated with the pre-configured range of values that includes the lesser one of the previous mid-sleep blood glucose measurement or the previous breakfast blood glucose measurement;

calculating, by the system processor, a new basal dose for the patient by multiplying the previous day basal dose times the adjustment factor;

retrieving, by the system processor, a configured time interval for administering the calculated new basal dose to the patient from the remote memory hardware, the configured time interval input to the remote memory hardware by the remote processor;

administering the calculated new basal dose to patient by transmitting the calculated new basal dose from the system processor to the dose administering system having the patient display at the configured time interval, the patient display configured to display the calculated new basal dose and trigger administration of the calculated new basal dose to the patient; and

storing the calculated new basal dose in the remote memory hardware.

2. The method of claim 1, further comprising:

when the current blood glucose measurement is less than the hypoglycemia threshold;

requesting, by the system processor, a user input from the remote processor, the user input indicating whether the consciousness of the patient is impaired;

when the user input indicates that the consciousness of the patient is not impaired, determining, by the system processor, the recommended dosage of oral glucose for the patient to ingest;

transmitting the recommended dosage of oral glucose from the system processor to the patient display the patient display configured to display the recommended dosage of oral glucose; and

storing the recommended dosage of oral glucose in the remote memory hardware.

3. The method of claim 2, further comprising:

when the user input indicates that the consciousness of the patient is impaired;

determining, by the system processor, the recommended dosage of glucagon for administration to the patient or the recommended dosage of saline and insulin for intravenous insertion to the patient;

transmitting the recommended dosage of glucagon or the recommended dosage of saline and insulin to the patient display, the patient display configured to display the recommended dosage of glucagon or the recommended dosage of saline and insulin; and

storing the recommended dosage of glucagon or the recommended dosage of saline and insulin in the remote memory hardware.

4. The method of claim 1, wherein the correction dose is calculated as:

5. The method of claim 1, further comprising:

when the blood glucose time period of the current blood glucose measurement is the pre-meal time and the meal type associated with the pre-meal time is one of breakfast, lunch, dinner or snack;

retrieving, by the system processor, a previous meal bolus administered by the patient for the associated meal type from the remote memory hardware;

determining, by the system processor, the current blood glucose measurement is within one of multiple pre-configured ranges of values;

setting, by the system processor, a meal bolus adjustment factor to a preconfigured meal bolus adjustment factor associated with the pre-configured range of values that includes the current blood glucose measurement;

determining, by the system processor, a current meal bolus for the patient based on the meal bolus adjustment factor and the previous meal bolus;

transmitting the current meal bolus from the system processor to the patient display the patient display configured to display the current meal bolus; and

storing the current meal bolus in the remote memory hardware.

6. The method of claim 5, wherein determining the current meal bolus comprises:

when the patient is on a fixed meal plan, calculating the current meal bolus by multiplying the previous meal bolus times the meal bolus adjustment factor;

or

when the patient is not on a fixed meal plan;

receiving an estimated number of carbohydrates to be ingested by the patient for the associated meal type from the user interface;

obtaining a current carbohydrate to insulin ratio for the associated meal type; and

calculating the current meal bolus by dividing the estimated number of carbohydrates by the current carbohydrate to insulin ratio for the associated meal type.

7. The method of claim 6, wherein obtaining the current carbohydrate to insulin ratio for the associated meal type comprises:

retrieving a previous carbohydrate to insulin ratio for the associated meal type from the remote memory hardware, the previous carbohydrate to insulin ratio associated with the previous meal bolus; and

calculating the current carbohydrate to insulin ratio for the associated meal type by dividing the previous carbohydrate to insulin ratio by the meal bolus adjustment factor.

8. The method of claim 7, wherein the previous carbohydrate to insulin ratio for the associated meal type is calculated as:

CIR_PB,L,D,S=450×

TDD_M×

ω

_s

wherein CIR_PB,L,D,S is the previous carbohydrate to insulin ratio for the associated meal type, TDD_M is a total daily dose of insulin multiplier inputted to the remote memory hardware by the remote processor, and ω

_s is a weight of the patient.

9. The method of claim 1, further comprising:

receiving, at the system processor, a user input indicating the patient plans to exercise or has recently exercised; and

when the current blood glucose measurement is less than the mid-point of the target blood glucose range;

determining, by the system processor, a duration of the exercise planned by the patient or recently completed by the patient;

determining, by the system processor, carbohydrate intake instructions for the patient including a predetermined amount of carbohydrates for the patient to ingest based on the duration of the exercise; and

transmitting the carbohydrate intake instructions from the system processor to the patient display the patient display configured to display the carbohydrate intake instructions; and

storing the carbohydrate intake instructions in the remote memory hardware.

10. A system comprising:

a blood glucose meter measuring blood glucose measurements of a patient;

remote memory hardware associated with a remote processor; and

a system processor locationally removed from the remote memory hardware and in communication with the glucometer and the remote memory hardware, the system processor;

receiving a current blood glucose measurement from the blood glucose meter;

obtaining a blood glucose time period associated with a time of measuring the current blood glucose measurement;

retrieving a hypoglycemia threshold and a target blood glucose range for the patient from the remote memory hardware, the hypoglycemia threshold and the target blood glucose range inputted to the remote memory hardware by a remote processor;

comparing the current blood glucose measurement to the hypoglycemia threshold and a mid-point of the target blood glucose range greater than the hypoglycemia threshold;

when the current blood glucose measurement is less than the hypoglycemia threshold, determining one of;

a recommend dosage of oral glucose for oral ingestion by the patient;

a recommended dosage of glucagon for administration to the patient;

or

a recommended dosage of saline and insulin for intravenous insertion to the patient;

when the current blood glucose measurement is greater than the hypoglycemia threshold and the mid-point of the target blood glucose range;

retrieving an insulin sensitivity factor for the patient from the remote memory hardware, the insulin sensitivity factor inputted to the remote memory hardware by the remote processor;

calculating a correction dose based on a function of the current blood glucose measurement, the mid-point of the target blood glucose range, and the insulin sensitivity factor;

administering the calculated correction dose to the patient by transmitting the calculated correction dose to a dose administering system having a patient display configured to display the calculated correction dose and trigger administration of the calculated correction dose to the patient; and

storing the calculated correction dose in the remote memory hardware;

determining whether the blood glucose time period of the current blood glucose measurement is within a pre-meal time period before the patient consumes food or other nutrients;

when the blood glucose time period of the current blood glucose measurement is not within the pre-meal time period, calculating the correction dose based on the function of the current blood glucose measurement, the mid-point of the target blood glucose range, and the insulin sensitivity factor; and

when the blood glucose time period of the current blood glucose measurement is within the pre-meal time;

determining whether a meal type associated with the pre-meal time period of the blood glucose time period is one of breakfast, lunch, dinner, or snack;

calculating a meal bolus for the patient when the meal type associated with the pre-meal time period of the blood glucose time period is one of breakfast, lunch, dinner, or snack; and

when the meal type associated with the pre-meal time period of the blood glucose time period is breakfast;

retrieving a previous day basal dose that was administered to the patient, a previous mid-sleep blood glucose measurement of the patient, and a previous breakfast blood glucose measurement of the patient from the remote memory hardware;

determining whether the lesser one of the previous mid-sleep blood glucose measurement or the previous breakfast blood glucose measurement is within one of multiple pre-configured ranges of values;

setting an adjustment factor to a preconfigured adjustment factor associated with the pre-configured range of values that includes the lesser one of the previous mid-sleep blood glucose measurement or the previous breakfast blood glucose measurement;

calculating a new basal dose for the patient by multiplying the previous basal dose times the adjustment factor;

retrieving a configured time interval for administering the calculated new basal dose to the patient from the remote memory hardware, the configured time interval inputted to the remote memory hardware by the remote processor;

administering the calculated new basal dose to the patient by transmitting the calculated new basal dose to the dose administering system having the patient display at the configured time interval, the patient display configured to display the calculated new basal dose and trigger administration of the calculated new basal dose to the patient; and

storing the calculated new basal dose in the remote memory hardware.

11. The system of claim 10, wherein the system processor:

when the current blood glucose measurement is less than the hypoglycemia threshold;

requests a user input indicating whether the consciousness of the patient is impaired;

when the user input indicates that the consciousness of the patient is not impaired, determines the recommended dosage of oral glucose for the patient to ingest;

transmits the recommended dosage of oral glucose to the patient display the patient display configured to display the recommended dosage of oral glucose; and

stores the recommended dosage of oral glucose in the remote memory hardware.

12. The system of claim 11, wherein the system processor:

when the user input indicates that the consciousness of the patient is impaired;

determines the recommended dosage of glucagon for administration to the patient or the recommended dosage of saline and insulin for intravenous insertion to the patient;

transmits the recommended dosage of glucagon or the recommended dosage of saline and insulin to the patient display, the patient display configured to display the recommended dosage of glucagon or the recommended dosage of saline and insulin; and

stores the recommended dosage of glucagon or the recommended dosage of saline and insulin in the remote memory hardware.

13. The system of claim 10, wherein the system processor calculates the correction dose:

14. The system of claim 10, wherein the system processor:

when the blood glucose time period of the current blood glucose measurement is the pre-meal time and the meal type associated with the pre-meal time is one of breakfast, lunch, dinner or snack;

retrieves a previous meal bolus administered by the patient for the associated meal type from the remote memory hardware;

determines the current blood glucose measurement is within one of multiple pre-configured ranges of values;

sets a meal bolus adjustment factor to a preconfigured meal bolus adjustment factor associated with the pre-configured range of values that includes the current blood glucose measurement;

determines a current meal bolus for the patient to administer based on the meal bolus adjustment factor and the previous meal bolus;

transmits the current meal bolus to the patient display the patient display configured to display the current meal bolus; and

stores the current meal bolus in the remote memory hardware.

15. The system of claim 14, wherein the system processor determines the current meal bolus by:

when the patient is on a fixed meal plan, calculating the current meal bolus by multiplying the previous meal bolus times the meal bolus adjustment factor;

or

when the patient is not on a fixed meal plan;

receiving an estimated number of carbohydrates to be ingested by the patient for the associated meal type from the user interface;

obtaining a current carbohydrate to insulin ratio for the associated meal type; and

calculating the current meal bolus by dividing the estimated number of carbohydrates by the current carbohydrate to insulin ratio for the associated meal type.

16. The system of claim 15, wherein the system processor obtains the current carbohydrate to insulin ratio for the associated meal type by:

retrieving a previous carbohydrate to insulin ratio for the associated meal type from the remote memory hardware, the previous carbohydrate to insulin ratio associated with the previous meal bolus; and

calculating the current carbohydrate to insulin ratio for the associated meal type by dividing the previous carbohydrate to insulin ratio by the meal bolus adjustment factor.

17. The system of claim 16, wherein the system processor calculates the previous carbohydrate to insulin ratio for the associated meal type as:

CIR_PB,L,D,S=450×

TDD_M×

ω

_s

wherein CIR_PB,L,D,S is the previous carbohydrate to insulin ratio for the associated meal type, TDD_M is a total daily dose of insulin multiplier inputted to the remote memory hardware by the remote processor, and ω

_s is a weight of the patient.

18. The system of claim 10, wherein the system processor:

receives a user input indicating the patient plans to exercise or has recently exercised; and

when the current blood glucose measurement is less than the mid-point of the target blood glucose range;

determines a duration of the exercise planned by the patient or recently completed by the patient;

determines carbohydrate intake instructions for the patient including a predetermined amount of carbohydrates for the patient to ingest based on the duration of the exercise; and

transmits the carbohydrate intake instructions to the patient display the patient display configured to display the carbohydrate intake instructions; and

stores the carbohydrate intake instructions in the remote memory hardware.