Note: Descriptions are shown in the official language in which they were submitted.
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GLUCOMETER AND METHOD FOR USE
FIELD OF THE INVENTION
The disclosure herein relates to the collection and management of medical data
of
diabetic patients. In particular, the disclosure relates to the transmission
of collected blood
glucose level information from a glucometer to a remote computing device, such
as a mobile
phone. It further relates to methods and systems for monitoring a supply of
test media and
facilitating ordering replacement test media, methods and systems for
transmitting information
between elements of the system, and methods and systems for administering a
dose of insulin to
a user.
BACKGROUND OF THE INVENTION
Diabetes is a metabolic disease characterized by high blood sugar, also called
glucose,
resulting from disruption in production of, or lack of proper response to,
insulin, a hormone
central to regulating carbohydrate and fat metabolism. It can cause serious
health complications
including heart disease, blindness, kidney failure, and lower-extremity
amputations. These
complications may be avoided through effective and efficient balance of sugar
levels. The
glucometers (also called a glucose meter) is one tool for reaching and
maintaining an optimal
balance of blood sugar.
Many glucometers use an electrochemical method, based on test media such as
test
strips. Test strips are a consumable element containing chemicals that react
with glucose in a
drop of blood used for each measurement. The test media are typically single-
use elements
which are sold in packages which must be replaced once they are all used. In
addition, insulin
pumps are a tool used to maintain an optimal balance of blood sugar by
regulating the level of
insulin in a user.
Typically, a user will measure his blood sugar, for example using a
glucometer. Based
on the measured blood sugar, he uses an insulin pump to administer an
appropriate dose of
insulin.
Transmission of medical data to remote care givers may be facilitated by a
wired or
wireless Internet connection in the home, using a USB cable connection, for
example. However,
collecting the glucose level data and transmitting is more complicated when a
user is outside of
his home. For example, the user may be a child at school, or a patient on
travel. Unless the user
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has access to a wired or wireless internet connection, a glucometer cannot
transmit recorded
glucose levels results to his physician or caregiver.
Moreover, a remote computing device that the user may have on hand, such as
the user's
cell phone, is not able to cooperate with a glucometer, particularly where the
remote computing
device is configured as a USB slave and the glucometer requires cooperation
with a computer
that is configured as a USB master.
SUMMARY
The disclosure herein relates to the collection and management of medical data
related to
diabetic patients. In particular, the disclosure relates to the transferring
of collected blood
glucose data over an audio-based channel, for example a wireless one, which
may be useful for
medical assessment and care of an individual suffering from diabetes.
It is an advantage of the current disclosure that it may improve blood glucose
level
monitoring and enable users' on-the-go to monitor their diabetes and transmit
the results to their
physicians, to their parents or other care givers. Furthermore, the system
described herein may
provide a more reliable system for logging diabetes related medical data.
Aspects of the disclosure present a system for collecting blood glucose level
information
and transmitting the collected data over a wireless audio-based channel for
further analysis and
storage. The glucometer measures glucose level of a user, using a test medium
and a media
reader component of a glucometer and structures the measurement into a record
by the data
processing unit of the device. The glucometer transmits the measurements
through the
transmitter unit, for example over a wireless audio based channel, to a remote
computing device,
such as a mobile phone. A pre-installed application may present the results,
history data and
additional medical assessments and further transmit the measured data to a
list of recipients such
as physicians, parents, other care givers, to a remote repository for storage
or the like.
Optionally, the glucometer and the remote computing device may communicate
using
protocols such as audio signaling, ultrasonic signaling, infrared
communication, BLUETOOTH
(i.e., one or more wireless technologies for exchanging distances over short
distances using
short-wavelength radio transmissions in the ISM band from 2400-2480 MHz as per
the
standards defined by the Bluetooth Special Interest Group), NEAR FIELD
COMMUNICATION (i.e., one or more technologies for smartphones and similar
devices to
establish radio communication with each other by touching them together or
bringing them into
close proximity, for example based on standards including, but not limited to,
ISO/IES 18092
and those defined by the NFC Forum), WI-FI (i.e., one or more wireless local
area network
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products that are based on the Institute of Electrical and Electonic
Engineers' 802.11 standards),
ZIGBEE (i.e., one or more of a suite of high level communication protocols
used to create
personal area networks built from small, low-power digital radios based on the
Institute of
Electrical and Electonic Engineers' 802.15 standard) or the like.
In some wireless audio based systems, the glucose level medical records may be
communicated at a variety of audio frequency levels, where one combination of
audio
frequencies may represent a '1' bit, and another combination of audio
frequencies may represent
a '0' bit. Accordingly, a synchronization string combination may be attached
before the record
data, while a cyclic redundancy check (CRC) data block may be appended to the
record data, for
error detection of the transmission. The system may include: at least one
glucometer for use in
measuring of at least one subject; at least one media reader unit for
obtaining at least a first
glucose level medical record from the at least one test medium; at least one
transmitter unit for
transmitting measured glucose level record; at least one remote computing
device for receiving
at least one glucose level record using a wireless audio based channel; and a
display mechanism
in the remote computing device via which the glucose level records may be
accessed.
In general, the glucometer may have no display, and may be unable to display
the
measured data. According to some modifications, the glucometer may have means
to be directly
connected to an external output unit, such as a computer, a monitor, a
telephone, a tablet, an e-
reader device, a handheld display device, or the like.
According to various embodiments, the glucometer may comprise at least one
data
processor unit, at least one media reader unit, at least one transmitter unit
and at least one power
source unit.
Optionally, the glucometer monitor may further comprise at least one memory
unit, at
least one mini/micro USB port and a rechargeable battery as a power source.
Additionally or alternatively, the mini/micro USB port may be used to recharge
the
rechargeable battery and / or optionally as an output mechanism operable to
upload measured
glucose medical records stored locally, to a central repository.
It may be noted that in order to implement the methods or systems of the
disclosure,
various tasks may be performed or completed manually, automatically, or
combinations thereof.
Moreover, according to selected instrumentation and equipment of particular
embodiments of
the methods or systems of the disclosure, some tasks may be implemented by
hardware,
software, firmware or combinations thereof using an operating system. For
example, hardware
may be implemented as a chip or a circuit such as an ASIC, integrated circuit
or the like. As
software, selected tasks according to embodiments of the disclosure may be
implemented as a
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plurality of software instructions being executed by a computing device using
any suitable
operating system.
In various embodiments of the disclosure, one or more tasks as described
herein may be
performed by a data processor, such as a computing platform or distributed
computing system
for executing a plurality of instructions. Optionally, the data processor
includes or accesses a
volatile memory for storing instructions, data or the like. Additionally or
alternatively, the data
processor may access a non-volatile storage, for example, a magnetic hard-
disk, flash-drive,
removable media or the like, for storing instructions and/or data. Optionally,
a network
connection may additionally or alternatively be provided. User interface
devices may be
provided such as visual displays, audio output devices, tactile outputs and
the like. Furthermore,
as required user input devices may be provided such as keyboards, cameras,
microphones,
accelerometers, motion detectors or pointing devices such as mice, roller
balls, touch pads,
touch sensitive screens or the like.
According to one aspect of the presently disclosed subject matter, there is
provided a
glucometer comprising:
= a reader configured to analyze a blood sample;
= a transmitter configured to wirelessly transmit data, encoded within an
audio signal,
regarding results of the analysis; and
= a controller configured to facilitate the encoding.
It will be appreciated that an audio signal is a mechanical wave, such as a
sound wave or
the like, comprising an oscillation of pressure which is transmitted through a
physical medium
such as air, water, or solid metal for example. As used herein, the term
'audio signal' is not
limited to sound within the range of human hearing but may include ultrasonic
waves, infrasonic
waves or the like which create effects in a medium which are detectable at a
distance by a
suitable sensor such as a microphone or the like. As described herein, audio
signals may be used
to carry a data communication.
The audio signal may be outside the range of human audible frequencies, or it
may be
within it.
The audio signal may be transmitted at a frequency detectable by at least one
microphone associated with a remote computing device. The at least one
microphone may be
selected from at least one of a group consisting of: an electromagnetic
induction microphone, a
dynamic microphone, a capacitance change microphone, a piezoelectric
generation microphone,
a light modulation microphone, a MEMS microphone, and combinations thereof.
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The transmitter may be configured to transmit sounds of different frequencies
to indicate
different values of the encoded data wherein, e.g., for each of the values of
the encoded data, the
audio signal comprises at least one of a set of frequencies. Each member of
the set may
correspond to an associated value of the encoded data.
The values may be coded as binary data, or non -binary data, such as decimal,
octal,
hexadecimal, for example based on the frequency of the sound.
The transmitter may be configured to transmit a synchronization string before
transmitting the data.
The transmitter may be configured to transmit one or more of an error-
detection code
(such as a cyclic redundancy check) and an error-correction code with the
data.
The transmitter may be configured to retransmit the data until a predefined
event occurs.
The pre-defined event may be the removal of a test medium from the glucometer,
activation of a
button or similar switch on the glucometer, and/or expiration of a timer or
counter.
The reader may be configured to analyze the glucose level when the blood
sample is
disposed on a test medium.
The transmitter may be further configured to transmit data regarding the
status of one or
more aspects of the glucometer, for example, the battery status.
The reader may be configured to analyze the blood sample when disposed on a
test
medium, wherein the data regarding the status of one or more aspects of the
glucometer
comprises information regarding the test medium, such as calibration
information, information
regarding to make/model of the test medium, etc.
The controller may be further configured to direct operation of the reader and
the
transmitter.
According to another aspect of the presently disclosed subject matter, there
is provided a
method of measuring a glucose level in a blood sample, the method comprising:
= providing a glucometer comprising a reader configured to analyze a blood
sample, and
a transmitter configured to transmit data, encoded within an audio signal,
regarding results
of the analysis;
= analyzing of the blood sample by the reader; and
=
transmitting, by the transmitter, data regarding results of the analysis as a
wireless
audio signal.
The method may further comprise:
= receiving and decoding, by a remote computing device, the audio signal;
and
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= displaying, by the remote computing device, the data.
The method may further comprise calculating, by the remote computing device
and
based on the data, the glucose level. In this case the data may comprise raw
data which is the
result of the analysis.
The method may further comprise calculating, by the glucometer, the glucose
level, the
data comprising the glucose level.
According to a further aspect of the presently disclosed subject matter, there
is provided
a glucometer comprising:
= a reader configured to analyze a blood sample;
= a transmitter configured to wirelessly transmit data regarding results of
the analysis;
and
= a controller configured to facilitate operation of the glucometer;
wherein the glucometer is free of a visual data presentation means configured
to present the data
to a user.
All the elements of the glucometer may be contained within a casing.
The controller may be configured to direct operation of the reader and the
transmitter.
The glucometer may be free of visual data presentation means configured to
present data
using alphanumeric characters.
The glucometer may be free of visual data presentation means configured to
present data
graphically.
The glucometer may be free of visual data presentation means configured to
indicate that
the level of glucose in the blood sample is no less than a predetermined
level.
The glucometer may be free of visual data presentation means configured to
indicate that
the level of glucose in the blood sample is no greater than a predetermined
level.
According to a still further aspect of the presently disclosed subject matter,
there is
provided a glucometer comprising:
= a reader configured to analyze a blood sample;
= transmitter configured to wirelessly transmit data regarding results of
the analysis to a
remote computing device; and
= a controller configured to facilitate operation of the glucometer;
wherein the glucometer is free of means configured to receive input from the
computing device.
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The transmitting may be performed as defined by a communications protocol, the
glucometer being free of means configured to receive input as defined by the
communications
protocol.
All the elements of the glucometer may be contained within a casing.
The controller may be configured to direct operation of the reader and the
transmitter.
The transmitter may be configured to transmit the data wirelessly.
The communications protocol may define encoding data within a wireless audio
signal.
The transmitter may be selected from a group including a radio transmitter, an
optical
transmitter, an infrared transmitter, a transmitter configured to operate as
per IEEE 802.11, a
Bluetooth transmitter, a near-field communications transmitter, and
combinations thereof.
According to a still further aspect of the presently disclosed subject matter,
there is
provided a method of analyzing a blood sample, the method comprising:
= providing a system configured to perform an analysis of a glucose level
of the blood
sample disposed on a test medium, wherein the test medium is one of a quantity
of test
media in a user's supply;
= monitoring, by the system, the number of test media of the supply used in
performing
the analysis;
= determining, by the system, that a threshold value of test media has been
reached, the
threshold value being less than the quantity; and
= performing, by the system, once the threshold value has been reached, an
ordering
procedure.
The system may comprise a glucometer configured to perform the analysis and
transmit
data, and a remote computing device configured to receive a transmission from
the glucometer.
The remote computing device may be configured to communicate with an external
network. For example, it may be selected from the group including a mobile
phone (e.g., built
on a mobile operating system) and a tablet computer.
The monitoring may comprise receiving an indication of the quantity of the
user's supply
of test media. The indication may be at least partially based on information
regarding a previous
ordering procedure.
The monitoring may comprise one (or both) of:
decrementing a value corresponding to the number of test media remaining in
the user's
supply when one or more test media is used; and
incrementing a value corresponding to the number of test media used from the
user's
supply when one or more test media is used.
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The expected daily usage of test media may be at least partially based on at
least one or
more of:
= expected daily usage of test media from the user's supply;
= usage history thereof; and
= expected shipping time of a new supply of test media.
The ordering procedure may comprise at least one or more of:
= the system automatically ordering test media;
= the system alerting a user to place an order; and
= the system presenting information necessary to order test media to a
user, wherein the
to method may further comprise the system ordering test media based on the
information
presented upon approval by a user.
The user's supply may comprise a single package of test media. It may comprise
more
than one package of test media.
According to a still further aspect of the presently disclosed subject matter,
there is
provided a system configured to perform an analysis of a glucose level of a
blood sample
disposed on a test medium , wherein the test medium is one of a quantity of
test media in a
user's supply, the system comprising:
= a glucometer configured to perform the analysis and to transmit data; and
= a remote computing device configured to receive a transmission from the
glucometer
and to communicate with an external network;
= wherein the system is further configured to:
= monitor the number of test media of the supply used in performing the
analysis;
= determine that a threshold value of test media has been reached, the
threshold value
being less than the quantity; and
= perform, once the threshold value has been reached, an ordering
procedure.
The monitoring may comprise receiving an indication of the quantity of the
user's supply
of test media.
The monitoring may comprise one of:
= decrementing a value corresponding to the number of test media remaining
in the
user's supply when one or more test media is used; and
= incrementing a value corresponding to the number of test media used from
the user's
supply when one or more test media is used.
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The ordering procedure may comprise one or more selected from the group
including
automatically ordering test media, alerting a user to place an order, and
presenting information
necessary to order test media to a user.
According to a still further aspect of the presently disclosed subject matter,
there is
provided a method of analyzing a blood sample, the method comprising:
= providing a glucometer configured to analyze a blood sample and a remote
computing
device separate from the glucometer;
= analyzing, by the glucometer, the blood sample;
= presenting, by the glucometer, a machine-readable visually-encoded
representation of
to one or more results of the analysis;
= imaging, by the remote computing device, the representation; and
= decoding, by the remote computing device, the representation, thereby
retrieving at
least one of the results.
The visually encoded representation may comprise a pattern. The pattern may be
selected from the group including one-dimensional and two-dimensional
barcodes. The pattern
may comprise alphanumeric characters.
The visually encoded representation may comprise a sequence of visual
elements. The
glucometer may comprise one or more LEDs, the visual elements being one or
more flashes of
the LEDs. The LEDs may be multi-color, wherein different colors of each LED
represent
different values of encoded data.
The method may further comprise presenting machine-readable visually-encoded
representation of at least one of error-correction and error-detection
information.
According to a still further aspect of the presently disclosed subject matter,
there is
provided a method of analyzing a blood sample, the method comprising:
= providing a glucometer configured to analyze a blood sample and
comprising a
capacitive profile output mechanism;
= providing a remote computing device separate from the glucometer and
comprising a
capacitive sensing input mechanism;
= analyzing, by the glucometer, the blood sample;
= encoding, by the glucometer, one or more results of the analysis as a
capacitive profile;
= producing, by the capacitive profile output mechanism, the capacitive
profile;
= reading, by the capacitive sensing input mechanism, the capacitive
profile; and
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= decoding, by the remote computing device, the capacitive profile, thereby
retrieving at
least one of the results.
The capacitive profile may comprise a sequence of capacitive states varying
over a
period of time.
The capacitive profile may comprise a plurality of regions, each exhibiting a
capacitive
state.
Each region may exhibit a sequence of capacitive states varying over a period
of time.
The capacitive profile may further comprise at least one of error-correction
and error-
detection information.
to According to a still further aspect of the presently disclosed subject
matter, there is
provided a glucometer comprising:
= a reader configured to analyze a blood sample;
= a processor configured to encode results of the analysis; and
= a capacitive output mechanism configured to represent the encoded
results.
The capacitive output mechanism may be configured to exhibit a sequence of
capacitive
states varying over a period of time.
The capacitive output mechanism may comprise a plurality of regions, each
region being
configured to exhibit a capacitive state independent of the other regions. The
glucometer may be
being configured to exhibit a sequence of capacitive states in each region
varying over a period
of time.
According to a still further aspect of the presently disclosed subject matter,
there is
provided a method of administering insulin to a user. The method comprises
providing a system
comprising a glucometer configured to analyze a blood sample, a remote
computing device
separate from the glucometer, and an insulin pump separate from the remote
computing device
and glucometer; analyzing, by the glucometer, a blood sample from a user, and
communicating
the results to the remote computing device; determining, by the remote
computing device and
based on the results, an insulin dosage to be administered; communicating, by
the remote
computing device, a command to the insulin pump to administer a dose of
insulin based on the
determined dosage; and administering the dose by the insulin pump.
The determining may comprise calculating a dosage to be administered.
The determining may comprise retrieving dosage information from one or more
tables
preloaded on the remote computing device.
The remote computing device may be configured to automatically communicate the
command.
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The remote computing device may be configured to communicate the command upon
confirmation by a user.
The communicating may further comprise transmitting one or more of error-
detection
and error-correction information.
The method may further comprise the system verifying that an intended command
was
received by the insulin pump.
The method may further comprise, prior to the administering, a user activating
a
mechanism on the insulin pump.
According to a still further aspect of the presently disclosed subject matter,
there is
provided a system configured to administer insulin to a user, the system
comprising a
glucometer configured to analyze a blood sample, a remote computing device
separate from the
glucometer, and an insulin pump separate from the remote computing device and
glucometer,
wherein the remote computing device is configured to receive communication
from the
glucometer regarding results of a blood analysis, determine, based on the
results, an insulin
dosage to be administered, and communicate a command to the insulin pump to
administer a
dose of insulin based on the determined dosage, the insulin pump being
configured to administer
the dose.
The remote computing device may be configured to determining the insulin dose
by
calculating a dosage to be administered.
The remote computing device may be configured to determining the insulin dose
by
retrieving dosage information from one or more tables preloaded on the remote
computing
device.
The remote computing device may be configured to automatically communicate the
command.
The remote computing device may be configured to communicate the command upon
confirmation by a user.
The remote computing device may be further configured to transmitting one or
more of
error-detection and error-correction information to the insulin pump.
The system may be configured to verify that an intended command was received
by the
insulin pump.
The insulin pump may be configured to administer the dose upon activation of a
mechanism thereof.
According to a still further aspect of the presently disclosed subject matter,
there is
provided a device configured to administer an insulin dose to a user, the
device comprising a
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pump configured for the administering, a communications interface configured
to receive
instructions from a remote computing device, and a processor, the processor
being configured to
receive at least one instruction via the communications interface and operate
the pump to
administer an insulin dose based on the instruction.
BRIEF DESCRIPTION OF THE FIGURES
For a better understanding of the embodiments and to show how it may be
carried into
effect, reference will now be made, purely by way of example, to the
accompanying drawings.
With specific reference now to the drawings in detail, it is stressed that the
particulars
shown are by way of example and for purposes of illustrative discussion of
selected
embodiments only, and are presented in the cause of providing what is believed
to be the most
useful and readily understood description of the principles and conceptual
aspects. In this
regard, no attempt is made to show structural details in more detail than is
necessary for a
fundamental understanding; the description taken with the drawings making
apparent to those
skilled in the art how the several selected embodiments may be put into
practice. In the
accompanying drawings:
Fig. 1 is a block diagram schematically representing selected components of an
example of a
system for gathering glucose level data using a plurality of devices;
Fig. 2A shows a glucometer incorporating selected elements operable to
transmit blood glucose
level of a subject, over a wireless audio based channel;
Fig. 2B shows a glucometer configured to communicate with a remote computing
device
transmitting blood glucose levels of a subject over a wireless audio based
channel;
Fig. 3 schematically represents possible elements for creating a record for
audio based
transmission from a glucometer with a sample transmission;
Fig. 4A schematically represents a possible record structure transmitted
between glucometer and
remote computing device of glucose level data;
Fig. 4B schematically represents a glucose record sample transmitted between
glucometer and
remote computing device;
Fig. 5 is an illustration of data integrity checking of a record (CRC based)
sent between
glucometer and remote computing devices;
Figs. 6A through 6D show simplified flowcharts of methods of using a
glucometer for gathering
and transmitting glucose level data, over a wireless audio based channel;
Fig. 7A shows a simplified flowchart of a method of a remote computing device
application for
receiving glucose level data, over a wireless audio based channel; and
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Fig. 7B shows a simplified flowchart of a method of a remote computing device
application for
receiving glucose and battery level data, over a wireless audio based channel.
Fig. 8 is a schematic illustration of another example of a system according to
the presently
disclosed subject matter;
Fig. 9 is a schematic illustration of a glucometer of the system illustrated
in Fig. 8;
Fig. 10 is a schematic illustration of a remote computing system of the system
illustrated in
Fig. 8; and
Fig. 11 illustrates a method for ordering test media, for example using the
system illustrated in
Fig. 8, according to the presently disclosed subject matter.
Fig. 12 is a schematic illustration of a further example of a system according
to one example of
the presently disclosed subject matter;
Fig. 13 is a schematic illustration of a glucometer of the system illustrated
in Fig. 12;
Fig. 14A illustrates an example of information encoded as alphanumeric
characters;
Figs. 14B and 14C illustrate, respectively, examples of one-dimensional and
two-dimensional
barcodes;
Fig. 15 is a schematic illustration of a remote computing device of the system
illustrated in
Fig. 12;
Fig. 16 illustrates a method for transmitting results of an analysis performed
by the glucometer
illustrated in Fig. 13 to the remote computing device illustrated in Fig. 14;
Fig. 17 is a schematic illustration of a system according to a still further
example of the
presently disclosed subject matter;
Fig. 18 is a schematic illustration of a glucometer of the system illustrated
in Fig. 17;
Figs. 19A and 19B are, respectively, schematic plan and side views of a
surface of a capacitive
output mechanism of the glucometer illustrated in Fig. 18;
Fig. 20 is a schematic illustration of a remote computing device of the system
illustrated in
Fig. 17; and
Fig. 21 illustrates a method for transmitting results of an analysis performed
by the glucometer
illustrated in Fig. 17 to the remote computing device illustrated in Fig. 20.
Fig. 22 is a schematic illustration of a system according to the presently
disclosed subject
matter;
Fig. 23 is a schematic illustration of a glucometer of the system illustrated
in Fig. 22;
Fig. 24 is a schematic illustration of an insulin pump of the system
illustrated in Fig. 22;
Fig. 25 is a schematic illustration of a remote computing device of the system
illustrated in
Fig. 22; and
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Fig. 26 illustrates a method by which the system illustrated in Fig. 22
administers a dose of
insulin.
DETAILED DESCRIPTION
Aspects of the present disclosure relate to communicating over audio based
channel the
measured glucose level medical data for diabetic patients, for determining the
approximate
concentration of glucose in the blood, using a medical measurement device.
Transferring the
data automatically, over an audio channel to a remote computing device, that
in turn may
optionally transfer the data to a predefined audience list of professional
care givers, parents and
the like, is an additional element of the present disclosure, supporting home
blood glucose
monitoring for example by people with diabetes mellitus or hypoglycemia.
Furthermore, related
aspects include a medical measurement device without a display, as well as a
medical
measurement device which is configured to one-way communication, i.e., it is
designed to
transmit messages using a data protocol, but is not provided with any means
configured to
receive such or similar messages.
It is noted that the systems and methods of the disclosure herein may not be
limited in its
application to the details of construction and the arrangement of the
components or methods set
forth in the description or illustrated in the drawings and examples. The
systems and methods of
the disclosure may be capable of other embodiments or of being practiced or
carried out in
various ways.
Alternative methods and materials similar or equivalent to those described
herein may be
used in the practice or testing of embodiments of the disclosure.
Nevertheless, particular
methods and materials are described herein for illustrative purposes only. The
materials,
methods, and examples are not intended to be necessarily limiting.
Reference is now made to Fig. 1 showing a block diagram schematically
representing
selected components incorporated into a distributed system 100 for the
gathering and remote
management of glucose level data using a plurality of devices.
The distributed system 100 comprises a plurality of devices, such as medical
measurement device 140, which may be, e.g., a glucometer, and remote computing
device 150
(which may be, e.g., a smartphone or any other suitable device such as a
communications
device, and which may constitute an output device). The medical measurement
device 140 and
remote computing device 150 may be in communication through a wireless audio
based channel
and may further communicate information to remote devices, such as a central
repository device
80, through a network 50 (such as internet- or mobile-based) to a recipient
list. For example, the
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medical measurement device 140 may transmit medical data through the remote
computing
device 150. The data may thereafter be communicated to a remote caregiver 90,
e.g., via a
computer or handheld device, such as a smartphone.
It will be appreciated that while the present disclosure is largely directed
toward
examples wherein the medical measurement device 140 is a glucometer, and the
medical data
measured thereby is glucose level, any device configured to measure medical
data may be
provided without departing from the spirit and the scope of the present
disclosure, mutatis
mutandis. For example, the medical measurement device 140 may be or comprise a
thermometer, a scale (measuring any one or more or weight, body fat, bone
density, and body
mass index), a pulmonary edema monitor, and/or be configured to measure blood
oxygen
level/saturation, heart rate, blood pressure, physical activity (e.g., a
pedometer) and/or calories
burnt.
It is noted that a user interface for using the remote computing device 150,
such as a
touch screen or the like, may serve both as input and output devices thereof.
Use of a touch
screen may allow the screen to be larger without compromising the size of a
separate input
device such as a key pad. Furthermore, a touch screen input device may be
easier to use for the
untrained user as it may use easy to interpret icons rather than complicated
text based
instructions.
Outbound communications channel 170A (the terms "outbound" and "inbound" when
used herein with reference to communication between the medical measurement
device 140 and
the remote computing device 150 are from the point of view of the medical
measurement
device) may be provided for communication from the medical measurement device
140 to the
remote computing device 150, which may be connected to the network directly.
According to
some optional and non-limiting modifications, an inbound communications
channel 170B may
be provided for communication from the remote computing device 150 to the
medical device
140 such that the devices may be operable to synchronize data with one
another.
The outbound communications channel 170A may be, e.g., an audio based
communication channel. As such, the medical measurement device 140 may
comprise a
transmitter 142, such as a speaker configured to transmit an audio signal
encoding data
regarding the measured medical data (such as, in the case of a glucometer,
blood glucose level)
for storage, display, or other purpose. The remote computing device 150 thus
comprises receiver
152, such as a microphone (e.g., an electromagnetic induction microphone, a
dynamic
microphone, a capacitance change microphone, a piezoelectric generation
microphone, a light
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modulation microphone, a MEMS microphone, or combinations of the above)
configured to
receive the signal transmitted by the transmitter 142.
Optionally, the remote computing device 150 may be configured for sending
measured
medical data stored thereupon to a professional care giver 90 or uploading to
a central repository
80 via a computer network 50. Optionally, the devices may communicate using
protocols such
as BLUETOOTH (i.e., one or more wireless technologies for exchanging distances
over short
distances using short-wavelength radio transmissions in the ISM band from 2400-
2480 MHz as
per the standards defined by the Bluetooth Special Interest Group), NEAR FIELD
COMMUNICATION (i.e., one or more technologies for smartphones and similar
devices to
establish radio communication with each other by touching them together or
bringing them into
close proximity, for example based on standards including, but not limited to,
ISO/IES 18092
and those defined by the NFC Forum), WI-FI (i.e., one or more wireless local
area network
products that are based on the Institute of Electrical and Electonic
Engineers' 802.11 standards),
or any other suitable protocol.
The remote computing device 150 may be pre-loaded with an application 160,
which
facilitates, inter alia, locally viewing and/or analyzing the data measured by
the medical
measurement device 140.
The application 160 may be configured to send information regarding the
measured
medical data to a pre-defined recipient list. Such a list may include medical
professionals, care
givers, parents, and the like. It may store data with a time stamp, so that
the measurement data
may be provided within a historical context. For example, it may be
configured, based on the
time-stamped data to graphically present multiple results showing how measured
data vary over
time.
It is noted that the particular architecture and functionality as described
hereinafter, by
way of example, refer to a one-way communication protocol between the medical
measurement
device 140 and the remote computing device 150 via the outbound communications
channel
170A. By employing only the outbound communications channel 170A, the medical
measurement device can be provided without a receiver, thereby lowering its
cost.
Optionally, it is assumed that while using a one-way communication protocol
the
transmission from the medical measurement device 140 may be repeated until a
predefined
event occurs. This event may be, for example, a test medium being removed from
the medical
measurement device 140, activation of a button or similar switch on the
medical measurement
device (in such a case, the application 160 may be configured to indicate to a
user when it has
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successfully received data via the outbound communications channel 170A and/or
instruct the
user to activate the button/switch), and/or expiration of a timer or counter.
Furthermore, the medical measurement device monitor 140 and the remote
computing
device 150 may be complementary interdependent modules, each of which relies
on the other to
perform the required operations it does not itself perform. For example, the
medical
measurement device 140 may not itself have a display unit and may only measure
the medical
data and transmit it. This may be done via a wireless signal. Additionally or
alternatively, the
medical measurement device 140 may connect to the remote computing device 150
via a cable
with a mini/micro USB plug.
Reference is now made to Fig. 2A where a medical measurement device 140 is
shown.
In the present example, the medical measurement device 140 is operable to
measure and store
information regarding a glucose level of a subject. It is also configured to
transmit data
regarding the information via outbound communications channel 170A. According
to some non-
limiting modifications, it may be configured to transmit the information as
data using a wireless
audio based communication protocol. The glucose level and related collected
information may
be sent to remote devices (not illustrated) used, e.g., by caregivers,
parents, etc., or to be stored
remotely in a central repository. The transmission may be configured to occur
automatically, for
example to a pre-defined set of devices, and/or may be initiated manually.
The medical measurement device 140 includes a central processing unit (CPU)
220
constituting a controller, a media reader 222 (for example a test strip
reader), a power source
224, a transmitter 142, and a media slot 232. Optionally various other
internal elements may be
added, such as memory 228 and a micro USB port 230.
As mentioned, the medical measurement device 140 may have a primary function
to
measure the blood glucose level of a subject. Accordingly, the user may
introduce a test medium
234 into the media slot 232 for reading by the media reader 222. Various test
media 234 may be
used with the medical measurement device 140 as known in the art. For example,
test media
may be plastic or paper strips impregnated with glucose sensitive chemicals
such as glucose
oxidase. The strips themselves may have various shapes as required. As known
in the art, a
subject typically applies a drop of blood to a test medium 234 before
introducing the test
medium 234 into the medical measurement device 140. The introduction of the
test medium 234
into the medical measurement device 140 initiates a process which includes
reading the media,
calculating the glucose level, and transmitting the glucose level via outbound
communications
channel 170A to the remote computing device 150.
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According to some modifications, the medical measurement device 140 also
transmits
via outbound communications channel 170A information regarding one or more
aspects of itself
and/or of the test medium. Such information may include, but is not limited
to, the battery level
of the medical measurement device 140, calibration data, and/or information
regarding specifics
of the test medium (model, etc.).
The CPU 220 of the medical measurement device 140 is configured to encode the
information before it is transmitted. The encoding may employ binary data,
e.g., with two
different tones (or ranges of tones) each representing different binary
digits, or non-binary, e.g.,
with several tones (or ranges of tones) being used, each representing a non-
binary digit. For
example, hexadecimal encoding may be used, with 16 different tones (or ranges
of tones) being
used, each to represent a digit between Ohõ and Fhõ. In addition, data
compression may be
employed, wherein a tone contains more than one bit or data. Alternatively,
the information may
be sent as an analog signal, for example by "speaking" the information, i.e.,
by producing
sounds mimicking human speech. According to any of the above, the audio signal
may be within
the range of human audible frequencies, or outside of it.
The CPU 220 is further configured to direct operation of the various elements
of the
medical measurement device 140, for example the media reader 222 and the
transmitter 142.
It will be appreciated that although the CPU 220 is described herein and with
reference
to the accompanying figures as a single element, it may comprise several
elements working
together to perform the functions thereof. In addition, some of the
functionality thereof may be
performed by other elements listed herein (e.g., encoding may be performed by
the same
element which functions as the transmitter 142). In such a case, the CPU 220
is considered to
comprise the elements which perform the functions of the CPU, despite the fact
that they are
physically located with other elements, mutatis mutandis.
According to some examples of the presently disclosed subject matter, the
transmitter
142 comprises an audio-based communicator, such as a speaker, operable to
transmit audio
signals. The application 160 running on the remote computing device 150 is
operable to detect
the transmitted audio signals, for example via the receiver 152 thereof. The
software application
may further be configured to decode the information carried by the audio
signals and display the
measured glucose level on a display of the remote computing device.
Optionally, the application
160 may additionally be configured to enable automatic external communication
of the
measured glucose level to a pre-defined list of recipients, or manually
communicate the
measured data to a desired communicator.
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Accordingly, according to some examples of the presently disclosed subject
matter, the
medical measurement device 140 is a closed "black-box" type device with few or
no external
features, with the exception of, inter alia, the media slot 232 and a battery
replacement
compartment.
Optionally, the medical measurement device 140 may include an internal memory
228
for storing recorded data which may be accessed later. The medical measurement
device may
include a micro USB port 230 that may be connected to another device via
mini/micro USB
cable. The micro USB port may provide dual functionality of charging the power
source 224, if
the power source is a rechargeable battery and connectivity to the processor
220 for
downloading measured information.
It is noted that various graphical user interfaces (GUI) for analyzing the
measured
glucose information may be used as required, through the application 160 of
the remote
computing device 150.
According to some modifications of the presently disclosed subject matter, a
display is
provided in the medical measurement device 140. This display may thus serve as
a user
interface, for example comprising a touch screen using where appropriate,
numerals or text that
may be input either via a virtual keypad (not shown) or adjusted using
adjustment arrows (not
shown), operable to receive user input to configure transmission parameters
for sending
measured glucose level over the communication channel.
Optionally, the medical measurement device may include a basic structure, with
a
minimal display functionality of buttons for a user to input data relating to
automatic or manual
configuration of the transmission, such as time interval for transmission
resend and the like.
Reference is now made to Fig. 2B, showing a representation of an audio
communication
system 200' in which a medical measurement device 140 is communicating, using
the outbound
communications channel 170A described above with reference to Fig. 1, with the
remote
computing device 150, installed with application 160 for analyzing received
glucose data. The
glucose level and related collected information may be stored into a record,
as described below
with reference to Fig. 4, and transmitted to the remote computing device 150
for management
and viewing thereof, and optionally for further transmission to caregivers,
parents, etc., or to be
stored remotely in a central repository.
The medical measurement device 140 may be configured to transmit a record
automatically, for example upon introduction of a test medium. Alternatively,
or additionally,
transmission may be initiated manually by a user, for example via an
activation button (not
shown) on the device. Transmission signals may be repeated at regular time
intervals at a pre-
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configured rate, for example, every 4 seconds. Accordingly, according to some
modifications of
the presently disclosed subject matter, the medical measurement device could
be provided free
of elements which facilitate its receiving input from the remote computing
device. This
simplification may serve to lower the price of the medical measurement device
140 and/or
increase its battery life.
The communication system representation 200' includes the medical measurement
device 140 comprising a transmitter 142, a remote computing device 150,
constituting a remote
output device, such as a smartphone installed with a suitable software
application 160 for
analyzing the glucose level data, and glucose level data records 206.
It may further be noted that the medical measurement device 140 may be pre-
configured
to send data signals such as medical content signals or power level
notifications at regular time
intervals, for example, every 4 seconds. Such data may be received by the
associated software
application 160 running on the remote computing device 150.
Reference is now made to Fig. 3, which schematically represents possible
elements for
creating a record structure for transmission from a medical measurement
device, using the
wireless audio based communication protocol. The protocol is presented for
illustrative purposes
only, it will be appreciated that other protocols may occur to those skilled
in the art and may be
alternatively or additionally utilized.
The communication transmission elements includes a synchronization sequence
310, a
bit of '1' representation 320 and a bit of '0' representation 330. These basic
elements enable
transmitting, for example, a sample level value of 5 ('101' binary sequence),
for example, as
presented in the 340 representation.
The communication protocol may be based on sending a sequence of '0' (s) and
'1' (s)
bits for each measurement of information sent, with 'AB' used as a
synchronization signal,
`CDE' as an indication for '1' and `FGH' as an indication for '0', and may use
the following
frequency levels, for example:
= A = 4000 Hz; B = 4200 Hz; (may be used for synchronization)
= C = 4400 Hz; D = 4600 Hz; E = 4800 Hz; (may be used for constructing bit
'1')
= F = 5000 Hz; G = 5200 Hz; H = 5400 Hz; (may be used for constructing bit
'0')
Every tone, an 'A', for example, may take 20 milliseconds of transmission.
Thus sending
a signal of 'AB' may take 40 milliseconds of transmission and a
synchronization signal of 'AB'
+ 'AB' may take 80 milliseconds, followed with the actual coded information.
Reference is now made to Fig. 4A, representing a possible audio communication
transmission 400 of glucose level measurement information from the medical
measurement
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device to a remote computing device, such as a mobile device, for example. The
transmission
starts with a synchronization signal 411 and ends with a cyclic redundancy
check (CRC) 414, an
error detection code for detecting errors in the transmitted data.
It may be noted that, according to some examples, the transmission is of one-
way
communication. As no acknowledgement signal may be sent back when one-way
communication is used, it may be useful to send the data signal, for example
including glucose
level related information repeatedly, e.g., every 4 seconds. According to some
modifications, the
records and audio communication protocol may, use functionality and commands
to
acknowledge successful reception of the record by the receiver, configure
record timeout,
request record resend, etc.
The communication transmission 400 includes a synchronization signal 411,
followed by
blood glucose level data measurement 412, optionally with battery level data
413 and ended
with an encoded CRC error detection sequence 414.
The synchronization signal 411 is of 4T (tones), and may include sending the
'AB'
signal twice in a sequence using 2 bits. The blood glucose level measurement
412 may be within
a range of 1 to 512 mg/di of 27T (tones) using 9 bits. The optional battery
level information 413
may take a value of 0 to 15 volts, thus of 12T (tones) using 4 bits. This may
be completed with
CRC error detection using 9 bits. Thus, the whole transmission may need a
total of 24 bits. The
transmission may also be repetitive, every 4 seconds, for example, and may
continue as long as
the test medium is inserted in its slot of the medical measurement device.
Transmission of each tone may take 20 milliseconds.
As illustrated in Fig. 4B, in one example, a synchronization signal may be
followed by a
glucose level value, a battery level value and an error detection signal. A
sample transmission of
an average glucose level of 72 mg/di ('01001000') with battery level of 6
(`110') may take the
format:
'AB' + 'AB', `FGH' + `CDE' + `FGH' + `FGH' + `CDE' + `FGH' + `FGH' + `FGH',
`CDE' + `CDE' + `FGH', CRC
where the leading string 'AB', 'AB' represents the synchronization signal, and
the terminal
value CRC represents the error detection.
The value of the cyclic redundancy check (CRC) for encoding the record by
adding a
fixed-length check value may be used for error detection and data integrity
verification. It may
be based on the remainder of a polynomial division or may take a simple format
of repeating a
value, for a single value record, such as the blood glucose level or sending
the sum of the two
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values, for a record containing the blood glucose level and the battery level,
such that in the
example above the value 78, being the sum of 72 and 6, may serve as the error
detection value.
Reference is now made to Fig. 5 illustrating selected data integrity actions
which are
indicated of a method for encoding and decoding a record. The record is
constructed on the
medical measurement device 140 by its CPU 220, after reading the glucose level
information
from the test medium and verified by a method on the application installed on
the remote
computing device 150.
According to the method flow, a cyclic redundancy check (CRC) block may be
attached
at the end of the glucose information record. The record may be composed using
the CPU 220
of the medical measurement device 140, resulting in a record having a length
of k bits (step
502). This record may include synchronization signal, followed with the
measured blood
glucose level by the media reader 222 of the medical measurement device140.
Optionally, the
battery level may be added to the record. After assembly of the record for
sending, a short block
of check data, having possibly 9 bits, may be attached at the end of the
constructed record (step
504). The record may repeatedly be sent from the medical measurement device
transmitter 226
and speaker 142 of the medical measurement device 140, over a wireless audio
based channel to
the remote computing device 150, at preconfigured time intervals, for example
every 4 seconds.
The record may be received by the communicator 160 receiver component 506, to
enable
decoding the attached data block by the application 160, for error detection
and correction
purposes. For example, a cyclic redundancy check may be used for error
detection, and error
correction codes (for example by including parity data) may be used for error
correction. Once
received, the information is decoded, using the attached CRC string to
validate the record
content (step 508), with a possible output of a record having a length of k
bits 510, if the record
was properly received.
It may be noted, that the form of cyclic redundancy check (CRC) may apply a
customized verification of data integrity, such as attaching the actual
transmitted value, if only
the blood glucose level is sent, or the sum of the measured glucose level and
the battery level, if
both values are send.
Referring to the flowchart of Fig. 6A selected actions are indicated of a
method for
transmitting blood glucose level measured data and related information from
the medical
measurement device 140 to a remote computing device 150, such as a mobile
device installed
with a pre-installed application 160. The transmission of the glucose measured
level data may be
communicated over a wireless audio channel-based system as described
hereinabove.
Alternatively, or additionally, the outbound communications channel 170A
between the medical
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measurement device 140 and the remote computing device 150 may use a wireless
communication system, a NEAR FIELD COMMUNICATION (i.e., one or more
technologies
for smartphones and similar devices to establish radio communication with each
other by
touching them together or bringing them into close proximity, for example
based on standards
including, but not limited to, ISO/IES 18092 and those defined by the NFC
Forum) system, and
the like.
It may be noted that for any network-based architecture such as audio, WI-FI
(i.e., one or
more wireless local area network products that are based on the Institute of
Electrical and
Electonic Engineers' 802.11 standards), Wireless, NEAR FIELD COMMUNICATION
(i.e., one
or more technologies for smartphones and similar devices to establish radio
communication with
each other by touching them together or bringing them into close proximity,
for example based
on standards including, but not limited to, ISO/IES 18092 and those defined by
the NFC Forum)
or the like, the record stream may have the same or similar record structures
answering the pre-
defined communication protocol definitions, as described hereinabove.
It may further be noted that the assembly of the record may be constructed on
the
medical measurement device, adding a cyclic redundancy check (CRC) indication
for checking
record integrity upon arrival of the record on the remote computing device.
Alternatively or additionally the form of cyclic redundancy check (CRC) may
apply a
customized verification of data integrity, such as repeating the measured
glucose level, for
decoding on the receiving side.
According to the method, as known in the art, a subject will typically apply a
drop of
blood to a test medium before introducing the test medium into the appropriate
medical
measurement device slot (step 602A). The medical measurement device will then
measure using
the media reader 222 to define the blood glucose level (step 604A), and
optionally store the
measured blood glucose level locally with appropriate timestamp.
The measured value of blood glucose level may be constructed into a record as
described
hereinabove of communication protocol details, attaching a CRC value for data
integrity and
error detection (step 606A). The constructed record may then be sent, over the
available wireless
audio channel (step 608A). It is noted that the remote computing device may
then receive the
transmitted signal.
If the test medium is still inserted in its slot of the medical measurement
device (step
610A), the transmitter of the medical measurement device may continue to
resend the current
record at pre-defined time intervals, for example, say, every 4 seconds (step
612A). If the test
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medium is pulled out, the transmitter of the medical measurement device may
move into a
holding state, until the next test medium is inserted and measured (step
614A).
Referring to the flowchart of Fig. 6B selected actions are indicated of a
method for
transmitting blood glucose level measured data, similar to the method
described hereinabove in
Fig 6A, but with adding related battery level information measured at the
medical measurement
device 140 for sending to a remote computing device 150. The transmission of
the blood
glucose measured level data and battery level information may be communicated
over a wireless
audio channel-based system as described hereinabove in Figs 3, 4 and 5, to a
remote computing
device 150, such as a mobile device pre-installed with application 160.
Similarly, a cyclic redundancy check (CRC) may additionally be applied for
verifying
the data integrity of the received record. The form of cyclic redundancy check
(CRC) may apply
a customized verification of data integrity, such as attaching the sum of the
measured glucose
level and the battery level, for decoding on the receiving side.
Alternatively, or additionally, the
outbound communications channel 170A between the medical measurement device
140 and the
remote computing device 150 may use a wireless communication system, a NEAR
FIELD
COMMUNICATION (i.e., one or more technologies for smartphones and similar
devices to
establish radio communication with each other by touching them together or
bringing them into
close proximity, for example based on standards including, but not limited to,
ISO/IES 18092
and those defined by the NFC Forum) system, and the like.
According to the method, as known in the art, a subject will typically apply a
drop of
blood to a test medium before introducing the test medium into the appropriate
medical
measurement device slot (step 602B). The medical measurement device will then
measure,
using the media reader 222 to define the blood glucose level (step 604B), and
further measure
the current battery level of the device itself (step 606B), and optionally
store the measured blood
glucose level and the battery level, locally with appropriate timestamp.
The measured value of blood glucose level combined with the battery level
value may be
constructed into a record as described hereinabove of communication protocol
details, attaching
a CRC value for data integrity and error detection (step 608B). The
constructed record may then
be sent, over the available wireless audio channel to the remote computing
device (step 610B).
If the test medium is still inserted in its slot of the medical measurement
device (step 612B), the
transmitter of the medical measurement device will continue to resend the
current record every
predefined time interval, for example, every 4 seconds (step 614B).
If the test medium is pulled out, the transmitter of the medical measurement
device may
move into a holding state, until the next test medium is inserted and measured
(step 616B).
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Referring to the flowchart of Fig. 6C, selected actions are indicated of a
method for
transmitting blood glucose level measured data, similar to the method
described hereinabove in
Fig 6A, but with substituting the "decision" of whether or not the user
acknowledged that the
remote computing device received the information transmitted by the medical
measurement
device 140. The methods described above with reference to Figs. 6A through 6C
may be useful,
for example, wherein the medical measurement device 140 is provided without
means to
establish an inbounds communications channel 170B.
Referring to the flowchart of Fig. 6D, selected actions are indicated of a
method for
transmitting blood glucose level measured data, similar to the method
described hereinabove in
Fig 6A, but without any specified decision regarding resending of data, and
with the data being
presented by the remote computing device 150. It will be appreciated that this
method may be
combined with other methods, e.g., it may include a decision step which may
necessitate
resending of data to the remote computing device 150. It will further be
appreciated that such a
method facilitates providing a medical measurement device 140 which is free of
a data
presentation means.
Referring to the flowchart of Fig. 7A selected actions are indicated of a
method for
receiving the signals, such as blood glucose level data, on an output device,
such as a computing
device running an associated software application method of a remote computing
device. The
transmission of the glucose measured level data from the medical measurement
device may be
received over a wireless audio channel using the command elements as described
hereinabove.
Alternatively, or additionally, the outbound communications channel 170A
between the medical
measurement device 140 and the remote computing device 150 may use a wireless
communication system, a NEAR FIELD COMMUNICATION (i.e., one or more
technologies
for smartphones and similar devices to establish radio communication with each
other by
touching them together or bringing them into close proximity, for example
based on standards
including, but not limited to, ISO/IES 18092 and those defined by the NFC
Forum) system, and
the like.
It may be noted that for any network-based architecture audio, Wireless, NEAR
FIELD
COMMUNICATION (i.e., one or more technologies for smartphones and similar
devices to
establish radio communication with each other by touching them together or
bringing them into
close proximity, for example based on standards including, but not limited to,
ISO/IES 18092
and those defined by the NFC Forum) or the like, the record stream may have
the same or
similar record structures answering the pre-defined communication protocol
definitions, as
described hereinabove with possible adjustment needed for the specific network
architecture.
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It may further be noted that the disassembly of the received record may
contain data
integrity validation mechanism, such as a cyclic redundancy check (CRC)
indication for
validating record integrity by the appropriately designed application of the
remote computing
device.
Alternatively or additionally the form of cyclic redundancy check (CRC) may
contain a
customized verification of data integrity, such as repeating the value of the
blood glucose level,
for performing error detection analysis on the receiving side.
According to the method, the initial step is receiving the assembled record at
the
communicator application (step 702A). The elements of the record are
disassembled, to fetch the
blood glucose level (step 704A), thereafter the CRC mechanism for error
detection may be used
to verify the data integrity of the fetched value (step 706A). If no error is
detected in the
received record data (step 708A), the blood glucose level may be compared to
previously
received values (within a specified time, using the timestamp as an indicator)
and, thereafter
stored for later analysis, immediately displayed, or any other pre-configured
activity (step
710A). Thereafter, the record may be dropped waiting for an additional record
(step 712A).
It is noted that it is a particular feature of the designed application that
the glucose level
measurement may be stored in the internal memory of the measurement device or
on the remote
computing device. The glucose level measurement may be time-stamped when
stored, such that
the measurement may provide an historical context, providing ability for
multiple results to be
presented graphically showing how glucose levels vary over time.
Referring to the flowchart of Fig. 7B, selected actions are indicated of an
appropriately
designed application method of a remote computing device, such as a mobile
device for
receiving blood glucose level measured data and related information from the
medical
measurement device. This method is similar to the method described in Fig 7A,
but with a
record including related battery level information measured at the medical
measurement device.
The transmission of the glucose related measured data may be received over a
wireless
audio channel-based system using the command elements as described.
Alternatively, or
additionally, the outbound communications channel 170A between the medical
measurement
device 140 and the remote computing device 150 may use a wireless
communication system, a
NEAR FIELD COMMUNICATION (i.e., one or more technologies for smartphones and
similar
devices to establish radio communication with each other by touching them
together or bringing
them into close proximity, for example based on standards including, but not
limited to, ISO/IES
18092 and those defined by the NFC Forum) system, and the like.
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It may be noted that for any network-based architecture audio, Wireless, NEAR
FIELD
COMMUNICATION (i.e., one or more technologies for smartphones and similar
devices to
establish radio communication with each other by touching them together or
bringing them into
close proximity, for example based on standards including, but not limited to,
ISO/IES 18092
and those defined by the NFC Forum) or the like, the record stream may have
the same or
similar record structures answering the pre-defined communication protocol
definitions, as
described hereinabove with possible adjustment needed for the specific network
architecture.
It may further be noted that the disassembly of the received record may
contain data
integrity validation mechanism, such as a cyclic redundancy check (CRC)
indication for
validating record integrity by the designed application of the remote
computing device.
Alternatively or additionally the form of cyclic redundancy check (CRC) may
contain a
customized verification of data integrity, such as sending the sum of the
blood glucose level and
the battery level of the medical measurement device, for performing error
detection analysis.
According to the method, the initial step is receiving the assembled record at
the
communicator application (step 702B). The elements of the record are
disassembled, to enable
fetching of the blood glucose level (step 704B), and the battery level
information (step 706B),
thereafter the CRC mechanism for error detection may be used to verify the
data integrity of the
fetched values (step 708B). If no error is detected in the received record
data (step 710B), the
fetched values of blood glucose level and battery level may be compared to
previously received
values (within a specified time, using the time-stamp as an indicator) and,
thereafter stored for
later analysis, immediately displayed, or any other pre-configured activity
(step 712B), then the
record may be dropped waiting for the next record (step 714B).
It is noted that it is a particular feature of the designed application that
the glucose level
measurement may be stored in the internal memory of the measurement device or
on the remote
computing device. The glucose level measurement may be time-stamped when
stored, such that
the measurement may provide an historical context, providing ability for
multiple results to be
presented graphically showing how glucose levels vary over time.
A particular embodiment is described hereinbelow for illustrative purposes
only, but is
not limiting and is purely shown by way of example. A medical measurement
device 140,
having an internal power source, such as an electrochemical cell, measures the
blood glucose
level using a test medium 234, and transmits the measured glucose level and/or
the power level,
over an audio-based outbound communications channel 170A to a remote computing
device 150
such as a mobile phone or the like. The medical data may be received on the
remote computing
device 150 by a dedicated application 160, providing ability of presenting
results, history data
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and additional medical assessments and further transmitting the measured data
to a list of
recipients such as physicians, parents, other care givers, to a remote
repository for storage or the
like. Optionally, in some embodiments, such a medical measurement device may
be a "black
box" device with having no output mechanism except for an audio output
configured to
communicate with a remote computing device running a dedicated software
application.
According to some modifications of the presently disclosed subject matter, the
medical
measurement device 140 is provided without a data presentation means, such as
an integral
display which is configured to present information regarding the measured
medical data to a
used, for example graphically (using charts, graphs, etc.) and/or using
alphanumeric characters.
In addition, the medical measurement device is provided without an integral
display (for
example an indicator light, LED, etc.) configured to present relative
information about the
measured medical data, for example if it is above or below a predetermined
threshold and/or
whether or not it is within a pre-determined range of a previous measurement
(or aggregation of
a set of previous measurements, e.g., the arithmetic means thereof).Not
providing such a display
may serve to lower the cost of the unit, and/or to increase its battery life.
The remote computing
device 150 is configured to receive information regarding measured data via
outbound
communications channel 170A, and to present it on its display.
According to other examples, as illustrated in Fig. 8, there is provided a
system, which is
generally indicated at 810, for measuring the glucose level of a user. The
system 810 comprises
a glucometer 812 and a remote computing device 814.
As illustrated figuratively in Fig. 9, the glucometer 812 comprises a
processor 816, one
or more memory modules 818 (which may comprise volatile and/or non-volatile
memory), a
media reader 820, a transmitter 822, and a power source 824. In addition, it
may optionally
comprise other elements (not illustrated), such as an external memory reader,
a visual display
such as an LCD or LED screen or LEDs, one or more ports configured for
connection to a data
cable, etc.
The media reader 820 is configured to facilitate analyzing a blood sample
disposed on a
test media (not illustrated), such as a test strip, disc, drum, cartridge, or
any other suitable
medium. It may be designed so as to facilitate detecting the glucose level in
the blood sample
using any suitable method. For example, in an electrochemical method, the
blood sample reacts
with one or more chemicals impregnated on the test medium. The amount of
products of the
reaction is proportional to the glucose level in the blood, and can be
measured electrically by the
media reader 820. Alternatively, the media reader 820 may operate using a
coulometric or
amperometric method, as is known in the art.
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In addition, the media reader 820 may be configured to read information
encoded on the
test medium, including, but not limited to, calibration information,
information regarding the
make and/or model of the test medium, and information regarding the
manufacturing of the test
medium (such as batch number, manufacture date, expiration date, etc.).
Typically, the media is provided in packages having a known number of
individual
media therein.
The transmitter 822 is configured to transmit information regarding the
results of the
analysis to the remote computing device 814. For example, the glucometer 812
may be
configured to transmit the information over a one-way communication channel,
such as an
audio-based channel, e.g., as described above, and/or using a visual display.
According to other
examples, the glucometer 812 may be configured to transmit the information
over a two-way
communication channel, including, but not limited to, BLUETOOTH (i.e., one or
more wireless
technologies for exchanging data over short distances using short-wavelength
radio
transmissions in the ISM band from 2400-2480 MHz as per the standards defined
by the
Bluetooth Special Interest Group), NEAR FIELD COMMUNICATION (i.e., one or more
technologies for smartphones and similar devices to establish radio
communication with each
other by touching them together or bringing them into close proximity, for
example based on
standards including, but not limited to, ISO/IES 18092 and those defined by
the NFC Forum),
WI-FI (i.e., one or more wireless local area network products that are based
on the Institute of
Electrical and Electonic Engineers' 802.11 standards), ZIGBEE (i.e., one or
more of a suite of
high level communication protocols used to create personal area networks built
from small, low-
power digital radios based on the Institute of Electrical and Electonic
Engineers' 802.15
standard), and/or other suitable protocols.
According to any of the above examples, the transmitter 822 comprises the
necessary
hardware to facilitate transmission. For example, in the case wherein the
glucometer 812 is
configured to transmit information over an audio-based channel, the
transmitter 822 comprises a
suitable speaker. The glucometer 812 may optionally comprise a visual display,
e.g., an LCD,
LED, or other suitable screen or display, for example in a case wherein it is
configured to
transmit information using a visual display.
The transmitter 822 may be configured to transmit information over a wired
and/or
wireless indication channel, mutatis mutandis.
The processor 816 is configured to direct operation of the elements of the
glucometer
812. As such, it may be configured to facilitate analysis of the blood sample,
encode information
for transmitting by the transmitter 822, direct operation of the transmitter,
etc. In performing
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these tasks, it may utilize the one or more memory modules 818 for short-term
storage of
information.
The remote computing device 814 is any suitable device configured to receive
information transmitted by the transmitter 822 of the glucometer 812, execute
a program,
display information to a user, and optionally receive commands from a user. It
may also be
configured to communicate with an external network, for example a public
network such as the
Internet, a POTS network, an ISDN network, cellular telephone system, and/or a
VoIP system.
As such, it may be any computing device, such as a mobile phone built on a
mobile operating
system (also referred to as a "smartphone"), a tablet computer, or any other
suitable device. In
particular, the remote computing device 814 is configured for installation
thereon of third-party
software.
As illustrated schematically in the Fig. 10, the remote computing device 814
comprises a
processor 826, one or more memory modules 828 (which may comprise volatile
and/or non-
volatile memory), a receiver 830, a user-input interface 832, a user-output
interface 834, and a
power source 836. The user-input interface 832 and user-output interface 834
may be part of the
same element, e.g., a touch-screen may constitute both.
In addition, the remote computing device 814 may comprise a transceiver 838,
such as a
modem and/or a wireless network adapter, configured to communicate with the
external
network. It will be appreciated that the receiver 830 may constitute part of
the transceiver 838.
The processor 826 is configured to direct operation of the remote computing
device 814.
Inter alia, it is configured to execute software stored in the memory modules
828. In addition,
the processor 826 may be configured to facilitate updating software stored in
the memory
modules 828, for example by downloading updated software from a remote server
via the
Internet.
When constituting part of the system 810, the remote computing device 814 is
loaded
with a software application which is configured to function with the
glucometer 812. For
example, the information transmitted by the glucometer 812 may contain raw
data obtained by
the media reader 820, which the software application is configured to
interpret and provide a
useful value based thereon. It may further be provided to track glucose levels
over time,
communicate with one or more outside servers, etc.
The system 810 as described above may be configured to monitor and/or track
usage of
test media by the glucometer 812. Software configured to perform the tracking
may be installed
in the memory of either the glucometer 812 or the remote computing device 814.
Alternatively,
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the glucometer 812 and remote computing device 814 may each be loaded with
complementary
software which together perform this task.
As illustrated in Fig. 11, the system 810, e.g., by running appropriate
software (either
installed on one of its constituent devices, or as complementary software on
both), is configured
to execute a method, which is generally indicated at 900. The method 900 may
be executed in
conjunction with the glucometer analyzing a test medium.
In step 910, a user utilizes the glucometer 812 to perform a blood analysis
using a test
medium, and the system 810 determines whether or not the medium being used for
the analysis
is the first one to be used from the package. According to some examples, the
system 810 makes
this determination based on user input, i.e., by prompting the user via the
user-output interface
834 of the remote computing device 814, and/or by receiving an indication,
which may be
solicited (e.g., in response to a prompt) or unsolicited, as such by the user
via the user-input
interface 832.
According to other examples, the system 810 makes this determination
automatically.
For example, it may determine this based on the previous analysis being
performed on the last
test medium in its package. Alternatively, it may determine this based on
information encoded
on the test medium (e.g., the batch number) differing from that of the medium
used in the
previous analysis. According to any of the above examples, the system 810 may
require that an
automatic determination made thereby be confirmed by a user.
It will be appreciated that the system 810 may be configured to make the
determination
in one of several ways. For example, it may be configured to use one or more
automatic
methods to make the determination, but also be configured to receive an
unsolicited indication
from a user.
If the system 810 determines in step 910 that the test medium used in the
analysis is the
first one used from its package, then it proceeds to step 920 of the method,
wherein it initializes
a counter, which tracks the number of test media remaining in the package, as
follows: C = N-
1, where C is the value of the counter, and N is the number of test media
initially in the
package. According to some examples, the value of N may be determined by
prompting a user,
via the user-output interface 834, for the number of test media in the
package. According to
other examples, the system 810, e.g., via the remote computing device 814, may
be configured
to scan a barcode, such as a one-dimensional or two-dimensional (sometimes
referred to as
"matrix") barcode, printed on the package, and associate information encoded
therein with the
quantity of test media within the package.
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Following step 920, the method terminates until the next analysis of a test
medium is
performed.
If the system 810 determines in step 910 that the test medium used in the
analysis is not
the first one used from its package, it proceeds to step 930 of the method
900, wherein it
decrements the counter by one, i.e., C = C ¨ 1. In the event that more than
one test medium was
used in the analysis, or if several analyses were performed before the system
decremented the
counter, the counter is decremented accordingly. For example, if n test media
were used in an
analysis, the counter would decrement as follows: C = C ¨ n.
After decrementing the counter in step 930, the system 810 determines in step
940
whether or not a predetermined threshold value T has been passed, i.e., if the
counter is lower
than the threshold (C < 7). The threshold value indicates at which quantity of
remaining test
media it is estimated that a new package should be ordered. The value may be
based on the
expected daily usage of test media, which may be provided by the user or
determined by the
system 810, for example based on usage history. In addition, the system 810
may take shipping
times into account when determining the threshold value, and may further
include a safety
factor, for example determining the threshold value based on when an order
should be placed to
ensure that the user receive an ordered package several days before the
current one is finished.
Alternatively, the system 810 may allow a user to set a threshold value
manually.
If the system 810 determines in step 940 that the threshold value has been
passed, it
proceeds to step 950 of the method, wherein it initiates an ordering
procedure. The ordering
procedure may be any procedure which is designed to facilitate or otherwise
directly contribute
toward a package of media being ordered.
According to some examples, the ordering procedure comprises the remote
computing
device 814 ordering one or more new packages of media via the Internet from an
Internet-based
merchant. This may be performed by the remote computing device 814
automatically.
Accordingly, the remote computing device 814 and/or Internet-based merchant
stores relevant
information, e.g., shipping address, product to be ordered, etc. According to
some modifications,
the remote computing device 814 and/or Internet-based merchant may further
store billing data,
such as credit card information, billing address, etc. The remote computing
device 814 may be
configured to survey several ordering options for the best value. For example,
it may check
several Internet-based merchants for the best price for a particular product,
it may check for the
best unit price (i.e., cost per test medium) among several equivalent
products, either at a single
or at several Internet-based merchants, etc., and order from the one which
provides the best
value. In addition, in may be configured to take a preselected action if it
identifies an unusually
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good value, for example as preset by the user. The preselected action may be
one or more of, but
is not limited to, ordering an increased quantity of packages and alerting the
user that it
identified the value. The user may preset what he considers to be a good
value, for example
more than a certain percentage lower per test medium than past purchases. The
past purchases
may be, e.g., an average or absolute best value of a predetermined number of
last purchases, or
an average or absolute best value of purchases made over a preselected amount
of time.
According to other examples, the ordering may be a manual process, wherein the
ordering procedure comprises alerting the user that the system 810 has
determined that an order
should be placed for a replacement package of test media. The remote computing
device 814
may optionally present information and/or direction to facilitate the ordering
by the user. For
example, it may present on its user-output interface 834 one or more links,
each redirecting a
user to an Internet-based merchant which sells one or more packages of
suitable test media.
According to further examples, some parts of the ordering may be automatic, as
described above, with one or more manual steps. According to some
modifications, the ordering
procedure may comprise the remote computing device 814 automatically
retrieving a website
via which the user can purchase a package of test media. According to other
modifications, the
ordering procedure may comprise the remote computing device 814 retrieving all
information
necessary to place an order, e.g., product, price, merchant, estimate of
shipping time, shipping
address, billing address, billing information, etc., and presenting to the
user for his approval,
upon which the remote computing devices places the order accordingly.
The system 810 may utilize information regarding the ordering procedure in
step 910, it
may assume that the next package to be used is the one ordered, and initiate
the counter C
accordingly. Optionally, the system 810 may prompt the user to confirm the
number of test
media in the package the next time the counter C is initiallized.
Following step 950, the method terminates until the next analysis of a test
medium is
performed.
If the system 810 does not determine in step 940 that the threshold value has
been
passed, the method 900 terminates until the next analysis of a test medium is
performed.
It will be appreciated that the above represents a basic method 900 which the
system 810
is configured to follow to facilitate ordering of replacement test media by
the system 810 based
on usage of test media by the glucometer. The method 900 may be modified
without departing
from the spirit and scope of the presently disclosed subject matter, mutatis
mutandis.
For example, the method as presented above may be modified, mutatis mutandis,
to
account for a user who orders more than one package of test media at a time,
in which case it
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would be relevant to monitor the user's supply of test media, not just the
media in one package.
It will be appreciated that in the case wherein the user maintains a supply of
one package, the
quantity of test media in a single package is equal to the user's supply.
Accordingly, the method
900 may be modified to add a second counter which monitors the number of
complete packages
of test media which have been used besides the number of test media remaining
in the current
package. For example, the counter C may be initialized to be the total number
of test media the
user purchases (for example, if the user orders 3 packages, each containing
850 test media, the
value in step 910 of N would be 150). Alternatively, the method 900 may
include an additional
counter which monitors the number of packages of test media. Alternatively,
the counter C may
initially be set to the total supply of test media, for example by prompting
the user for relevant
information regarding his supply.
In addition or alternatively, the counter C may start at 0 or 1, and
increment, with the
threshold being passed in step 940 if the counter is higher than the
threshold, i.e., C < T.
Furthermore, the numerical operations presented herein may be shifted (e.g.,
in step 940, the
system may determine that the threshold has been reached, i.e., that C = T; in
step 920, the
counter may be initialized as C = N; etc.).
According to a further example, as illustrated schematically in Fig. 12, there
is provided
a system, which is generally indicated at 1010, for measuring the glucose
level of a user. The
system 1010 comprises a glucometer 1012 and a remote computing device 1014.
As illustrated schematically in Fig. 13, the glucometer 1012 comprises a
processor 1016,
one or more memory modules 1018 (which may comprise volatile and/or non-
volatile memory),
a media reader 1020, a visual display 1022, and a power source 1024. In
addition, it may
optionally comprise other elements (not illustrated), such as an external
memory reader, a
transmitter, one or more ports configured for connection to a data cable, etc.
The media reader 1020 is configured to facilitate analyzing a blood sample
disposed on a
test media (not illustrated), such as a test strip, disc, drum, cartridge, or
any other suitable
medium. It may be designed so as to facilitate detecting the glucose level in
the blood sample
using any suitable method. For example, in an electrochemical method, the
blood sample reacts
with one or more chemicals impregnated on the test medium. The amount of
products of the
reaction is proportional to the glucose level in the blood, and can be
measured electrically by the
media reader 1020. Alternatively, the media reader 1020 may operate using a
coulometric or
amperometric method, as is known in the art.
In addition, the media reader 1020 may be configured to read information
encoded on
the test medium, including, but not limited to, calibration information,
information regarding the
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make and/or model of the test medium, and information regarding the
manufacturing of the test
medium (such as batch number, manufacture date, expiration date, etc.).
The processor 1016 is configured to direct operation of the elements of the
glucometer
1012. As such, it may be configured to facilitate analysis of the blood
sample, encode
information measured by the media reader 1020 for display by, and direct
operation of, the
visual display 1022, etc. In performing these tasks, it may utilize the one or
more memory
modules 1018 for short-term storage of information.
The visual display 1022 comprises one or more elements configured to visually
present
encoded data. It may comprise, e.g., one or more LEDs (for example multi-color
LEDs, i.e.,
being configured to selectively produce light of different colors), a screen,
such as LCD, LED,
OLED, plasma display, ELD, electronic paper, or electronic ink, or any other
suitable display
elements. In addition, it may comprise a combination of two or more different
display
technologies.
As mentioned, the processor 1016 is configured to facilitate displaying of
encoded
information regarding the results of the analysis by the visual display 1022.
The encoding may
be accomplished by any suitable method. The method of displaying of the
encoded results is
dependent on the type of visual display 1022.
The results may be encoded as a sequence of visual elements. For example,
according to
a modification wherein the visual display 1022 comprises one or more LEDs, the
information
may be encoded and displayed as a time sequence of on/off states of the LEDs.
In addition,
different colors may be used to encode values of data. (For example, a multi-
color LED may
encode two bits of binary data in a single flash thereof, wherein each of four
different colors
indicates one of 00, 01, 10, and 11.) In addition, different durations of a
flash may indicate
different values. Combinations of the above may be employed, wherein the value
transmitted by
an LED depends both on the color and duration of its flash. According to some
modifications,
the visual display 1022 comprises several LEDs, wherein the processor 1016 is
configured to
transmit data separately via each LED simultaneously, jointly using all LEDS
as a single data
channel, or in combinations thereof.
The results may be encoded as a pattern. For example, according to a
modification
wherein the visual display 1022 comprises a screen, the processor 1016 is
configured to encode
the information and direct the visual display 1022 to present it as
alphanumeric characters, for
example as illustrated in Fig. 14A. According to other modifications, the
processor 1016 is
configured to encode the information and direct the visual display 1022 to
present it as a
barcode, e.g., as a one-dimensional barcode (an example of which is
illustrated in Fig. 14B) or a
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two-dimensional barcode (examples of which are illustrated in Fig. 14C). It
will be appreciated
that if the visual display 1022 is a color display, information may be encoded
using different
colors to indicate different values of encoded data.
In addition to information relating to the results of the analysis, the visual
display 1022
may present error-detection and/or error-correction information, e.g., as is
well-known in the art.
The remote computing device 1014 is any suitable device configured to receive
information transmitted by the visual display 1022 of the glucometer 1012,
execute a program,
display information to a user, and optionally receive commands from a user. It
may also be
configured to communicate with an external network, for example a public
network such as the
Internet, a POTS network, an ISDN network, cellular telephone system, and/or a
VoIP system.
As such, it may be any computing device, such as a mobile phone built on a
mobile operating
system (also referred to as a "smartphone"), a tablet computer, a desktop or
laptop computer, or
any other suitable device. In particular, the remote computing device 1014 is
configured for
installation thereon of third-party software.
As illustrated schematically in the Fig. 15, the remote computing device 1014
comprises
a processor 1026, one or more memory modules 1028 (which may comprise volatile
and/or non-
volatile memory), a user-input interface 1030, a user-output interface 1032, a
power
source 1034, and an imaging device 1036. The user-input interface 1030 and
user-output
interface 1032 may be part of the same element, e.g., a touch-screen may
constitute both.
In addition, the remote computing device 1014 may comprise a transceiver 1038,
such as
a modem and/or a wireless network adapter, configured to communicate with the
external
network.
The processor 1026 is configured to direct operation of the remote computing
device
1014. Inter alia, it is configured to execute software stored in the memory
modules 1028. In
addition, the processor 1026 may be configured to facilitate updating software
stored in the
memory modules 1028, for example by downloading updated software from a remote
server via
the Internet.
The imaging device 1036 may be any suitable device for digitally capturing an
image,
for example a digital camera integrated into a smartphone or tablet computer,
or a digital still or
video camera in communication with a desktop or laptop computer (such as a
webcam). The
processor 1026 is configured to analyze an image captured by the imaging
device 1036. In
particular, it is configured to analyze the image to establish whether is
contains encoded data,
and to decode the data. The remote computing device 1014 may be loaded with a
software
application which is configured to facilitate the decoding. For example, the
information
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transmitted by the glucometer 1012 may contain raw data obtained by the media
reader 1020,
which the software application is configured to interpret and provide a useful
value based
thereon. It may further be provided to track glucose levels over time,
communicate with one or
more outside servers, etc.
The system 1010 as described above may be configured to monitor and/or track
usage of
test media by the glucometer 1012. Software configured to perform the tracking
may be
installed in the memory of either the glucometer 1012 or the remote computing
device 1014.
Alternatively, the glucometer 1012 and remote computing device 1014 may each
be loaded with
complementary software which together perform this task.
to
As illustrated in Fig. 16, the system 1010, e.g., by running appropriate
software (either
installed on one of its constituent devices, or as complementary software on
both), is configured
to execute a method, which is generally indicated at 1050, for transmitting
information from the
glucometer 1012 to the remote computing device 1014.
In step 1052, a user utilizes the glucometer 1012 to perform a blood analysis.
This may
be performed according to any suitable method known in the art.
In step 1054, the processor 1016 encodes the results of the analysis as a
visual pattern,
for example as described above in connection with Figs. 13 through 14C, and
presents the
encoded results via the visual display 1022 of the glucometer 1012.
In step 1056, the remote computing device 1014 is used to image the encoded
results
presented by the visual display 1022 in step 1054, for example using the
imaging device 1036.
According to some modifications, the remote computing device 1014 receives an
image of the
encoded results presented by the visual display 1022 via a third-party device,
e.g., a user of the
glucometer 1012 may capture an image of the visual display 1022 and send it
electronically to
the remote computing device 1014.
In step 1058, the processor 1026 of the remote computing device 1014 analyzes
the
captured image. If it determines that the image comprises encoded data, it
decodes the
information. The remote computing device 1014 may take any suitable
predetermined action,
e.g., presenting the decoded information via the user-output interface 1032,
storing it,
performing calculations based thereon, making one or more recommendations to
the user based
thereon, transmitting it to a third-party (for example via the transceiver
1038) such as a medical
professional or an Internet-based storage system, etc.
According to another example, as illustrated schematically in Fig. 17, there
is provided a
system, which is generally indicated at 1110, for measuring the glucose level
of a user. The
system 1110 comprises a glucometer 1112 and a remote computing device 1114.
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As illustrated schematically in Fig. 18, the glucometer 1112 comprises a
processor 1116,
one or more memory modules 1118 (which may comprise volatile and/or non-
volatile memory),
a media reader 1120, a capacitance output mechanism 1122, and a power source
1124. In
addition, it may optionally comprise other elements (not illustrated), such as
an external memory
reader, a visual display, a transmitter, one or more ports configured for
connection to a data
cable, etc.
The media reader 1120 is configured to facilitate analyzing a blood sample
disposed on a
test media (not illustrated), such as a test strip, disc, drum, cartridge, or
any other suitable
medium. It may be designed to facilitate detecting the glucose level in the
blood sample using
any suitable method. For example, in an electrochemical method, the blood
sample reacts with
one or more chemicals impregnated on the test medium. The amount of products
of the reaction
is proportional to the glucose level in the blood, and can be measured
electrically by the media
reader 1120. Alternatively, the media reader 1120 may operate using a
coulometric or
amperometric method, as is known in the art.
In addition, the media reader 1120 may be configured to read information
encoded on
the test medium, including, but not limited to, calibration information,
information regarding the
make and/or model of the test medium, and information regarding the
manufacturing of the test
medium (such as batch number, manufacture date, expiration date, etc.).
The processor 1116 is configured to direct operation of the elements of the
glucometer
1112. As such, it may be configured to facilitate analysis of blood sample,
encode information
measured by the media reader 1120 for representation via, and direct operation
of, the capacitive
output mechanism 1122, etc. In performing these tasks, it may utilize the one
or more memory
modules 1118 for short-term storage of information.
The capacitive output mechanism 1122 is configured to produce a capacitive
profile, i.e.,
a pattern of capacitive states. The capacitive profile may be time-based,
wherein the capacitive
output mechanism 1122 exhibits a sequence of varying capacitive states (i.e.,
levels of electrical
charge storage capacity) over a period of time, for example changing between
exhibiting no
electrical charge storage capacity and a non-zero value of electrical charge
storage capacity.
Alternatively, as will be described below, the capacitive profile may be
location-based. In
addition, the capacitive profile may be a combination of location- and time-
based. According to
any example, the capacitive profile may include error-detection and/or error-
correction
information, e.g., as is well-known in the art.
An example of a surface 1170 of the capacitive output mechanism 1122 which is
configured for producing a location-based capacitive profile is illustrated in
Figs. 19A and 19B.
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The surface 1170 is defined by nine regions 1172 (only one of which is shown
in profile in Fig.
19B), each being electrically connected on a back side thereof to a switch
1174, which is
configured to selectively toggle its respective region between connected and
disconnected states
with electrical charged conductance source 1176. The source 1176 may be
electronics-based.
Alternatively, it may be a surface of the glucometer 1112 which is positioned
so as to be in
contact with a user's hand while in use, thereby taking advantage of the
natural electrical charge
conductance of the user. The processor 1116 is configured to control each of
the switches 1174
such that its respective region 1172 displays the proper capacitive state
(i.e., electrical charge
storage capacity), e.g., at the proper time.
As mentioned, the processor 1116 is configured to facilitate representation of
encoded
information regarding the results of the analysis via the capacitive output
mechanism 1122. This
representation is accomplished by controlling the capacitive profile.
According to modifications wherein the capacitive profile is time-based, the
duration of
time for which the capacitive output mechanism exhibits, e.g., a non-zero
value of electrical
charge storage capacity, may represent a certain value. For example, a
predetermined interval of
non-zero electrical charge storage capacity may represent the binary digit 1,
while the same
interval of no electrical charge storage capacity may represent the binary
digit 0.
According to modifications wherein the capacitive profile is location-based,
each region
1172 may represent a predetermined bit in a binary string. One or more of the
regions 1172 may
be utilized to indicate the orientation of the surface 1170, for example by
rapidly toggling its
capacitive state in a predetermined fashion.
According to modifications wherein the capacitive profile is a combination of
location-
and time-based, each region 1172 may produce a time-based capacitive profile
independent of
the other regions. In this way, multiple time-based capacitive profiles may be
produces
simultaneously, increasing the rate at which encoded information is
represented via the
capacitive output mechanism 1122. One or more of the regions 1172 may be
utilized to indicate
the orientation of the surface 1170, for example by rapidly toggling its
capacitive state in a
predetermined fashion.
As illustrated schematically in the Fig. 20, the remote computing device 1114
comprises
a processor 1126, one or more memory modules 1128 (which may comprise volatile
and/or non-
volatile memory), a capacitive sensing user-input interface 1130, a user-
output interface 1132,
and a power source 1134. The capacitive user-input interface 1130 and user-
output interface
1132 may be part of the same element, e.g., a capacitive touch-screen may
constitute both.
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According to some modifications, the capacitive user-input interface 1130 may
use multi-touch
technology, i.e., it is configured to detect capacitive input at several
locations simultaneously.
In addition, the remote computing device 1114 may comprise a transceiver 1136,
such as
a modem and/or a wireless network adapter, configured to communicate with the
external
network.
The processor 1126 is configured to direct operation of the remote computing
device
1114. Inter alia, it is configured to execute software stored in the memory
modules 1128. In
addition, the processor 1126 may be configured to facilitate updating software
stored in the
memory modules 1128, for example by downloading updated software from a remote
server via
1() the Internet.
In particular, the processor 1126 is configured to analyze a capacitive
profile captured by
the capacitive user-input interface 1130. It is configured to analyze the
detected capacitive
profile to establish whether is contains encoded data, and to decode the data.
The remote
computing device 1114 may be loaded with a software application which is
configured to
facilitate the decoding. For example, the information transmitted by the
glucometer 1112 may
contain raw data obtained by the media reader 1120, which the software
application is
configured to interpret and provide a useful value based thereon. It may
further be provided to
track glucose levels over time, communicate with one or more outside servers,
etc.
The system 1110 as described above may be configured to monitor and/or track
usage of
test media by the glucometer 1112. Software configured to perform the tracking
may be
installed in the memory of either the glucometer 1112 or the remote computing
device 1114.
Alternatively, the glucometer 1112 and remote computing device 1114 may each
be loaded with
complementary software which together perform this task.
As illustrated in Fig. 21, the system 1110, e.g., by running appropriate
software (either
installed on one of its constituent devices, or as complementary software on
both), is configured
to execute a method, which is generally indicated at 1150, for transmitting
information from the
glucometer 1112 to the remote computing device 1114.
In step 1152, a user utilizes the glucometer 1112 to perform a blood analysis.
This may
be performed according to any suitable method known in the art.
In step 1154, the processor 1116 encodes the results of the analysis as a
capacitive
profile, for example as described above in connection with Figs. 19A and 19B,
and presents the
encoded results via the capacitive output mechanism 1122 of the glucometer
1112.
In step 1156, the capacitive sensing user-interface 1130 of the remote
computing device
1114 reads the capacitive profile. This is accomplished by bringing the
surface 1170 of the
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capacitive output mechanism 1122 of the glucometer 1112 into contact with the
capacitive
sensing user-input interface 1130. The processor 1126 detects the encoded
results presented via
the capacitive output mechanism 1122, thereby receiving the capacitive
profile. In receiving the
capacitive profile, the processor 1126 may expect a predetermined orientation
of the surface
1170 of the capacitive output mechanism 1122. Alternatively, the capacitive
profile may include
information indicating its orientation, for example as described above. The
processor 1126 may
be configured to present, via the user-output interface 1132, messages related
to the contacting,
for example that the orientation was invalid, that the contact was incomplete,
that the capacitive
profile was correctly received, etc.
In step 1158, the processor 1126 of the remote computing device 1114 analyzes
the
detected capacitive profile. If it determines that the image comprises encoded
data, it decodes
the information. The remote computing device 1114 may take any suitable
predetermined
action, e.g., presenting the decoded information via the user-output interface
1134, storing it,
performing calculations based thereon, making one or more recommendations to
the user based
thereon, transmitting it to a third-party (for example via the transceiver
1136) such as a medical
professional or an Internet-based storage system, etc.
According to further example, as illustrated in Fig. 22, there is provided a
system, which
is generally indicated at 1210, for measuring the glucose level of a user. The
system 1210
comprises a glucometer 1212, an insulin pump 1214, and a remote computing
device 1216.
As illustrated figuratively in Fig. 23, the glucometer 1212 comprises a
processor 1215,
one or more memory modules 1218 (which may comprise volatile and/or non-
volatile memory),
a media reader 1220, a transmitter 1222, and a power source 1224. In addition,
it may optionally
comprise other elements (not illustrated), such as an external memory reader,
a visual display
such as an LCD or LED screen or LEDs, one or more ports configured for
connection to a data
cable, etc.
The media reader 1220 is configured to facilitate analyzing a blood sample,
for example
disposed on a test media (not illustrated), such as a test strip, disc, drum,
cartridge, or any other
suitable medium. It may be designed so as to facilitate detecting the glucose
level in the blood
sample using any suitable method. For example, in an electrochemical method,
the blood sample
reacts with one or more chemicals impregnated on the test medium. The amount
of products of
the reaction is proportional to the glucose level in the blood, and can be
measured electrically by
the media reader 1220. Alternatively, the media reader 1220 may operate using
a coulometric or
amperometric method, as is known in the art.
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In addition, the media reader 1220 may be configured to read information
encoded on
the test medium, including, but not limited to, calibration information,
information regarding the
make and/or model of the test medium, and information regarding the
manufacturing of the test
medium (such as batch number, manufacture date, expiration date, etc.).
Typically, the media is provided in packages having a known number of
individual
media therein.
The transmitter 1222 is configured to transmit information regarding the
results of the
analysis to the remote computing device 1216. For example, the glucometer 1212
may be
configured to transmit the information over a one-way communication channel,
such as an
audio-based channel, e.g., as described above, and/or using a visual display.
According to other
examples, the glucometer 1212 may be configured to transmit the information
over a two-way
communication channel, including, but not limited to, BLUETOOTH (i.e., one or
more wireless
technologies for exchanging data over short distances using short-wavelength
radio
transmissions in the ISM band from 2400-2480 MHz as per the standards defined
by the
Bluetooth Special Interest Group), NEAR FIELD COMMUNICATION (i.e., one or more
technologies for smartphones and similar devices to establish radio
communication with each
other by touching them together or bringing them into close proximity, for
example based on
standards including, but not limited to, ISO/IES 18092 and those defined by
the NFC Forum),
WI-FI (i.e., one or more wireless local area network products that are based
on the Institute of
Electrical and Electonic Engineers' 802.11 standards), ZIGBEE (i.e., one or
more of a suite of
high level communication protocols used to create personal area networks built
from small, low-
power digital radios based on the Institute of Electrical and Electonic
Engineers' 802.15
standard), and/or other suitable protocols.
According to any of the above examples, the transmitter 1222 comprises the
necessary
hardware to facilitate transmission. For example, in the case wherein the
glucometer 1212 is
configured to transmit information over an audio-based channel, the
transmitter 1222 comprises
a suitable speaker. The glucometer 1212 may optionally comprise a visual
display, e.g., an LCD,
LED, or other suitable screen or display, for example in a case wherein it is
configured to
transmit information using a visual display.
The transmitter 1222 may be configured to transmit information over a wired
and/or
wireless indication channel, mutatis mutandis.
The processor 1216 is configured to direct operation of the elements of the
glucometer
1212. As such, it may be configured to facilitate analysis of the blood
sample, encode
information for transmitting by the transmitter 1222, direct operation of the
transmitter, etc. In
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performing these tasks, it may utilize the one or more memory modules 1218 for
short-term
storage of information.
The insulin pump 1214 is any device configured to administer a dose of insulin
to a user.
As illustrated figuratively in Fig. 24, it comprises a processor 1226, one or
more memory
modules 1228 (which may comprise volatile and/or non-volatile memory), a
reservoir 1230
configured for containing therein insulin, an infusion set interface 1232
configured for
attachment thereto of an infusion set, a pump 1234 configured to move the
insulin from the
reservoir to the infusion set interface by mechanical means, a transceiver
1236, and a power
source 1238.
to As noted above, the reservoir 1230 is configured for containing therein
insulin. It may be
a refillable insulin reservoir, either permanently mounted within or
detachable from/re-
attachable to the insulin pump 1214. Alternatively, it may be configured for
receiving therein
insulin a single time, for example by the manufacturer, and for being disposed
of by the user
when the insulin supply therein is depleted. The processor 1226 may be
configured for
determining the amount of insulin remaining in the reservoir 1230, and to
facilitate transmission
of information regarding to amount remaining via the transceiver 1236.
The transceiver 1236 is configured to transmit and receive electronic
communications.
For example, the insulin pump 1214 may be configured to transmit the
information over a two-
way communication channel, including, but not limited to, BLUETOOTH (i.e., one
or more
wireless technologies for exchanging data over short distances using short-
wavelength radio
transmissions in the ISM band from 2400-2480 MHz as per the standards defined
by the
Bluetooth Special Interest Group), NEAR FIELD COMMUNICATION (i.e., one or more
technologies for smartphones and similar devices to establish radio
communication with each
other by touching them together or bringing them into close proximity, for
example based on
standards including, but not limited to, ISO/IES 18092 and those defined by
the NFC Forum),
WI-FI (i.e., one or more wireless local area network products that are based
on the Institute of
Electrical and Electonic Engineers' 802.11 standards), ZIGBEE (i.e., one or
more of a suite of
high level communication protocols used to create personal area networks built
from small, low-
power digital radios based on the Institute of Electrical and Electonic
Engineers' 802.15
standard), and/or other suitable protocols.
According to any of the above examples, the transceiver 1236 comprises the
necessary
hardware to facilitate transmission and receiving.
The remote computing device 1216 is any suitable device configured to receive
information transmitted by the transmitter 1222 of the glucometer 1212,
transmit and receive
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information to the transceiver 1236 of the insulin pump 1214, execute a
program, display
information to a user, and receive commands from a user. It may also be
configured to
communicate with an external network, for example a public network such as the
Internet, a
POTS network, an ISDN network, cellular telephone system, and/or a VoIP
system. As such, it
may be any computing device, such as a mobile phone built on a mobile
operating system (also
referred to as a "smartphone"), a tablet computer, or any other suitable
device. In particular, the
remote computing device 1216 is configured for installation thereon of third-
party software.
As illustrated schematically in the Fig. 25, the remote computing device 1216
comprises
a processor 1240, one or more memory modules 1242 (which may comprise volatile
and/or non-
volatile memory), one or more transceivers 1244, a user-input interface 1246,
a user-output
interface 1248, and a power source 1250. The user-input interface 1246 and
user-output
interface 1248 may be part of the same element, e.g., a touch-screen may
constitute both.
The processor 1240 is configured to direct operation of the remote computing
device
1216. Inter alia, it is configured to execute software stored in the memory
modules 1242. In
addition, the processor 1226 may be configured to facilitate updating software
stored in the
memory modules 1228, for example by downloading updated software from a remote
server via
the Internet.
The transceivers 1244 are each configured to transmit and receive electronic
communications. For example, the transceivers 1244 may comprise a modem and/or
devices
configured to transmit information over a two-way communication channel,
including, but not
limited to, one or more of BLUETOOTH (i.e., one or more wireless technologies
for
exchanging data over short distances using short-wavelength radio
transmissions in the ISM
band from 2400-2480 MHz as per the standards defined by the Bluetooth Special
Interest
Group), NEAR FIELD COMMUNICATION (i.e., one or more technologies for
smartphones
and similar devices to establish radio communication with each other by
touching them together
or bringing them into close proximity, for example based on standards
including, but not limited
to, ISO/IES 18092 and those defined by the NFC Forum), WI-FI (i.e., one or
more wireless local
area network products that are based on the Institute of Electrical and
Electonic Engineers'
802.11 standards), ZIGBEE (i.e., one or more of a suite of high level
communication protocols
used to create personal area networks built from small, low-power digital
radios based on the
Institute of Electrical and Electonic Engineers' 802.15 standard), and/or
other suitable protocols.
According to any of the above examples, the transceiver 1244 comprises the
necessary
hardware to facilitate transmission and receiving.
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When constituting part of the system 1210, the remote computing device 1216 is
loaded
with a software application which is configured to function with the
glucometer 1212. For
example, the information transmitted by the glucometer 1212 may contain raw
data obtained by
the media reader 1220, which the software application is configured to
interpret and provide a
useful value based thereon. It may further be provided to track glucose levels
over time,
communicate with one or more outside servers, etc.
In addition, the remote computing device 1216, when constituting part of the
system
1210, is loaded with a software application which is configured to direct
operation of the insulin
pump 1214. It will be appreciated that in order to safely direct operation of
the insulin pump
1214, the software application is configured to both issue commands to and
receive information
from the insulin pump.
As illustrated in Fig. 26, the system 1210, e.g., by running appropriate
software (either
installed on one of its constituent devices, or as complementary software on
two or more
thereof), is configured to execute a method, which is generally indicated at
1300, for facilitating
the remote computing device 1216 to direct operation of the insulin pump 1214.
In step 1310, a user utilizes the glucometer 1212 to analyze a blood sample to
measure
its glucose level. This may be performed according to any suitable method
known in the art, for
example as described above with reference to Fig. 23.
In step 1312, the glucometer 1212 transmits information to the remote
computing device
1216 regarding the results of the blood analysis performed in step 1310.
In step 1314, the remote computing device 1216 determines an insulin dosage to
be
administered to the user, based on the information transmitted to it by the
glucometer 1212 in
step 1312. In making the determination, the remote computing device 1216 may
perform a
calculation based on relevant factors. Alternatively, the remote computing
device 1216 may be
configured to retrieve dosage information from one or more tables, preloaded
thereon,
containing pre-calculated insulin dosages based on one or more relevant
factors.
In step 1316, the remote computing device 1216 transmits a command to the
insulin
pump 1214 to administer a dose of insulin to the user based on the dosage
determined in step
1314. The command to administer a dose of insulin may be transmitted via one
of the
transceivers 1244 of the remote computing device 1216 to the transceiver 1236
of the insulin
pump 1214. According to some examples, this remote computing device 1216 is
configured to
automatically transmit the command when it determines that administering the
determined
dosage is necessary. According to other examples, the remote computing device
1216 is
configured to prompt the user to confirm that the command be transmitted to
the insulin pump
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1214, and only transmit the command upon the user's confirmation. According to
either of the
above examples, the remote computing device 1216 may be configured to alert
the user to
ensure that the insulin pump 1214 is ready to administer a dose of insulin,
e.g., that it is powered
on, properly connected, etc. According to some modifications, the remote
computing device
1216 is configured to transmit error-detection and/or error-correction
information to the insulin
pump 1214 with the command, for example as is known in the art.
In step 1318, the insulin pump 1214 receives the command transmitted by the
remote
computing device 1216. This step may further comprise verification of the
command by the
insulin pump 1214.
to
According to some examples, the system 1210 is configured to verify that the
intended
command was received by the insulin pump. Upon receiving the command, the
insulin pump
1214 transmits a message to the remote computing device 1216, containing
relevant information
from the command it received. The remote computing device 1216 verifies that
information in
the message it received from the insulin pump 1214 matches the relevant
information in the
command that it issues. Upon verifying the match, the remote computing device
1216 sends an
acknowledgment message to the insulin pump 1214, thereby verifying that the
command that
the insulin pump 1214 received contained proper information.
In step 1320, the insulin pump 1214 administers a dose of insulin to the user
based on
the command issue to it by the remote computing device 1216. According to some
examples,
this step requires that a user activates a mechanism, such as a button, knob,
switch, etc., of the
insulin pump 1214 before administration of the insulin commences. This step
may further
comprise the insulin pump 1214 communicating to the remote computing device
1216 that the
dose was successfully administered.
The system 1210 may be configured to determine the quantity of insulin
remaining in the
reservoir 1230 and to initiate an ordering procedure once the level of insulin
reaches or is below
a predetermined threshold. In determining the threshold, the system 1210 may
take into account
not only the amount of insulin contained in the reservoir 1230, but also the
user's total supply of
insulin.
If the system 1210 determines that the threshold value has been passed, it
initiates an
ordering procedure. The ordering procedure may be any procedure which is
designed to
facilitate or otherwise directly contribute toward additional insulin being
ordered.
According to some examples, the ordering procedure comprises the remote
computing
device 1216 ordering a new supply of insulin via the Internet from an Internet-
based merchant.
This may be performed by the remote computing device 1216 automatically.
Accordingly, the
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remote computing device 1216 and/or Internet-based merchant stores relevant
information, e.g.,
shipping address, product to be ordered, etc. According to some modifications,
the remote
computing device 1216 and/or Internet-based merchant may further store billing
data, such as
credit card information, billing address, etc. The remote computing device
1216 may be
configured to survey several ordering options for the best value. For example,
it may check
several Internet-based merchants for the best price for a particular product,
it may check for the
best unit price among several equivalent products, either at a single or at
several Internet-based
merchants, etc., and order from the one which provides the best value. In
addition, in may be
configured to take a preselected action if it identifies an unusually good
value, for example as
preset by the user. The preselected action may be one or more of, but is not
limited to, ordering
an increased quantity of insulin and/or alerting the user that it identified
the value. The user may
preset what he considers to be a good value, for example more than a certain
percentage lower
per unit volume of insulin than past purchases. The past purchases may be,
e.g., an average or
absolute best value of a predetermined number of previous purchases, an
average or absolute
best value of purchases made over a preselected amount of time, etc.
According to other examples, the ordering may be a manual process, wherein the
ordering procedure comprises alerting the user that the system 1210 has
determined that an
order should be placed for additional insulin. The remote computing device
1216 may optionally
present information and/or direction to facilitate the ordering by the user.
For example, it may
present on its user-output interface 1248 one or more links, each redirecting
a user to an
Internet-based merchant which sells one or more packages of suitable insulin.
According to further examples, some parts of the ordering may be automatic, as
described above, with one or more manual steps. According to some
modifications, the ordering
procedure may comprise the remote computing device 1216 automatically
retrieving a website
via which the user can purchase a package of insulin. According to other
modifications, the
ordering procedure may comprise the remote computing device 1216 retrieving
all information
necessary to place an order, e.g., product, price, merchant, estimate of
shipping time, shipping
address, billing address, billing information, etc., and presenting to the
user for his approval,
upon which the remote computing devices places the order accordingly.
According to any of the above examples, the system 1210 may be configured to
conduct
the ordering procedure in accordance with a prescription issued by the user's
physician.
Those skilled in the art to which this invention pertains will readily
appreciate that
numerous changes, variations and modifications can be made without departing
from the scope
of the invention mutatis mutandis.
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Technical and scientific terms used herein should have the same meaning as
commonly
understood by one of ordinary skill in the art to which the disclosure
pertains. Nevertheless, it is
expected that during the life of a patent maturing from this application many
relevant systems
and methods will be developed. Accordingly, the scope of the terms such as
computing unit,
network, display, memory, server and the like are intended to include all such
new technologies
a priori.
As used herein the term "about" refers to at least 10 %.
The terms "comprises", "comprising", "includes", "including", "having" and
their
conjugates mean "including but not limited to" and indicate that the
components listed are
included, but not generally to the exclusion of other components. Such terms
encompass the
terms "consisting of' and "consisting essentially of'.
The phrase "consisting essentially of' means that the composition or method
may
include additional ingredients and/or steps, but only if the additional
ingredients and/or steps do
not materially alter the basic and novel characteristics of the composition or
method.
As used herein, the singular form "a", "an" and "the" may include plural
references
unless the context clearly dictates otherwise. For example, the term "a
compound" or "at least
one compound" may include a plurality of compounds, including mixtures
thereof.
The word "exemplary" is used herein to mean "serving as an example, instance
or
illustration". Any embodiment described as "exemplary" is not necessarily to
be construed as
preferred or advantageous over other embodiments or to exclude the
incorporation of features
from other embodiments.
The word "optionally" is used herein to mean "is provided in some embodiments
and not
provided in other embodiments". Any particular embodiment of the disclosure
may include a
plurality of "optional" features unless such features conflict.
Whenever a numerical range is indicated herein, it is meant to include any
cited numeral
(fractional or integral) within the indicated range. The phrases
"ranging/ranges between" a first
indicate number and a second indicate number and "ranging/ranges from" a first
indicate
number "to" a second indicate number are used herein interchangeably and are
meant to include
the first and second indicated numbers and all the fractional and integral
numerals therebetween.
It should be understood, therefore, that the description in range format is
merely for convenience
and brevity and should not be construed as an inflexible limitation on the
scope of the
disclosure. Accordingly, the description of a range should be considered to
have specifically
disclosed all the possible subranges as well as individual numerical values
within that range. For
example, description of a range such as from 1 to 6 should be considered to
have specifically
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disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to
4, from 2 to 6, from
3 to 6 etc., as well as individual numbers within that range, for example, 1,
2, 3, 4, 5, and 6 as
well as non- integral intermediate values. This applies regardless of the
breadth of the range.
It is appreciated that certain features of the disclosure, which are, for
clarity, described in
the context of separate embodiments, may also be provided in combination in a
single
embodiment. Conversely, various features of the disclosure, which are, for
brevity, described in
the context of a single embodiment, may also be provided separately or in any
suitable
subcombination or as suitable in any other described embodiment of the
disclosure. Certain
features described in the context of various embodiments are not to be
considered essential
features of those embodiments, unless the embodiment is inoperative without
those elements.
Although the disclosure has been described in conjunction with specific
embodiments
thereof, it is evident that many alternatives, modifications and variations
will be apparent to
those skilled in the art. Accordingly, it is intended to embrace all such
alternatives,
modifications and variations that fall within the spirit and broad scope of
the disclosure.
All publications, patents and patent applications mentioned in this
specification are
herein incorporated in their entirety by reference into the specification, to
the same extent as if
each individual publication, patent or patent application was specifically and
individually
indicated to be incorporated herein by reference. In addition, citation or
identification of any
reference in this application shall not be construed as an admission that such
reference is
available as prior art to the present disclosure. To the extent that section
headings are used, they
should not be construed as necessarily limiting.