System for optimizing a patient's insulin dosage regimen

• US 10,272,198 B2
• Filed: 04/23/2013
• Issued: 04/30/2019
• Est. Priority Date: 04/04/2008
• Status: Active Grant

• Current Assignee: Hygieia, Inc.
• Original Assignee: Hygieia, Inc.
• Inventors: Bashan, Eran, Hodish, Israel
• Primary Examiner(s): Riggs, II, Larry D
• Application Number:
  US13/868,612
• Publication Number:
  US 20130289883A1
• Time in Patent Office: 2,198 Days
• Field of Search: None
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• 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 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

Abstract

A system for optimizing a patient'"'"'s insulin dosage regimen over time, comprising at least a first memory for storing data inputs corresponding at least to one or more components in a patient'"'"'s present insulin dosage regimen, and data inputs corresponding at least to the patient'"'"'s blood-glucose-level measurements determined at a plurality of times, and a processor operatively connected to the at least first memory. The processor is programmed at least to determine from the data inputs corresponding to the patient'"'"'s blood-glucose-level measurements determined at a plurality of times whether and by how much to vary at least one of the one or more components in the patient'"'"'s present insulin dosage regimen in order to maintain the patient'"'"'s future blood-glucose-level measurements within a predefined range.

Claims

1. A system for optimizing a patient'"'"'s insulin dosage regimen over time, comprising:

at least a first memory for storing data inputs corresponding at least to one or more components of a patient'"'"'s present insulin dosage regimen, and data inputs corresponding at least to the patient'"'"'s blood-glucose-level measurements determined at a plurality of times;

a timer to monitor a predetermined time period;

a processor operatively connected to the at least first memory, the processor programmed to increment the timer based on at least one of the passage of a predetermined increment of time and the receipt of at least one of the plurality of blood glucose-level measurements and at the end of the predetermined time period, determine from the data inputs corresponding to the patient'"'"'s blood-glucose-level measurements determined at a plurality of times within the predetermined time interval, whether and by how much to vary at least one of the one or more components in the patient'"'"'s present insulin dosage regimen in order to maintain the patient'"'"'s future blood-glucose-level measurements within a predefined range, wherein the timer is reinitiated after the determination of whether and by how much to vary at least one of the one or more components in the patient'"'"'s present insulin dosage regimen; and

a display configured to receive and display the revised at least one of the one or more components in the patients insulin dosage regimen;

wherein the predetermined time interval is longer than a time period between any two consecutive blood-glucose-level measurements,

wherein the processor is programmed to determine, prior to receiving a subsequent data input, whether the current data input corresponding to the patient'"'"'s blood-glucose-level measurements represents a severe hypoglycemic event, and to vary at least one of the one or more components in the patient'"'"'s present insulin dosage regimen in response to a determination that a data input corresponding to the patient'"'"'s blood-glucose-level measurements represents a severe hypoglycemic event; and

wherein the processor is further programmed to determine from the data inputs corresponding to the patient'"'"'s blood-glucose-level measurements determined at a plurality of times if there have been an excessive number of hypoglycemic events over the predetermined time period, and to vary at least one of the one or more components in the patient'"'"'s present insulin dosage regimen in response to a determination that there have been an excessive number of such hypoglycemic events over the predetermined time period.

2. The system of claim 1, wherein the at least first memory and the processor are resident in a single apparatus.

3. The system of claim 2, wherein the single apparatus further comprises a glucose meter.

4. The system of claim 2, further comprising a glucose meter that is separate from the single apparatus, the glucose meter adapted to communicate to the at least first memory of the single apparatus the data inputs corresponding at least to the patient'"'"'s blood-glucose-level measurements determined at a plurality of times.

5. The system of claim 2, wherein the single apparatus further comprises data entry means for entering data inputs corresponding at least to the patient'"'"'s blood-glucose-level measurements determined at a plurality of times directly into the at least first memory.

6. The system of claim 5, further comprising data entry means disposed at a location remote from the single apparatus for remotely entering data inputs corresponding at least to the one or more components in the patient'"'"'s present insulin dosage regimen into the at least first memory.

7. The system of claim 1, further comprising at least first data entry means disposed at a location remote from the at least first memory and processor for remotely entering data inputs corresponding at least to the one or more components in the patient'"'"'s present insulin dosage regimen into the at least first memory, and at least second data entry means, disposed at a location remote from the at least first memory, processor and at least first data entry means, for remotely entering data inputs corresponding at least to the patient'"'"'s blood-glucose-level measurements determined at a plurality of times into the at least first memory.

8. The system of claim 1, wherein the data inputs corresponding at least to the patient'"'"'s blood-glucose-level measurements determined at a plurality of times are each associated with an identifier indicative of when the measurement was input into the memory.

9. The system of claim 8, further comprising data entry means enabling a user to define the identifier associated with each blood-glucose-level measurement data-input.

10. The system of claim 8, further comprising data entry means enabling a user to confirm the correctness of the identifier associated with each blood-glucose-level measurement data-input.

11. The system of claim 8, further comprising data entry means enabling a user to modify the identifier associated with each blood-glucose-level measurement data-input.

12. The system of claim 1, wherein the processor is programmed to determine on a predefined schedule whether and by how much to vary at least one of the one or more components in the patient'"'"'s present insulin dosage regimen.

13. The system of claim 1, wherein the processor is programmed to determine from the data inputs corresponding at least to the patient'"'"'s blood-glucose-level measurements determined at a plurality of times if the patient'"'"'s blood-glucose level measurements fall within or outside of a predefined range, and to vary at least one of the one or more components in the patient'"'"'s present insulin dosage regimen only if the patient'"'"'s blood-glucose level measurements fall outside of the predefined range.

14. The system of claim 13, wherein the processor is further programmed to determine from the data inputs corresponding at least to the patient'"'"'s blood-glucose-level measurements determined at a plurality of times whether the patient'"'"'s blood-glucose-level measurements determined at a plurality of times represent a normal or abnormal distribution.

15. The system of claim 14, wherein the determination of whether the patient'"'"'s blood-glucose-level measurements determined at a plurality of times represent a normal or abnormal distribution comprises determining whether the third moment of the distribution of the patient'"'"'s blood-glucose-level measurements determined at a plurality of times fall within a predefined range.

16. The system of claim 8, wherein the one or more components in the patient'"'"'s present insulin dosage regimen comprise a long-acting insulin dosage component, and wherein the processor is programmed to determine from the identifier indicative of when a measurement was input into the memory at least whether the measurement is a morning or bed-time blood-glucose-level measurement, to determine whether the patient'"'"'s morning and bed-time blood-glucose-level measurements fall within a predefined range, and to determine by how much to vary the patient'"'"'s long-acting insulin dosage component only when the patient'"'"'s morning and bed-time blood-glucose-level measurements are determined to fall outside of the said predefined range.

17. The system of claim 16, wherein, in connection with the determination of by how much to vary at least one of the one or more components in the patient'"'"'s present insulin dosage regimen, the processor is programmed to factor in an insulin sensitivity correction factor that defines both the percentage by which any of the one or more components of the insulin dosage regimen may be varied and the direction in which any fractional variations in any of the one or more components are rounded to the nearest whole number.

18. The system of claim 17, wherein the at least first memory further stores data inputs corresponding to a patient'"'"'s present weight, and wherein the insulin sensitivity correction factor is in part determined from the patient'"'"'s present weight.

19. The system of claim 17, wherein the determination of by how much to vary the long-acting insulin dosage component of a patient'"'"'s present insulin dosage regimen is a function of the present long-acting insulin dosage, the insulin sensitivity correction factor, and the patient'"'"'s blood-glucose-level measurements.

20. The system of claim 1, wherein the one or more components in the patient'"'"'s present insulin dosage regimen comprise a short-acting insulin dosage component defined by a carbohydrate ratio and plasma glucose correction factor, and wherein the processor is programmed to determine whether and by how much to vary the patient'"'"'s carbohydrate ratio and plasma glucose correction factor.

21. The system of claim 20, wherein, in connection with the determination of by how much to vary at least one of the one or more components in the patient'"'"'s present insulin dosage regimen, the processor is programmed to factor in an insulin sensitivity correction factor that defines both the percentage by which any one or more components of the insulin dosage regimen may be varied and the direction in which any fractional variations in the one or more components are rounded to the nearest whole number.

22. The system of claim 21, wherein the determination of by how much to vary the present plasma glucose correction factor component of a patient'"'"'s insulin dosage regimen is a function of a predefined value divided by the mean of the total daily dosage of insulin administered to the patient, the patient'"'"'s present plasma glucose correction factor, and the insulin sensitivity correction factor.

23. The system of claim 22, wherein a value representing twice the patient'"'"'s daily dosage of long-acting insulin in the present insulin dosage regimen is substituted for the mean of the total daily dosage of insulin administered to the patient as an approximation thereof.

24. The system of claim 22, wherein the plasma glucose correction factor component of the patient'"'"'s insulin dosage regimen is quantized to predefined steps of mg/dL.

25. The system of claim 21, wherein the determination of by how much to vary the present carbohydrate ratio component of a patient'"'"'s insulin dosage regimen is a function of a predefined value divided by the mean of the total daily dosage of insulin administered to the patient, the patient'"'"'s present carbohydrate ratio, and the insulin sensitivity correction factor.

26. The system of claim 25, wherein a value representing twice the patient'"'"'s daily dosage of long-acting insulin in the present insulin dosage regimen is substituted for the mean of the total daily dosage of insulin administered to the patient as an approximation thereof.

27. The system of claim 25, wherein the processor is programmed to determine a correction factor that allows variations to the carbohydrate ratio component of a patient'"'"'s insulin dosage regimen to be altered in order to compensate for a patient'"'"'s individual response to insulin at different times of the day.

28. The system of claim 1, wherein the one or more components in the patient'"'"'s present insulin dosage regimen comprise a long-acting insulin dosage component, and the determination of by how much to vary the long-acting insulin dosage component is constrained to an amount of variation within predefined limits.

29. The system of claim 1, wherein the one or more components in the patient'"'"'s present insulin dosage regimen comprise a short-acting insulin dosage component defined by a carbohydrate ratio and plasma glucose correction factor, and the determination of by how much to vary any one or more of each component in the short-acting insulin dosage is constrained to an amount of variation within predefined limits.

30. The system of claim 1, wherein the one or more components in the patient'"'"'s present insulin dosage regimen comprise a short-acting insulin dosage component taken according to a sliding scale, and wherein the processor is programmed to determine whether and by how much to vary at least the sliding scale in order to maintain the patient'"'"'s future blood-glucose-level measurements within a predefined range.

31. The system of claim 30, wherein the determination of by how much to vary the sliding scale is constrained to an amount of variation within predefined limits.