Method and apparatus for providing glycemic control

• US 9,931,075 B2
• Filed: 11/12/2014
• Issued: 04/03/2018
• 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): Riggs, II, Larry D
• Application Number:
  US14/539,402
• Publication Number:
  US 20150073243A1
• Time in Patent Office: 1,238 Days
• Field of Search: None
• CPC Class Codes: A61B 5/0004 characterised by the type of physiological signal transmitted
• 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 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/486 Bio-feedback A61B5/375 takes precedence
• CPC Class Codes: A61B 5/4866 Evaluating metabolism A61B5/083 takes precedence
• CPC Class Codes: A61B 5/6849 in combination with a needle set
• 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: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61B 5/7475 User input or interface means, e.g. keyboard, pointing device, joystick
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• 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 40/67 for remote operation

Abstract

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

Claims

1. A computer-implemented method to determine one or more parameters associated with a physiological condition of a person, comprising:

determining a correlation between a mean glucose value information and a current and target HbA1C levels of the person;

determining a rate of glycation of the person based at least in part on the determined correlation between the mean glucose value information and the current HbA1C level;

applying one or more person specific parameters to the determined correlation between the mean glucose value information and the current HbA1C level;

updating the target HbA1C level based on the determined rate of glycation and the application of received one or more person specific parameters to the determined correlation;

modifying a stored medication intake level for delivery by an infusion device based on the updated target HbA1C level; and

delivering medication according to the modified medication intake level using the infusion device.

2. The method of claim 1, wherein the mean glucose value information determination includes monitoring glucose level information over a predetermined time period applying a weighting function to received monitored glucose level information.

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 1, wherein the one or more person specific parameters includes an age of the person, a history of hypoglycemia, an activity level of the person, a medication intake information of the person, or a risk associated with high or low blood glucose levels of the person.

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

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

8. The method of claim 1, wherein the rate of glycation is a ratio of the mean glucose value information with respect to the current 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, 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.

10. The method of claim 9, wherein the glucose sensor is factory calibrated.

11. An apparatus, comprising:

a medication delivery mechanism;

one or more processors operatively coupled to the medication delivery mechanism; 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 mean glucose value information and current and target HbA1C levels, determine a rate of glycation of a person based at least in part on the determined correlation between the mean glucose value information and the current HbA1C level, apply one or more person specific parameters to the determined correlation between the mean glucose value information and the current HbA1C level, update the target HbA1C level based on the determined rate of glycation of the person and the application of received one or more person specific parameters to the determined correlation, modify a stored medication intake level for delivery by the medication delivery mechanism based on the updated target HbA1C level; and

deliver medication according to the modified medication intake level using the medication delivery mechanism.

12. 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 receive monitored glucose level information over a predetermined time period, and to apply a weighting function to the received monitored glucose level information to determine the mean glucose value information.

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 11, wherein the one or more person specific parameters includes an age of the person, a history of hypoglycemia, an activity level of the person, a medication intake information of the person, or a risk associated with high or low blood glucose levels of the person.

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

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 current or target HbA1C level, the determined correlation between the mean glucose value information and the current HbA1C level, and the updated target HbA1C level.

18. The apparatus of claim 11, wherein the rate of glycation is a ratio of the mean glucose value information with respect to the current 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, 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.

20. The apparatus of claim 19, wherein the glucose sensor is factory calibrated.