Closed loop control with improved alarm functions

• US 9,610,046 B2
• Filed: 04/29/2014
• Issued: 04/04/2017
• 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 Alan
• Primary Examiner(s): CARPENTER, WILLIAM R
• Application Number:
  US14/265,065
• Publication Number:
  US 20140235981A1
• Time in Patent Office: 1,071 Days
• 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:

determining a predictive glucose response based on prior monitored glucose sensor data and one or more exogenous factors;

detecting a condition associated with hypoglycemia including determining a level of uncertainty in a monitored glucose level based on a predicted or anticipated glucose level;

determining a probability that the detected condition associated with hypoglycemia corresponds to a hypoglycemic condition including determining whether glucose sensor data indicates a persistent low glucose level;

comparing the determined probability that the detected condition associated with hypoglycemia corresponds to the hypoglycemic condition, to a probability threshold level to confirm a presence of the hypoglycemic condition;

modifying a first medication delivery rate adjustment frequency to a second medication delivery rate adjustment frequency based on a variation in the monitored glucose level; and

determining periodically at the second medication delivery rate adjustment frequency whether to adjust a medication delivery rate.

2. The method of claim 1, further including outputting a notification when the determined probability exceeds the probability threshold level and after the presence of the hypoglycemic condition is confirmed, wherein outputting the notification reduces outputting false low glucose alarms based on a presence of a glucose sensor signal dropout or a glucose sensor early signal attenuation condition.

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

4. The method of claim 1, further comprising reverting to a pre-programmed medication delivery rate when the determined probability exceeds the probability threshold level, wherein the pre-programmed medication delivery rate is less than a delivery rate of an administration of a medication of a closed loop control operation.

5. The method of claim 1, further comprising delaying outputting a notification for a predetermined period of time when the determined probability exceeds the probability threshold level and after the presence of the hypoglycemic condition is confirmed.

6. The method of claim 5, wherein the predetermined period of time is based, at least in part, on a time required to determine whether the probability of the detected condition associated with hypoglycemia exceeds the probability threshold level.

7. The method of claim 1, wherein determining the level of uncertainty in the monitored glucose level includes determining a confidence level of an accuracy of the monitored glucose level, wherein the confidence level is based, at least in part, on at least one of an amount of insulin delivered, insulin on board information, and rate of change information.

8. The method of claim 1, further comprising:

determining whether detected glucose sensor anomalies exceed a preset safety level; and

when the detected glucose sensor anomalies exceed the preset safety level, administering a medication according to a pre-programmed delivery rate that is within the preset safety level.

9. The method of claim 8, further comprising disabling a closed loop control operation when a presence of the detected glucose sensor anomalies is not confirmed within a predetermined time period.

10. The method of claim 1, wherein the glucose level is monitored using a glucose sensor including a plurality of electrodes including a working electrode, wherein the working electrode comprises a glucose-responsive enzyme and a mediator, wherein at least one of the glucose-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode, and wherein at least one of the glucose-responsive enzyme and the mediator is crosslinked with the polymer.