REAL TIME MANAGEMENT OF DATA RELATING TO PHYSIOLOGICAL CONTROL OF GLUCOSE LEVELS

• US 20110021898A1
• Filed: 07/23/2010
• Published: 01/27/2011
• 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: Hayter, Gary A., Wei, Charles
• Granted Patent: US 8,798,934 B2
• Time in Patent Office: Days
• US Class Current: 600/365
• 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 monitoring system, comprising:

a memory configured to store data relating to at least two measurements of a physiological glucose level in a patient, wherein the two measurements are taken at different time points t1 and t2, a safe range of glucose for the patient; and

at least one other medically relevant patient-specific data point of exogenous data;

a user interface comprising a visual display; and

a processor comprising computer-executable instructions to;

determine a rate of change between the at least two glucose level measurements and based on the determined rate of change, further determine a glucose level at a future time t3;

process the glucose level determined for time t3 with the stored exogenous data to result in an integrated glucose level for time t3; and

provide an alarm at the user interface if the projected integrated glucose level for time t3 is outside the safe range.

2. The integrated glucose monitoring system of claim 1, wherein the exogenous data is selected from the group of insulin on board, insulin sensitivity, prior carbohydrate intake, basal rate, and available insulin bolus.

3. The integrated glucose monitoring system of claim 1, wherein the processor comprises a further computer-executable instruction to determine a recommended change to one or more of the medically relevant data points.

4. The integrated glucose monitoring system of claim 3, wherein the recommended change to one or more of the medically relevant data points comprises a therapeutic response.

5. The integrated glucose monitoring system of claim 4, wherein the recommended therapeutic response comprises one or more of an insulin bolus, intake of a particular level of carbohydrates, and temporary change to a basal insulin rate.

6. The integrated glucose monitoring system of claim 5, wherein the processor comprises a further computer-executable instruction to display the recommended therapeutic response on the visual display.

7. The integrated glucose monitoring system of claim 1, wherein the user interface comprises a graphical user interface on the visual display and an input device for communicating data and instructions from a patient to the processor, and wherein the alarm comprises a visual alarm provided on the graphical user interface.

8. The integrated glucose monitoring system of claim 1, further comprising a communication module configured to communicate with an insulin delivery pump engaged with the patient to acquire patient-specific insulin delivery data including insulin on board, wherein the processor processes the glucose level determined for time t3 from the rate of change data as a function of the insulin delivery data received from the delivery pump to result in the integrated glucose level for time t3.

9. The integrated glucose monitoring system of claim 1, further comprising a communication module configured to communicate an alarm to a remote location wirelessly or by wired connection.

10. The integrated glucose monitoring system of claim 9, wherein the processor comprises a further computer-executable instruction to control the communication module to communicate measured glucose level data, and alarms to a remote location.

11. An integrated glucose monitoring system, comprising

a memory configured to store data relating to at least two measurements of a physiological glucose level in a patient, wherein the two measurements are taken at different time points t1 and t2, a safe range of glucose for the patient;

and at least one other medically relevant patient-specific data point of exogenous data;

wherein the exogenous data is selected from the group of insulin on board, insulin sensitivity, prior carbohydrate intake, basal rate, and available insulin bolus;

a user interface comprising a graphical user interface on a visual display and an input device for communicating data and instructions from a patient;

a processor comprising computer-executable instructions to;

determine a rate of change between the at least two glucose level measurements and based on the determined rate of change, further determine a glucose level at a future time t3;

process the glucose level determined for time t3 with the stored exogenous data to result in an integrated glucose level for time t3;

provide a visual alarm on the graphical user interface if the projected integrated glucose level for time t3 is outside the safe range; and

determine a recommended change to one or more of the medically relevant data points comprising a change to one or more of an insulin bolus, intake of a particular level of carbohydrates, and temporary change to a basal insulin rate, and to communicate the recommended change through the user interface;

a communication module configured to communicate with an insulin delivery pump engaged with the patient to acquire patient-specific insulin delivery data including insulin on board, wherein the processor processes the glucose level determined for time t3 from the rate of change data as a function of the insulin delivery data received from the delivery pump to result in the integrated glucose level for time t3.

12. The integrated glucose monitoring system of claim 11, wherein the recommended therapeutic response comprises one or more of an insulin bolus, intake of a particular level of carbohydrates, and temporary change to a basal insulin rate.

13. A method of integrated glucose monitoring, comprising:

storing data relating to at least two measurements of a physiological glucose level in a patient, wherein the two measurements are taken at different time points t1 and t2,

storing a safe range of glucose for the patient;

storing at least one other medically relevant patient-specific data point of exogenous data;

determining a rate of change between the stored at least two glucose level measurements and based on the determined rate of change, further determining a glucose level at a future time t3;

processing the glucose level determined for time t3 with the stored exogenous data to result in an integrated glucose level for time t3; and

providing an alarm if the projected integrated glucose level for time t3 is outside the stored safe range.

14. A method for reducing false alarms in managing projected alarms related to glucose levels, comprising:

determining a rate of change between at least two glucose level measurements taken at different time points t1 and t2;

identifying whether an expected glucose level at a future time point t3 is above or below a target glucose level;

determining a recommended change to one or more medically relevant data points comprising determining a therapeutic response if a difference between the expected glucose level and the target glucose level exceeds a preset warning value; and

identifying whether the recommended change to one or more of the medically relevant data points has been performed at a predetermined time point t4 before future time point t3 has been reached, wherein an alarm is provided only where the recommended change to one or more of the medically relevant data points has not been performed at the predetermined time point t4, thereby reducing false alarms.

15. The method of claim 14, wherein the expected glucose level is a function of the rate of change between the at least two glucose level measurements and at least one or more of the medically relevant data points.

16. The method of claim 15, wherein the one or more medically relevant data points is selected from the group of insulin on board, insulin sensitivity, prior carbohydrate intake, basal insulin, available insulin bolus;

projection time, insulin action time, carbohydrate ratio, carbohydrate uptake time.

17. The method of claim 14, wherein the recommended therapeutic response comprises one or more of a particular insulin bolus, intake of a particular level of carbohydrates, and temporary change to a basal insulin level.

18. The method of claim 14, further comprising displaying the recommended therapeutic response on a visual display.

19. The method of claim 14, wherein time point t3 is up to thirty minutes after time point t2 and time point t4 is between time points t2 and t3.

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

a memory configured to record and store data representing measurements of physiological glucose levels in a patient, and to store exogenous data in the 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 level measurement data into the memory during defined time periods;

tag each of the recorded series of glucose level 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 the same profile name;

compare the recorded data of the plurality of retrieved 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 a persistent pattern is detected in the data of the retrieved plurality of profiles; and

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

21. The integrated glucose management system of claim 20, wherein the processor computer-executable instructions include an excess insulin manager configured to provide a plurality of alternative recommended changes to the patient-specific insulin data.

22. The integrated glucose management system of claim 21, wherein the excess insulin manager is further configured to prioritize a recommended increase in carbohydrate intake lower than recommended changes to insulin delivery.

23. The integrated glucose management system of claim 20, wherein the exogenous patient-specific insulin data comprises basal rate, carb ratio, and insulin sensitivity.

24. The integrated glucose management system of claim 20, wherein the profiles include a skip-meal profile, a meal test profile, and a correction bolus test profile.

25. The integrated glucose management system of claim 20, wherein the processor comprises a further computer-executable instruction to require that a minimum number of profiles must be outside the safe range before a recommendation will be provided.

26. The integrated glucose management system of claim 20, wherein the processor comprises a further computer-executable instruction to require that all profiles retrieved for comparison must have been recorded within a selected time period.

27. The integrated glucose management system of claim 20, wherein the processor comprises a further computer-executable instruction to require that a recommendation for change of basal rate, carb ratio, and insulin sensitivity cannot exceed a predetermined amount.