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

• US 10,555,705 B2
• Filed: 10/26/2018
• Issued: 02/11/2020
• Est. Priority Date: 10/30/2012
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Hampapuram, Hari, Davis, Anna Leigh, Bhavaraju, Naresh, Kamath, Apurv Ullas, Cobelli, Claudio, Sparacino, Giovanni, Facchinetti, Andrea, Zecchin, Chiara
• Primary Examiner(s): McNally, Kerri L
• Application Number:
  US16/172,550
• Publication Number:
  US 20190059826A1
• Time in Patent Office: 473 Days
• Field of Search: 3405731
• 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 for improving an interface with a continuous analyte sensor by avoiding unnecessary hyperglycemic alerts, the method comprising:

determining, by a processor module, that sensor data from the continuous analyte sensor meet one of one or more first criteria associated with a hyperglycemic condition of a host or one or more first criteria associated with a hypoglycemic condition of a host;

modifying a user interface associated with the continuous analyte sensor to indicate a first hyperglycemic alert when the data meets the one or more first criteria associated with the hyperglycemic condition or a first hypoglycemic alert when the data meets the one or more first criteria associated with the hypoglycemic condition;

actively monitoring, by the processor module, data associated with the hypoglycemic or hyperglycemic condition during a waiting time period; and

modifying, by the processor module, the user interface during the waiting time period to indicate a second hyperglycemic alert based on the data associated with the hyperglycemic condition meeting one or more second criteria during the waiting time period or a second hypoglycemic alert based on the data associated with the hypoglycemic condition meeting one or more second criteria during the waiting time period; and

transitioning to an inactive alert state based on the data associated with the hyperglycemic condition or hypoglycemia condition not meeting one or more third criteria after the waiting time period.

2. The method of claim 1, wherein the actively monitoring comprises determining an average glucose over a window of time.

3. The method of claim 1, wherein the actively monitoring comprises determining an amplitude and/or direction of rate of change.

4. The method of claim 1, wherein the actively monitoring comprises determining an amplitude and/or direction of rate of acceleration.

5. The method of claim 1, wherein the actively monitoring comprises evaluating insulin information.

6. The method of claim 1, wherein the actively monitoring comprises evaluating meal information or timing.

7. The method of claim 1, wherein the waiting time period is user selectable.

8. The method of claim 1, further comprising not modifying the user interface during the waiting period to indicate the second hyperglycemic alert based on the data associated with the host'"'"'s hyperglycemic condition not meeting the one or more second criteria or the second hypoglycemic alert based on the data associated with the host'"'"'s hypoglycemic condition not meeting the one or more second criteria.

9. The method of claim 1, wherein the one or more first criteria and the one or more second criteria are the same.

10. The method of claim 1, wherein the one or more first criteria and the one or more second criteria are different.

11. The method of claim 1, wherein the one or more third criteria and the one or more second criteria are the same.

12. The method of claim 1, wherein the one or more third criteria and the one or more second criteria are different.

20. The method of claim 1, wherein the one or more third criteria and the one or more first criteria are the same or the one or more third criteria and the one or more first criteria are different.

13. 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;

determine that sensor data from the continuous analyte sensor meet one of one or more first criteria associated with a hyperglycemic condition of the body or one or more first criteria associated with a hypoglycemic condition of the body;

modify a user interface associated with the continuous analyte sensor to indicate a first hyperglycemic alert when the data meets the one or more first criteria associated with the hyperglycemic condition or a first hypoglycemic alert when the data meets the one or more first criteria associated with the hypoglycemic condition;

actively monitor data associated with the hyperglycemic or hypoglycemic condition during a waiting time period; and

modify the user interface during the waiting time period to indicate a second hyperglycemic alert based on the data associated with the hyperglycemic condition meeting one or more second criteria during the waiting time period or a second hypoglycemic alert based on the data associated with the hypoglycemic condition meeting one or more second criteria during the waiting time period; and

transition to an inactive alert state based on the data associated with the hyperglycemic condition or hypoglycemia condition not meeting one or more third criteria after the waiting time period.

14. The system of claim 13, wherein the actively monitoring comprises determining an average glucose over a window of time.

15. The system of claim 13, wherein the actively monitoring comprises determining an amplitude and/or direction of rate of change.

16. The system of claim 13, wherein the actively monitoring comprises determining an amplitude and/or direction of rate of acceleration.

17. The system of claim 13, wherein the one or more third criteria and the one or more second criteria are the same.

18. The system of claim 13, wherein the one or more third criteria and the one or more second criteria are different.

19. The system of claim 13, wherein the one or more third criteria and the one or more first criteria are the same or the one or more third criteria and the one or more first criteria are different.