(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2008/0119705 A1
`(43) Pub. Date:
`May 22, 2008
`Patel et al.
`
`US 200801 19705A1
`
`(54) SYSTEMS AND METHODS FOR DIABETES
`MANAGEMENT USING CONSUMER
`ELECTRONIC DEVICES
`
`(75) Inventors:
`
`Himanshu Patel, Northridge, CA
`(US); Emil S. Istoc, Winnetka, CA
`(US); Jack E. Lin, Stevenson
`Ranch, CA (US); Ajit S. Narang,
`North Hills, CA (US)
`
`Correspondence Address:
`MEDTRONIC MINIMED INC.
`18OOO DEVONSHIRE STREET
`NORTHRIDGE, CA 91325-1219
`
`(73) Assignee:
`
`MEDTRONIC MINIMED, INC.,
`Northridge, CA (US)
`
`(21) Appl. No.:
`
`11/931,363
`
`(22) Filed:
`
`Oct. 31, 2007
`
`Related U.S. Application Data
`(60) Provisional application No. 60/866,409, filed on Nov.
`17, 2006.
`Publication Classification
`
`(51) Int. Cl.
`(2006.01)
`A6B 5/05
`(52) U.S. Cl. ........................................................ 6OO/347
`(57)
`ABSTRACT
`The invention is embodied in a system for diabetes manage
`ment including a medical device (MD) and a consumer elec
`tronic device (CED). The CED may be used to monitor and/or
`control the MD. In particular embodiments, the system may
`include a connector that plugs into the CED to allow commu
`nication between the MD and the CED. The medical device
`may be an external infusion device, implantable pump, glu
`cose meter, glucose monitor, continuous glucose monitoring
`system, or the like. The CED may be any type of consumer
`electronic device including, but not limited to, cellular
`phones, personal digital assistants (PDAs), BlackBerry,
`Smartphones, pocketpc phones, mp3 players, radios, CD
`players, and the like.
`
`Page 1 of 25
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`Patent Application Publication May 22, 2008 Sheet 1 of 15
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`US 2008/01 19705 A1
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`
`
`se
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`vow e
`a
`to
`o a
`p
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`too
`
`s
`
`FIGURE 1
`
`Page 2 of 25
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`Patent Application Publication May 22, 2008 Sheet 2 of 15
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`
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`Page 3 of 25
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`Patent Application Publication May 22, 2008 Sheet 3 of 15
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`US 2008/01 19705 A1
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`
`
`FIGURE 3
`
`Page 4 of 25
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`Patent Application Publication May 22, 2008 Sheet 4 of 15
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`US 2008/01 19705 A1
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`400
`
`450
`
`(a)
`
`
`
`450
`
`(b)
`
`400
`
`FIGURE 4
`
`Page 5 of 25
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`Patent Application Publication
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`May 22, 2008 Sheet 5 of 15
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`US 2008/01 19705 A1
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`520
`
`
`
`500
`
`Sk
`
`- 3 hrs
`
`2
`
`FIGURE 5
`
`Page 6 of 25
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`Patent Application Publication
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`May 22, 2008 Sheet 6 of 15
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`US 2008/01 19705 A1
`
`600
`
`Power On
`BlackBerry
`
`Pair Devices
`
`No
`
`BlackBerry paired
`with Bluetooth
`Module?
`
`
`
`/. to
`
`b{ communicate
`with module?
`
`608
`
`Sync the devices
`
`
`
`618
`
`
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`
`After Sensor
`End of life
`
`
`
`Sensor
`Detected
`
`
`
`No
`
`Search and pair
`with sensor
`
`Wait for Sensor to
`initialize and enter
`normat operation
`
`-
`
`Enter Meter BG
`and Calibrated?
`
`After calibration expires,
`ask for new calibration
`(Every 6 or 12 hrs)
`
`Yes
`
`
`
`5 minutes--------->
`
`1. s btained messag
`
`from bluetooth
`module
`
`
`
`622
`
`Monitor BG
`
`1
`
`FIGURE 6
`
`Yes
`y
`
`Process Data
`
`Page 7 of 25
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`

`

`Patent Application Publication May 22, 2008 Sheet 7 of 15
`
`US 2008/01 19705 A1
`
`710
`Hyperglycemia Region (Blue)
`
`712
`Normal Region (Green)
`
`714
`Hypoglycemia Region (Red) -
`716 Event Bar -
`Data Bar -
`718
`
`
`
`722
`Current BG Reading
`
`
`
`
`
`700
`Unit of time for
`the time axis
`
`702
`Date and Time
`
`704
`Signal Strength
`
`Shis 52 SEM, IZ.
`
`32
`
`O
`
`3.
`
`N
`
`706
`Graph region (BG axis)
`
`708
`TimeAxis
`
`(a)
`
`720
`Cursor
`
`
`
`Meter BG
`Aldrin Hist
`AE GO
`Events
`Help
`COE
`
`Menu 724
`
`726
`Event Marker
`
`Missing Data
`728
`
`(b)
`
`FIGURE 7
`
`Page 8 of 25
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`

`

`Patent Application Publication May 22, 2008 Sheet 8 of 15
`
`US 2008/01 19705 A1
`
`
`
`.47 MOn Mar 2
`3 ha
`Yttrettt Titty" it "Yttitt
`
`ad:
`
`TARGET BG SELECTION
`.
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`17:3O 95-145
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`Type
`
`(c)
`
`FIGURE 8
`
`Page 9 of 25
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`Patent Application Publication
`
`May 22, 2008 Sheet 9 of 15
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`US 2008/01 19705 A1
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`
`
`6 CHIRI[10][H
`
`
`
`
`
`
`
`Page 10 of 25
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`

`

`Patent Application Publication May 22, 2008 Sheet 10 of 15
`
`US 2008/01 19705 A1
`
`1000
`
`
`
`1237 Tue Mari Meter BG
`Aar Hit
`. Aerts
`SESOr
`; Ewant
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`
`1010
`
`&
`
`ERTS HISTORY
`3'
`s
`
`FIGURE 10
`
`Page 11 of 25
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`Patent Application Publication
`
`May 22, 2008 Sheet 11 of 15
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`US 2008/01 19705 A1
`
`90 I I
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`Page 12 of 25
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`

`Patent Application Publication
`
`May 22, 2008 Sheet 12 of 15
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`US 2008/01 19705 A1
`
`90Z I
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`adae, quelv azoous dn?essww
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`Page 13 of 25
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`

`

`Patent Application Publication May 22, 2008 Sheet 13 of 15
`
`US 2008/01 19705 A1
`
`
`
`FIGURE 13
`
`1302
`
`
`
`Serving of:
`
`Page 14 of 25
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`Patent Application Publication May 22, 2008 Sheet 14 of 15
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`US 2008/01 19705 A1
`
`
`
`vibrate
`
`FIGURE 14
`
`Page 15 of 25
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`

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`Patent Application Publication May 22, 2008 Sheet 15 of 15
`
`US 2008/01 19705 A1
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`1500
`
`
`
`HYPOGLYCEMA
`Y
`Glucose (mgfoL): 50
`Target BG (TngldL): 70
`
`assoccer resences
`
`FIGURE 15
`
`Page 16 of 25
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`

`

`US 2008/01 19705 A1
`
`May 22, 2008
`
`SYSTEMIS AND METHODS FOR DIABETES
`MANAGEMENT USING CONSUMER
`ELECTRONIC DEVICES
`
`RELATED APPLICATIONS
`0001. This application claims the benefit of prior filed U.S.
`Provisional Application Ser. No. 60/866,409, filed on Nov.
`17, 2006.
`
`FIELD OF THE INVENTION
`0002 Embodiments of the invention relate to diabetes
`management Systems and, more particularly, to managing
`diabetes utilizing consumer electronic devices including cel
`lular phones, MP3/digital audio players, personal digital
`assistants (PDAs), Smartphones, hybrid devices, and the like.
`
`BACKGROUND OF THE INVENTION
`0003 Infusion devices and glucose monitoring systems
`are relatively well known in the medial arts, particularly for
`use monitoring blood glucose levels and delivering or dis
`pensing a prescribed medication to a user. In many cases, the
`user suffers from diabetes—a disease in which the body does
`not produce or properly use insulin. Approximately 13 mil
`lion people in the United States have been diagnosed with
`some form of diabetes. Type 1 diabetes results from the
`body's failure to produce insulin. Type 2 diabetes results from
`insulin resistance in which the body fails to properly use
`insulin. In order to effectively manage and/or control the
`disease, diabetics must closely monitor and manage their
`blood glucose levels through exercise, diet and medications in
`addition to Supplying their body with appropriate amounts of
`insulin based on daily routines. In particular, both Type 1 and
`Type 2 diabetics rely on insulin delivery and blood glucose
`monitoring systems to control diabetes.
`0004 External infusion devices have been used to deliver
`medication to a patient as generally described in U.S. Pat.
`Nos. 4,562,751; 4,678,408; 4,685,903; 6,554,798, and 6,551,
`276 which are specifically incorporated by reference herein.
`In recent years, continuous glucose monitoring systems have
`been developed utilizing the latest sensor technologies incor
`porating both implantable and external sensors, as generally
`described in U.S. Pat. No. 5,391,250 entitled “Method of
`Fabricating Thin Film Sensors”, U.S. Pat. No. 6,484,046
`entitled “Electrochemical Analyte Sensor, and U.S. Pat. Nos.
`5,390,671, 5,568,806 and 5,586,553, entitled “Transcutane
`ous Sensor Insertion Set, all of which are specifically incor
`porated by reference herein. Newer systems deliver the pre
`ciseness of finger Stick measurements coupled with the
`convenience of not having to repeatedly prick the skin to
`obtain glucose measurements. These newer systems provide
`the equivalent of over 200 finger stick readings per day. Addi
`tionally, continuous glucose monitoring systems allow phy
`sicians and patients to monitor blood glucose trends of their
`body and suggest and deliver insulin based on each patients
`particular needs. Accordingly, physicians and medical device
`companies are always searching for more convenient ways to
`keep diabetic patients aware of their blood glucose levels
`throughout the day.
`0005 Diabetic patients utilizing infusion therapy and con
`tinuous glucose monitoring systems depend on extremely
`precise and accurate systems to assure appropriate blood
`glucose readings and insulin delivery amounts. However, ulti
`lizing these forms of therapy requires the user to carry mul
`
`tiple medical devices containing intricate circuitry and pro
`cessing capabilities. Although today's infusion devices and
`glucose monitoring systems are indeed compact, there
`remains a need in the art for more compact and/or converged
`systems to manage diabetes, such that the user's life style and
`mobility are not restricted.
`
`SUMMARY OF THE DISCLOSURE
`0006. According to an embodiment of the invention, a
`system is for managing diabetes using a consumer electronic
`device, including a medical device for taking a physiological
`reading of a user. The medical device includes a transmitter
`for communicating the physiological readings. In addition,
`the system includes a consumer electronic device, which
`includes Software for managing and processing data obtained
`by the medical device. The system also includes a connector
`removably coupled to the consumer electronic device for
`facilitating communication between the medical device and
`the consumer electronic device. In some embodiments, the
`connector receives data from the medical device in a first
`communication protocol, and the connector transmits data to
`the consumer electronic device in a second communication
`protocol.
`0007. In other embodiments, the medical device is a con
`tinuous glucose monitoring system and/oran infusion device.
`In still additional embodiments, the consumer electronic
`device is a Smartphone. In still further embodiments, the
`consumer electronic device is an MP3 player. In some
`embodiments, the software on the consumer electronic device
`is a Java application.
`0008. In further embodiments, the Smartphone transmits
`the received data to a central server using an internet connec
`tion and/or transmits the received data to a different cellular
`phone using "Short Message Service' (commonly known as
`“SMS or "text messaging”). In other embodiments, the
`Smartphone initiates a cellular phone call based on a particu
`lar event. In yet further embodiments, the software includes
`alarm capabilities to alert the user of a particular event. In
`other additional embodiments, the first communication pro
`tocol is a proprietary protocol maintained by the medical
`device manufacturer and the second communication protocol
`is Bluetooth.
`0009. According to another embodiment of the invention,
`a method is for managing diabetes using a consumer elec
`tronic device, including the steps of pairing a connector to a
`consumer electronic device. Next the consumer electronic
`device is programmed to communicate with a medical device
`for taking a physiological reading of a user, where the medical
`device is pre-programmed to communicate with the connec
`tor, allowing communication between the consumer elec
`tronic device and the medical device thorough the connector.
`Later, data is sent from the medical device to the consumer
`electronic device via the connector. The data is processed and
`displayed on the consumer electronic device. In some
`embodiments, the medical device is a continuous glucose
`monitoring system. In other embodiments, the consumer
`electronic device is a Smartphone.
`0010. According to a further embodiment of the invention,
`a system for providing information obtained from a medical
`device to an individual at a remote location is disclosed. The
`system includes a medical device for taking a physiological
`reading of a user, where the medical device includes a trans
`mitter for communicating the physiological reading. The sys
`tem also includes a local consumer electronic device, where
`
`Page 17 of 25
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`

`US 2008/01 19705 A1
`
`May 22, 2008
`
`the local consumer electronic device includes software for
`receiving, managing and processing data obtained by the
`medical device. A connector is also used by the system and
`the connector is removably coupled to the local consumer
`electronic device for facilitating communication between the
`medical device and the local consumer electronic device.
`Finally, a remote consumer electronic device is included for
`receiving information sent from the local consumer elec
`tronic device, where the connector receives data from the
`medical device in a first communication protocol, and the
`connector transmits data to the local consumer electronic
`device in a second communication protocol. In particular
`embodiments, the remote consumer electronic device
`receives information from the local consumer electronic
`device through a third communication protocol. In other
`embodiments, the first communication protocol is a propri
`etary protocol maintained by the medical device manufac
`turer, the second communication protocol is Bluetooth, and
`the third communication protocol is cellular communication.
`Still in additional embodiments, the cellular communication
`allows the local consumer electronic device to send informa
`tion to the remote consumer electronic device using SMS,
`MMS, or email.
`0011. In yet another embodiment of the invention, a con
`nector is for use with a consumer electronic device and a
`medical device. The connector includes a connecting struc
`ture for attaching the connector to the consumer electronic
`device and a power Supply for providing power to the con
`nector. The connector further includes a first communication
`protocol for transmitting data between the medical device and
`the connector and a second communication protocol for
`transmitting data between the connector and the consumer
`electronic device. In particular embodiments, the first com
`munication protocol is a proprietary protocol maintained by a
`manufacturer of the medical device and the second commu
`nication protocol is Bluetooth.
`0012. According to another embodiment of the invention,
`a software-based application for receiving, managing and
`processing medical device data on a consumer electronic
`device is disclosed. In some embodiments, the software
`based application includes a graphical user interface for dis
`playing data to a patient, an input mechanism for use by the
`patient to adjust settings in the software-based application,
`and alarms for alerting and reminding the patient.
`0013. Other features and advantages of the invention will
`become apparent from the following detailed description,
`taken in conjunction with the accompanying drawings which
`illustrate, by way of example, various features of embodi
`ments of the invention.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`0014. A detailed description of embodiments of the inven
`tion will be made with reference to the accompanying draw
`ings, where like numerals designate corresponding parts or
`cross-sections in the several figures.
`0015 FIG. 1 is a simplified diagram of a diabetes manage
`ment system including a PDA/Smartphone, a connector, and
`a glucose monitoring device in accordance with an embodi
`ment of the present invention.
`0016 FIG. 2 shows perspective views of a PDA/Smart
`phone and connector in accordance with an embodiment of
`the present invention.
`
`0017 FIG.3 is a simplified diagram of a diabetes manage
`ment system including an MP3 player, a connector, and a
`glucose monitoring device in accordance with an embodi
`ment of the present invention.
`(0018 FIG. 4 shows perspective views of a PDA/Smart
`phone and connector in accordance with an embodiment of
`the present invention.
`(0019 FIG. 5 shows the graphical user interface of the
`medical device Software running on the consumer electronic
`device (BlackBerry) in accordance with an embodiment of
`the present invention.
`0020 FIG. 6 is a flow diagram describing operation of the
`diabetes management system using a BlackBerry, a connec
`tor and a blood glucose monitoring system in accordance with
`an embodiment of the present invention.
`0021
`FIG. 7 shows screenshots of the software's graphi
`cal user interface (including menus and graphs) running on
`the consumer electronic device in accordance with an
`embodiment of the present invention.
`0022 FIG. 8 shows screenshots of glucose threshold pro
`files and menus on the consumer electronic device in accor
`dance with an embodiment of the present invention.
`0023 FIG. 9 shows screenshots of the menu structure for
`the "Meter BG’ sub-menu in accordance with an embodi
`ment of the present invention.
`0024 FIG. 10 shows screenshots of the menu structure for
`the Alarm History' sub-menu in accordance with an
`embodiment of the present invention.
`0025 FIG. 11 shows screenshots of the menu structure for
`the “Alerts' sub-menu in accordance with an embodiment of
`the present invention.
`0026 FIG. 12 shows screenshots of the menu structure for
`the “Sensor’ sub-menu in accordance with an embodiment of
`the present invention.
`0027 FIG. 13 shows screenshots of the menu structure for
`the "Events' sub-menu in accordance with an embodiment of
`the present invention.
`0028 FIG. 14 shows screenshots of the software's indica
`tion profile menu in accordance with an embodiment of the
`present invention.
`0029 FIG. 15 shows a screenshot of a sample hypoglyce
`mic alarm issued in the Software running on the consumer
`electronic device in accordance with an embodiment of the
`present invention.
`
`DETAILED DESCRIPTION OF THE PREFERRED
`EMBODIMENTS
`0030. As shown in the drawings for purposes of illustra
`tion, the invention is embodied in a system for diabetes man
`agement including a medical device (MD) and a consumer
`electronic device (CED). The CED may be used to monitor
`and/or control the MD. In particular embodiments, the system
`may include a connector that plugs into the CED to allow
`communication between the MD and the CED. The medical
`device may be an external infusion device, implantable pump,
`glucose meter, glucose monitor, continuous glucose monitor
`ing system, or the like. The CED may be any type of consumer
`electronic device including, but not limited to, cellular
`phones, personal digital assistants (PDAs), BlackBerry,
`Smartphones, pocketpc phones, mp3 players, radios, CD
`players, and the like. The CED may run its own proprietary
`operating system and would be capable of running a program
`to communicate and/or interact with the MD. The program
`may be Java based, web-based, contained on a digital
`
`Page 18 of 25
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`

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`
`May 22, 2008
`
`memory card (SD, compact flash, microSD, or the like),
`and/or bundled on a CD-ROM with the MD. In particular
`embodiments, the program may work on multiple operating
`systems used on CEDs including, but not limited to, Black
`Berry OS, Windows Mobile, Palm OS, .NET framework,
`Symbian, iPod OS, iPhone OS, Zune OS, and the like. Com
`munication between the CED and the MD may be established
`using a connector that attaches to the CED. The connector
`would receive communication from the MD and relay that
`communication to the CED via a hard wired or wireless
`connection.
`0031. In particular embodiments, the connector may plug
`into an available port (i.e., mini-USB) on the CED (Black
`Berry) and the connector may communicate with the Black
`Berry via the mini-USB port or via Bluetooth communica
`tion. In these particular embodiments, a Java program would
`run on the BlackBerry to receive and control data received
`from the MD. In some embodiments, the MD may be a
`glucose sensor/transmitter of the type described in U.S. Pat.
`No. 5,391,250 entitled “Method of Fabricating Thin Film
`Sensors, U.S. Pat. No. 6,484,046 entitled “Electrochemical
`Analyte Sensor.” U.S. Pat. Nos. 5,390,671, 5,568,806 and
`5,586,553, entitled “Transcutaneous Sensor Insertion Set,”
`U.S. Pat. No. 6,809,653 entitled “Telemetered Characteristic
`Monitor System And Method Of Using The Same.” and U.S.
`patent application Ser. Nos. 09/377,472, 11/225,790, 11/225,
`296, 1 1/322,568 and entitled “Telemetered Characteristic
`Monitor System And Method Of Using The Same, all of
`which are specifically incorporated by reference herein. The
`glucose sensor/transmitter would be capable of sending data
`to the connector using proprietary communication between
`the connector and the glucose sensor/transmitter. The data
`would then be sent to the BlackBerry and manipulated using
`the Java based program. The data obtained by the CED can
`show graphs, glucose trends, highs, lows, etc.—all accom
`plished using the familiar CED interface the user is accus
`tomed to working with.
`0032. In further embodiments, the program may include
`alarm capabilities using the hardware and Software available
`on, for example, a BlackBerry. Additionally, the data received
`from the glucose sensor/transmitter may be communicated to
`other locations using the BlackBerry's cellular capabilities.
`Data can be sent to other phones, central servers, and the like
`using “Short Message Service' (commonly known as "SMS
`or "text messaging'). Data may also be sent to email
`addresses, other computers, and/or central servers using the
`BlackBerry’s internet capabilities (GPRS, EDGE, EV-DO,
`1xRTT, UMTS/HSDPA, Wi-Fi, WiMax, ZigBee, Wi-bro, and
`the like). In addition, based on certain conditions, the data
`may also provoke the BlackBerry to initiate a telephone call to
`emergency services (i.e., 911), a caregiver's house, a cell
`phone number, a central management station, or the like. In
`further embodiments, the Java program may include pre
`recorded messages to playback upon initiation of a cellular
`telephone call to alert the person or computer receiving the
`call that a particular condition has been met. The Java pro
`gram may also allow the user to perform event logging to
`associate particular events with glucose readings taken a cer
`tain time of day or during a particular activity (exercise,
`flying, driving, etc.). This data can then be uploaded to a web
`based diabetes management server like Carelink(R) (managed
`by Medtronic MiniMed, Inc.). The data may also be sent to
`other servers, doctors offices, parents, caregivers, or the like
`and insulin dosage recommendations may be made.
`
`0033. As shown in FIG. 1, a diabetes management system
`according to an embodiment of the invention includes a PDA/
`Smartphone 100, a connector 110 and a glucose monitoring
`device 120. The glucose monitoring device 120 includes a
`glucose transmitter 125 and a Subcutaneous glucose sensor
`130 of the type described U.S. Pat. No. 5,391,250 entitled
`“Method of Fabricating Thin Film Sensors”, U.S. Pat. No.
`6,484,046 entitled “Electrochemical Analyte Sensor.” U.S.
`Pat. Nos. 5,390,671, 5,568,806 and 5,586,553, entitled “Tran
`scutaneous Sensor Insertion Set, U.S. Pat. No. 6,809,653
`entitled “Telemetered Characteristic Monitor System And
`Method Of Using The Same and U.S. patent application Ser.
`Nos. 09/377,472, 1 1/225,790, 11/225,296, 1 1/322,568 and
`entitled “Telemetered Characteristic Monitor System And
`Method Of Using The Same, all of which are specifically
`incorporated by reference herein. In particular embodiments,
`the connector 110 has a mini-USB connector that plugs into
`an available port on the PDA/Smartphone 100. Upon connec
`tion, the connector 110 allows communication between the
`PDA/Smartphone 100 and the glucose transmitter 125. The
`connector 110 may be used when a user chooses to use a
`glucose monitoring system 120 made by a different manufac
`turer from the PDA/Smartphone. For example, if a diabetic
`wanted to use the Guardian(R) RT Continuous Glucose Moni
`toring System developed by Medtronic MiniMed, Inc. with
`his BlackBerry PDA/Smartphone, the user would only need
`the appropriate connector 110 manufactured by Medtronic
`MiniMed that would plug into his BlackBerry. Upon connec
`tion, the Guardian RRT system would communicate with the
`user's BlackBerry.
`0034. The PDA/Smartphone 100 may be selected from
`any number of devices including the very popular Black
`Berry(R) line of devices manufactured by Research in Motion.
`Other devices include the popular Treo devices produced
`Palm, Inc (Treo 600, 650, 680, 700w, 700p, 700w)x, 750w),
`the HTC line of devices (AT&T 8525, AT&T Tilt, T-Mobile
`Dash, T-Mobile Wing, and the like), the Apple iPhone, and the
`like. Other devices and connectors are of the type described in
`U.S. Pat. Nos. 6,558,320 and 6,641,533 entitled “Handheld
`Personal Data Assistant (PDA) with a Medical Device and
`Method of Using the Same,” and U.S. patent application Ser.
`No. 10/429,385 entitled “Handheld Personal Data Assistant
`(PDA) with a Medical Device and Method of Using the
`Same, all of which are specifically incorporated by reference
`herein.
`0035. The connector 110 may be of the type described in
`U.S. patent application Ser. No. 10/335,256 filed on Dec. 12,
`2002 and entitled “Relay Device for Transferring Information
`Between a Sensor System and Fluid Delivery System,” which
`is specifically incorporated by reference herein. The connec
`tor 110 may include its own power supply or it may be
`powered through the connection to the CED. In some
`embodiments, the connector battery may charge its battery
`when plugged into the CED. The connector 110 allows com
`munication between the CED and MD. In most situations, the
`MD will use a proprietary communication protocol that is
`associated with its monitor. However, the connector would
`communicate with the MD using the proprietary communi
`cation protocol and then relay the received data from the MD
`to the CED using any number of communication Solutions.
`Such communication solutions include, but are not limited to,
`IR, RF, Bluetooth, wired connection via mini-USB, Wi-Fi,
`Zigbee, and the like.
`
`Page 19 of 25
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`

`

`US 2008/01 19705 A1
`
`May 22, 2008
`
`0036 An example of a connector for a BlackBerry device
`is shown in FIGS. 2 and 4. FIG. 2(a) shows a front perspective
`view of a BlackBerry device 200 with a connector 250
`attached to the BlackBerry 200 mini-USB port. As shown in
`the figures, the connector 250 (or comlink) would have a
`Small profile and fit nicely on the device to avoid changing the
`portable nature of the BlackBerry 200. Additionally, the con
`nector 250 would include a male end that would plug into the
`BlackBerry 200 and a female end 255 that would allow the
`BlackBerry to continue its normal functionality-plug into a
`power outlet to charge, plug into a computer to synchronize
`data, etc. In particular embodiments, the connector 250 could
`communicate with the BlackBerry 200 using a wireless radio
`contained on the BlackBerry. In this aspect, a connector 250
`can be attached to the BlackBerry 200 and can carry out
`protocol conversion. It can speak directly with the sensor
`transmitters hardware to receive the data, and then it can send
`that data to the BlackBerry 200 using a standard communi
`cation protocol that the BlackBerry 200 can interpret (Blue
`tooth, IR, Zigbee, etc.) In other embodiments, the connector
`250 communicates with the BlackBerry 200 via direct com
`munication through the mini-USB port. For other devices that
`don’t include a mini-USB port, the connector may be adapted
`to take the shape of an SD card to fit in a SDIO slot, or any
`other memory card shape to fit in the particular CED’s avail
`able port (miniSD, microSD, memory stick, memory stick
`pro, memory stick duo, etc.).
`0037 Another example of a connector is shown in FIG. 4.
`FIG.4(a) shows a rear perspective view of the CED 400 with
`a connector 450 attached to the back of the CED. FIGS. 4(b)
`and (c) show other perspective views of the connector 450
`attached to the back of the CED. In this example, the connec
`tor may be self charged with its own power Supply, or may
`draw power from the battery pack installed in the BlackBerry.
`The connector 450 shown in FIG. 4 need not utilize the
`mini-usb plug on the BlackBerry device. Instead, the connec
`tor 450 simply attaches to the back of the CED and remains
`self-powered.
`0038. The glucose monitoring device 120 may be replaced
`by any number of medical devices including, but not limited
`to a sensor with a built-in transmitter/receiver, a glucose
`monitor, a glucose meter, an insulin pump, and the like. In
`particular embodiments, glucose sensor 130 is a continuous
`glucose sensor capable of taking readings from a user on a
`continuous or near-continuous basis throughout the day. The
`glucose sensor transmitter 125 transmits blood glucose (BG)
`data to the connector 110 which is plugged into the CED 100.
`The CED 100 can take the BG data and display the informa
`tion to the patient using the interface and control available on
`the CED 100 the user is already familiar with.
`0039. In these embodiments, software may be down
`loaded and/or preinstalled on the CED 100 to manipulate and
`manage the data received from the MD 120. The CED 100
`may also include drivers to use the connector. In particular
`embodiments, the software will be written as a Java applica
`tion-allowing the user to use their Java-enabled CED 100 to
`control and manage the data received from the MD 120. Java
`is a common mobile platform utilized by over 150 carriers.
`Currently, there are over 1.2 billion Java-enabled handsets
`and 8 out of 10 new phones shipped in 2005 were Java
`enabled. Additionally, there are 5 million Java developers
`worldwide. A Java application can be installed on any CED
`that includes Java capabilities (BlackBerry, T-Mobile Dash,
`Palm Treo, etc.). The installed Java application (as shown in
`
`FIG. 5) can display the BG data and can output the data in
`graphs, excel sheets, multi-day trackers, etc. Other program
`ming options include, but are not limited to Windows CE,
`Windows Mobile, Palm Operating System, iPhone Operating
`System, NET framework, Web-based Interface (no software
`needed to install, just run it from a Supported browser, e.g.
`minimo, opera, pocket IE, Safari, etc.) Utilizing a web-based
`interface would allow seamless updates to the software with
`out bothering the user on their CED.
`0040. As shown in FIG.3, a diabetes management system
`according to an embodiment of the invention includes an
`MP3 player 300, a connector 310 and a glucose monitoring
`device 320. The glucose monitoring device 320 includes a
`glucose transmitter 325 and a Subcutaneous glucose sensor
`330. In these embodiments, the iPod would be the CED of
`choice. The iPod 300 has become a world renowned device
`used by millions world wide. Allowing medical device man
`agement Software to run on an iPod allows much more wide
`spread use of important medical device technology—namely,
`the capability to receive and manage BG readings from a
`glucose monitoring system 320. The connector 310 may
`resemble the connector sold with the Nike--iPod Sports Kit
`currently marketed by Nike and Apple. However, in some
`embodiments, the connector need not plug into the iPod con
`nector and may communicate with the iPod and CED via
`wireless communication. The connector 310 would receive
`BG data from the glucose transmitter 325 and show the
`received data on the iPod 300. The iPod may be replaced by
`any number of MP3 and/or digital audio players including the
`Sansa, Zune, Gigabeat S, and the like.
`0041. In all embodiments described above, the BG data
`received by the CED can be manipulated by the software on
`the CED to show graphs, excel files, initiate reminders to
`check BG after a certain period of time and determine if BG
`readings are in a target range. In addition, Software on the
`CED can track and manage BG information coupled with
`event markers inputted by the user.
`0042. In embodiments where the CED is a PDA/Smart
`phone, cellphone, or any other device with external commu
`nication capabilities, the CED may be configured to transmit
`the received BG data to external sources. For example, where
`the CED is a cellular PDA/Smartphone that includes cellular
`connectivity (voice and/or data) the software installed on the
`CED can transmit the received BG data (or any other data
`received from the MD) to the internet, caregivers, doctors,
`parents, and the like. The data can be transmitted via SMS,
`which has become a widely adopted communication mecha
`nism all over the world. The software on the CED could be
`configured to send an SMS to the user's caregiver if a BG
`reading it too low, too high, or even if the user forgot to check
`his/her BG levels in for example, the last hour. In addition to
`SMS messages