QUICONNYTA
`
`US 20130127627A1
`
`as) United States
`a2) Patent Application Publication (io) Pub. No.: US 2013/0127627 Al
`Hayteret al.
`(43) Pub. Date:
`May23, 2013
`
`(54) MITIGATING SINGLE POINT FAILURE OF
`DEVICES IN AN ANALYTE MONITORING
`SYSTEM AND METHODS THEREOF
`
`(71) Applicant: Abbott Diabetes Care Inc., Alameda,
`CA (US)
`
`(72)
`
`Inventors: Gary Alan Hayter, Oakland, CA (US):
`Mare Barry Taub, Mountain View, CA
`(US)
`
`(22)
`
`(60)
`
`Filed:
`
`Nov. 21, 2012
`sonst
`<
`Related U.S. Application Data
`Provisional application No. 61/563,518, filed on Nov.
`23. 2011.
`
`Publication Classification
`
`(51)
`
`Int. Cl.
`G08B 21/18
`(52) U.S.Cl.
`
`(2006.01)
`
`3)
`
`Assi
`
`gs
`
`1d
`
`(73) Assignee os Care Inc., Alameda
`
`i
`
`s
`
`ey J
`
`(21) Appl. No.: 13/684,078
`
`’
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`cae
`
`ABSTRACT
`(57)
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`Page | of 19
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`Patent Application Publication May 23,2013 Sheet 1 of 6
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`US 2013/0127627 Al
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`Patent Application Publication May 23,2013 Sheet 2 of 6
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`Patent Application Publication May 23,2013 Sheet 3 of 6
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`Patent Application Publication May 23,2013 Sheet 6 of 6
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`predetermined amount of time
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`Annunciate alarmif secon
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`device is not functioning
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`US 2013/0127627 Al
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`May 23, 2013
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`MITIGATING SINGLE POINT FAILURE OF
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`DEVICES IN AN ANALYTE MONITORING
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`SYSTEM AND METHODS THEREOF
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`RELATED APPLICATION
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`[0001] This application claims priority to U.S. provisional
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`application no. 61/563,518, filed Nov. 23, 2011, entitled
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`“Mitigating Single Point Failure of Devices in an Analyte
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`Monitoring System and Methods Thereof”, the disclosure of
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`whichis incorporated herein by referencein its entirety forall
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`BACKGROUND
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`[0002] The detection of the level of glucose or other ana-
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`lytes, such as lactate, oxygenor the like, in certain individuals
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`is vitally importantto their health. For example, the monitor-
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`ing of glucoseis particularly important to individuals with
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`diabetes. Diabetics may need to monitor glucose levels to
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`determine wheninsulin is needed to reduce glucoselevels in
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`their bodies or whenadditional glucose is needed to raise the
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`level of glucose in their bodies.
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`[0003] Devices have been developed for continuous or
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`automatic monitoring of analytes, such as glucose, in bodily
`fluid such as in the blood streamorin interstitial fluid. Some
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`of these analyte measuring devices are configured sothat at
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`least a portion of the devices are positioned below a skin
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`surface ofa user, e.g., ina blood vessel or in the subcutaneous
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`SUMMARY
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`[0004] Embodiments of the present disclosure include
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`methods for mitigating single point failure of at least one
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`device in an analyte monitoring system. Certain aspects
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`include requesting that a functionality check of one or more
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`components of a first device be performed and that data
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`related to the functionality check ofthe one or more compo-
`nents of the first device be communicated to a second device,
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`receiving, information fromthefirst device that is related to
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`functionality of the one or more components of the first
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`device, communicating the information related to the func-
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`tionality of the one or more components ofthe first device to
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`a third device, receiving a requestfrom the third device that an
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`alarm be annunciated ifit is determined by the third device
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`that the one or more components of thefirst device is not
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`functioning in accordance with at least one predetermined
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`criterion and annunciating an alarmtoalert a userthat the one
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`or more components of the first device is not functioning in
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`accordance withthe at least one predetermined criterion.
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`[0005] Embodiments of the present disclosure include
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`computer-implemented methods for mitigating single point
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`failure of at least one device in an analyte monitoring. Certain
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`aspects include requesting that a functionality check ofone or
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`more components ofa first device be performed andthat data
`related to the functionality check of the one or more compo-
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`nents of the first device be communicated to a second device,
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`receiving the data related to the functionality of the one or
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`more componentsof thefirst device, retrieving a list including
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`at least one predetermined criterion related to the functional-
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`ity of the one or more components ofthe first device from a
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`storage componentofthe second device, comparing the data
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`related to the functionality of the one or more components of
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`the first device with the list including the at least one prede-
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`termined criterion and determining if the one or more com-
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`ponents of the first device is functioning in accordance with
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`the at least one predetermined criterion.
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`[0006] Embodiments of the present disclosure include
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`computer-implemented methods for mitigating single point
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`failure of at least one device in an analyte monitoring. Certain
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`aspects include requestingthat a functionality check of one or
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`more components ofa first device be performed andthat data
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`related to the functionality check ofthe one or more compo-
`nents ofthe first device be communicated to a second device
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`and determining that the one or more componentsof thefirst
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`device is not functioning properly if the data related to the
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`functionality check of the components of thefirst device is not
`received at the second device, wherein an alarm is annunci-
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`ated fromat least one of the second deviceor a third device to
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`alert a user that one or more componentsof thefirst device is
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`not functioning properly.
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`BRIEF DESCRIPTION OF THE DRAWINGS
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`FIG. 1 shows a data monitoring and management
`[0007]
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`system suchas, for example, an analyte (e.g., glucose) moni-
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`toring systemin accordance with certain embodiments ofthe
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`present disclosure;
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`FIG. 2 illustrates a data monitoring and manage-
`[0008]
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`ment systemfor real time glucose measurement data acqui-
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`sition and processing in one aspect of the present disclosure;
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`[0009]
`FIG. 3 isa block diagram ofa receiver/monitor unit
`such as that shown in FIG. 1 in accordance with certain
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`embodiments;
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`FIG. 4 is a Nowchart illustrating a method for miti-
`[0010]
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`gating single point failure ofat least one device in an analyte
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`monitoring system in accordance with certain embodiments
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`of the present disclosure;
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`[0011]
`FIG. 5 is a flowchart illustrating a method for miti-
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`gating single point failure ofat least one device in an analyte
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`monitoring system in accordance with certain embodiments
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`of the present disclosure;
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`[0012]
`FIG. 6 is a Nowchart illustrating a method for miti-
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`gating single point failure ofat least one device in an analyte
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`monitoring system in accordance with certain embodiments
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`ofthe present disclosure; and
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`[0013]
`FIG. 7 is a flowchart illustrating a method for miti-
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`gating single pointfailure of at least one device in an analyte
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`monitoring system in accordance with certain embodiments
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`of the present disclosure.
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`DETAILED DESCRIPTION
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`[0014] Before the presentdisclosureis further described,it
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`is to be understood that this disclosure is not limited to par-
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`ticular embodiments described, as such may, of course, vary.
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`It is also to be understoodthatthe terminology used herein is
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`for the purpose ofdescribing particular embodiments only,
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`and is not intended to be limiting, since the scope of the
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`present disclosure will be limited only by the appended
`claims.
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`[0015] As will be apparent to those of skill in the art upon
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`reading this disclosure, each of the individual embodiments
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`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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`[0016] Where arangeof valuesis provided, it is understood
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`that eachintervening value, to the tenthof the unit of the lower
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`Page 8 of 19
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`US 2013/0127627 Al
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`May 23, 2013
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`limit unless the context clearly dictates otherwise, between
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`the upper and lower limit ofthat range and any other stated or
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`intervening value inthat stated range, is encompassed within
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`the disclosure. The upper and lowerlimits of these smaller
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`ranges may independently be included in the smaller ranges,
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`and are also encompassed within the disclosure, subject to
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`any specifically excluded limit in the stated range. Where the
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`stated range includes oneor both of the limits, ranges exclud-
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`ing either or both ofthose included limits are also included in
`the disclosure.
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`[0017] 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 whichthis
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`disclosure belongs. Although any methods and materials
`similar or equivalent to those described herein can also be
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`used in the practice or testing of the present disclosure, exem-
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`plary methods and materials are nowdescribed. All publica-
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`tions mentioned herein are incorporated herein by reference
`to disclose and describe the methods and/or materials in con-
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`nection with which the publicationsare cited.
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`[0018] As used herein and in the appended claims, the
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`singular forms “a,” “an,” and “the” include plural referents
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`unless the context clearly dictates otherwise. It is further
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`noted that the claims may be drafted to exclude any optional
`element. As such, this statement is intended to serve as ante-
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`cedentbasis for use ofsuch exclusive terminology as “solely,”
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`“only” and the like in connection with therecitation of claim
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`elements, or use of a “negative” limitation.
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`[0019] The publications discussed herein are provided
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`solely for their disclosure priorto the filing date of the present
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`application. Nothing hereinis to be construed as an admission
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`that the present disclosure is not entitled to antedate such
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`publicationbyvirtue of prior disclosure. Further, the dates of
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`publication provided maybe different from the actual publi-
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`cation dates which may need to be independently confirmed.
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`[0020]
`FIG. 1 shows a data monitoring and management
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`system suchas, for example, an analyte(e.g., glucose) moni-
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`toring system in accordance with certain embodiments ofthe
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`present disclosure. Embodiments ofthe subjectdisclosure are
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`described primarily with respect
`to glucose monitoring
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`devices and systems, and methods of using two or more
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`devices in a glucose monitoring system to reduce the likeli-
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`hood ofa failure ofone or moreofthe devices in the glucose
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`monitoring system going unnoticed by a user.
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`[0021] Analytes that may be monitored include, but are not
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`limited to, 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
`hormone, and troponin. The concentration of drugs, suchas,
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`for example, antibiotics (e.g., gentamicin, vancomycin, and
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`the like), digitoxin, digoxin, drugs ofabuse, theophylline, and
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`warfarin, may also be monitored. In those embodimentsthat
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`monitor more than one analyte, the analytes may be moni-
`tored at the sameor different times.
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`[0022] Referring to FIG. 1, the analyte monitoring system
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`100 includes a sensor 101, a data processing unit (e.g., sensor
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`electronics) 102 connectable to the sensor 101, and a primary
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`receiver unit 104 whichis configured to communicate with
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`the data processing unit 102 via a communicationlink 103. In
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`aspects ofthe present disclosure, the sensor 101 and the data
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`processing unit (sensor electronics) 102 may be configured as
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`asingle integrated assembly 110. In certain embodiments, the
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`integrated sensor and sensorelectronics assembly 110 may be
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`configured as an on-body patch device. In such embodiments,
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`the on-body patch device may be configuredfor, for example,
`RFID or RF communication with a reader device/receiver
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`unit, and/or an insulin pump.
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`[0023]
`In certain embodiments, the primary receiver unit
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`104 may be further configured to transmit data to a data
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`processing terminal 105 to evaluate or otherwise process or
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`format data received by the primary receiver unit 104. The
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`data processing terminal 105 may be configured to receive
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`data directly from the data processing unit 102 via a commu-
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`nication link which may optionally be configured for bi-
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`directional communication. Further, the data processing unit
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`102 may include a transmitter or a transceiver to transmit
`and/or receive data to and/or fromthe primary receiver unit
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`104, the data processing terminal 105 or optionally the sec-
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`ondary receiver unit 106,
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`[0024] Also shown in FIG. 1 is an optional secondary
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`receiver unit 106 whichis operatively coupled to the commu-
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`nication link and configured to receive data transmitted from
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`the data processing unit 102. The secondary receiver unit 106
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`may be configured to communicate withthe primary receiver
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`unit 104, as well as the data processing terminal 105. The
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`secondary receiver unit 106 may be configuredfor bi-direc-
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`tional wireless communication with each of the primary
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`receiver unit 104 and the data processing terminal 105, As
`discussedin further detail below, in certain embodiments the
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`secondary receiver unit 106 may be a de-featured receiver as
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`comparedto the primary receiver unit 104, 1.¢., the secondary
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`receiver unit 106 may include a limited or minimal number of
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`functionsand features as comparedwiththe primary receiver
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`unit 104. As such, the secondary receiver unit 106 may
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`include a smaller (in one or more, including all, dimensions),
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`compact housing or embodied in a device such as a wrist
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`watch, armband, etc., 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 functions and features as the primary
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`receiver unit 104. The secondary receiver unit 106 may
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`include a docking portion to be mated with a docking cradle
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`unit for placementby, e.g., the bedside for night time moni-
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`toring, and/or bi-directional communication device.
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`[0025] Only one sensor 101, data processing unit 102 and
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`data processing terminal 105 are shown in the embodimentof
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`the analyte monitoring system 100 illustrated in FIG. 1. How-
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`ever, it will be appreciated by one of ordinary skill in the art
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`that the analyte monitoring system 100 may include more
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`than one sensor 101 and/or more than one data processing unit
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`102, and/or more than one data processing terminal 105.
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`[0026] The analyte monitoring system 100 may be a con-
`tinuous monitoring system, or semi-continuous, or a discrete
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`monitoring system. In a multi-component environment, each
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`component may be configured to be uniquely identified by
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`one or more of the other components in the system sothat
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`communicationconflict may be readily resolved betweenthe
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`various components within the analyte monitoring system
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`100. For example, unique IDs, communication channels, and
`the like, may be used.
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`[0027]
`Incertain embodiments, the sensor 101 is physically
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`positioned in or on the body ofa user whose analyte levelis
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`being monitored. The sensor 101 may be configured to at least
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`periodically perform a functionality check and convert the
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`results of the functionality check into a correspondingsignal
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`for transmission by the data processing unit 102.
`Page 9 of 19
`Page 9 of 19
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`US 2013/0127627 Al
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`May 23, 2013
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`[0028] The data processing unit 102 is coupleable to the
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`sensor 101 so that both devices are positioned in or on the
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`user’s body, with at least a portion ofthe analyte sensor 101
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`positioned transcutaneously. The data processing unit 102 in
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`certain embodiments may include a portion of the sensor 101
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`(proximal section ofthe sensorin electrical communication
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`with the data processing unit 102) which is encapsulated
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`within or onthe printed circuit board of the data processing
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`unit 102 with, for example, potting material or other protec-
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`tive material. The data processing unit 102 performs data
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`processing functions, where such functions may include but
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`are not limited to, filtermg and encodingof data signals, each
`of which corresponds to a sampled analyte level ofthe user,
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`for transmission to the primary receiver unit 104 via the
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`communicationlink 103. In one embodiment, the sensor 101
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`or the data processing unit 102 or a combined sensor/data
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`processing unit may be wholly implantable under the skin
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`layer of the user.
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`[0029]
`In one aspect, the primary receiver unit 104 may
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`include an analog interface section including an RF receiver
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`and an antenna that is configured to communicate with the
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`data processing unit 102 via the communication link 103, and
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`a data processing section for processing the received data
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`fromthe data processing unit 102 such as data decoding, error
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`detection and correction, data clock generation, and/or data
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`bit recovery.
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`[0030]
`In operation, the primary receiverunit 104 in certain
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`embodiments is configured to synchronize with the data pro-
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`cessing unit 102 to uniquely identify the data processing unit
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`102, based on, for example, an identification information of
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`the data processing unit 102, and thereafter, to periodically
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`receive signals transmitted fromthe data processing unit 102
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`associated with the monitored analyte levels detected by the
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`sensor 101. That is, when operating in the CGM mode, the
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`receiver unit 104 in certain embodiments is configured to
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`automatically receive data related to the functionality ofthe
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`sensor from the analyte sensor/sensor electronics whenthe
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`communication link (e.g., RF range) is maintained between
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`these components.
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`[0031] Referring again to FIG. 1, the data processingter-
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`minal 105 may include a personal computer, a portable data
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`processing devices or computers such as a laptop computer or
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`a handheld device (e.g., personal digital assistants (PDAs),
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`communication devices suchas a cellular phone(e.g., a mul-
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`timedia and Internet-enabled mobile phone such as an
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`iPhone, a Blackberry device, a Palm device such as Palm Pre,
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`Treo, or similar phone), mp3 player, pager, and the like), drug
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`delivery device, insulin pump, each of which maybe config-
`ured for data communication with the receiver via a wired or
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`a wireless connection. Additionally, the data processing ter-
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`minal 105 may further be connected to a data network (not
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`shown).
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`[0032] The data processing terminal 105 may include an
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`infusion device suchas an insulin infusion pumpor the like,
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`which may be configured to administer insulin to patients,
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`and which may be configured to communicate with the pri-
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`mary receiver unit 104 for receiving, among others, the mea-
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`sured analyte level. Alternatively, the primary receiver unit
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`104 maybe configured to integrate an infusion device therein
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`so that the primary receiver unit 104 is configured to admin-
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`ister insulin (or other appropriate drug) therapy to patients,
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`for example, for administering and modifying basal profiles,
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`as well as for determining appropriate boluses for adminis-
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`tration based on, among others, the detected analyte levels
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`received from the data processing unit 102. An infusion
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`device may be an external device or an internal device
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`(wholly implantable in a user).
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`In particular embodim