throbber
as) United States
`a2) Patent Application Publication (0) Pub. No.: US 2019/0216373 Al
`(43) Pub. Date:
`Jul. 18, 2019
`Harper
`
`US 20190216373A1
`
`(54) METHODS AND SYSTEMS FOR EARLY
`SIGNAL ATTENUATION DETECTION AND
`PROCESSING
`
`(71) Applicant: ABBOTT DIABETES CARE INC.,
`Alameda, CA (US)
`
`(72)
`
`Inventor: Wesley Scott Harper, Alameda, CA
`(US)
`
`(21) Appl. No.: 16/228,910
`
`(22) Filed:
`
`Dee. 21, 2018
`
`Related U.S. Application Data
`
`(63) Continuation of application No. 15/061,774, filed on
`Mar. 4, 2016, now Pat. No. 10,194,844, which is a
`continuation of application No. 13/925,694, filed on
`Jun, 24, 2013, now Pat. No. 9,310,230, which is a
`continuation of application No. 12/769,635, filed on
`Apr. 28, 2010, now Pat. No. 8,483,967.
`
`(60) Provisional application No. 61/173,600, filed on Apr.
`29, 2009.
`
`Publication Classification
`
`(51)
`
`Int. CL
`AGIB 5/145
`GOIN 31/22
`
`(2006.01)
`(2006.01)
`
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`
`GOIN 33/66
`G01D 18/00
`A61B 5/1473
`GI16H 40/40
`AGIB 5/1495
`(52) U.S.CL
`CPC veseeees AG6IB 5/14532 (2013.01); GOIN 31/22
`(2013.01); GOIN 33/66 (2013.01); AGIB
`5/1495 (2013.01); A6IB 5/1473 (2013.01);
`GI6H 40/40 (2018.01); GOID 18/00 (2013.01)
`
`(57)
`
`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, pro-
`cessing the retrieved sensor data during the adverse condi-
`tion time period, and outputting the processed retrieved
`sensor data.
`
`RECEIVE ANALYTE
`RELATED SENSOR DATA
`510
`
`CALIBRATED?
`520
`
`§/16/2023 14:37:47
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`
`
`Pagel of 17
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`PROCESS SENSOR
`DATA
`530
`
`STORE ANALYTE
`RELATED
`SENSOR DATA
`550
`
`
`
`DISPLAY PROCESSED
`DISABLE
`SENSOR DATA
`DISPLAY
`540
`560
`
`
`
`
`

`

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`Patent Application Publication
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`Patent Application Publication
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`Patent Application Publication
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`Patent Application Publication
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`Jul. 18,2019 Sheet 4 of 7
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`US 2019/0216373 Al
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`RECEIVE ANALYTE
`
`
`
`RELATED SENSOR DATA
`
`
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`420
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`
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`PROCESS SENSOR
`
`DATA
`
`430
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`
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`DISPLAY PROCESSED
`
`
`SENSOR DATA
`
`440
`
`410 CALIBRATED?
`
`
`
`
`STORE ANALYTE
`
`RELATED
`
`
`SENSOR DATA
`
`450
`
`
`
`
`
`FIG. 4
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`PageS of 17
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`Page5 of 17
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`Patent Application Publication
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`Jul. 18,2019 Sheet 5 of 7
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`US 2019/0216373 Al
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`RECEIVE ANALYTE
`
`
`
`RELATED SENSOR DATA
`
`
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`
`
`
`
`520
`
`
`
`
`
`PROCESS SENSOR
`
`DATA
`
`530
`
`
`
`
`STORE ANALYTE
`
`RELATED
`
`SENSOR DATA
`
`590
`
`
`
`510 CALIBRATED?
`
`
`DISPLAY PROCESSED
`
`
`SENSOR DATA
`
`540
`
`
`
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`DISABLE
`
`DISPLAY
`
`560
`
`
`
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`FIG. 5
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`Page6o of 17
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`Patent Application Publication
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`Jul. 18,2019 Sheet 6 of 7
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`US 2019/0216373 Al
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`DETECT PERIOD OF DISABLED
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`OUTPUT OF SENSOR DATA
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`610
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`PROCESS SENSOR DATA FROM
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`PERIOD OF DISABLED OUTPUT
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`620
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`DISPLAY BACKFILLED PROCESSED
`
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`SENSOR DATA
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`630
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`FIG. 6
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`Page7 of 17
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`Patent Application Publication
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`Jul. 18,2019 Sheet 7 of 7
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`US 2019/0216373 Al
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`Glucose(mg/dL)
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`hoS
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`50
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`0
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`12
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`FIG. 7A
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`"he
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`m4 ==>
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`(mg/dL)
`Glucose
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`FIG. 7B
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`US 2019/0216373 Al
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`Jul. 18, 2019
`
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`
`
`METHODS AND SYSTEMS FOR EARLY
`
`
`
`
`
`SIGNAL ATTENUATION DETECTION AND
`
`
`
`PROCESSING
`
`
`
`
`RELATED APPLICATIONS
`
`
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`
`
`[09001] The present application is a continuation of US.
`
`
`
`
`
`
`
`
`
`patent application Ser. No. 15/061,774, filed Mar. 4, 2016,
`
`
`
`
`
`
`
`
`
`
`which is a continuation of U.S. patent application Ser. No.
`13/925,694, filed Jun. 24, 2013, now U.S. Pat. No. 9,310,
`
`
`
`
`
`
`
`
`
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`
`
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`
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`230, which is a continuation of U.S. patent application Ser.
`
`
`
`
`
`
`
`
`
`
`No. 12/769,635, filed Apr. 28, 2010, now U.S. Pat. No.
`8,483,967, which claims the benefit of U.S. Provisional
`
`
`
`
`
`
`
`
`Patent Application No. 61/173,600,filed Apr. 29, 2009, the
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
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`disclosures of all of which are incorporated herein by
`
`
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`
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`reference in their entireties for all purposes.
`
`BACKGROUND
`
`
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`[0002] Analyte, e.g., glucose monitoring systems includ-
`
`
`
`
`
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`ing continuous and discrete monitoring systems generally
`
`
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`
`
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`include a small, lightweight battery powered and micropro-
`
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`
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`cessor controlled system which is configured to detect
`
`
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`
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`signals proportional to the corresponding measured glucose
`
`
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`
`
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`levels using an electrometer. RF signals may be used to
`
`
`
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`
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`transmit the collected data. One aspect of certain analyte
`
`
`
`
`
`
`monitoring systems include a transcutaneous or subcutane-
`
`
`
`
`
`
`
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`ous analyte sensor configuration which is, for example, at
`
`
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`
`
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`least partially positioned through the skin layer of a subject
`
`
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`
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`whose analyte level is to be monitored. The sensor may use
`
`
`
`
`
`
`
`
`a two or three-electrode (work, reference and counter elec-
`
`
`
`
`
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`trodes) configuration driven by a controlled potential (poten-
`
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`
`
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`tiostat) analog circuit connected through a contact system.
`
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`[0003] An analyte sensor may be configured so that a
`
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`
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`portion thereof is placed under the skin ofthe patient so as
`
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`to contact analyte of the patient, and another portion or
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`segment of the analyte sensor may be in communication
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`with the transmitter unit. The transmitter unit may be
`
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`configured to transmit the analyte levels detected by the
`sensor over a wireless communication link such as an RF
`
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`(radio frequency) communication link to a receiver/monitor
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`unit. The receiver/monitor unit may perform data analysis,
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`among other functions, on the received analyte levels to
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`generate information pertaining to the monitored analyte
`levels.
`
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`SUMMARY
`
`
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`[0004] Devices and methods for analyte monitoring,e.g.,
`
`
`
`
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`glucose monitoring, and/or therapy management system
`
`
`
`
`
`
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`including, for example, medication infusion device are pro-
`
`
`
`
`
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`vided. Embodiments include transmitting information from
`
`
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`
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`a first location to a second, e.g., using a telemetry system
`
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`such as RF telemetry. Systems herein include continuous
`
`
`
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`
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`analyte monitoring systems, discrete analyte monitoring
`
`
`
`
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`system, and therapy management systems.
`
`
`
`
`
`
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`[0005] Embodiments include 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 moni-
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`toring system, disabling the output of the sensor data during
`
`
`
`
`
`
`
`
`
`a 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
`
`5/16/2023 14:37:47
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`sensor data during the adverse condition time period, and
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`outputting the processed retrieved sensor data.
`
`
`
`
`
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`
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`[0006] Embodiments include detecting a condition unsuit-
`able for calibration of an analyte sensor for a predetermined
`
`
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`time period, disabling output ofinformation associated with
`
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`the analyte sensor, determining a successful calibration of
`
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`the analyte sensor, retrieving one or more parameters asso-
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`ciated with the successful calibration, processing sensor data
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`during the time period of disabled output of information
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`with the one or more parameters associated with the suc-
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`cessful calibration, and displaying the processed sensor data
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`for the time period of disabled information output.
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`[0007] Embodiments include an interface configured to
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`receive sensor data, a first memory configured to store the
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`received sensordata, a processor coupled to the memory and
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`configured to process the stored sensor data, a second
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`memory coupled to the processor and configured to store the
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`processed sensor data, and a display unit coupled to the
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`second memory and configured to display the processed
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`sensor data, where the processor is further configured to
`detect a condition unsuitable for calibration of a sensor for
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`a predetermined time period, disable display of processed
`sensor data, determine a successful calibration of the sensor,
`
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`retrieve one or more parameters associated with the suc-
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`cessful calibration, process the sensor data during the time
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`period of disabled display of sensor data with the one or
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`more parameters associated with the successful calibration,
`
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`and display the processed sensor data for the time period of
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`disabled information output.
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`[0008] These and other objects, features and advantages of
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`the present disclosure will become more fully apparent from
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`the following detailed description of the embodiments, the
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`appended claims and the accompanying drawings.
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`INCORPORATION BY REFERENCE
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`[0009] The following patents, applications and/or publi-
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`cations are incorporated herein by reference for all purposes:
`US. Pat. Nos. 4,545,382; 4,711,245: 5,262,035; 5,262,305;
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`5,264,104; 5,320,715; 5,509,410; 5,543,326; 5,593,852:
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`5,601,435; 5,628,890; 5,820,551; 5,822,715; 5,899,855,
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`5,918,603; 6,071,391; 6,103,033; 6,120,676; 6,121,009;
`6,134,461; 6,143,164; 6,144,837; 6,161,095; 6,175,752;
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`6,270,455; 6,284,478; 6,299,757; 6,338,790; 6,377,894;
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`6,461,496; 6,503,381; 6,514,460; 6,514,718; 6,540,891;
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`6,560,471; 6,579,690; 6,591,125; 6,592,745; 6,600,997;
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`6,605,200; 6,605,201; 6,616,819; 6,618,934; 6,650,471;
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`6,654,625; 6,676,816; 6,730,200; 6,736,957; 6,746,582;
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`6,749,740; 6,764,581; 6,773,671; 6,881,551; 6,893,545;
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`6,932,892; 6,932,894; 6,942,518; 7,167,818; and 7,299,082;
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`U.S. Published Application Nos. 2004/0186365; 2005/
`0182306; 2007/0056858; 2007/0068807; 2007/0227911;
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`2007/0233013; 2008/0081977; 2008/0161666; and 2009/
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`0054748; U.S. patent application Ser. Nos. 11/831,866;
`11/831,881; 11/831,895; 12/102.839; 12/102,844; 12/102,
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`12/102,855; 12/102,856; 12/152,636; 12/152,648;
`847;
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`12/152,650; 12/152,652; 12/152,657; 12/152,662; 12/152,
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`12/152,673; 12/363,712; 12/131,012; 12/242,823;
`670;
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`12/363,712: 12/393,921; 12/495,709; 12/698,124; 12/699,
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`653; 12/699,844; 12/714,439; 12/761,372; and 12/761.387
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`and U.S. Provisional Application Nos. 61/230,686 and
`61/227,967.
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`US 2019/0216373 Al
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`Jul. 18, 2019
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`BRIEF DESCRIPTION OF THE DRAWINGS
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`FIG. 1 illustrates a block diagram of a data moni-
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`toring and management system for practicing one or more
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`embodiments of the present disclosure;
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`FIG. 2 is a block diagram ofthe transmitter unit of
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`the data monitoring and management system shownin FIG.
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`in accordance with one embodiment of the present dis-
`1
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`FIG. 3 is a block diagram of the receiver/monitor
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`unit of the data monitoring and management system shown
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`in FIG. 1 in accordance with one embodimentofthe present
`disclosure;
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`FIG. 4 illustrates analyte sensor data processing in
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`accordance with one embodimentof the present disclosure;
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`FIG. 5 illustrates analyte sensor data processing in
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`accordance with one embodimentof the present disclosure;
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`FIG. 6 illustrates backfilling gaps in sensor data in
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`one embodiment of the present disclosure; and
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`[0016]
`FIGS. 7A and 7B illustrate backfill of gaps of a
`period of uncalibrated sensor data in one embodiment.
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`DETAILED DESCRIPTION
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`[0017] Before the present disclosure is described in addi-
`tional detail, it is to be understood that this disclosure is not
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`limited to particular embodiments described, as such may, of
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`course, vary. It is also to be understood that the terminology
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`used herein is for the purpose of describing particular
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`embodiments only, and is not intended to be limiting, since
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`the scope of the present disclosure will be limited only by
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`the appended claims.
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`[0018] Where a range of values is provided, it is under-
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`stood that each intervening value, to the tenth of the unit of
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`the lowerlimit unless the context clearly dictates otherwise,
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`between the upper and lower limit of that range and any
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`other stated or intervening value in that stated range,
`is
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`encompassed within the disclosure. The upper and lower
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`limits of these smaller
`ranges may independently be
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`included in the smaller ranges is also encompassed within
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`the disclosure, subject to any specifically excluded limit in
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`the stated range. Where the stated range includes one or both
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`of the limits, ranges excluding either or both of those
`included limits are also included in the disclosure.
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`[0019] Unless defined otherwise, all technical and scien-
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`tific terms used herein have the same meaning as commonly
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`understood by one of ordinary skill in the art to which this
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`disclosure belongs. Although any methods and materials
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`similar or equivalent to those described herein can also be
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`used in the practice or testing of the present disclosure, the
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`preferred methods and materials are now described. All
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`publications mentioned herein are incorporated herein by
`reference to disclose and describe the methods and/or mate-
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`rials in connection with whichthe publications are cited.
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`[0020]
`It must be noted that as used herein and in the
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`appended claims, the singular forms “a”, “an”, and “the”
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`include plural referents unless the context clearly dictates
`otherwise.
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`[0021] The publications discussed herein are provided
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`solely for their disclosure prior to the filing date of the
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`present application. Nothing herein is to be construed as an
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`admission that
`the present disclosure is not entitled to
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`antedate such publication by virtue of prior disclosure.
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`5/16/2023 14:37:47
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`Further, the dates of publication provided may be different
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`from the actual publication dates which may need to be
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`independently confirmed.
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`[0022] As will be apparent to those ofskill in the art upon
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`reading this disclosure, each of the individual embodiments
`described andillustrated herein has discrete components and
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`features which may be readily separated from or combined
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`with the features of any of the other several embodiments
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`without departing from the scope or spirit of the present
`disclosure.
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`[0023] The figures shownherein are not necessarily drawn
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`to scale, with some components and features being exag-
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`gerated for clarity.
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`Asdescribed in further detail below, in accordance
`[0024]
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`with the various embodiments of the present disclosure,
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`there is provided a method and system for positioning a
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`controller unit within a transmission range for close prox-
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`imity communication, transmitting one or more predefined
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`close proximity commands, and receiving a response packet
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`in response to the transmitted one or more predefined close
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`proximity commands. For example,
`in one aspect, close
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`proximity communication includes short range wireless
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`communication between communication components or
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`devices, where the communication range is limited to about
`10 inchesor less, about 5 inches or less, or about 2 inches
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`or less, or other suitable, short range or distance between the
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`devices. The close proximity wireless communication in
`certain embodiments includes a bi-directional communica-
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`tion where a command sending communication device,
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`whenpositioned within the short communicationrangeor in
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`close proximity to the commandreceiving communication
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`device, is configured to transmit one or more commands to
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`command
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`communication
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`example, when a user activates or actuates a transmit com-
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`mand button or switch). In response, the commandreceiving
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`communication device may be configured to perform one or
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`more routines associated with the received command,and/or
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`return or send back a response data packet or signal to the
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`command sending communication device. Example of such
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`functions and or commands mayinclude, but not limited to
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`activation of certain functions or routines such as analyte
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`related data processing, and the like.
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`FIG. 1 illustrates a data monitoring and manage-
`[0025]
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`ment system such as, for example, analyte (e.g., glucose)
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`monitoring system 100 in accordance with one embodiment
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`of the present disclosure. The subject invention is further
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`described primarily with respect to a glucose monitoring
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`system for convenience and such description is in no way
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`intended to limit the scope of the invention.
`It
`is to be
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`understood that
`the analyte monitoring system may be
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`configured to monitor a variety of analytes, e.g., lactate, and
`the like.
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`for
`[0026] Analytes that may be monitored include,
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`example, acetyl choline, amylase, bilirubin, cholesterol,
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`chorionic gonadotropin, creatine kinase (e.g., CK-MB), cre-
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`atine, DNA, fructosamine, glucose, glutamine, growth hor-
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`mones, hormones, ketones, lactate, peroxide, prostate-spe-
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`cific antigen, prothrombin, RNA,
`thyroid stimulating
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`hormone,and troponin, The concentrationof drugs, such as,
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`for example, antibiotics (e.g., gentamicin, vancomycin, and
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`the like), digitoxin, digoxin, drugs of abuse, theophylline,
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`and warfarin, may also be monitored. More than one analyte
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`may be monitored by a single system, e.g. a single analyte
`sensor.
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`Pagel0 of 17
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`Page10 of 17
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`

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`US 2019/0216373 Al
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`Jul. 18, 2019
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`[0027] The analyte monitoring system 100 includes a
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`sensor unit 101, a data processing and transmitter unit 102
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`coupleable to the sensor unit 101, and a primary receiver
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`unit 104 which is configured to communicate withthe data
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`processing and transmitter unit 102 via a bi-directional
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`communication link 103. The primary receiver unit 104 may
`be further configured to transmit data to a data processing
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`terminal 105 for evaluating the data received by the primary
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`receiver unit 104. Moreover, the data processing terminal
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`105 in one embodiment may be configured to receive data
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`directly from the data processing and transmitter unit 102
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`via a communication link which may optionally be config-
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`ured for bi-directional communication. Accordingly, data
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`processing and transmitter unit 102 and/or receiver unit 104
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`may include a transceiver.
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`[0028] Also shown in FIG. 1 is an optional secondary
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`receiver unit 106 which is operatively coupled to the com-
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`munication link and configured to receive data transmitted
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`from the data processing and transmitter unit 102. Moreover,
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`as shown in the Figure, the secondary receiver unit 106 is
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`configured to communicate with the primary receiver unit
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`104 as wellas the data processing terminal 105. Indeed, the
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`secondary receiver unit 106 may be configured for bi-
`directional wireless communication with each or one of the
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`primary receiver unit 104 and the data processing terminal
`105. As discussed in further detail] below, in one embodi-
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`ment of the present disclosure, the secondary receiver unit
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`106 may be configured to include a limited number of
`functions and features as compared with the primary
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`receiver unit 104. As such, the secondary receiver unit 106
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`may be configured substantially in a smaller compact hous-
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`ing or embodied in a device such as a wrist watch, pager,
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`mobile phone, PDA, for example. Alternatively, the second-
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`ary receiver unit 106 may be configured with the same or
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`substantially similar functionality as the primary receiver
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`unit 104. The receiver unit may be configured to be used in
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`conjunction with a docking cradle unit, for example for one
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`or more of the following or other functions: placement by
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`bedside, for re-charging, for data management, for night
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`time monitoring,
`and/or bi-directional
`communication
`device.
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`[0029]
`In one aspect sensor unit 101 may include two or
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`more sensors, each configured to communicate with data
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`processing and transmitter unit 102. Furthermore, while only
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`one, data processing and transmitter unit 102, communica-
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`tion link 103, and data processing terminal 105 are shown in
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`the embodiment of the analyte monitoring system 100
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`illustrated in FIG. 1. However, it will be appreciated by one
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`of ordinary skill in the art that the analyte monitoring system
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`100 may include one or more sensors, multiple transmitter
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`units 102, communication links 103, and data processing
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`terminals 105. Moreover, within the scope of the present
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`disclosure, the analyte monitoring system 100 may be a
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`continuous monitoring system, or semi-continuous, or a
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`discrete monitoring system. In a multi-component environ-
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`ment, each device is configured to be uniquely identified by
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`eachof the other devices in the system so that communica-
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`tion conflict is readily resolved between the various com-
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`ponents within the analyte monitoring system 100.
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`In one embodiment of the present disclosure, the
`[0030]
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`sensor unit 101 is physically positioned in or on the body of
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`a user whose analyte level is being monitored. The sensor
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`unit 101 may be configured to continuously sample the
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`analyte level of the user and convert the sampled analyte
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`5/16/2023 14:37:47
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`level into a corresponding data signal for transmission by the
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`data processing and transmitter unit 102. In certain embodi-
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`ments, the data processing and transmitter unit 102 may be
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`physically coupled to the sensor unit 101 so that both
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`devices are integrated in a single housing and positioned on
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`the user’s body. The data processing and transmitter unit 102
`may perform data processing suchasfiltering and encoding
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`on data signals and/or other functions, each of which cor-
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`responds to a sampled analyte level of the user, and in any
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`event data processing and transmitter unit 102 transmits
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`analyte information to the primary receiver unit 104 via the
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`communication link 103. Examples of such integrated sen-
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`sor and transmitter units can be found in, amongothers, U.S.
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`patent application Ser. No. 12/698,124, incorporated herein
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`by reference.
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`[0031]
`In one embodiment, the analyte monitoring system
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`100 is configured as a one-way RF communication path
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`from the data processing and transmitter unit 102 to the
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`primary receiver unit 104. In such embodiment, the data
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`processing and transmitter unit 102 transmits the sampled
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`data signals received from the sensor unit 101 without
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`acknowledgement from the primary receiver unit 104 that
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`the transmitted sampled data signals have been received. For
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`example, the data processing and transmitter unit 102 may
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`be configured to transmit the encoded sampled data signals
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`at a fixed rate (e.g., at one minute intervals) after the
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`completion of the initial power on procedure. Likewise, the
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`primary receiver unit 104 may be configured to detect such
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`transmitted encoded sampled data signals at predetermined
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`time intervals. Alternatively, the analyte monitoring system
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`100 may be configured with a bi-directional RF (or other-
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`wise) communication between the data processing and trans-
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`mitter unit 102 and the primary receiver unit 104.
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`[0032] Additionally, in one aspect, the primary receiver
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`unit 104 may include two sections. The first section is an
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`analog interface section that is configured to communicate
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`with the data processing and transmitter unit 102 via the
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`communication link 103. In one embodiment, the analog
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`interface section may include an RFreceiver and an antenna
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`for receiving and amplifying the data signals from the data
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`processing and transmitter unit 102, which are thereafter,
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`demodulated with a local oscillator and filtered through a
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`band-pass filter. The second section of the primary receiver
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`unit 104 is a data processing section which is configured to
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`process the data signals received from the data processing
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`and transmitter unit 102 such as by performing data decod-
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`ing, error detection and correction, data clock generation,
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`and data bit recovery.
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`[0033]
`In operation, upon completing the power-on pro-
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`cedure, the primary receiver unit 104 is configured to detect
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`the presence of the data processing and transmitter unit 102
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`within its range based on, for example, the strength of the
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`detected data signals received from the data processing and
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`transmitter unit 102 and/or a predetermined transmitter
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`identification information. Upon successful synchronization
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`with the corresponding data processing and transmitter unit
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`102, the primary receiver unit 104 is configured to begin
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`receiving from the data processing and transmitter unit 102
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`data signals corresponding to the user’s detected analyte
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`level. More specifically, the primary receiver unit 104 in one
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`embodiment is configured to perform synchronized time
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`hopping with the corresponding synchronized data process-
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`ing and transmitter unit 102 via the communication link 103
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`to obtain the user’s detected analyte level.
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`Pagell of 17
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`Page11 of 17
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`US 2019/0216373 Al
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`Jul. 18, 2019
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`the data processing
`[0034] Referring again to FIG. 1,
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`terminal 105 may include a personal computer, a portable
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`computer such as a laptop or a handheld device (e.g.,
`personal digital assistants (PDAs)), and the like, each

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