Real time management of data relating to physiological control of glucose levels

• US 8,798,934 B2
• Filed: 07/23/2010
• Issued: 08/05/2014
• Est. Priority Date: 07/23/2009
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Wei, Charles, Hayter, Gary A.
• Primary Examiner(s): Riggs, II, Larry D
• Application Number:
  US12/842,838
• Publication Number:
  US 20110021898A1
• Time in Patent Office: 1,474 Days
• US Class Current: 702/19
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2230/201 Glucose concentration
• 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: G06F 16/285 Clustering or classification
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 40/60 for the operation of medical equipment or devices
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders

Abstract

Continuous glucose monitoring (CGM) data and insulin delivery data are used to generate more reliable projected alarms related to a projected glucose levels. A memory stores endogenous data related to measurements of glucose level in a patient, and also stores exogenous data, such as insulin on board, both of which are used by a processor to create projected alarms. Profiles of CGM data are created for use in tuning patient-specific insulin data, such at basal rate, carb ratio, and insulin sensitivity. A processor searches for patterns in the data profiles and if found, recommended changes to patient-specific insulin data are provided to permit more accurate control over a patient'"'"'s glucose levels.

Claims

1. An integrated glucose management system for tuning patient-specific insulin data, comprising:

a memory configured to record and store glucose measurement data representing measurements of physiological glucose levels, and to store exogenous data in a form of attributes tagged to the stored glucose measurement data;

a user interface comprising a visual display and an input device configured to receive and communicate user input data and instructions; and

a processor comprising computer-executable instructions to;

record multiple series of glucose measurement data into the memory during defined time periods;

tag each of the recorded series of glucose measurement data with exogenous attributes including a profile name, wherein the name of the profile is selected to identify the data recording as belonging to a particular category of patient conditions;

access the memory to retrieve a plurality of profiles having a same profile name;

compare the retrieved plurality of profiles to detect a persistent pattern of undesirable measured glucose levels existing in the plurality of profiles;

provide an alarm at the user interface if the persistent pattern is detected in the retrieved plurality of profiles; and

provide a recommended change to patient-specific insulin data as a result of the detected persistent pattern, and display the recommended change on the user interface;

wherein the computer-executable instructions include an excess insulin manager configured to provide a plurality of alternative recommended changes to the patient-specific insulin data; and

further

wherein the excess insulin manager is further configured to prioritize a recommended increase in carbohydrate intake lower than recommended changes to insulin delivery.

2. The integrated glucose management system of claim 1, wherein the patient-specific insulin data comprises a basal rate, a carb ratio, and an insulin sensitivity.

3. The integrated glucose management system of claim 1, wherein the plurality of profiles includes a skip-meal profile, a meal test profile, and a correction bolus test profile.

4. The integrated glucose management system of claim 1, wherein the processor comprises a further computer-executable instruction to require that a minimum number of the retrieved plurality of profiles must be outside a safe range before providing the recommended change to the patient-specific insulin data.

5. The integrated glucose management system of claim 1, wherein the processor comprises a further computer-executable instruction to require that the plurality of profiles retrieved for comparison must have been recorded within a selected time period.

6. The integrated glucose management system of claim 1, wherein the processor comprises a further computer-executable instruction to require that a recommendation for change of a basal rate, a carb ratio, and an insulin sensitivity cannot exceed a predetermined amount.

7. The integrated glucose management system of claim 1, wherein the processor comprises a further computer-executable instruction to record the multiple series of the glucose measurement data into the memory during the defined time periods upon receiving a manual start signal or an automatic start control.

8. The integrated glucose management system of claim 1, wherein the tag includes at least one of meal data, breakfast data, high-fat meal data, or post-prandial data.

9. The integrated glucose management system of claim 1, wherein the glucose measurement data is obtained using a glucose sensor comprising 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. An integrated glucose management system for tuning patient-specific insulin data, comprising:

a memory configured to record and store glucose measurement data representing measurements of physiological glucose levels, and to store exogenous data in a form of attributes tagged to the stored glucose measurement data;

a user interface comprising a visual display and an input device configured to receive and communicate user input data and instructions; and

a processor comprising computer-executable instructions to;

record multiple series of glucose measurement data into the memory during defined time periods;

tag each of the recorded series of glucose measurement data with exogenous attributes including a profile name, wherein the name of the profile is selected to identify the data recording as belonging to a particular category of patient conditions;

access the memory to retrieve a plurality of profiles having a same profile name;

compare the retrieved plurality of profiles to detect a persistent pattern of undesirable measured glucose levels existing in the plurality of profiles;

provide an alarm at the user interface if the persistent pattern is detected in the retrieved plurality of profiles;

provide a recommended change to patient-specific insulin data as a result of the detected persistent pattern, and display the recommended change on the user interface; and

require that a minimum number of the retrieved plurality of profiles must be outside a safe range before providing the recommended change to the patient-specific insulin data.

11. The integrated glucose management system of claim 10, wherein the patient-specific insulin data comprises a basal rate, a carb ratio, and an insulin sensitivity.

12. The integrated glucose management system of claim 10, wherein the plurality of profiles includes a skip-meal profile, a meal test profile, and a correction bolus test profile.

13. The integrated glucose management system of claim 10, wherein the processor comprises a further computer-executable instruction to require that the plurality profiles retrieved for comparison must have been recorded within a selected time period.

14. The integrated glucose management system of claim 10, wherein the processor comprises a further computer-executable instruction to record the multiple series of the glucose measurement data into the memory during the defined time periods upon receiving a manual start signal or an automatic start control.

15. The integrated glucose management system of claim 10, wherein the tag includes at least one of meal data, breakfast data, high-fat meal data, or post-prandial data.

16. The integrated glucose management system of claim 10, wherein the glucose measurement data is obtained using a glucose sensor comprising 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.

17. An integrated glucose management system for tuning patient-specific insulin data, comprising:

a memory configured to record and store glucose measurement data representing measurements of physiological glucose levels, and to store exogenous data in a form of attributes tagged to the stored glucose measurement data;

a user interface comprising a visual display and an input device configured to receive and communicate user input data and instructions; and

a processor comprising computer-executable instructions to;

record multiple series of glucose measurement data into the memory during defined time periods;

tag each of the recorded series of glucose measurement data with exogenous attributes including a profile name, wherein the name of the profile is selected to identify the data recording as belonging to a particular category of patient conditions;

access the memory to retrieve a plurality of profiles having a same profile name;

compare the retrieved plurality of profiles to detect a persistent pattern of undesirable measured glucose levels existing in the plurality of profiles;

provide an alarm at the user interface if the persistent pattern is detected in the retrieved plurality of profiles;

provide a recommended change to patient-specific insulin data as a result of the detected persistent pattern, and display the recommended change on the user interface; and

require that a recommendation for change of a basal rate, a carb ratio, and an insulin sensitivity cannot exceed a predetermined amount.

18. The integrated glucose management system of claim 17, wherein the patient-specific insulin data comprises the basal rate, the carb ratio, and the insulin sensitivity.

19. The integrated glucose management system of claim 17, wherein the plurality of profiles includes a skip-meal profile, a meal test profile, and a correction bolus test profile.

20. The integrated glucose management system of claim 17, wherein the processor comprises a further computer-executable instruction to require that a minimum number of the retrieved plurality of profiles must be outside a safe range before providing the recommended change to the patient-specific insulin data.

21. The integrated glucose management system of claim 17, wherein the processor comprises a further computer-executable instruction to require that the plurality of profiles retrieved for comparison must have been recorded within a selected time period.

22. The integrated glucose management system of claim 17, wherein the processor comprises a further computer-executable instruction to record the multiple series of the glucose measurement data into the memory during the defined time periods upon receiving a manual start signal or an automatic start control.

23. The integrated glucose management system of claim 17, wherein the glucose measurement data is obtained using a glucose sensor comprising 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.

24. A method, comprising:

recording and storing, using a memory, glucose measurement data representing measurements of physiological glucose levels;

storing, using the memory, exogenous data in a form of attributes tagged to the stored glucose measurement data;

receiving and communicating, using a user interface comprising a visual display and an input device, user input data and instructions;

recording, using a processor comprising computer-executable instructions, multiple series of glucose measurement data into the memory during defined time periods;

tagging, using the processor comprising the computer-executable instructions, each of the recorded series of glucose measurement data with exogenous attributes including a profile name, wherein the name of the profile is selected to identify the data recording as belonging to a particular category of patient conditions;

accessing, using the processor comprising the computer-executable instructions, the memory to retrieve a plurality of profiles having a same profile name;

comparing, using the processor comprising the computer-executable instructions, the retrieved plurality of profiles to detect a persistent pattern of undesirable measured glucose levels existing in the plurality of profiles;

providing, using the processor comprising the computer-executable instructions, an alarm at the user interface if the persistent pattern is detected in the retrieved plurality of profiles;

providing, using the processor comprising the computer-executable instructions, a recommended change to patient-specific insulin data as a result of the detected persistent pattern, and display the recommended change on the user interface;

providing, using an excess insulin manager, a plurality of alternative recommended changes to the patient-specific insulin data; and

prioritizing, using the excess insulin manager, a recommended increase in carbohydrate intake lower than recommended changes to insulin delivery.

25. The method of claim 24, wherein the glucose measurement data is obtained using a glucose sensor comprising 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.

26. A method, comprising:

recording and storing, using a memory, glucose measurement data representing measurements of physiological glucose levels;

storing, using the memory, exogenous data in a form of attributes tagged to the stored glucose measurement data;

receiving and communicating, using a user interface comprising a visual display and an input device, user input data and instructions;

recording, using a processor comprising computer-executable instructions, multiple series of glucose measurement data into the memory during defined time periods;

tagging, using the processor comprising the computer-executable instructions, each of the recorded series of glucose measurement data with exogenous attributes including a profile name, wherein the name of the profile is selected to identify the data recording as belonging to a particular category of patient conditions;

accessing, using the processor comprising the computer-executable instructions, the memory to retrieve a plurality of profiles having a same profile name;

comparing, using the processor comprising the computer-executable instructions, the retrieved plurality of profiles to detect a persistent pattern of undesirable measured glucose levels existing in the plurality of profiles;

providing, using the processor comprising the computer-executable instructions, an alarm at the user interface if the persistent pattern is detected in the retrieved plurality of profiles;

providing, using the processor comprising the computer-executable instructions, a recommended change to patient-specific insulin data as a result of the detected persistent pattern, and display the recommended change on the user interface; and

requiring, using the processor comprising the computer-executable instructions, that a minimum number of the retrieved plurality of profiles must be outside a safe range before providing the recommended change to the patient-specific insulin data.

27. The method of claim 26, wherein the glucose measurement data is obtained using a glucose sensor comprising 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.