Alarm characterization for analyte monitoring devices and systems

• US 9,730,650 B2
• Filed: 01/15/2016
• Issued: 08/15/2017
• Est. Priority Date: 11/10/2008
• Status: Expired due to Fees

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: McGarraugh, Geoffrey V.
• Primary Examiner(s): JANG, CHRISTIAN YONGKYUN
• Application Number:
  US14/997,463
• Publication Number:
  US 20160128645A1
• Time in Patent Office: 578 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 5/145 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 performed by one or more processors, the method comprising:

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;

setting an alarm parameter based on at least two of (i) the determined rate of occurrence of the glycemic excursion event, (ii) the frequency of the alarm activation associated with the glycemic excursion event or (iii) the determined analyte level; and

controlling an administration of a therapy based on the alarm parameter.

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 an 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 in vivo 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 frequency of the alarm activation 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 associated with an analyte monitoring system based on the alarm parameter.

11. 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, determine a frequency of alarm activation associated with the glycemic excursion event, determine an analyte level associated with the alarm activation, set an alarm parameter based on at least two of (i) the determined rate of occurrence of the glycemic excursion event, (ii) the frequency of the alarm activation associated with the glycemic excursion event, or (iii) the determined analyte level; and

control an administration of a therapy based on the alarm parameter.

12. The apparatus of claim 11, wherein the glycemic excursion event includes one of a hypoglycemic event or a hyperglycemic event.

13. The apparatus of claim 11, wherein the memory stores 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 an in vivo analyte sensor.

14. The apparatus of claim 13, wherein the in vivo 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.

15. The apparatus of claim 11, wherein the memory stores 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.

16. The apparatus of claim 11, wherein the memory stores 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.

17. The apparatus of claim 11, wherein the memory stores 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.

18. The apparatus of claim 11, wherein the interface component includes an output unit, and further, wherein the parameter for the alarm activation is displayed on the output unit.