Alarm characterization for analyte monitoring devices and systems

• US 9,326,707 B2
• Filed: 11/10/2009
• Issued: 05/03/2016
• Est. Priority Date: 11/10/2008
• Status: Expired due to Fees

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Inventors: McGarraugh, Geoffrey V.
• Primary Examiner(s): JANG, CHRISTIAN YONGKYUN
• Application Number:
  US12/616,129
• Publication Number:
  US 20100121167A1
• Time in Patent Office: 2,366 Days
• Field of Search: 600/345, 600/347, 600/365
• US Class Current: 1/1
• 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 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• 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

Abstract

Methods and apparatus including determining a rate of occurrence of a glycemic excursion event, determining a frequency of an alarm activation associated with the glycemic excursion event, determining an analyte level associated with the alarm activation, and setting an alarm parameter based on one or more of the determined rate of occurrence of the glycemic excursion event, the frequency of the alarm activation associated with the glycemic excursion event or the determined analyte level are provided.

Claims

1. A method, comprising:

positioning an in vivo analyte sensor in fluid contact with interstitial fluid under a skin surface;

monitoring an analyte level in the interstitial fluid with the in vivo analyte sensor;

determining, using one or more processors, a rate of occurrence of a glycemic excursion event based on the monitored analyte level;

determining, using the one or more processors, a number of alarm activations associated with the glycemic excursion event based on the monitored analyte level;

setting, using the one or more processors, a parameter for the alarm activation based on the determined rate of occurrence of the glycemic excursion event and the number of alarm activations associated with the glycemic excursion event, wherein setting the parameter for the alarm activation is programmable; and

controlling administration of therapy based on the parameter for the alarm activation.

2. The method of claim 1, wherein the glycemic excursion event includes one of a hypoglycemic event or a hyperglycemic event.

3. The method of claim 1, further including determining an analyte level associated with the alarm activation based at least in part on analyte sensor data from the in vivo analyte sensor.

4. The method of claim 3, including determining a rate of change of the analyte level associated with the glycemic excursion event or the alarm activation, or a combination thereof.

5. The method of claim 3, wherein the transcutaneous analyte sensor comprises a plurality of electrodes including a working electrode, wherein the working electrode comprises an analyte-responsive enzyme and a mediator, wherein at least one of the analyte-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode, and wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer.

6. The method of claim 1, wherein determining the rate of occurrence of the glycemic excursion event includes:

monitoring a glucose level for a predetermined time period;

detecting the monitored glucose level transcending a predetermined threshold glucose level; and

determining the rate of occurrence based on the detected monitored glucose level transcending the predetermined threshold glucose level within the predetermined time period.

7. The method of claim 1, including programming an alarm function based on the parameter for the alarm activation.

8. The method of claim 1, wherein the number of alarm activations is a number of alarm occurrences over a predetermined time period, and wherein setting the parameter for the alarm activation includes modifying a threshold level of the alarm activation based on determining the number of alarm activations.

9. The method of claim 1, wherein modifying the parameter for the alarm activation is programmable to reduce the rate of occurrence of the glycemic excursion event.

10. The method of claim 1, including generating a notification function associated with an analyte monitoring system when the programmable parameter for the alarm activation is set.

11. The method of claim 10, wherein the notification function includes outputting information corresponding to the set parameter for the alarm activation.

12. An apparatus, comprising:

an interface component;

one or more processors operatively coupled to the interface component; and

a memory storing instructions which, when executed by the one or more processors, causes the one or more processors to determine a rate of occurrence of a glycemic excursion event based on monitored analyte level from an in vivo analyte sensor in fluid contact with interstitial fluid under a skin surface, determine a number of alarm activations associated with the glycemic excursion event based on the monitored analyte level, and set a parameter for the alarm activation based on the determined rate of occurrence of the glycemic excursion event and the frequency of the alarm activation associated with the glycemic excursion event, and control administration of therapy based on the parameter for the alarm activation, wherein setting the parameter for the alarm activation is programmable.

13. The apparatus of claim 12, wherein the glycemic excursion event includes one of a hypoglycemic event or a hyperglycemic event.

14. The apparatus of claim 12, wherein the memory storing instructions which, when executed by the one or more processors, causes the one or more processors to determine an analyte level associated with the alarm activation based at least in part on analyte sensor data from the in vivo analyte sensor.

15. The apparatus of claim 14, wherein the transcutaneous analyte sensor comprises a plurality of electrodes including a working electrode, wherein the working electrode comprises an analyte-responsive enzyme and a mediator, wherein at least one of the analyte-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode, and wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer.

16. The apparatus of claim 12, wherein the memory storing instructions which, when executed by the one or more processors, causes the one or more processors to monitor a glucose level for a predetermined time period, detect the monitored glucose level transcending a predetermined threshold glucose level, and determine the rate of occurrence based on the detected monitored glucose level transcending the predetermined threshold glucose level within the predetermined time period.

17. The apparatus of claim 12, wherein the memory storing instructions which, when executed by the one or more processors, causes the one or more processors to determine a rate of change of an analyte level associated with the glycemic excursion event or the alarm activation, or a combination thereof.

18. The apparatus of claim 12, wherein the memory storing instructions which, when executed by the one or more processors, causes the one or more processors to program an alarm function based on the parameter for the alarm activation.

19. The apparatus of claim 12, wherein the interface component includes an output unit, and further, wherein the parameter for the alarm activation is displayed on the output unit.

20. The apparatus of claim 12, wherein the number of alarm activations is a number of occurrences of the alarm activation over a predetermined time period, and wherein the memory storing instructions which, when executed by the one or more processors, causes the one or more processors to modify a threshold level of the alarm activation based at least in part on the number of alarm activations over a predetermined time period.

21. A method, comprising:

monitoring an analyte level based on one or more signals generated from a factory calibrated in vivo analyte sensor in fluid contact with interstitial fluid;

determining, using one or more processors, a number of alarm activations associated with a glycemic excursion event based on the monitored analyte level;

setting, using the one or more processors, a parameter for the alarm activation based on a determined rate of occurrence of the glycemic excursion event and the number of alarm activations associated with the glycemic excursion event;

outputting a notification associated with the parameter for the alarm activation; and

controlling administration of therapy based on the parameter for the alarm activation;

wherein the parameter for the alarm activation is updated after outputting the notification associated with the parameter for the alarm activation.

22. The method of claim 21, wherein the in vivo analyte sensor is calibrated without an in vitro analyte measurement obtained when the one or more signals are generated from the in vivo analyte sensor.