# US 9,750,439 B2 · Method and apparatus for providing notification function in analyte monitoring systems

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- Number: US 9,750,439 B2
- Document ID: US9750439B2
- Status: Granted
- Kind: B2
- Application number: 15/094,991
- Filed: 2016-04-08
- Published: 2016-08-04
- Granted: 2017-09-05
- Earliest claimed: 2009-09-29
- Assignees: Abbott Diabetes Care Inc.
- Applicants: Abbott Diabetes Care Inc.
- Inventors: Kenneth J. Doniger; Glenn Howard Berman; Geoffrey V. McGarraugh
- Web page: https://patentgrep.com/patent/US9750439B2

## CPC

- A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- 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 5/6846: {specially adapted to be brought in contact with an internal body part, i.e. invasive}
- A61B 5/7235: {Details of waveform analysis (detecting specific parameters of the electrocardiograph cycle A61B5/349)}
- A61B 5/746: {Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms}
- G16H 40/67: for remote operation
- 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

Method and apparatus for determining and outputting projected alarms or notifications associated with anticipated hyperglycemic or hypoglycemic conditions are provided. Systems and kits employing the devices described herein executing the one or more routines described are also provided.

## Claims

### Claim 1

An analyte monitoring system, comprising:
an analyte sensor in operative contact with an analyte, the sensor adapted to generate a plurality of data points associated with a monitored analyte concentration;
an alarm associated with the monitored analyte concentration;
a processor adapted to process the plurality of data points generated by the analyte sensor; and
logic implemented by the processor to:
determine whether a current data point of the plurality of data points is within a predetermined threshold zone, wherein if it is determined that the current data point is within the predetermined threshold zone, the logic implemented by the processor determines a rate of change of an analyte level based on the plurality of data points;
determine if the rate of change indicates a projected glucose value exceeding an alarm threshold within a predetermined amount of time;
perform a line fit analysis of a slope based on the plurality of data points associated with the monitored analyte concentration;
assert the alarm associated with the monitored analyte concentration when the determined rate of change indicates that the projected glucose value will exceed the alarm threshold within the predetermined amount of time, and when the line fit analysis of the slope is not within an acceptable level; and
control administration of a therapy based on the assertion of the alarm associated with the monitored analyte concentration.

### Claim 2 (depends on 1)

The system of claim 1, further comprising logic implemented by the processor to perform an anticipated alarm condition persistence evaluation.

### Claim 3 (depends on 1)

The system of claim 1, wherein the logic implemented by the processor performs the line fit analysis of the slope by at least determining a mean value error based on the plurality of data points within a predetermined deviation range.

### Claim 4 (depends on 3)

The system of claim 3, wherein the predetermined deviation range is about 10%.

### Claim 5 (depends on 1)

The system of claim 1, further comprising the logic implemented by the processor to evaluate an anticipated alarm condition persistence including determining that the determined rate of change indicates that the projected glucose value exceeds the alarm condition during the predetermined amount of time.

### Claim 6 (depends on 5)

The system of claim 5, wherein the anticipated alarm condition is one of an anticipated hypoglycemic condition or an anticipated hyperglycemic condition.

### Claim 7 (depends on 5)

The system of claim 5, wherein the predetermined amount of time includes a consecutive time period spanning about 30 minutes or less, about 25 minutes or less, about 20 minutes or less, about 15 minutes or less, or about 10 minutes or less.

### Claim 8 (depends on 1)

The system of claim 1, wherein the logic implemented by the processor determines the rate of change based on a least squares technique.

### Claim 9 (depends on 1)

The system of claim 1, wherein the acceptable level of the slope of the line fit includes an acceptable level of mean square error based on the plurality of data points associated with the monitored analyte concentration.

### Claim 10

An apparatus, comprising:
an alarm;
a processor; and
a memory storing instructions which, when executed by the processor, causes the processor to:
receive a plurality of data points associated with a monitored analyte concentration, the plurality of data points generated by an analyte sensor in operative contact with an analyte;
determine whether a current data point of the plurality of data points is within a predetermined threshold zone, wherein if it is determined that the current data point is within the predetermined threshold zone, the processor determines a rate of change of an analyte level based on the plurality of data points;
determine if the rate of change indicates a projected glucose value exceeding an alarm threshold within a predetermined amount of time;
perform a line fit analysis of a slope based on the plurality of data points associated with the monitored analyte concentration;
assert the alarm when the determined rate of change indicates that the projected glucose value will exceed the alarm threshold within the predetermined amount of time, and when the line fit analysis of the slope is not within an acceptable level; and
control administration of a therapy based on the assertion of the alarm associated with the monitored analyte concentration.

### Claim 11 (depends on 10)

The apparatus of claim 10, further comprising instructions which cause the processor to perform an anticipated alarm condition persistence evaluation.

### Claim 12 (depends on 10)

The apparatus of claim 10, wherein the instructions cause the processor to perform the line fit analysis of the slope by at least determining a mean value error based on the plurality of data points within a predetermined deviation range.

### Claim 13 (depends on 12)

The apparatus of claim 12, wherein the predetermined deviation range is about 10%.

### Claim 14 (depends on 10)

The apparatus of claim 10, further comprising instructions which cause the processor to evaluate an anticipated alarm condition persistence including determining that the determined rate of change indicates that the projected glucose value exceeds the alarm condition during the predetermined amount of time.

### Claim 15 (depends on 14)

The apparatus of claim 14, wherein the anticipated alarm condition is one of an anticipated hypoglycemic condition or an anticipated hyperglycemic condition.

### Claim 16 (depends on 14)

The apparatus of claim 14, wherein the predetermined amount of time includes a consecutive time period spanning about 30 minutes or less, about 25 minutes or less, about 20 minutes or less, about 15 minutes or less, or about 10 minutes or less.

### Claim 17 (depends on 10)

The apparatus of claim 10, wherein the instructions cause the processor to determine the rate of change based on a least squares technique.

### Claim 18 (depends on 10)

The apparatus of claim 10, wherein the acceptable level of the slope of the line fit includes an acceptable level of mean square error based on the plurality of data points associated with the monitored analyte concentration.
