# US 10,117,606 B2 · Method and apparatus for detecting false hypoglycemic conditions

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 10,117,606 B2
- Document ID: US10117606B2
- Status: Granted
- Kind: B2
- Application number: 14/730,077
- Filed: 2015-06-03
- Published: 2015-09-24
- Granted: 2018-11-06
- Earliest claimed: 2009-10-30
- Assignees: Abbott Diabetes Care Inc.
- Applicants: Abbott Diabetes Care Inc.
- Inventors: Benjamin Jay Feldman; Adam Heller; Namvar Kiaie
- Web page: https://patentgrep.com/patent/US10117606B2

## CPC

- A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- A61B 5/01: Measuring temperature of body parts {; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue} (clinical contact thermometers G01K13/20)
- A61B 5/1451: {for interstitial fluid}
- A61B 5/14546: {for measuring analytes not otherwise provided for, e.g. ions, cytochromes}
- A61B 5/14865: {invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors}
- A61B 5/746: {Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Embodiments of the present disclosure include detecting a concurrent occurrence of a decrease in monitored analyte level and a corresponding decrease in monitored on-skin temperature, confirming a presence of an impending hypoglycemic condition, and asserting a notification corresponding to the confirmed impending hypoglycemic condition. Devices, methods, systems and kits incorporating the same are also provided.

## Claims

### Claim 1

A system, comprising:
an analyte sensor positioned in fluid contact with interstitial fluid under a skin layer and configured to generate signals corresponding to a monitored analyte level in the interstitial fluid;
sensor electronics electrically coupled to the analyte sensor and configured to generate analyte data based on the signals generated by the analyte sensor; and
a data receiver configured to receive the generated analyte data from the sensor electronics, the data receiver configured to trigger a hold assertion function to temporarily prevent the assertion of a programmed notification after the programmed notification has initiated when a rate of change of the monitored analyte level determined from the generated analyte data exceeds a predetermined analyte threshold during a monitoring time period, and to assert the programmed notification when the rate of change of a monitored temperature exceeds a predetermined temperature threshold during the monitoring time period.

### Claim 2 (depends on 1)

The system of claim 1, wherein the predetermined analyte threshold includes a decreasing rate of the analyte level of approximately 2 mg/dL/minute.

### Claim 3 (depends on 1)

The system of claim 1, wherein the asserted programmed notification indicates a hypoglycemic condition.

### Claim 4 (depends on 1)

The system of claim 1, wherein the data receiver is configured to assert the programmed notification when a direction of the analyte level rate of change and a direction of the monitored temperature rate of change are the same.

### Claim 5 (depends on 1)

The system of claim 1, wherein the monitored analyte level includes one or more of glucose level or lactate level.

### Claim 6 (depends on 1)

The system of claim 1, wherein the data receiver is configured to receive monitored temperature information to determine the rate of change of the monitored temperature.

### Claim 7 (depends on 1)

The system of claim 1, wherein the predetermined temperature threshold includes a decreasing rate of a temperature level of approximately 2° C./15 minutes.

### Claim 8 (depends on 1)

The system of claim 1, wherein the analyte sensor includes a plurality of electrodes including a working electrode comprising an analyte-responsive enzyme bonded to a polymer disposed on the working electrode.

### Claim 9 (depends on 8)

The system of claim 8, wherein the analyte-responsive enzyme is chemically bonded to the polymer disposed on the working electrode.

### Claim 10 (depends on 8)

The system of claim 8, wherein the working electrode comprises a mediator bonded to the polymer disposed on the working electrode.

### Claim 11 (depends on 10)

The system of claim 10, wherein the mediator is crosslinked with the polymer disposed on the working electrode.

### Claim 12 (depends on 1)

The system of claim 1, wherein the analyte sensor includes a plurality of electrodes including a working electrode comprising a mediator bonded to a polymer disposed on the working electrode.

### Claim 13

A system, comprising
sensor electronics configured to receive signals from an analyte sensor in fluid contact with interstitial fluid, and to generate analyte data corresponding to a monitored analyte level in interstitial fluid; and
a data receiver configured to receive the generated analyte data from the sensor electronics, the data receiver configured to temporarily prevent the assertion of a programmed notification after the programmed notification has initiated when a rate of change of the monitored analyte level determined from the generated analyte data exceeds a predetermined analyte threshold during a monitoring time period, but to assert the programmed notification when a rate of change of a monitored temperature exceeds a predetermined temperature threshold during the monitoring time period.

### Claim 14 (depends on 13)

The system of claim 13, wherein the predetermined analyte threshold includes a decreasing rate of the analyte level of approximately 2 mg/dL/minute.

### Claim 15 (depends on 13)

The system of claim 13, wherein the predetermined temperature threshold includes a decreasing rate of a temperature level of approximately 2° C./15 minutes.

### Claim 16 (depends on 13)

The system of claim 13, wherein the data receiver is configured to assert the programmed notification when a direction of the analyte level rate of change and a direction of the temperature level rate of change are the same.
