Systems, methods and devices for achieving glycemic balance

• US 10,736,562 B2
• Filed: 11/19/2015
• Issued: 08/11/2020
• 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): Lin, Jerry
• Application Number:
  US14/946,259
• Publication Number:
  US 20160073952A1
• Time in Patent Office: 1,727 Days
• Field of Search: 702 19
• 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: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/507 Head Mounted Displays [HMD]
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• 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: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• 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

Systems, methods and/or devices 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. Also disclosed are systems, methods and/or devices for treating a patient'"'"'s diabetes by providing treatment guidance, wherein the patient'"'"'s current glycemic state is determined relative to a desired balance point; and determining from at least one of 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 present insulin dosage regimen to get closer to the patient'"'"'s desired balance point; wherein the desired balance point is the patient'"'"'s lowest blood glucose-level within a predetermined range achievable before increasing the frequency of hypoglycemic events above a predetermined threshold.

Claims

1. A method for treating a patient'"'"'s diabetes, the method comprising:

storing one or more components of the patient'"'"'s insulin dosage regimen;

obtaining data corresponding to the patient'"'"'s blood glucose-level measurements determined at a plurality of times;

tagging each of the blood glucose-level measurements with an identifier reflective of when or why the reading was obtained;

determining the patient'"'"'s current glycemic state relative to a desired balance point;

determining from at least one of 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 present insulin dosage regimen to get closer to the patient'"'"'s desired balance point;

outputting an instruction to (1) decrease the administration of at least one of the one or more components of the patients insulin regimen if the number of hypoglycemic events exceeds a predetermined threshold or if the patient'"'"'s blood glucose level is below a first threshold blood glucose level, or (2) increase the administration of at least one of the one or more components of the patients insulin regimen if the number of hypoglycemic events is below the predetermined threshold and the patient'"'"'s blood glucose level is above a second threshold blood glucose level; and

administering at least one of the one or more components of the patients insulin regimen in accordance with the outputted instruction;

wherein the desired balance point is the patient'"'"'s lowest blood glucose-level within a predetermined range achievable before increasing the frequency of hypoglycemic events above the predetermined threshold, and

wherein the predetermined threshold of hypoglycemic events is 50, 60, 70, 75, 80, 85, 90, 100, 110, or 120 events/year.

2. The method of claim 1, wherein the adjustment to the patient'"'"'s insulin dosage regimen is performed in substantially real time.

3. The method of claim 1 wherein an initial insulin dosage regimen is provided by a physician or other healthcare professional.

4. The method of claim 1, wherein the method is performed without any intervention from a doctor or other healthcare professional.

5. The method of claim 1 wherein the patient'"'"'s current balance point changes over time and the adjustment to patient'"'"'s insulin dosage regimen is to get closer to the most recent desired balance point.

6. The method of claim 5 wherein the patient'"'"'s insulin dosage regimen is adjusted in a manner that dampens or prevents unstable oscillations.

7. The method of claim 5 wherein the scope of the oscillations are reduced by ensuring that the current increase in the patient'"'"'s insulin dosage regimen is less than the previous decrease in the patient'"'"'s insulin dosage regimen.

8. The method of claim 1 wherein the identifiers reflective of when the reading was obtained are selected from Breakfast, Lunch, Dinner, Bedtime, Nighttime, and Other.

9. The method of claim 8 wherein the measurements tagged as “

other”

are classified based on the classification of the previous measurement and an elapsed time since the previous measurement.

10. The method of claim 1 wherein the predetermined threshold is one severe hypoglycemic event.

11. The method of claim 10 wherein the severe hypoglycemic event is defined as a blood glucose-level measurement of less than 55 mg/dL.

12. The method of claim 1 wherein the hypoglycemic event is defined as a blood glucose-level measurement of less than 65 mg/dL.

13. The method of claim 1 wherein the predetermined threshold is three hypoglycemic events in 24 hours.

14. The method of claim 1 wherein the predetermined threshold is two hypoglycemic events for the same identifier.

15. The method of claim 1 wherein the predetermined threshold is more than three hypoglycemic events since the current dosage has been instated.