# US 11,298,056 B2 · Methods and systems for early signal attenuation detection and processing

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- Number: US 11,298,056 B2
- Document ID: US11298056B2
- Status: Granted
- Kind: B2
- Application number: 17/411,154
- Filed: 2021-08-25
- Published: 2021-12-09
- Granted: 2022-04-12
- Earliest claimed: 2009-04-29
- Assignees: Abbott Diabetes Care Inc.
- Applicants: Abbott Diabetes Care Inc.
- Inventors: Wesley Scott Harper
- Web page: https://patentgrep.com/patent/US11298056B2

## CPC

- A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- A61B 5/1473: invasive, e.g. introduced into the body by a catheter
- A61B 5/1495: Calibrating or testing of in-vivo probes
- G01D 18/00: Testing or calibrating apparatus or arrangements provided for in groups G01D1/00 - G01D15/00
- G01N 31/22: using chemical indicators (G01N31/02 takes precedence)
- G01N 33/66: involving blood sugars, e.g. galactose
- G16H 40/40: for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G01D: MEASURING NOT SPECIALLY ADAPTED FOR A SPECIFIC VARIABLE; ARRANGEMENTS FOR MEASURING TWO OR MORE VARIABLES NOT COVERED IN A SINGLE OTHER SUBCLASS; TARIFF METERING APPARATUS; MEASURING OR TESTING NOT OTHERWISE PROVIDED FOR
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

Provided are methods and apparatus for receiving sensor data from an analyte sensor of a sensor monitoring system, processing the received sensor data with time corresponding calibration data, outputting the processed sensor data, detecting one or more adverse conditions associated with the sensor monitoring system, disabling the output of the sensor data during the adverse condition time period, determining that the one or more detected adverse conditions is no longer present in the sensor monitoring system, retrieving the sensor data during the adverse condition time period, processing the retrieved sensor data during the adverse condition time period, and outputting the processed retrieved sensor data.

## Claims

### Claim 1

A glucose monitoring system for backfilling data gaps that occur while a user monitors glucose levels, the glucose monitoring system comprising:
a glucose sensor, a portion of which is configured to be positioned under skin of the user, wherein the glucose sensor is configured to sample a biological fluid of the user to provide sensor data;
a data processing and transmitter unit coupled to the glucose sensor, the data processing and transmitter unit comprising a power supply, a processor of the data processing and transmitter unit, memory of the data processing and transmitter unit, and a radio frequency transceiver of the data processing and transmitter unit, wherein the data processing and transmitter unit is configured to:
receive the sensor data from the glucose sensor and store the sensor data in the memory of the data processing and transmitter unit;
process the sensor data using calibration data to provide processed sensor data, wherein the calibration data comprises data associated with a sensitivity of the glucose sensor, and wherein the processed sensor data is stored in the memory of the data processing and transmitter unit; and
transmit the processed sensor data over a Bluetooth wireless communication link using the radio frequency transceiver of the data processing and transmitter unit; and
a receiver unit comprising a processor of the receiver unit, memory of the receiver unit, a radio frequency transceiver of the receiver unit, an antenna, and a display, wherein the receiver unit is configured to:
receive, using the antenna and the radio frequency transceiver of the receiver unit, the processed sensor data over the Bluetooth wireless communication link,
output to the display of the receiver unit, a numerical value representing the processed sensor data,
output to the display of the receiver unit, a first line graph that is a substantially continuous depiction of the processed sensor data over time,
wherein the glucose monitoring system is configured to detect an adverse condition, wherein the adverse condition results in the receiver unit displaying a data gap such that the first line graph displayed on the receiver unit has an end corresponding to a time associated with a start of the adverse condition;
wherein, during a time period corresponding to the adverse condition, sensor data, processed sensor data, or both, are stored in the memory of the data processing and transmitter unit;
wherein the receiver unit is configured to output to the display, after the adverse condition is corrected, processed sensor data for the time period corresponding to the adverse condition such that the data gap is backfilled, and
wherein the processed sensor data for the time period corresponding to the adverse condition that is outputted to the display after the adverse condition is corrected comprises a second line graph having a first end corresponding to the time associated with the start of the adverse condition and a second end corresponding to a time associated with an end of the adverse condition.

### Claim 2 (depends on 1)

The glucose monitoring system of claim 1, wherein the first line graph and the second line graph are outputted to a same graph comprising a first axis having a time unit of measurement and a second axis having a glucose concentration unit of measurement.

### Claim 3 (depends on 1)

The glucose monitoring system of claim 1, wherein the adverse condition comprises a sensor communication error.

### Claim 4 (depends on 1)

The glucose monitoring system of claim 1, wherein the adverse condition comprises a signal error associated with the glucose sensor.

### Claim 5 (depends on 1)

The glucose monitoring system of claim 1, wherein the adverse condition comprises a signal error associated with the data processing and transmitter unit.

### Claim 6 (depends on 1)

The glucose monitoring system of claim 1, wherein the adverse condition comprises a signal error associated with the receiver unit.

### Claim 7 (depends on 1)

The glucose monitoring system of claim 1, wherein the adverse condition comprises a system malfunction associated with the data processing and transmitter unit or a system malfunction associated with the receiver unit.

### Claim 8 (depends on 1)

The glucose monitoring system of claim 1, wherein the adverse condition comprises an inability of the receiver unit to display or output at least a portion of the the first line graph.

### Claim 9 (depends on 1)

The glucose monitoring system of claim 1, wherein the adverse condition comprises a sensor instability condition.

### Claim 10 (depends on 1)

The glucose monitoring system of claim 1, wherein the adverse condition comprises a calibration failure condition.

### Claim 11 (depends on 1)

The glucose monitoring system of claim 1, wherein the adverse condition comprises a monitoring system failure condition.

### Claim 12 (depends on 1)

The glucose monitoring system of claim 1, wherein the glucose sensor comprises a working electrode and a counter electrode.

### Claim 13 (depends on 1)

The glucose monitoring system of claim 1, wherein the adverse condition comprises a sensor misposition error.

### Claim 14 (depends on 1)

The glucose monitoring system of claim 1, wherein the on body unit further comprises a temperature sensor, and wherein the adverse condition comprises a temperature measurement outside a predetermined range.

### Claim 15 (depends on 1)

The glucose monitoring system of claim 1, wherein the adverse condition comprises an analyte level exceeding a predetermined threshold.

### Claim 16 (depends on 1)

The glucose monitoring system of claim 1, wherein the adverse condition comprises a rate of change of an analyte level exceeding a predetermined threshold.

### Claim 17 (depends on 1)

The glucose monitoring system of claim 1, wherein the adverse condition comprises a data unavailability condition.

### Claim 18 (depends on 1)

The glucose monitoring system of claim 1, wherein the receiver unit is further configured to display the second line graph immediately after the correction of the adverse condition.

### Claim 19 (depends on 1)

The glucose monitoring system of claim 1, wherein the receiver unit is further configured to wait a predetermined period of time after the correction of the adverse condition before displaying the second line graph.

### Claim 20 (depends on 1)

The glucose monitoring system of claim 1, wherein the data processing and transmitter unit, the receiver unit, or both is further configured to store time information associated with the adverse condition.

### Claim 21 (depends on 1)

The glucose monitoring system of claim 1, wherein the data processing and transmitter unit and at least a portion of the glucose sensor are disposed within a single integrated housing.

### Claim 22 (depends on 1)

The glucose monitoring system of claim 1, wherein the receiver unit comprises a mobile phone.

### Claim 23 (depends on 1)

The glucose monitoring system of claim 1, wherein the time period associated with the adverse condition comprises at least one hour.

### Claim 24 (depends on 1)

The glucose monitoring system of claim 1, wherein the glucose monitoring system is further configured for periodic calibration, and wherein the calibration data is based at least in part on glucose reference data received after the portion of the glucose sensor has been positioned under the skin of the user.

### Claim 25 (depends on 24)

The glucose monitoring system of claim 24, wherein the adverse condition comprises a signal error associated with the blood glucose reference data.

### Claim 26 (depends on 24)

The glucose monitoring system of claim 24, wherein the glucose monitoring system is further configured for calibration twelve hours after the portion of the glucose sensor has been positioned under the skin of the user.

### Claim 27 (depends on 1)

The glucose monitoring system of claim 1, wherein the data processing and transmitter unit is configured to transition from a low-power mode to an operating mode, and wherein the data processing and transmitter unit consumes more power from the power supply in the operating mode than in the low-power mode.

### Claim 28 (depends on 1)

The glucose monitoring system of claim 1, wherein the power supply of the data processing and transmitter unit is configured to provide power for about three months of continuous operation.

### Claim 29 (depends on 1)

The glucose monitoring system of claim 1, further comprising a secondary receiver unit, wherein the secondary receiver unit is configured to include a limited number of functions as compared with the receiver unit, wherein the secondary receiver unit is configured to receive processed sensor data from the data processing and transmitter unit, and wherein the secondary receiver unit is a watch.

### Claim 30 (depends on 1)

The glucose monitoring system of claim 1, wherein the glucose sensor is further configured to continuously sample the biological fluid of the user to provide the sensor data.