Apparatus for optimizing a patient's insulin dosage regimen

• US 10,335,546 B2
• Filed: 10/30/2013
• Issued: 07/02/2019
• 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:
  US14/067,479
• Publication Number:
  US 20140094745A1
• Time in Patent Office: 2,071 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

An apparatus for optimizing a patient'"'"'s insulin dosage regimen over time, comprising: at least a first computer-readable memory for storing data inputs corresponding at least to one or more components in a patient'"'"'s present insulin dosage regimen and the patient'"'"'s blood-glucose-level measurements determined at a plurality of times; a processor operatively connected to the at least first computer-readable memory, the processor 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 of the patient'"'"'s present insulin dosage regimen in order to maintain the patient'"'"'s future blood-glucose-level measurements within a predefined range; and a display operative to display information corresponding to at least the patient'"'"'s present insulin dosage regimen.

Claims

1. An apparatus for improving a patient'"'"'s insulin dosage regimen, comprising:

at least one computer-readable memory for storing;

programming instructions, data inputs corresponding at least to one or more components in the patient'"'"'s insulin dosage regimen, and a patient'"'"'s blood-glucose-level measurements determined at a plurality of times within a predefined period of time;

a timer for monitoring the predefined period of time, the timer being incremented based on at least one of;

passage of a separate predetermined increment of time or receipt of at least one of the patient'"'"'s of blood-glucose-level measurements;

a display operative to display information corresponding to at least the patient'"'"'s insulin dosage regimen; and

a processor configured to communicate with the at least one computer-readable memory and to execute the programming instructions stored in the at least one computer-readable memory to cause the apparatus to perform a method comprising;

(i) determining a number that represents excessive hypoglycemic events within the predefined period of time;

(ii) determining, after obtaining at least one blood-glucose-level measurement but before obtaining a subsequent blood-glucose-level measurement, whether the obtained blood-glucose-level measurement reflects a hypoglycemic event or a severe hypoglycemic event;

(iii) reducing at least one of the one or more components in the patient'"'"'s insulin dosage regimen in response to a determination that the obtained blood-glucose-level measurement represents a severe hypoglycemic event;

(iv) reducing at least one of the one or more components in the patient'"'"'s insulin dosage regimen in response to a determination that the obtained blood-glucose-level measurements results in an excessive number of hypoglycemic events during the predefined period of time;

wherein the timer is reinitiated after the determination that there have been an excessive number of hypoglycemic events over the predefined period of time; and

(v) determining, at the end of the predefined period of time, from a plurality of the data corresponding to the patient'"'"'s blood-glucose-level measurements whether and by how much to vary at least one of the one or more components in the patient'"'"'s insulin dosage regimen in order to maintain the patient'"'"'s blood-glucose-level measurements within a predefined range; and

(vi) communicating the revised at least one of the one or more components in the patients insulin dosage regimen to the display to enable the patient'"'"'s insulin dosage regimen to be updated on the display;

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 insulin dosage regimen.

2. The apparatus of claim 1, further comprising data entry means for entering into the at least one computer-readable memory the data inputs corresponding to at least one of the one or more components of the patient'"'"'s present insulin dosage regimen, the data entry means operatively connected to the computer-readable memory.

3. The apparatus of claim 1, further comprising a glucose meter operative to provide to the at least one computer-readable memory the data inputs corresponding at least to the patient'"'"'s blood-glucose-level measurements determined at a plurality of times.

4. The apparatus of claim 3, further comprising data entry means for entering into the at least one computer-readable memory the data inputs corresponding to at least one of the one or more components of the patient'"'"'s present insulin dosage regimen.

5. The apparatus of claim 3, wherein the processor is operative to associate with the data inputs corresponding at least to the patient'"'"'s blood-glucose-level measurements determined at a plurality of times an identifier indicative of when the measurement was input into the memory.

6. The apparatus of claim 5, further comprising data entry means enabling a user to define the identifier associated with each blood-glucose-level measurement data-input.

7. The apparatus of claim 5, further comprising data entry means enabling a user to confirm the correctness of the identifier associated with each blood-glucose-level measurement data-input.

8. The apparatus of claim 5, further comprising data entry means enabling a user to modify the identifier associated with each blood-glucose-level measurement data-input.

9. The apparatus of claim 1, further comprising an insulin pump operatively connected to the processor, the insulin pump operative to deliver insulin to a patient according to the patient'"'"'s present insulin dosage regimen.

10. The apparatus of claim 9, further comprising data entry means for entering into the at least one computer-readable memory the data inputs corresponding to at least one of the one or more components of the patient'"'"'s present insulin dosage regimen, the data entry means operatively connected to the computer-readable memory.

11. The apparatus of claim 9, further comprising a glucose meter operative to provide to the at least one computer-readable memory the data inputs corresponding at least to the patient'"'"'s blood-glucose-level measurements determined at a plurality of times.

12. The apparatus of claim 11, further comprising data entry means for entering into the at least one computer-readable memory the data inputs corresponding to at least one of the one or more components of the patient'"'"'s present insulin dosage regimen.

13. The apparatus of claim 11, wherein processor is operative to associate with the data inputs corresponding at least to the patient'"'"'s blood-glucose-level measurements determined at a plurality of times an identifier indicative of when the measurement was input into the memory.

14. The apparatus of claim 13, further comprising data entry means enabling a user to define the identifier associated with each blood-glucose-level measurement data-input.

15. The apparatus of claim 13, further comprising data entry means enabling a user to confirm the correctness of the identifier associated with each blood-glucose-level measurement data-input.

16. The apparatus of claim 13, further comprising data entry means enabling a user to modify the identifier associated with each blood-glucose-level measurement data-input.

17. The apparatus of claim 10, wherein the data inputs further comprise data inputs corresponding to the patient'"'"'s weight, and the data entry means facilitate entering into the at least first memory the data inputs corresponding to the patient'"'"'s weight.

18. The apparatus of claim 10, wherein the data inputs further comprise data inputs corresponding to the foods consumed by a patient, the data entry means facilitate entering into the at least first memory data inputs corresponding to the foods consumed by a patient, and the processor is operative to determine from the data inputs corresponding to the foods consumed by a patient the number of carbohydrates associated those foods.

19. The apparatus of claim 10, wherein the data inputs further comprise data inputs corresponding to the number of insulin units administered by a patient on a periodic basis, and the data entry means facilitate entering into the at least one computer-readable memory inputs corresponding to the said number of insulin units administered by a patient.

20. The apparatus of claim 9, wherein the insulin pump is operative to provide to the at least one computer-readable memory data inputs corresponding to the rate at which insulin is delivered to the patient by the pump according to the patient'"'"'s present insulin dosage regimen.

21. The apparatus of claim 2, wherein the data inputs further comprise data inputs corresponding to the patient'"'"'s weight, and the data entry means facilitate entering into the at least first memory the data inputs corresponding to the patient'"'"'s weight.

22. The apparatus of claim 2, wherein the data inputs further comprise data inputs corresponding to the foods consumed by a patient, the data entry means facilitate entering into the at least first memory data inputs corresponding to the foods consumed by a patient, and the processor is operative to determine from the data inputs corresponding to the foods consumed by a patient.

23. The apparatus of claim 2, wherein the data inputs further comprise data inputs corresponding to the number of insulin units administered by a patient on a periodic basis, and the data entry means facilitate entering into the at least one computer-readable memory data inputs corresponding to the said number of insulin units administered by a patient.