Method and apparatus for providing glycemic control

• US 10,327,682 B2
• Filed: 10/20/2017
• Issued: 06/25/2019
• Est. Priority Date: 05/30/2008
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Taub, Marc Barry, Dunn, Timothy Christian, Crouther, Nathan Christopher
• Primary Examiner(s): Downey, John R
• Application Number:
  US15/789,950
• Publication Number:
  US 20180042532A1
• Time in Patent Office: 613 Days
• Field of Search: 600300, 600301
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/6849 in combination with a needle set
• CPC Class Codes: A61B 5/7246 using correlation, e.g. template matching or determination of similarity
• 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: G01N 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders

Abstract

Methods to provide glycemic control and therapy management based on monitored glucose data, and current and/or target HbA1C levels are provided. Systems to provide glycemic control and therapy management based on monitored glucose data, and current and/or target HbA1C levels are provided. Kits to provide glycemic control and therapy management based on monitored glucose data, and current and/or target HbA1C levels are provided.

Claims

1. A method implemented using one or more processors, comprising:

obtaining, for a subject, a mean glucose value information, a glycemic risk weight, and a HbA1C level of the subject;

determining, using the one or more processors, a rate of glycation of the subject based on a ratio of the mean glucose value information of the subject and the HbA1C level of the subject;

determining, using the one or more processors, a target HbA1C level for the subject based at least in part on two or more subject-specific weights including at least the rate of glycation of the subject and the glycemic risk weight;

providing, using the one or more processors, a therapy recommendation including a dosage for an insulin bolus on a display device operatively coupled to the one or more processors based at least in part on the determined target HbA1C level of the subject; and

administering the insulin bolus to the subject using an infusion device according to the therapy recommendation.

2. The method of claim 1, further comprising obtaining monitored glucose level information for the subject, and wherein the mean glucose value information includes information obtained by applying a weighting function to the monitored glucose level information over a predetermined time period.

3. The method of claim 2, wherein the weighting function is based on a time of day information associated with the monitored glucose level information.

4. The method of claim 2, wherein the weighting function is based on a time period associated with the monitored glucose level information.

5. The method of claim 2, wherein the predetermined time period includes one of approximately 30 days, approximately 45 days, or approximately 90 days.

6. The method of claim 1, wherein providing the therapy recommendation includes generating a visual output associated with the determined target HbA1C level and one or more of the mean glucose value information, the rate of glycation, and the HbA1C level.

7. The method of claim 1, further including storing one or more of the mean glucose value information, the HbA1C level, the rate of glycation, the ratio of the mean glucose value information and the HbA1C level, the determined target HbA1C level, and the therapy recommendation.

8. The method of claim 1, wherein the mean glucose value information is obtained using a glucose sensor that comprises a plurality of electrodes including a working electrode comprising a glucose-responsive enzyme bonded to a polymer disposed on the working electrode.

9. The method of claim 8, wherein the glucose-responsive enzyme is chemically bonded to the polymer disposed on the working electrode.

10. The method of claim 8, wherein the working electrode comprises a mediator bonded to the polymer disposed on the working electrode.

11. The method of claim 10, wherein the mediator is crosslinked with the polymer disposed on the working electrode.

12. An apparatus, comprising:

a display device;

one or more processors operatively coupled to the display device; and

a memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to;

obtain, for a subject, a mean glucose value information, a glycemic risk weight, and a HbA1C level of the subject;

determine a rate of glycation of the subject based on a ratio of the mean glucose value information of the subject and the HbA1C level of the subject;

determine a target HbA1C level for the subject based at least in part on two or more subject-specific weights including at least the rate of glycation of the subject and the glycemic risk weight;

provide a therapy recommendation including a dosage for an insulin bolus on the display device based at least in part on the determined target HbA1C level of the subject; and

administer the insulin bolus to the subject using an infusion device according to the therapy recommendation.

13. The apparatus of claim 12, storing instructions to obtain monitored glucose level information for the subject, and wherein the mean glucose value information includes information obtained by applying a weighting function to the monitored glucose level information over a predetermined time period.

14. The apparatus of claim 13, wherein the weighting function is based on a time of day information associated with the monitored glucose level information.

15. The apparatus of claim 13, wherein the weighting function is based on a time period associated with the monitored glucose level information.

16. The apparatus of claim 13, wherein the predetermined time period includes one of approximately 30 days, approximately 45 days, or approximately 90 days.

17. The apparatus of claim 12, wherein the therapy recommendation includes a visual output associated with the determined target HbA1C level and one or more of the mean glucose value information, the rate of glycation, and the HbA1C level.

18. The apparatus of claim 12, wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to store one or more of the mean glucose value information, the HbA1C level, the rate of glycation, the ratio of the mean glucose value information and the HbA1C level, the determined target HbA1C level, and the therapy recommendation.

19. The apparatus of claim 12, wherein the mean glucose value information is obtained using a glucose sensor that comprises a plurality of electrodes including a working electrode comprising a glucose-responsive enzyme bonded to a polymer disposed on the working electrode.

20. The apparatus of claim 19, wherein the glucose-responsive enzyme is chemically bonded to the polymer disposed on the working electrode.

21. The apparatus of claim 20, wherein the working electrode comprises a mediator bonded to the polymer disposed on the working electrode.

22. The apparatus of claim 21, wherein the mediator is crosslinked with the polymer disposed on the working electrode.