Closed Loop Control With Improved Alarm Functions

• US 20100057042A1
• Filed: 08/31/2008
• Published: 03/04/2010
• Est. Priority Date: 08/31/2008
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Hayter, Gary
• Granted Patent: US 8,734,422 B2
• Time in Patent Office: Days
• US Class Current: 604/504
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• 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 5/7282 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: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades

Abstract

Methods, system and devices for monitoring control parameters in a closed loop control operation including continuously monitoring glucose level and automatic administration of a medication, detecting a condition associated with hypoglycemia, determining whether a probability of the detected condition associated with hypoglycemia exceeding a threshold level, and outputting a notification based upon the determination are provided.

Claims

1. A method, comprising:

monitoring control parameters in a closed loop control operation including continuously monitoring glucose level and automatic administration of a medication;

detecting a condition associated with hypoglycemia;

determining whether a probability of the detected condition associated with hypoglycemia exceeding a threshold level; and

outputting a notification based upon the determination.

2. The method of claim 1 including updating the closed loop control operation to modify the administration of the medication.

3. The method of claim 1 wherein the medication includes insulin or glucagon or a combination thereof.

4. The method of claim 1 wherein determining the probability of the detected condition includes:

retrieving the monitored glucose level over a predetermined time period; and

determining whether the signal level associated with the glucose level monitored indicates a persistent hypoglycemic condition.

5. The method of claim 1 wherein outputting the notification includes:

outputting an alert notification upon detection of the condition associated with hypoglycemia; and

outputting an alarm notification when the determined probability of the detected condition exceeds the threshold level.

6. The method of claim 5 wherein the alarm notification is more intense than the alert notification.

7. The method of claim 5 wherein the alert notification or the alarm notification includes one or more of a visual notification, an audible notification, a vibratory notification, or one or more combinations thereof.

8. The method of claim 1 wherein when the determined probability exceeds the threshold level, hypoglycemic condition is confirmed.

9. The method of claim 1 further including adjusting the rate of medication administration.

10. The method of claim 1 wherein the detected condition associated with hypoglycemia is derived from an analyte sensor signal.

11. A device, comprising:

one or more processors; and

a memory operatively coupled to the one or more processors, the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to monitor control parameters in a closed loop control operation including continuously monitoring glucose level and automatic administration of a medication, detect a condition associated with hypoglycemia, determine whether a probability of the detected condition associated with hypoglycemia exceeding a threshold level, and output a notification based upon the determination.

12. The device of claim 11 wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to update the closed loop control operation to modify the administration of the medication.

13. The device of claim 11 wherein the medication includes insulin or glucagon or a combination thereof.

14. The device of claim 11 wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to retrieve the monitored glucose level over a predetermined time period, and determine whether the signal level associated with the glucose level monitored indicates a persistent hypoglycemic condition.

15. The device of claim 11 wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to output an alert notification upon detection of the condition associated with hypoglycemia, and output an alarm notification when the determined probability of the detected condition exceeds the threshold level.

16. The device of claim 15 wherein the alarm notification is more intense than the alert notification.

17. The device of claim 15 wherein the alert notification or the alarm notification includes one or more of a visual notification, an audible notification, a vibratory notification, or one or more combinations thereof.

18. The device of claim 11 wherein when the determined probability exceeds the threshold level, hypoglycemic condition is confirmed.

19. The device of claim 11 wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to adjust the rate of medication administration.

20. The device of claim 11 wherein the detected condition associated with hypoglycemia is derived from an analyte sensor signal.