Model based variable risk false glucose threshold alarm prevention mechanism

• US 9,622,691 B2
• Filed: 10/30/2012
• Issued: 04/18/2017
• Est. Priority Date: 10/31/2011
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Budiman, Erwin Satrya
• Primary Examiner(s): Jang, Christian
• Application Number:
  US14/128,583
• Publication Number:
  US 20140121488A1
• Time in Patent Office: 1,631 Days
• 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 5/0031 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 5/1451 for interstitial fluid
• 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 5/6849 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 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take 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: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

Methods of determining when to activate an analyte, e.g. glucose, related alarm, such as a hypoglycemia alarm, of a continuous analyte monitor is provided. Also provided are systems, devices and kits. Embodiments include methods for determining when to activate an analyte alarm of a continuous analyte monitor. The methods may include receiving information from the continuous analyte monitor related to the user'"'"'s analyte concentration, wherein the information is received at a data processing component. The methods may also include receiving information that is input by the user, and the information is related to the user'"'"'s analyte concentration.

Claims

1. A computer-implemented method for determining when to activate an alarm of a continuous analyte monitor, comprising:

receiving, at a data processing component, information from a continuous analyte monitor related to a user'"'"'s analyte concentration;

determining, at the data processing component, the user'"'"'s analyte concentration using the information received from the continuous analyte monitor;

receiving, at the data processing component, information from the user related to the user'"'"'s analyte concentration;

determining, at the data processing component, a best-estimate of the user'"'"'s analyte concentration based upon the information from the continuous analyte monitor and information from the user;

determining, at the data processing component, at least one condition for activating alarm; and

modifying, at the data processing component, the at least one condition for activating the alarm based on a comparison between the determination of the user'"'"'s analyte concentration and the best-estimate of the user'"'"'s analyte concentration.

2. The method according to claim 1, wherein the best-estimate of the user'"'"'s analyte concentration includes a range of variance.

3. The method according to claim 2, wherein the best-estimate of the user'"'"'s analyte concentration is at least partially determined using at least one of a Kalman filter and other state observers.

4. The method according to claim 1, comprising:

activating, at the data processing component, the analyte alarm if at least one of a data signal related to the user'"'"'s analyte concentration satisfies the at least one determined condition.

5. The method according to claim 1, wherein the at least one condition for activating the analyte alarm includes receiving a data signal that indicates that the user'"'"'s analyte concentration has reached a threshold value.

6. The method according to claim 1, wherein the at least one condition includes that the user'"'"'s analyte concentration crosses a threshold value for a predetermined length of time.

7. The method according to claim 1, wherein when the comparison between the determination of the user'"'"'s analyte concentration and the best-estimate of the user'"'"'s analyte concentration are in high agreement with each other, this suggests an increased likelihood of true physiological events such as a hypoglycemic event.

8. The method according to claim 7, wherein when the comparison between the determination of the user'"'"'s analyte concentration and the best-estimate of the user'"'"'s analyte concentration suggests an increased likelihood of a hypoglycemic event, a threshold value is increased, and wherein when the comparison between the determination of the user'"'"'s analyte concentration and the best-estimate of the user'"'"'s analyte concentration suggests a low likelihood of a hypoglycemic event, the threshold value is decreased.

9. The method according to claim 1, wherein when the comparison between the determination of the user'"'"'s analyte concentration and the best-estimate of the user'"'"'s analyte concentration are in high agreement with each other, this suggests an increased likelihood of a true physiological events such as a hyperglycemic event.

10. The method according to claim 1, wherein the modification includes increasing or decreasing a threshold value of the user'"'"'s analyte concentration.

11. The method according to claim 1, wherein the modification includes increasing or decreasing a predetermined duration that the user'"'"'s analyte concentration may cross a threshold value.

12. The method according to claim 1, wherein the modification includes increasing or decreasing a threshold value for the user'"'"'s analyte concentration, and includes increasing or decreasing a predetermined duration that the user'"'"'s analyte concentration may cross the threshold value.

13. The method according to claim 1, wherein the information from the continuous analyte monitor includes at least one data signal.

14. An integrated analyte monitoring device assembly, comprising:

an analyte sensor for transcutaneous positioning through a skin layer and maintained in fluid contact with an interstitial fluid under the skin layer during a predetermined time period, the analyte sensor having a proximal portion and a distal portion; and

sensor electronics coupled to the analyte sensor, the sensor electronics comprising;

a circuit board having a conductive layer and a sensor antenna disposed on the conductive layer;

one or more electrical contacts provided on the circuit board and coupled with the proximal portion of the analyte sensor to maintain continuous electrical communication; and

a data processing component provided on the circuit board and in signal communication with the analyte sensor, the data processing component configured to execute one or more routines for processing signals received from the analyte sensor, the data processing component configured to control the transmission of data associated with the processed signals received from the analyte sensor to a remote location using the sensor antenna in response to a request signal received from the remote location, the data processing component configured to receive information from a continuous analyte monitor related to a user'"'"'s analyte concentration, the data processing component configured to determine the user'"'"'s analyte concentration using the information received from the continuous analyte monitor, the data processing component configured to receive data from the user related to the user'"'"'s analyte concentration, the data processing component configured to determine a best-estimate of the user'"'"'s analyte concentration based upon the information received from the continuous analyte monitor and the data received from the user at the data processing component, the data processing component configured to determine at least one condition for activating an alarm, the data processing component configured to modify the at least one condition for activating the alarm based on a comparison between the determination of the user'"'"'s analyte concentration and the best-estimate of the user'"'"'s analyte concentration.

15. The assembly according to claim 14, wherein the best-estimate of the user'"'"'s analyte concentration includes a range of variance.

16. The assembly according to claim 15, wherein the best-estimate of the user'"'"'s analyte concentration is at least partially determined using at least one of a Kalman filter and other state observers.

17. The assembly according to claim 14, wherein the data processing component is further configured to activate the alarm if at least one of the data signals related to the user'"'"'s analyte concentration and the best-estimate of the user'"'"'s analyte concentration satisfies the at least one determined condition.

18. The assembly according to claim 14, wherein the at least one condition for activating the alarm includes receiving a data signal that indicates that a user'"'"'s glucose concentration has reached a threshold value.

19. The assembly according to claim 14, wherein the at least one condition includes that the user'"'"'s analyte concentration crosses a threshold value for a predetermined length of time.

20. The assembly according to claim 14, wherein when the comparison between the determination of the user'"'"'s analyte concentration and the best-estimate of the user'"'"'s analyte concentration are in high agreement with each other, this suggests an increased likelihood of a hypoglycemic event.

21. The assembly according to claim 20, wherein when the comparison between the determination of the user'"'"'s analyte concentration and the best-estimate of the user'"'"'s analyte concentration suggests an increased likelihood of a hypoglycemic event, the threshold value is increased, and wherein when the comparison between the determination of the user'"'"'s analyte concentration and the best-estimate of the user'"'"'s analyte concentration suggests a low likelihood of a hypoglycemic event, a threshold value is decreased.

22. The assembly according to claim 14, wherein when the comparison between the determination of the user'"'"'s analyte concentration and the best-estimate of the user'"'"'s analyte concentration are in high agreement with each other, this suggests an increased likelihood of true physiological events such as a hyperglycemic event.

23. The assembly according to claim 14, wherein the modification includes increasing or decreasing a threshold value of a user'"'"'s glucose concentration.

24. The assembly according to claim 14, wherein the modification includes increasing or decreasing a predetermined duration that the user'"'"'s analyte concentration may cross a threshold value.

25. The assembly according to claim 14, wherein the modification includes increasing or decreasing a threshold value for the user'"'"'s analyte concentration, and includes increasing or decreasing a predetermined length of time that the user'"'"'s analyte concentration may cross the threshold value.

26. The assembly according to claim 14, wherein the information from the continuous analyte monitor includes at least one data signal.

27. An integrated analyte monitoring device, comprising:

a data processing component provided on a circuit board and in signal communication with a continuous analyte monitor, the data processing component configured to;

execute one or more routines for processing signals received from the continuous analyte monitor;

control the transmission of data associated with the processed signals received from the continuous analyte monitor to a remote location using an antenna in response to a request signal received from the remote location;

receive information from the continuous analyte monitor related to a user'"'"'s analyte concentration;

determine the user'"'"'s analyte concentration using the information received from the continuous analyte monitor;

receive data from the user related to the user'"'"'s analyte concentration;

determine a best-estimate of the user'"'"'s analyte concentration based upon the information received from the continuous analyte monitor and data received from the user at the data processing component;

determine at least one condition for activating an alarm; and

modify the at least one condition for activating the alarm based on a comparison between the determination of the user'"'"'s analyte concentration and the best-estimate of the user'"'"'s analyte concentration.