Method and apparatus for providing glycemic control

• US 9,795,328 B2
• Filed: 01/06/2017
• Issued: 10/24/2017
• 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:
  US15/400,959
• Publication Number:
  US 20170112421A1
• Time in Patent Office: 291 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 Hb1AC levels are provided. Systems to provide glycemic control and therapy management based on monitored glucose data, and current and/or target Hb1AC levels are provided. Kits to provide glycemic control and therapy management based on monitored glucose data, and current and/or target Hb1AC levels are provided.

Claims

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

determining, using the one or more processors, a correlation between a mean glucose value information and an HbA1C level associated with a subject;

determining, using the one or more processors, a rate of glycation of the subject based at least in part on the determined correlation between the mean glucose value information and the HbA1C level;

applying, using the one or more processors, one or more subject specific parameters to the determined correlation between the mean glucose value information and the HbA1C level;

determining, using the one or more processors, a target HbA1C level based on determining the rate of glycation of the subject and applying the one or more subject specific parameters to the determined correlation; and

providing, using the one or more processors, a therapy recommendation on a display device operatively coupled to the one or more processors including at least the determined target HbA1C level;

wherein the one or more subject specific parameters includes an age of the subject, an activity level of the subject, a medication intake information of the subject, or a living condition of the subject.

2. The method of claim 1, wherein the mean glucose value information includes applying a weighting function to 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 including the determined target HbA1C level on the display device 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, HbA1C level, and the subject specific parameters.

7. The method of claim 1, further including storing one or more of the mean glucose value information, the HbA1C level, the determined correlation between the mean glucose value information and the HbA1C level, and the target HbA1C level.

8. The method of claim 1, wherein the rate of glycation is a ratio of the mean glucose value information and the HbA1C level.

9. 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.

10. The method of claim 9, wherein the working electrode comprises a glucose-responsive enzyme and a mediator, wherein at least one of the glucose-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode, and wherein at least one of the glucose-responsive enzyme and the mediator is crosslinked with the polymer.

11. 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 determine a correlation between a mean glucose value information and an HbA1C level associated with a subject, to determine a rate of glycation of the subject based at least in part on the determined correlation between the mean glucose value information and the HbA1C level, to apply one or more subject specific parameters to the determined correlation between the mean glucose value information and the HbA1C level, to determine a target HbA1C level based on determining the rate of glycation of the subject and applying the one or more subject specific parameters to the determined correlation, and to provide a therapy recommendation on the display device including at least the determined target HbA1C level, wherein the one or more subject specific parameters includes an age of the subject, an activity level of the subject, a medication intake information of the subject, or a living condition of the subject.

12. The apparatus of claim 11, wherein the mean glucose value information is determined by applying a weighting function to monitored glucose level information over a predetermined time period.

13. The apparatus of claim 12, wherein the weighting function is based on a time of day information associated with the monitored glucose level information.

14. The apparatus of claim 12, wherein the weighting function is based on a time period associated with the monitored glucose level information.

15. The apparatus of claim 12, wherein the predetermined time period includes one of approximately 30 days, approximately 45 days, or approximately 90 days.

16. The apparatus of claim 11, wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to provide the therapy recommendation on the display device by 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, HbA1C level, and the subject specific parameters.

17. The apparatus of claim 11, 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 determined correlation between the mean glucose value information and the HbA1C level, and the target HbA1C level.

18. The apparatus of claim 11, wherein the rate of glycation is a ratio of the mean glucose value information and the HbA1C level.

19. The apparatus of claim 11, wherein the mean glucose value information is obtained using a glucose sensor that comprises a plurality of electrodes including a working electrode.

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

21. The apparatus of claim 20, further including a mediator crosslinked with the polymer.