# US 11,026,640 B1 · Systems and methods for dynamically and intelligently monitoring a host's glycemic condition after an alert is triggered

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- Number: US 11,026,640 B1
- Document ID: US11026640B1
- Status: Granted
- Kind: B1
- Application number: 17/157,623
- Filed: 2021-01-25
- Published: 2021-05-20
- Granted: 2021-06-08
- Earliest claimed: 2012-10-30
- Assignees: DexCom, Inc.
- Applicants: DexCom, Inc.
- Inventors: Hari Hampapuram; Anna Leigh Davis; Naresh C. Bhavaraju; Apurv Ullas Kamath; Claudio Cobelli; Giovanni Sparacino; Andrea Facchinetti; Chiara Zecchin
- Web page: https://patentgrep.com/patent/US11026640B1

## CPC

- A61B 5/746: {Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms}
- A61B 5/0004: {characterised by the type of physiological signal transmitted}
- A61B 5/0022: {Monitoring a patient using a global network, e.g. telephone networks, internet}
- A61B 5/0031: {Implanted circuitry}
- 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)}
- A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- A61B 5/4848: {Monitoring or testing the effects of treatment, e.g. of medication}
- A61B 5/4866: {Evaluating metabolism (using breath test A61B5/083)}
- A61B 5/7221: {Determining signal validity, reliability or quality (preventing, reducing or removing noise induced by motion artefacts A61B5/7207; noise originating from a therapeutic or surgical apparatus A61B5/7217)}
- 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}
- G16H 40/67: for remote operation
- G16H 50/30: for calculating health indices; for individual health risk assessment
- A61B 5/002: {Monitoring the patient using a local or closed circuit, e.g. in a room or building (A61B5/0017 takes precedence)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

Systems and methods for providing sensitive and specific alarms indicative of glycemic condition are provided herein. In an embodiment, a method of processing sensor data by a continuous analyte sensor includes: evaluating sensor data using a first function to determine whether a real time glucose value meets a first threshold; evaluating sensor data using a second function to determine whether a predicted glucose value meets a second threshold; activating a hypoglycemic indicator if either the first threshold is met or if the second threshold is predicted to be met; and providing an output based on the activated hypoglycemic indicator.

## Claims

### Claim 1

A method of activating a glycemic indicator based on continuous glucose sensor data, the method comprising:
evaluating sensor data to determine whether a first real time glucose value meets one or more user settable first criteria;
evaluating sensor data to determine whether a second real time glucose value meets one or more non user settable second criteria;
activating a glycemic indicator if one of the one or more user settable first criteria is met or if one of the one or more non user settable second criteria is met; and
providing an output based on the activated glycemic indicator.

### Claim 2 (depends on 1)

The method of claim 1, wherein the glycemic indicator comprises a hypoglycemic indicator.

### Claim 3 (depends on 2)

The method of claim 2, wherein the one or more user settable first criteria comprise a first low threshold that is configured to be user settable.

### Claim 4 (depends on 2)

The method of claim 2, wherein the one or more non user settable second criteria comprise a second low threshold that is not user settable.

### Claim 5 (depends on 1)

The method of claim 1, wherein the glycemic indicator comprises a hyperglycemic indicator.

### Claim 6 (depends on 5)

The method of claim 5, wherein the one or more user settable first criteria comprise a first high threshold that is configured to be user settable.

### Claim 7 (depends on 5)

The method of claim 5, wherein the one or more non user settable second criteria comprise a second high threshold that is not user settable.

### Claim 8 (depends on 1)

The method of claim 1, wherein the evaluating sensor data to determine whether a first real time glucose value meets one or more user settable first criteria comprise determining whether the first real time glucose value passes a glucose threshold.

### Claim 9 (depends on 1)

The method of claim 1, wherein the evaluating sensor data to determine whether a second real time glucose value meets one or more non user settable second criteria comprises determining whether the second real time glucose value passes a glucose threshold.

### Claim 10 (depends on 1)

The method of claim 1, wherein the evaluating sensor data to determine whether a second real time glucose value meets one or more non user settable second criteria comprises determining whether an amplitude of rate of change or direction of rate of change meets a rate of change criterion.

### Claim 11 (depends on 1)

The method of claim 1, wherein the one or more second criteria comprise a fixed predetermined glucose threshold.

### Claim 12 (depends on 11)

The method of claim 11, wherein the fixed predetermined glucose threshold is factory set such that the user is not able to modify the fixed predetermined threshold.

### Claim 13 (depends on 1)

The method of claim 1, wherein the glycemic indicator comprises an indicator that has a particular set of instructions associated with it depending on whether the glycemic indicator was activated based on sensor data meeting the one or more user settable first criteria or whether the glycemic indicator was activated based on sensor data meeting the one or more non user settable second criteria.

### Claim 14 (depends on 1)

The method of claim 1, wherein the output comprises at least one of an audible, tactile or visual output.

### Claim 15 (depends on 1)

The method of claim 1, wherein the output is differentiated and/or provides information selectively based on whether the glycemic indicator was activated based on the first real time glucose value meeting the one or more user settable first criteria or whether the glycemic indicator was activated based on the second real time glucose value meeting the one or more non user settable second criteria.

### Claim 16

A device configured to provide glycemic indicators based on continuous glucose sensor data, the device comprising:
one or more processors configured to receive and process sensor data derived from sensor signals generated by a transcutaneous analyte sensor configured to be implanted within a body, wherein one or more of the one or more processors is configured to:
evaluate sensor data to determine whether a first real time glucose value meets one or more user settable first criteria;
evaluate sensor data to determine whether a second real time glucose value meets one or more non user settable second criteria;
activate a first glycemic indicator if one of the one or more user settable first criteria is met or activate a second glycemic indicator if one of the one or more non user settable second criteria is met; and
provide an output based on the activated glycemic indicator.

### Claim 17 (depends on 16)

The device of claim 16, wherein each of the first glycemic indicator and the second glycemic indicator comprises a hypoglycemic indicator.

### Claim 18 (depends on 17)

The device of claim 17, wherein the one or more user settable first criteria comprise a first low threshold that is configured to be user settable and wherein the one or more non user settable second criteria comprise a second low threshold that is not user settable.

### Claim 19 (depends on 16)

The device of claim 16, wherein each of the first glycemic indicator and the second glycemic indicator comprises a hyperglycemic indicator.

### Claim 20 (depends on 19)

The device of claim 19, wherein the one or more user settable first criteria comprise a first high threshold that is configured to be user settable and wherein the one or more non user settable second criteria comprise a second high threshold that is not user settable.

### Claim 21 (depends on 16)

The device of claim 16, wherein the evaluating sensor data to determine whether a first real time glucose value meets one or more user settable first criteria comprises determining whether the first real time glucose value passes a glucose threshold.

### Claim 22 (depends on 16)

The device of claim 16, wherein the evaluating sensor data to determine whether a second real time glucose value meets one or more non user settable second criteria comprises determining whether the second real time glucose value passes a glucose threshold.

### Claim 23 (depends on 16)

The device of claim 16, wherein the evaluating sensor data to determine whether a second real time glucose value meets one or more non user settable second criteria comprises determining whether an amplitude of rate of change or direction of rate of change meets a rate of change criterion.

### Claim 24 (depends on 16)

The device of claim 16, wherein the one or more non user settable second criteria comprise a fixed predetermined glucose threshold.

### Claim 25 (depends on 24)

The device of claim 24, wherein the fixed predetermined glucose threshold is factory set such that a user is not able to modify the fixed predetermined threshold.

### Claim 26 (depends on 16)

The device of claim 16, wherein each of the first glycemic indicator and the second glycemic indicator comprises an indicator that has a particular set of instructions associated with it depending on whether the first glycemic indicator was activated based on sensor data meeting the one or more user settable first criteria or whether the second glycemic indicator was activated based on sensor data meeting the one or more non user settable second criteria.

### Claim 27 (depends on 16)

The device of claim 16, wherein the output is differentiated and/or provides information selectively based on whether the first glycemic indicator was activated based on the first real time glucose value meeting the one or more user settable first criteria or whether the second glycemic indicator was activated based on the second real time glucose value meeting the one or more non user settable second criteria.

### Claim 28

A non-transitory computer-readable medium storing instructions that are configured to cause a computing system to perform a method comprising:
evaluating sensor data to determine whether a first real time glucose value meets one or more user settable first criteria;
evaluating sensor data to determine whether a second real time glucose value meets one or more non user settable second criteria;
activating a glycemic indicator if one of the one or more user settable first criteria is met or if one of the one or more non user settable second criteria is met; and
providing an output based on the activated glycemic indicator.

### Claim 29 (depends on 16)

The device of claim 16, wherein the at least one of the one or more processors is further configured to:
evaluate sensor data to determine whether a predicted glucose value meets one or more third criteria;
activate a third glycemic indicator if the one or more third criteria are met; and
provide the output based on the third glycemic indicator being activated.

### Claim 30 (depends on 29)

The device of claim 29, wherein the one or more third criteria comprise one or more criteria determined based on the second criteria.

### Claim 31 (depends on 29)

The device of claim 29, wherein the one or more third criteria comprise one or more non user settable: thresholds.

### Claim 32 (depends on 16)

The device of claim 16, wherein at least one of the one or more processors is communicably coupled to sensor electronics coupled to the transcutaneous analyte sensor, the sensor electronics configured to receive one or more sensor signals from the transcutaneous analyte sensor.

### Claim 33 (depends on 32)

The device of claim 32, wherein the sensor electronics is configured to process the one or more sensor signals and generate data representative of the processed sensor signals for deriving the sensor data.

### Claim 34 (depends on 16)

The device of claim 16, wherein the device comprises sensor electronics operably connected to the transcutaneous analyte sensor.

### Claim 35 (depends on 16)

The device of claim 16, wherein the device is a hand-held receiver.

### Claim 36

A method of activating a glycemic indicator based on glucose sensor data, the method comprising:
evaluating sensor data to determine whether a first real time glucose value meets one or more user settable first criteria;
evaluating sensor data to determine whether a second real time glucose value meets one or more non user settable second criteria;
evaluating sensor data to determine whether a predicted glucose value meets one or more third criteria;
activating a glycemic indicator if one of the one or more user settable first criteria is met, if one of the one or more non user settable second criteria is met or if the one or more third criteria are met; and
providing an output based on the activated glycemic indicator.

### Claim 37 (depends on 36)

The method of claim 36, wherein the one or more third criteria comprise one or more criteria determined based on the first criteria.

### Claim 38 (depends on 36)

The method of claim 36, wherein the one or more third criteria comprise one or more criteria determined based on the second criteria.

### Claim 39 (depends on 36)

The method of claim 36, wherein the one or more third criteria comprise one or more non user settable thresholds.
