Systems and methods for dynamically and intelligently monitoring a host's glycemic condition after an alert is triggered

• US 9,119,529 B2
• Filed: 01/16/2013
• Issued: 09/01/2015
• Est. Priority Date: 10/30/2012
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Hampapuram, Hari, Rack-Gomer, Anna Leigh, Bhavaraju, Naresh C., Kamath, Apurv Ullas, Cobelli, Claudio, Sparacino, Giovanni, Facchinetti, Andrea, Zecchin, Chiara
• Primary Examiner(s): MCNALLY, KERRI L
• Application Number:
  US13/742,841
• Publication Number:
  US 20140118166A1
• Time in Patent Office: 958 Days
• Field of Search: 340/870.16, 340/573.1
• US Class Current: 1/1
• CPC Class Codes: A61B 5/0004 characterised by the type of physiological signal transmitted
• CPC Class Codes: A61B 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/4866 Evaluating metabolism A61B5/083 takes precedence
• CPC Class Codes: A61B 5/7221 Determining signal validity, reliability or quality A61B5/7207 and A61B5/7217 take precedence
• 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 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

Systems and methods for providing sensitive and specific alarms indicative of glycemic condition are provided herein. In an embodiment, a method of processing sensor data by a continuous analyte sensor includes: evaluating sensor data using a first function to determine whether a real time glucose value meets a first threshold; evaluating sensor data using a second function to determine whether a predicted glucose value meets a second threshold; activating a hypoglycemic indicator if either the first threshold is met or if the second threshold is predicted to be met; and providing an output based on the activated hypoglycemic indicator.

Claims

1. A method of transitioning between states associated with a host'"'"'s glycemic condition, the method comprising:

evaluating sensor data from a continuous glucose sensor and activating an alert state based on the sensor data meeting one or more active transition criteria associated with a hypoglycemic condition or hyperglycemic condition;

providing an output associated with the active alert state, wherein the output is indicative of the hypoglycemic condition or hyperglycemic condition;

transitioning from the active state to an acknowledged state for a time period responsive to at least one of a user acknowledgment of the alert state or data indicative of the host'"'"'s glucose trending toward euglycemia;

actively monitoring data associated with the host'"'"'s hypoglycemic or hyperglycemic condition for a time period in the acknowledged state; and

transitioning from the acknowledged state to the inactive state responsive to receiving insulin data and/or meal information.

2. The method of claim 1, wherein the transitioning from the active state to an acknowledged state comprises transitioning from the active state to the acknowledged state based on the data indicative of the host'"'"'s glucose trending toward euglycemia, wherein the data is selected from the group consisting of a) sensor data indicative of a change in glucose trend or b) insulin information associated with a correction of the condition.

3. The method of claim 1, wherein the transitioning from the active state to an acknowledged state comprises transitioning from the active state to the acknowledged state based on the a user acknowledgment, wherein the data is selected from the group consisting of a) a user acknowledgement of the alert on a user interface or b) user input insulin information or c) user input of meal information.

4. The method of claim 1, wherein the actively monitoring comprises monitoring at least one of the sensor data, sensor diagnostic information, meal information, insulin information, or event information.

5. The method of claim 1, wherein transitioning from the acknowledged state further comprises transitioning from the acknowledged state to the active state based on the one or more active transition criteria associated with a hypoglycemic condition or hyperglycemic condition being met and based on an expiration of a predetermined time period.

6. The method of claim 1, wherein after receiving the user acknowledgement of the alert state and determining data is indicative of the host'"'"'s glucose trending toward euglycemia, further comprising transitioning from the acknowledged state to the active state based on the host'"'"'s glucose trending away from euglycemia during the active monitoring time period.

7. The method of claim 1, further comprising selectively outputting information associated with the state transition.

8. The method of claim 7, wherein the output associated with a transition to the active state is different from the output association with a transition from the acknowledged state to the inactive state.

9. A system for processing data, the system comprising:

a continuous analyte sensor configured to be implanted within a body; and

sensor electronics configured to receive and process sensor data output by the sensor, the sensor electronics including a processor configured to;

evaluate sensor data from a continuous glucose sensor and activating an alert state based on the sensor data meeting one or more active transition criteria associated with a hypoglycemic condition or hyperglycemic condition;

provide an output associated with the active alert state, wherein the output is indicative of the hypoglycemic condition or hyperglycemic condition;

transition from the active state to an acknowledged state for a time period responsive to at least one of a user acknowledgment of the alert state or data indicative of the host'"'"'s glucose trending toward euglycemia;

actively monitor data associated with the host'"'"'s hypoglycemic or hyperglycemic condition for a time period in the acknowledged state; and

transition from the acknowledged state to the inactive state based on received insulin data and/or meal information.

10. The system of claim 9, wherein the sensor electronics configured to transition from the active state to an acknowledged state are configured to transition from the active state to the acknowledged state based on the data indicative of the host'"'"'s glucose trending toward euglycemia, wherein the data is selected from the group consisting of a) sensor data indicative of a change in glucose trend or b) insulin information associated with a correction of the condition.

11. The system of claim 9, wherein sensor electronics configured to transition from the active state to an acknowledged state are configured to transition from the active state to the acknowledged state based on the a user acknowledgment, wherein the data is selected from the group consisting of a) a user acknowledgement of the alert on a user interface or b) user input insulin information or c) user input of meal information.

12. The system of claim 9, wherein the sensor electronics configured to actively monitor data are configured to actively monitor at least one of the sensor data, sensor diagnostic information, meal information, insulin information, or event information.

13. The system of claim 9, wherein sensor electronics configured to transition from the acknowledged state are further configured to transition from the acknowledged state to the active state based on the one or more active transition criteria associated with a hypoglycemic condition or hyperglycemic condition being met and based on an expiration of a predetermined time period.

14. The system of claim 9, wherein the sensor electronics are configured to transition from the acknowledged state to the active state based on the host'"'"'s glucose trending away from euglycemia during the active monitoring time period responsive to receipt of the user acknowledgement of the alert state and determining data is indicative of the host'"'"'s glucose trending toward euglycemia.

15. The system of claim 9, further comprising the sensor electronics configured to selectively output information associated with the state transition.

16. The system of claim 15, wherein the output associated with a transition to the active state is different from the output association with a transition from the acknowledged state to the inactive state.

17. A method of identifying and alerting a user in a rebound hypoglycemic or hyperglycemic situation, the method comprising:

receiving sensor data;

initially activating an alert state responsive to the sensor data meeting one or more activation criteria associated with a hypoglycemic or hyperglycemic condition being met;

transitioning to recovering sub-state for a predetermined active monitoring time period responsive to the sensor data meeting one or more recovering sub-state criteria indicative of the host'"'"'s glucose trending toward euglycemia;

actively monitoring, by a processor module, the sensor data associated with the host'"'"'s hypoglycemic or hyperglycemic condition during the predetermined active monitoring time period; and

transitioning back to the initially activated alert state responsive to the sensor data meeting one or more re-activation criteria indicative of the host'"'"'s glucose trending away from euglycemia during the active monitoring time period while in the recovering sub-state, wherein the one or more re-activation criteria are different from the one or more activation criteria.

18. The method of claim 17, further comprising providing a first output associated with the initially activating and providing a second output associated with the transitioning back.

19. The method of claim 18, wherein the first output and the second output are different.

20. A system for processing data, the system comprising:

a continuous analyte sensor configured to be implanted within a body and to provide sensor data output indicative of the host'"'"'s glucose levels; and

sensor electronics configured to receive and process sensor data output by the sensor, the sensor electronics including a processor configured to;

initially activate alert state based on one or more activation criteria responsive to the sensor data meeting one or more recovering sub-state criteria associated with a hypoglycemic or hyperglycemic condition being met;

transition to recovering sub-state for a predetermined active monitoring time period responsive to the sensor data meeting one or more recovering sub-state criteria indicative of the host'"'"'s glucose trending toward euglycemia;

actively monitor the sensor data associated with the host'"'"'s hypoglycemic or hyperglycemic condition during the predetermined active monitoring time period; and

transition back to the initially activated alert state responsive to the sensor data meeting one or more re-activation criteria indicative of the host'"'"'s glucose trending away from euglycemia during the active monitoring time period while in the recovering sub-state, wherein the one or more re-activation criteria are different from the one or more activation criteria.

21. The system of claim 20, further comprising providing a first output associated with the initially activating and providing a second output associated with the transitioning back.

22. The system method of claim 21, wherein the first output and the second output are different.