WO2015140597A1 - Glucometer and method for use - Google Patents

Glucometer and method for use Download PDF

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Publication number
WO2015140597A1
WO2015140597A1 PCT/IB2014/059968 IB2014059968W WO2015140597A1 WO 2015140597 A1 WO2015140597 A1 WO 2015140597A1 IB 2014059968 W IB2014059968 W IB 2014059968W WO 2015140597 A1 WO2015140597 A1 WO 2015140597A1
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WO
WIPO (PCT)
Prior art keywords
glucometer
data
computing device
remote computing
transmitter
Prior art date
Application number
PCT/IB2014/059968
Other languages
French (fr)
Inventor
Dov Moran
Yiftah Ben Aharon
Roee Tuval
Itay Cohen
Original Assignee
Glucome Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Glucome Ltd. filed Critical Glucome Ltd.
Priority to EP14886443.2A priority Critical patent/EP3119282A4/en
Priority to CA2942510A priority patent/CA2942510A1/en
Priority to CN201480077284.2A priority patent/CN106068095B/en
Priority to KR1020167027671A priority patent/KR20160134715A/en
Priority to PCT/IB2014/059968 priority patent/WO2015140597A1/en
Publication of WO2015140597A1 publication Critical patent/WO2015140597A1/en
Priority to IL247797A priority patent/IL247797A0/en

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Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483Physical analysis of biological material
    • G01N33/487Physical analysis of biological material of liquid biological material
    • G01N33/48785Electrical and electronic details of measuring devices for physical analysis of liquid biological material not specific to a particular test method, e.g. user interface or power supply
    • G01N33/48792Data management, e.g. communication with processing unit
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0015Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
    • A61B5/0017Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system transmitting optical signals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0015Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
    • A61B5/0022Monitoring a patient using a global network, e.g. telephone networks, internet
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0026Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by the transmission medium
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/40ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/40ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation

Definitions

  • the disclosure herein relates to the collection and management of medical data of diabetic patients.
  • 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.
  • 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
  • the glucometers is one tool for reaching and maintaining an optimal balance of blood sugar.
  • 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.
  • insulin pumps are a tool used to maintain an optimal balance of blood sugar by regulating the level of insulin in a user.
  • 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.
  • collecting the glucose level data and transmitting is more complicated when a user is outside of his home.
  • the user may be a child at school, or a patient on travel.
  • a glucometer cannot transmit recorded glucose levels results to his physician or caregiver.
  • 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.
  • the disclosure herein relates to the collection and management of medical data related to diabetic patients.
  • 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.
  • 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.
  • 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 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.
  • the glucose level medical records may be communicated at a variety of audio frequency levels, where one combination of audio frequencies may represent a ⁇ ' 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.
  • CRC cyclic redundancy check
  • 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.
  • the glucometer may have no display, and may be unable to display the measured data.
  • 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.
  • 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.
  • 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.
  • 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.
  • tasks may be performed or completed manually, automatically, or combinations thereof.
  • some tasks may be implemented by hardware, software, firmware or combinations thereof using an operating system.
  • hardware may be implemented as a chip or a circuit such as an ASIC, integrated circuit or the like.
  • selected tasks according to embodiments of the disclosure may be implemented as a plurality of software instructions being executed by a computing device using any suitable operating system.
  • 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.
  • the data processor includes or accesses a volatile memory for storing instructions, data or the like.
  • 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.
  • 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.
  • 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.
  • a glucometer comprising:
  • a transmitter configured to wirelessly transmit data, encoded within an audio signal, regarding results of the analysis
  • 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.
  • a mechanical wave such as a sound wave or the like
  • 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.
  • 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.
  • 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.
  • an error-detection code such as a cyclic redundancy check
  • 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.
  • a method of measuring a glucose level in a blood sample comprising:
  • 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;
  • the method may further comprise:
  • the method may further comprise calculating, by the remote computing device and based on the data, the glucose level.
  • 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.
  • a glucometer comprising:
  • 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.
  • a glucometer comprising:
  • transmitter configured to wirelessly transmit data regarding results of the analysis to a remote computing device
  • the glucometer is free of means configured to receive input from the computing device.
  • 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.
  • a method of analyzing a blood sample comprising:
  • 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.
  • 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:
  • test media may be at least partially based on at least one or more of:
  • the ordering procedure may comprise at least one or more of:
  • the 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.
  • 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 remote computing device configured to receive a transmission from the glucometer and to communicate with an external network
  • 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:
  • 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.
  • a method of analyzing a blood sample comprising:
  • 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.
  • a method of analyzing a blood sample comprising:
  • 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.
  • a glucometer comprising:
  • 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.
  • a method of administering insulin to a user 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.
  • 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.
  • 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.
  • a device configured to administer an insulin dose to a user, the device comprising a 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.
  • 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
  • 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.
  • 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;
  • 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 Fig. 26 illustrates a method by which the system illustrated in Fig. 22 administers a dose of insulin.
  • 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.
  • 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.
  • 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.
  • the 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.
  • 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.
  • 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.
  • a user interface for using the remote computing device 150 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.
  • 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.
  • 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.
  • 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 modulation microphone, a MEMS microphone, or combinations of the above) configured to receive the signal transmitted by the transmitter 142.
  • a microphone e.g., an electromagnetic induction microphone, a dynamic microphone, a capacitance change microphone, a piezoelectric generation microphone, a light modulation microphone, a MEMS microphone, or combinations of the above
  • 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.
  • 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.
  • BLUETOOTH i.e., one or more wireless technologies for exchanging distances over short distances using short-wave
  • 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.
  • a pre-defined recipient 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.
  • the particular architecture and functionality as described hereinafter 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.
  • the medical measurement device can be provided without a receiver, thereby lowering its cost.
  • 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 successfully received data via the outbound communications channel 170 A and/or instruct the user to activate the button/switch), and/or expiration of a timer or counter.
  • 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.
  • 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.
  • the medical measurement device 140 may connect to the remote computing device 150 via a cable with a mini/micro USB plug.
  • 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.
  • CPU central processing unit
  • media reader 222 for example a test strip reader
  • power source 224 for example a test strip reader
  • transmitter 142 for example a test strip reader
  • media slot 232 for example a test strip reader
  • various other internal elements may be added, such as memory 228 and a micro USB port 230.
  • 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.
  • 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.
  • 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.
  • 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.
  • binary data e.g., with two different tones (or ranges of tones) each representing different binary digits
  • non-binary e.g., with several tones (or ranges of tones) being used, each representing a non-binary digit.
  • hexadecimal encoding may be used, with 16 different tones (or ranges of tones) being used, each to represent a digit between 0 hex and F hex .
  • data compression may be employed, wherein a tone contains more than one bit or data.
  • the information may be sent as an analog signal, for example by "speaking
  • 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.
  • 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.
  • 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.
  • 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.
  • GUI graphical user interfaces
  • 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.
  • 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.
  • 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- 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.
  • 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.
  • Fig. 3 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 T representation 320 and a bit of '0' representation 330. These basic elements enable transmitting, for example, a sample level value of 5 ( ⁇ 0 binary sequence), for example, as presented in the 340 representation.
  • the communication protocol may be based on sending a sequence of '0' (s) and T (s) bits for each measurement of information sent, with 'AB' used as a synchronization signal, 'CDE' as an indication for T and 'FGH' as an indication for ⁇ ', and may use the following frequency levels, for example:
  • an ⁇ ' may take 20 milliseconds of transmission.
  • 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.
  • Fig. 4A representing a possible audio communication transmission 400 of glucose level measurement information from the medical measurement 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.
  • CRC cyclic redundancy check
  • the transmission is of one-way communication.
  • 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.
  • 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/dl 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.
  • 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/dl ('01001000') with battery level of 6 ('110') may take the format:
  • leading string ' ⁇ ', ' ⁇ ' represents the synchronization signal
  • 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 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.
  • 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.
  • 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 devicel40.
  • the battery level may be added to the record.
  • 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.
  • 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.
  • CRC cyclic redundancy check
  • FIG. 6 A 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.
  • the outbound communications channel 170 A 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.
  • a wireless communication system 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
  • the record stream may have the same or similar record structures answering the predefined communication protocol definitions, as described hereinabove.
  • 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.
  • CRC cyclic redundancy check
  • CRC cyclic redundancy check
  • 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 608 A). It is noted that the remote computing device may then receive the transmitted signal.
  • 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 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).
  • 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.
  • a cyclic redundancy check 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.
  • 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.
  • 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).
  • the transmitter of the medical measurement device may move into a holding state, until the next test medium is inserted and measured (step 616B).
  • steps 616B 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.
  • 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.
  • FIG. 7 A 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.
  • the outbound communications channel 170 A 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.
  • a wireless communication system 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
  • 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.
  • 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.
  • CRC cyclic redundancy check
  • CRC cyclic redundancy check
  • the form of cyclic redundancy check 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.
  • 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 706 A). 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).
  • 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 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • CRC cyclic redundancy check
  • 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.
  • 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).
  • 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 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 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.
  • 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.
  • 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.
  • 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 170 A, and to present it on its display.
  • 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.
  • 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.
  • 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.).
  • 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.
  • 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.
  • 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
  • the transmitter 822 comprises the necessary hardware to facilitate transmission.
  • 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 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.
  • the remote computing device 814 comprises a processor 826, one or more memory modules 828 (which may comprise volatile and/or nonvolatile 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.
  • 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.
  • 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.
  • the remote computing device 814 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.
  • 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.
  • the glucometer 812 and remote computing device 814 may each be loaded with complementary software which together perform this task.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the system 810 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.
  • a barcode such as a one-dimensional or two-dimensional (sometimes referred to as "matrix") barcode
  • 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 ⁇ T).
  • 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.
  • 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.
  • the system 810 may allow a user to set a threshold value manually.
  • step 940 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.
  • 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.
  • the user 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • step 950 the method terminates until the next analysis of a test medium is performed.
  • step 940 the method 900 terminates until the next analysis of a test medium is performed.
  • 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.
  • 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 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.
  • 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).
  • the method 900 may include an additional counter which monitors the number of packages of test media.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 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.
  • 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.
  • ELD electronic paper
  • electronic ink electronic ink
  • 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.
  • 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.
  • different colors may be used to encode values of data.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 two-dimensional barcode (examples of which are illustrated in Fig. 14C).
  • a barcode e.g., as a one-dimensional barcode (an example of which is illustrated in Fig. 14B) or a two-dimensional barcode (examples of which are illustrated in Fig. 14C).
  • the visual display 1022 is a color display, information may be encoded using different colors to indicate different values of encoded data.
  • 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.
  • the remote computing device 1014 comprises a processor 1026, one or more memory modules 1028 (which may comprise volatile and/or nonvolatile 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.
  • 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.
  • 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.
  • the information 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.
  • the glucometer 1012 and remote computing device 1014 may each be loaded with complementary software which together perform this task.
  • 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.
  • a user utilizes the glucometer 1012 to perform a blood analysis. This may be performed according to any suitable method known in the art.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the capacitive profile may be location-based.
  • the capacitive profile may be a combination of location- and time-based.
  • the capacitive profile may include error-detection and/or error-correction information, e.g., as is well-known in the art.
  • FIG. 19A and 19B 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.
  • 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.
  • 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.
  • the duration of time for which the capacitive output mechanism exhibits may represent a certain value.
  • a predetermined interval of no n- zero electrical charge storage capacity may represent the binary digit 1
  • the same interval of no electrical charge storage capacity may represent the binary digit 0.
  • 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.
  • each region 1172 may produce a time-based capacitive profile independent of the other regions.
  • 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.
  • the remote computing device 1114 comprises a processor 1126, one or more memory modules 1128 (which may comprise volatile and/or nonvolatile 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.
  • the capacitive user-input interface 1130 may use multi-touch technology, i.e., it is configured to detect capacitive input at several locations simultaneously.
  • 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.
  • 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 the Internet.
  • 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.
  • 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.
  • the glucometer 1112 and remote computing device 1114 may each be loaded with complementary software which together perform this task.
  • 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.
  • a user utilizes the glucometer 1112 to perform a blood analysis. This may be performed according to any suitable method known in the art.
  • 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.
  • 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 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.
  • 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.
  • 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.
  • 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.
  • 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.).
  • 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.
  • 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.
  • 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
  • the transmitter 1222 comprises the necessary hardware to facilitate transmission.
  • 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 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.
  • 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.
  • 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
  • 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 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.
  • 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.
  • 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
  • the transceiver 1244 comprises the necessary hardware to facilitate transmission and receiving.
  • the remote computing device 1216 is loaded with a software application which is configured to function with the glucometer 1212.
  • 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.
  • 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.
  • 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.
  • 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.
  • step 1312 the glucometer 1212 transmits information to the remote computing device 1216 regarding the results of the blood analysis performed in step 1310.
  • 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.
  • 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.
  • this remote computing device 1216 is configured to automatically transmit the command when it determines that administering the determined dosage is necessary.
  • the remote computing device 1216 is configured to prompt the user to confirm that the command be transmitted to the insulin pump 1214, and only transmit the command upon the user's confirmation.
  • 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.
  • 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.
  • 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.
  • the system 1210 is configured to verify that the intended command was received by the insulin pump.
  • the insulin pump 1214 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.
  • 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.
  • 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.
  • 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.
  • the ordering procedure may be any procedure which is designed to facilitate or otherwise directly contribute toward additional insulin being ordered.
  • 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 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.
  • 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.
  • 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.
  • the ordering procedure may comprise the remote computing device 1216 automatically retrieving a website via which the user can purchase a package of insulin.
  • 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.
  • the system 1210 may be configured to conduct the ordering procedure in accordance with a prescription issued by the user's physician.
  • 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.
  • a compound or “at least one compound” may include a plurality of compounds, including mixtures thereof.
  • ranges such as from 1 to 6 should be considered to have specifically 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.

Abstract

A glucometer is provided, 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.

Description

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 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 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 Ί ' 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 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. 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 • 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. 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. 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 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. 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 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 • 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.
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. 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 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 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 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 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 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 successfully received data via the outbound communications channel 170 A 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. 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 0hex and Fhex. 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. 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- 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 T representation 320 and a bit of '0' representation 330. These basic elements enable transmitting, for example, a sample level value of 5 (Ί0 binary sequence), for example, as presented in the 340 representation.
The communication protocol may be based on sending a sequence of '0' (s) and T (s) bits for each measurement of information sent, with 'AB' used as a synchronization signal, 'CDE' as an indication for T and 'FGH' as an indication for Ό', 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 Ί ')
• F = 5000 Hz; G = 5200 Hz; H = 5400 Hz; (may be used for constructing bit Ό')
Every tone, an Ά', 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 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/dl 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/dl ('01001000') with battery level of 6 ('110') may take the format:
'AB' + 'ΑΒ', 'FGH' + 'CDE' + 'FGH' + 'FGH' + 'CDE' + 'FGH' + 'FGH' + 'FGH',
'CDE' + 'CDE' + 'FGH', CRC
where the leading string 'ΑΒ', 'ΑΒ' 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 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 devicel40. 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. 6 A 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 170 A 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 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 predefined 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 608 A). 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 61 OA), 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 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). 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. 7 A 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 170 A 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. 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 706 A). 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. 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 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 170 A, 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. 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 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 nonvolatile 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, 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. 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 < T). 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 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 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 = Γ; 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 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 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 nonvolatile 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 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.
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. 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. 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 no n- 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 nonvolatile 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. 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 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 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. 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 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.
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 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. 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 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.
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 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. 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 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.

Claims

1. 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.
2. The glucometer according to claim 1, wherein said audio signal is outside the range of human audible frequencies.
3. The glucometer according to claim 1, wherein said audio signal is within the range of human audible frequencies.
4. The glucometer according to claim 1, wherein said audio signal is transmitted at a frequency detectable by at least one microphone associated with a remote computing device.
5. The glucometer according to claim 4, wherein said at least one microphone is 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.
6. The glucometer according to claim 1, wherein said transmitter is configured to transmit sounds of different frequencies to indicate different values of the encoded data, wherein for each of the encoded data values said audio signal comprises at least one of a set of frequencies.
7. The glucometer according to claim 6, wherein each member of said set corresponds to an associated value of the encoded data.
8. The glucometer according to claim 6, wherein said values are coded as at least one of binary data and non-binary data.
9. The glucometer according to claim 1, said transmitter being configured to transmit a synchronization string before transmitting said data.
10. The glucometer according to claim 1, said transmitter being configured to transmit one or more of an error-detection code and an error-correction code with said data.
11. The glucometer according to claim 1, said transmitter being configured to retransmit said data until a predefined event occurs.
12. The glucometer according to claim 11, wherein the reader is configured to analyze said glucose level when the blood sample is disposed on a test medium, said predefined event being the removal of said test medium from the glucometer.
13. The glucometer according to claim 1, wherein the reader is configured to analyze said glucose level when the blood sample is disposed on a test medium.
14. The glucometer according to claim 1, said transmitter being further configured to transmit data regarding the status of one or more aspects of the glucometer.
15. The glucometer according to claim 14, said reader being configured to analyze said blood sample when disposed on a test medium, wherein said data regarding the status of one or more aspects of the glucometer comprises information regarding the test medium.
16. The glucometer according to claim 1, wherein the controller is further configured to direct operation of the reader and the transmitter.
17. 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 said reader; and transmitting, by said transmitter, data regarding results of the analysis as a wireless audio signal.
18. The method according to claim 17, further comprising: receiving and decoding, by a remote computing device, said audio signal; and displaying, by said remote computing device, the data.
19. The method according to claim 17, further comprising calculating, by said remote computing device and based on the data, said glucose level.
20. The method according to claim 17, further comprising calculating, by said glucometer, said glucose level, said data comprising said glucose level.
PCT/IB2014/059968 2014-03-19 2014-03-19 Glucometer and method for use WO2015140597A1 (en)

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CA2942510A CA2942510A1 (en) 2014-03-19 2014-03-19 Glucometer and method for use
CN201480077284.2A CN106068095B (en) 2014-03-19 2014-03-19 Blood glucose meter and application method
KR1020167027671A KR20160134715A (en) 2014-03-19 2014-03-19 Glucometer and method for use
PCT/IB2014/059968 WO2015140597A1 (en) 2014-03-19 2014-03-19 Glucometer and method for use
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