Systems, devices, and methods for alleviating glucotoxicity and restoring pancreatic beta-cell function in advanced diabetes mellitus

• US 10,624,577 B2
• Filed: 08/05/2014
• Issued: 04/21/2020
• 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:
  US14/452,140
• Publication Number:
  US 20140343530A1
• Time in Patent Office: 2,086 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: A61B 5/4842 Monitoring progression or stage of a disease
• 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 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

Abstract

Systems, methods and/or devices for treating diabetes mellitus by alleviating glucotoxicity and restoring pancreatic beta-cell function, 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 components of the patient'"'"'s present insulin dosage regimen. Also disclosed are systems, methods, and/or devices for alleviating glucotoxicity and restoring pancreatic beta-cell function, comprising establishing the patient'"'"'s current glycemic state relative to a desired glycemic range 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 adjust at least one of the components in the patient'"'"'s present insulin dosage regimen.

Claims

1. A method of diagnosing and treating glycemic imbalance in a patient, said method comprising:

obtaining a blood sample from a human patient at a plurality of times;

detecting the patient'"'"'s blood glucose levels in said blood samples and tagging each of said blood glucose-level detections with an identifier reflective of when said blood sample was obtained;

determining a glycemic state of the patient using at least the blood glucose detections;

diagnosing the patient with glycemic imbalance by comparing a glycemic state of the patient to a desired glycemic range and determining that the glycemic state of the patient is outside the desired glycemic range;

adjusting at least one component of a present insulin dosage regimen of the patient to stay within said desired glycemic range and dampen or prevent unstable oscillations; and

performing said steps of the method until at least one component of the insulin dosage regimen required to stay within the desired glycemic range is lowered to a predetermined level.

2. The method of claim 1 wherein said unstable oscillations are dampened or prevented by ensuring that said adjustment is limited to an intermittent value.

3. The method of claim 1 wherein said unstable oscillations are dampened or prevented by ensuring that a current increase in the patient'"'"'s insulin dosage regimen is less than a previous decrease in the patient'"'"'s insulin dosage regimen.

4. The method of claim 1 wherein said unstable oscillations are dampened or prevented by ensuring that a current decrease in the patient'"'"'s insulin dosage regimen is less than a previous increase in the patient'"'"'s insulin dosage regimen.

5. The method of claim 1 wherein said unstable oscillations are dampened or prevented by inserting off intervals between different directions of dosage adjustments.

6. The method of claim 1 wherein a determination of by how much to adjust at least one component of the patient'"'"'s present insulin dosage regimen is made by calculating a total daily amount of insulin.

7. The method of claim 1 wherein a determination of by how much to adjust at least one component of the patient'"'"'s present insulin dosage regimen is made by calculating the amount by which a component of the dosage is greater than the same component for a previous dosage.

8. The method of claim 1 wherein a determination of by how much to adjust at least one component of the patient'"'"'s present insulin dosage regimen is made by majority voting rule.

9. The method of claim 1 wherein a determination of by how much to adjust at least one component of the patient'"'"'s present insulin dosage regimen is subject to a consecutive dosage increment rule to establish an off period if a more than a desired number of increments has occurred.

10. The method of claim 9, wherein said consecutive dosage increment rule prevents two consecutive increments from occurring and creates an off period after each dosage increment.

11. The method of claim 9, wherein said consecutive dosage increment rule allows more than two consecutive increments but no more than eight consecutive increments.

12. The method of claim 1, wherein the desired glycemic range is between 85 mg/dL and 200 mg/dL.