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WO2019048875A1 - Dispositif de communication de santé mobile de machine à machine pour surveillance à distance du diabète - Google Patents

Dispositif de communication de santé mobile de machine à machine pour surveillance à distance du diabète Download PDF

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Publication number
WO2019048875A1
WO2019048875A1 PCT/GB2018/052548 GB2018052548W WO2019048875A1 WO 2019048875 A1 WO2019048875 A1 WO 2019048875A1 GB 2018052548 W GB2018052548 W GB 2018052548W WO 2019048875 A1 WO2019048875 A1 WO 2019048875A1
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WO
WIPO (PCT)
Prior art keywords
communications
glucose meter
communications device
internet
glucose
Prior art date
Application number
PCT/GB2018/052548
Other languages
English (en)
Inventor
Robert Shukri Habib ISTEPANIAN
Original Assignee
iKhare Limited
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
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Publication of WO2019048875A1 publication Critical patent/WO2019048875A1/fr

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Classifications

    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT 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
    • G16H40/60—ICT 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
    • G16H40/63—ICT 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 local operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0004—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by the type of physiological signal transmitted
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0015—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
    • A61B5/0022—Monitoring a patient using a global network, e.g. telephone networks, internet
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/60—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records

Definitions

  • the present invention relates to a machine-to-machine mobile health
  • Diabetes Meliitus is a major global chronic disease pandemic with estimated 382 million people living with diabetes worldwide and further 316 million with impaired glucose tolerance are at high risk from the disease - an alarming number that is set to reach 471 million by 2035 (International Diabetes Federation, IDF DIABETES ATLAS Sixth edition, ISBN: 2-930229-85-3, 2013 www.idf.org/diabetesatlas).
  • SMBG blood glucose monitoring
  • a patient glucose meter and other medical devices used in the diabetes management are connected wirelessly usually via Bluetooth connectivity between the patient and the patient's smart phone or tablet.
  • the smart phone or tablet is equipped with an application developed to cause it to cooperate with the glucose meter, and to in turn transmit the acquired blood glucose data or other medical data via a cellular phone network to a remote server for further viewing and advice by doctors or other healthcare providers.
  • the blood glucose data (or other medical data) can be accessed and viewed by the patient and physician via web portals for follow-up purposes by the healthcare
  • the data is stored in servers usually hosted in secure locations and located in the hospitals or in the healthcare provider (HCP) vicinity.
  • the key medical monitoring device and sensors for the diabetes self-management system are typically the glucose meters that measure the blood sugar levels in the body given to any patient diagnose with Type-1 or Type-2 diabetes.
  • the additional medical devices and sensors related to diabetes management such as blood pressure, weight scale and insulin pump are usually recommended by the clinicians and diabetic specialists depending on the type of the diabetes (T1 D or T2D) and the stage of diagnosis or prognosis of the disease.
  • the schedule and frequency of taking the daily blood glucose readings and other medical data is also dependent on the individual care plan and recommendations for each patient by their specialist and based on their individual diabetes type, treatment protocol and progress.
  • the timing of these is usually set in the patient's diabetic smart phone apps to remind the patient on the timings of these readings according to these pre-set schedules.
  • the clinical principle of diabetes self-management systems is that the patients with their smart phones and connected wireless blood glucose meters play central part in their glycaemic control process to avoid any undesirable changes in their own blood glucose level through monitoring their blood glucose and maintaining these to specific clinically acceptable levels. This process is supplemented by proper wellness educational and meal intake activities, daily activity presented to the patient through using the patient's own mobile phone application (APP).
  • APP mobile phone application
  • This feedback information process empowers the diabetic patients to better control their blood glucose levels and also aid their clinicians to better plan their patient treatment plans for insulin administration levels and thus avoid any unacceptable complications such hyperglycaemias.
  • This concept has been subject to many patent applications in the past. However, these patent applications illustrate one communications connectivity path with a single type of medical device or glucose meter type with single smart phone application connected to it.
  • Existing techniques usually use a proprietary approach with each smart phone application and phone device being capable of communicating only with single and specific glucose meter types.
  • the specific glucose meter types may be all glucose meters associated with a particular manufacturer, or may be only a subset of the glucose meters of a particular manufacturer (that is, there may be multiple
  • the biometric data is mostly blood glucose data, but can also include other information that some blood glucose devices generate, such as B- Ketone monitoring, which is important for Type-1 diabetes monitoring.
  • B- Ketone monitoring which is important for Type-1 diabetes monitoring.
  • This lack of interoperability in this case for using different proprietary platforms are only designed and developed to operate and communicate with their own blood glucose meter specific manufacturer bound communications connectivity modules.
  • Each of these individual blood glucose meters operates with different communication protocols designed and developed within their own specific data communications and packet messaging sequences. Most of these are used to download the biometric (glucose) data using only their specific input/output interface ports tied with specific manufacturer's own software platform and only compatible with specific smart phone connectivity application (App).
  • biometric glucose
  • App smart phone connectivity application
  • IOT Internet of Things
  • the present invention is intended to address certain of the limitations associated with existing technology in this field.
  • a mobile health gateway communications device for diabetes remote monitoring said
  • the communications device being connectable to a plurality of different types of glucose meter and the Internet, the device comprising:
  • a first communications interface for connecting to a glucose meter, the glucose meter being one of a plurality of different types of glucose meter to which the first communications interface can connect, and receiving blood glucose
  • a second communications interface for connecting to the Internet and transmitting the received blood glucose measurements over the Internet to a remote server
  • controller is operable to activate the communications device in response to the motion sensor detecting movement of the communications device.
  • the activation of the communications device by the controller may be considered an automatic self-activation of the communications device in response to movement of the device being detected.
  • the controller may be operable to deactivate the communications device after the expiry of a predetermined time period.
  • the predetermined time period may be measured from the time of activation of the communications device.
  • the motion sensor may be an acceierometer.
  • the communications device can be activated only in response to the motion sensor detecting movement of the device. In other words, no separate mechanism (such as an manually operated actuator or power switch) is present on the device to activate it.
  • the controller may be responsive to the signal from the motion sensor to establish communications with a glucose meter using the first communications interface. That is, in addition to powering on the device, the detection of movement causes the device to attempt to set up a connection with a connected or connectable glucose meter.
  • Establishing communications with the glucose meter may comprise detecting and identifying a glucose meter connected to the device as one of a plurality of different types of glucose meter which the communications device is capable of communicating with.
  • a mobile health gateway communications device for diabetes remote monitoring said communications device being connectable to a plurality of different types of glucose meter and the Internet, the device comprising:
  • a first communications interface for connecting to a glucose meter, the glucose meter being one of a plurality of different types of glucose meter to which the first communications interface can connect, and receiving blood glucose
  • a second communications interface for connecting to the Internet and transmitting the received blood glucose measurements over the Internet to a remote server
  • controller is configurable to communicate with a plurality of different types of glucose meter using respective different communications protocols, the controller being responsive to signature data received from the glucose meter to determine a type of that glucose meter, to identify which of the communications protocols to use to communicate with the glucose meter, and to communicate with that glucose meter via the first communications interface using that communications protocol.
  • the first communications interface communicatively couples the communications device to a glucose meter - either by wired or wireless means.
  • the second communications interface communicatively couples the communications device to the Internet - either by way of a WiFi connection or a cellular connection.
  • the controller may be operable to broadcast an interrogation message, the signature data being transmitted by the glucose meter in response to the interrogation message.
  • the interrogation message may be one of a plurality of stored
  • interrogation messages each corresponding to one of the types of glucose meters, the controller being operable to transmit the stored interrogation messages in turn, until signature data is received from the glucose meter which matches an expected response to a transmitted interrogation message.
  • the interrogation messages may be stored in a table and a pointer may be used to select which of the interrogation messages is to be sent, the pointer being incremented (or decremented) each time an expected response to an interrogation message is not received.
  • interrogation messages may be stored in the controller.
  • communications device may be an interrogation message corresponding to a glucose meter most recently connected to the communications device prior to the communications device being deactivated.
  • the interrogation message may be a standard protocol message of one type of glucose meter, and the signature may correspondingly be a standard protocol message which a glucose meter of that type would be expected to transmit in response to the interrogation message.
  • the controller may be further operable to detect and connect wirelessly with a Bluetooth capable glucose meter.
  • the controller may be operable to detect a glucose meter which is connected via a wire to the first communications interface.
  • the device may receive via the first communications interface a glucose
  • the device may be operable to receive biometric data from one or more further medical devices via the first communications interface, and transmit the received biometric data via the second communications interface.
  • the controller may be operable to establish a local master/slave network with the communications device as a master and the glucose meter and each further medical device as slaves, the device being operable to relay data generated by devices on the master/slave network via the Internet to the remote server.
  • the first communications interface may comprise a Bluetooth connection or other short range wireless connection.
  • the first communications interface may comprise an RS232 and/or Micro-USB connection.
  • the controller may be operable to transmit received measurement data to a personal electronic device via the first communications interface.
  • the first communications interface may comprise both a wired connection capability and a wireless connection capability.
  • a mobile health gateway communications device for diabetes remoting monitoring said
  • the communications device being connectable to a plurality of different types of glucose meter and the Internet, the device comprising:
  • a controller for connecting to a glucose meter, the glucose meter being one of a plurality of different types of glucose meter to which the first communications interface can connect, and receiving blood glucose
  • a second communications interface for connecting to the Internet and transmitting the received blood glucose measurements over the Internet to a remote server
  • the second communications interface comprises first and second modules for establishing a connection to the Internet via respective different first and second communications channels, the controller being operable to first attempt to use the first module to connect to the Internet using the first communications channel, and if the first module is unable to connect to the Internet, to use the second module to connect to the Internet using the second communications channel.
  • the controller may be responsive to the receipt of measurement data via the first communications interface to establish the connection to the Internet via the second communications interface.
  • the first communications channel may be a WiFi connection and the second communications channel may be a cellular telecommunications channel.
  • the controller may be operable to use the first or second module to establish an Internet communications session with the remote server via the selected
  • the glucose measurements and any other biometric data may be communicated to the remote server and stored for further viewing using the available device machine to machine internet cellular or WiFi protocols.
  • the acquired glucose measurements may be transmitted to the remote server using either a HTTP or MQTT protocol depending on the available communication channel identified by the device and a type of first and second module used for Internet communications for each communication channel.
  • a diabetes remote monitoring method using a mobile health gateway communications device which is connectable to a plurality of different types of glucose meter and the Internet, the device comprising a controller, a first communications interface for connecting to a glucose meter, the glucose meter being one of a plurality of different types of glucose meter to which the first communications interface can connect, and receiving blood glucose measurements from the connected glucose meter, a second communications interface for connecting to the internet and transmitting the received blood glucose measurements over the Internet to a remote server, a battery, for powering the medical communications device, and a motion sensor, the method comprising activating the communications device in response to the motion sensor detecting movement of the communications device.
  • a method of diabetes remote monitoring using mobile health gateway communications device which is connectable to a plurality of different types of glucose meter and the
  • the device comprising a controller, a first communications interface for connecting to a glucose meter, the glucose meter being one of a plurality of different types of glucose meter to which the first communications interface can connect, and receiving blood glucose measurements from the connected glucose meter, and a second communications interface for connecting to the Internet and transmitting the received blood glucose measurements over the Internet to a remote server, the controller being configurable to communicate with a plurality of different types of glucose meter using respective different communications protocols, the method comprising determining, in response to signature data received from the glucose meter, a type of that glucose meter, identifying which of the communications protocols to use to communicate with the glucose meter, and communicating with that glucose meter via the first communications interface using that communications protocol.
  • a method of diabetes remote monitoring using a mobile health gateway communications device which is connectable to a plurality of different types of glucose meter and the
  • the device comprising a controller, a first communications interface for connecting to a glucose meter, the glucose meter being one of a plurality of different types of glucose meter to which the first communications interface can connect, and receiving blood glucose measurements from the connected glucose meter, and a second communications interface for connecting to the Internet and transmitting the received blood glucose measurements over the Internet to a remote server, the second communications interface comprising first and second modules for establishing a connection to the Internet via respective different first and second communications channels, the method comprising first attempting to use the first module to connect to the Internet using the first communications channel, and if the first module is unable to connect to the Internet, using the second module to connect to the Internet using the second communications channel.
  • first, second and third aspects of the present invention have been defined distinctly, two or more of these aspects may be (and preferably are) combined. Further, the optional features associated with each aspects may, where applicable, be applied as optional features of the other aspects.
  • combining the three aspects provides an integrated modular device which is automatically (motion) activated to trigger an end-to-end procedure of connecting to one of several different types of glucose meter to acquire glucose data and then connecting via one of at least two different communications channels to the Internet to provide that glucose data to a remote server - all without explicit input by the user.
  • the present technique provides a unifying interoperable platform with a machine-to- machine communications path without the need to change the patient's smart phone applications and platforms to be compatible with different glucose meter models used and each time these devices are used. Further, the new unifying smart device and platform for remote diabetes monitoring and care embeds direct Internet connectivity and a communications model.
  • Machine-to-Machine ( 2M) 2M
  • Various embodiments described herein comprise a smart unifying reconfigurable communication device for connecting different types or glucose meters (and other diabetes related medical devices) to provide a medical sensor device agnostic communications platform using compact and integrated machine-to-machine Internet connectivity and transmission modules.
  • Figure 1 schematically illustrates a system for smart reconfigurable M2M device communications for diabetes monitoring
  • Figure 2 schematically illustrates reconfigurable smart identification and pairing between the communications device and a glucose meter
  • FIG. 3 schematically illustrates the modules of an integrated M2M device
  • Figure 4 schematically illustrates an automated accelerometer-based powering module of the device
  • Figure 5 is a schematic flow diagram of the overall operation of the system of Figure 1 ;
  • Figure 6 is a schematic flow diagram of a method for establishing communications between the device and a connected glucose meter.
  • FIG. 1 shows a block diagram of a compact reconfigurable communications device 30.
  • the device 30 is connected, either wirelessly or via a cable to a glucose meter 20, which usually includes a built-in strip reader 10 to measure the glucose content from a drop of blood that is deposited onto that strip (not shown) by a patient 110.
  • the acquired blood sample is then processed inside the glucose meter and converted to representative values of the blood glucose data.
  • other biometric data such as B- ketone data which is acquired by some blood glucose meters, can also be captured and processed by the present technique.
  • the following explanations will discuss blood glucose data, but it will be appreciated that this may include other biometric data generated by the blood glucose meter.
  • RS232 serial (RS232) or micro-USB input/output wired port cables.
  • RS232 serial communication protocol widely used in computers and digital systems. It is described as asynchronous because there is no separate synchronizing clock signal as is the case with other serial protocols such as SPI and I2C. Instead, the protocol automatically synchronizes itself.
  • Micro USB is a miniaturized version of the
  • USB Universal Serial Bus
  • the communications device 30 has a wireless communications module having an RF (radio-frequency) antenna 70 suitable for communicating using a required communications channel, via which it is able to wirelessly transmit the glucose measurements externally of the device, preferably to a cloud based server 100.
  • the communications device 30 is able to wirelessly transmit the glucose measurements to a wireless receiver device 80, which may for example be a WiFi router or a communications mast and receiver of a mobile (e.g. 3G or 4G)
  • telecommunications cellular network.
  • separate communications modules for example dedicated chips
  • WiFi and cellular communications are used for each of WiFi and cellular communications, but these are embedded on chip within the
  • the glucose measurements may then be conveyed to the cloud-based server 100 via an Internet connection 90.
  • the communication device 30 is also able to wirelessly communicate with a smartphone 120 associated by the user 110.
  • the wireless communication between the communications device 30 and the smartphone 120 is preferably via Bluetooth, but may in principle instead be via a WiFi network or the Internet.
  • the smartphone 120 may run a mobile health app which provides visualisation of the glucose measurement for the patient 110, and may in some cases be able to share data with their healthcare professional and their cloud-based servers 100. It will be appreciated that the smartphone app may carry out other mobile health functions.
  • the communications device is thus linked with a unified smart phone application (app) platform, which is used for graphical viewing of the glucose data and any other biometric data, and for patient self-management and diabetes care.
  • the communications device 30 has three main components (embedded and integrated modules) as shown in Figure 1 , these being a smart reconfigurable pairing adaptor module 40 (explained in detail with reference to Figure 2), an integrated machine-to-machine (M2M) gateway module 50 (explained in detail with reference to Figure 3), and an automated accelerometer powering module 60 (explained in detail with reference to Figure 4).
  • a smart reconfigurable pairing adaptor module 40 (explained in detail with reference to Figure 2)
  • M2M) gateway module 50 (explained in detail with reference to Figure 3)
  • an automated accelerometer powering module 60 (explained in detail with reference to Figure 4).
  • communications device 30 are provided in a single housing including the power supply unit 60 (which is the largest component). Other components of the other modules, also provided inside the housing, are of relatively small size.
  • the communications device 30 can be seen to comprise an input/output RS232 to micro USB communication port or socket 150, which is part of the pairing adapter module 40.
  • This port is linked to the patient's 110 glucose meter 20 via either an RS232 cable, or micro-USB cable connected to an input/output communication port or socket of the patient's glucose meter 20.
  • the communications device 30 has an in-built micro-USB to RS232 adaptor circuit that acquires the data via the programmed central microcontroller from the input/output port configuration of the connected glucometer used by the patient.
  • a digital data sequence representing the value of the acquired glucose level is provided via the port of the glucose meter 20 and sent to the communications device via the input/output port 150.
  • the reconfigurable adaptor module 40 acts as a central processing unit of the communications device 30 and is responsible for all the processing, control, algorithmic identification, interrogation, compare and fetch (I2CF) detection and pairing functions in relation to the connected glucose meters together with node networking communication functions with any Bluetooth enabled glucose meter model or other medical sensor that are used by the diabetic patient (e.g. weight scale or blood pressure devices).
  • I2CF compare and fetch
  • the embedded Bluetooth unit allows it (the communications device) to pair with different types of Bluetooth enabled blood glucose meters for remote Internet data transmission to the Internet or the cloud.
  • the communications device 30 can similarly be programmed to initiate the communication networking and search discovery of any additional Bluetooth enabled devices and sensors present within the vicinity of the patient that request readings from these devices such as blood pressure or weight scale. In this way, the communications device 30 can act as the master node (sensor) connecting the other medical devices as the slave nodes within the vicinity of such available short range communication network.
  • the communications device 30 can be further reconfigured to allow for a low power Bluetooth reconfigurable M2M networking to pair as master network node with other Bluetooth enabled (glucometers) or any additional Bluetooth enabled medical devices.
  • Wireless Sensor Network (WSN) configuration can be used be for example if necessary to connect the (Device) with other clinically prescribed medical devices required for the diabetic patient for monitoring and management purposes such as blood pressure, Insulin pump, weight and activity sensors etc. that are usually equipped with embedded low power Bluetooth wireless connectivity features.
  • the smart device described in this embodiment with the embedded reconfigurable M2M hub and gateway also enables the node communications with other medical devices (e.g. insulin pump, blood pressure and weight scales) as different diabetes self management and monitoring purposes. Since most of these wireless medical devices are usually equipped with low power Bluetooth capabilities, the communications device allows these devices to act as Wireless Sensor Network (WSN) nodes with (master/slave) communication connectivity with the
  • the device 30 acts as a master node and hub in a wireless master/slave network which acquires data from glucose meters and/or other devices within the network, and sends these on to an external server via the Internet.
  • the wireless master/slave network is in this sense part of the first communications interface. From the perspective of a remote server, there is no need to separately receive and correlate data from a plurality of different devices associated with a given user - instead the remote server receives all biometric data for a given user via a single communications device 30.
  • the device automatically distinguishes a connected glucose meter and a relevant communication protocol for communicating with that connected glucose meter via an input/output port, then transmits the acquired blood glucose data to a remote cloud server for further processing and viewing.
  • the smart reconfigurable and pairing adaptor module 40 comprises a microcontroller unit 160 that receives digital sequence data from the I/O port unit 150 representing glucose data measurements. Through an appropriate coding process and
  • the microprocessor 160 carried out an I2CF procedure that uses multiple (Identify, Interrogate, Compare and Fetch) processing functionalities
  • the memory unit 180 also stores a set of glucose meter unique identification look-up table codes (GUILC) which are used to identify each glucose meter uniquely by its communication protocol.
  • GUIC glucose meter unique identification look-up table codes
  • the device automatically identifies this code as part of the (I2CF) identify, interrogate, compare and fetch procedure described herein.
  • I2CF insulin meter unique identification look-up table codes
  • the same I2CF approach is used whether the communications link between the communications device 30 and the glucose meter is a wired (e.g. RS232) or wireless (e.g. Bluetooth) link. In the case of the latter, an additional Bluetooth pairing step may need to be carried out (once only) in order to establish the wireless link. This will be the case if the patient's glucose meter is equipped with wireless Bluetooth (some newer types of glucose meters are provided with this wireless connectivity facility).
  • the communications device 30 will detect (pair) such blood glucose meter as a wireless node in a master/slave network, and act as a master node to communicate with the specific glucose meter as a wireless slave node and automatically pair with it to acquire the measured blood glucose data. The communications device 30 then transmits the glucose measurement acquired in this way to the cloud server 100 over the Internet 90 via the M2 gateway module 50.
  • FIG. 2 shows the detailed diagram system of M2M reconfigurable smart identification adaptor device.
  • the device 30 comprises three embedded and integrated modules: the 'reconfigurable smart identification and pairing adaptor module 40, the 'M2M gateway module' 50 and the 'automated accelerometer based device powering' module.
  • the reconfigurability adaptor module 40 act as the central processing unit of the device and is responsible for all the processing, control, detection and pairing functions of the user glucose meters used together with the node networking communications functions with any Bluetooth enabled glucose meter or other medical sensor also Bluetooth enabled that are used by the diabetic patient such as weight scale or blood pressure devices.
  • the M2M gateway module 50 consist of two embedded M2M modules of WiFi and Cellular units that provides the 2M wireless communications and the Internet transmission and based on the availability of either WiFi (Hotspot) or cellular wireless communication networks and to trigger the appropriate data transmission and the Internet connectivity mode by the communications device 30.
  • the WiFi module can generally be expected to be a separate chip from the cellular M2M module.
  • the data once communicated either via WiFi or cellular communication channels (these are both IP based) to the cloud platform provides an IOT (Internet of Things) application space (in this case the disease management system) that links to hospital servers and sends the educational or alerting data back to the patient, for example to his smartphone or tablet via the smartphone app.
  • IOT Internet of Things
  • the communications device 30 sends biometric data to the remote server via the available Internet channel in the manner described above, and the smartphone then obtains the biometric data and/or any other data derived therefrom, via the remote server.
  • the user's smartphone may be used as a personal wireless hotspot to enable the communications device 30 to connect to the Internet using a WiFi rather than cellular connection.
  • the integrated Machine-to-Machine (M2M) gateway module 50 is shown and can be seen to comprise two embedded communication modules of WiFi 190 and Cellular (LTE) 200 circuits that provide the M2M communications channel and the Internet link based on the availability of either WiFi (Hotspot) or cellular wireless communication channel to the Internet (Cloud). These channels can be detected and triggered to provide the available mobile data transmission mode and the Internet connectivity by the communications device 30. In particular, the measured medical or glucose data identified by the device are sent wirelessly via whichever of the M2M communication protocol (WiFi or Celluar) wireless channels are available at the time and locality of the blood glucose data reading in the vicinity of the patient.
  • WiFi WiFi
  • LTE Cellular
  • a WiFi hub may be available, or away from the home/on the move an appropriate LTE/4G cellular channel may be the only option to communicate via the Internet.
  • These gateway communication modules are embedded within the circuitry of the communications device 30. They reconfigure and link the device 30 for the Internet data connectivity and transmission to the remote cloud or server, in dependence on availability. Communication priority is allocated to the (WiFi) hotspot network as a first preference, should this be available. Only in the case that a WiFi connection is not available for use will the communications device 30 instead use the cellular communication channel.
  • a remote cloud based application server may then process the transmitted biometric data and send back the required monitoring and viewing information to the smart phone or tablet device of the patient via a smart unifying application (App) developed for this purpose. This data may also be sent to and accessed by the healthcare providers (HCP) for further viewing and feedback and advice if required.
  • the communications device 30 therefore provides an embedded gateway which is used to transmit the acquired BG data over the Internet to a remote cloud server hosting server.
  • the communications device 30 serves to identify a connected glucose meter, and effectively convert a non-wireless glucose meter (or at least a glucose meter which requires a dedicated separate wireless communications device or smartphone to upload glucose measurements to a remote server) to a wireless glucose meter that will then communicate with either the Wi-Fi hub or the cellular network (M2M network domain) to upload glucose measurements to the remote server.
  • a non-wireless glucose meter or at least a glucose meter which requires a dedicated separate wireless communications device or smartphone to upload glucose measurements to a remote server
  • M2M network domain cellular network
  • MQTT Message Queue Telemetry Transport
  • HTTP HyperText Transfer Protocol
  • the automated accelerometer based device powering and activation module 60 can be seen to comprise a battery supply (or battery supply or charging unit compartment containing a battery) 130 together with an embedded accelerometer 140 that automatically turns on (powers) and turns off (powers down) the communications device 30. It will be appreciated that, instead of an
  • the accelerometer 140 detects any displacement or movement of the communications device 30 by the patient (which would be expected during a blood glucose meter measurement procedure), and powers on the communications device 30 in response to this detection, for example by connecting the battery 140 to the circuitry of the communications device 30.
  • the activation module 60 also allows the communications device 30 to revert to a sleep/idle mode when the blood glucose measurement procedures are completed. In this case, the communications device 30 may be in a static condition following the completion of the blood glucose measurement. This negates the need for any powering and switching the device by the patient when in use or not in use.
  • the accelerometer circuitry and chipset powers the communications device 30 using the motion detection by the patient when taking the glucose readings and allows the automatic power activation of the device to start the pairing and connection process with the specific glucose meter used by the patient to download the glucose data from the device to the patient's own smart phone or tablet. Further, this
  • the powering module 60 may allow the device to revert back to the sleep mode on the idle (static) condition when the blood glucose measurement procedures are completed and the device is idle after elapse of 20 second duration. This can provide both power saving of the modules of the communications device and remove the need of any human on-off powering of the communications device and the usage of a manual power activation switch each time it is required to be activated for the blood glucose data measurement and transmission.
  • One simple implementation of this is for movement of the device (at any time) to cause the accelerometer circuitry 140 to activate (power up) the communications device 30, and for the device to remain on for a predetermined period of time following activation.
  • the predetermined period of time should be sufficient for the patient to be able to set up the glucose meter 20, plug it into the communications device 30 (in the case that the glucose meter 20 does not have a wireless
  • a flow diagram describes the main process.
  • the user connects the communications device 30 to a glucose meter 20 using a serial cable connecting the input/output port of the glucose meter 20 to the
  • the communications device 30 input port as described above. This connection process need only be carried out once by the user.
  • the glucose meter may simply be switched on and the glucose meter 20 and communications device 30 placed in the vicinity of each other.
  • the communications device 30 is automatically activated and powered by the displacement and the wake-up of the power activation module 60 by the accelerometer unit 140.
  • the communications device 30 automatically establishes the serial communications link or the Bluetooth pairing process with the Bluetooth enabled blood glucose meter connection.
  • the Bluetooth pairing is established using the Device 30 Bluetooth module 170 to enable Bluetooth connectivity with glucose meters and/or with other devices equipped with Bluetooth wireless connections.
  • the communication link is established and detected by the serial port connectivity 150 linking the communications device 30 with the blood glucose meter serial communication port.
  • a step S4 it is determined whether a glucose meter and/or other device is connected via a serial interface or Bluetooth (and if Bluetooth, paired). If it has not, the process returns to the step S3.
  • the steps S3 and S4 may be repeated, either periodically or continuously, until the
  • step S4 If at the step S4 it is determined that a glucose meter has been connected, and in particular once the initial pairing process is established between the communications device 30 and the blood glucose meter 20, an (I2CF) (Identify, Interrogate, Compare and Fetch) procedure is triggered at a step S5 to automatically identify the communications device 30 and the blood glucose meter 20.
  • I2CF Identify, Interrogate, Compare and Fetch
  • a step S6 it is determined if the I2CF procedure is complete and that the biometric (glucose) measurement data has been acquired and stored at the communications device 30. if not, the process waits until the I2CF procedure is complete. If the I2CF process is complete, the glucose data is ready for remote transmission.
  • a step S7 once the data has been fetched by the communications device 30, snooping for an available Internet transmission channel (WiFi or cellular) is initiated by the communications device 30. Since WiFi is the preferred transmission channel, at a step S8 the communications device 30 snoops for WiFi hotspots, seeking to detect an available WiFi transmission hotspot or hub. If a WiFi channel is detected, then at a step S9 the WiFi gateway module 190 is activated and used to transmit the acquired data onto the internet via the detected WiFi connection. It will be
  • this process may require the WiFi connection to have been set up for use with the communications device 30.
  • This may be achieved as a function of the smartphone app described above.
  • a patient may have set up the communications device 30 in advance (by entering passwords or network keys) to be able to access WiFi hotspots at his or her own home, place of work, family and friends houses, gym or favourite restaurants for example.
  • Once the communications device 30 has been set up in this way, access to such hotspots may be automatic with no user input being required. If at the step S8 no WiFi channel is detected then at a step S10 the communications device 30 snoops for a cellular channel.
  • the cellular gateway module 200 is activated at a step S1 1 , to send the acquired data via the available cellular communication M2M protocol at a step S12.
  • a step S13 it is determined whether the Internet transmission of the acquired data has been successfully completed and acknowledged by the communications device 30. If so, the communications device 30 reverts back to the sleep-mode at a step S14, and waits for the next blood glucose data reading by the user and the next wake-up for the process to be repeated (that is, the process returns to the step S1 ). If it is
  • the procedure returns to the step S12 to attempt retransmission.
  • Figure 5 shows the motion activation of the communications device 30 not only causes the device to be powered on, but also triggers the processes of Figures 5 and 6 (that is, connecting to a glucose meter and acquiring glucose data, and connecting to the Internet and transmitting the glucose data remotely), since no human intervention is required for these processes to be initiated.
  • Figure 6 shows the I2CF (Identify-lnterrogate-Compare-Fetch) procedure (corresponding to the step S6 of Figure 5) used for the identification, interrogation and data synchronisation and the communication connectivity between the I2CF (Identify-lnterrogate-Compare-Fetch) procedure (corresponding to the step S6 of Figure 5) used for the identification, interrogation and data synchronisation and the communication connectivity between the I2CF (Identify-lnterrogate-Compare-Fetch) procedure (corresponding to the step S6 of Figure 5) used for the identification, interrogation and data synchronisation and the communication connectivity between the I2CF (Identify-lnterrogate-Compare-Fetch) procedure (
  • This procedure fetches the acquired blood glucose data from the specific connected glucose meter 20 connected to the communications device 30.
  • the process starts at a step U1 , when the user glucose meter is successfully connected/paired to the
  • the communications device 30 initialises (for example loads from memory or other storage medium) a glucometer table which contains a set of entries each defining a glucose meter type and a corresponding identification test message.
  • a glucometer table which contains a set of entries each defining a glucose meter type and a corresponding identification test message.
  • all types of glucose meter with which the communications device is able to operate have an entry in the table.
  • the identification test message of a particular glucometer type may be any message defined in a protocol for communicating with the glucometer type which, when received by a glucometer of that type, will cause the glucometer to reply with an expected (and known, or predetermined) response message. For example, a disconnect command could be used as an identification test message.
  • both the interrogation test message that is, the message used to elicit a response from the glucose meter
  • the response message itself are propriety protocols of the manufacturers of each glucose meter.
  • an incremental pointer Ni is set in the table for a first interrogation message between the communications device 30 and the connected glucose meter.
  • the protocol data test interrogation messages are used to carry out the interrogation of the connected glucose meter for protocol message codes allocated and associated uniquely with each glucose meter 20.
  • the communications device 30 waits for a response message from the glucometer 20. Any such response
  • the connected glucose meter 20 can be expected to respond to a compatible interrogation message with an expected (known) reply, and to either respond with an error or unexpected reply, or not respond at all, to a non-compatible interrogation message. If a response message is received, at a step U6 the communications device 30 reads the identified glucometer message from the look-up table message content, and then compares the glucometer response message with the test message at a step U7 to determine if there is a match.
  • each type of possible connected glucose meter is identified by a signature matching sequence code (GUIC). This code is identified by the communications device 30 from the response message and compared with a set of codes in a look-up table in the memory module 180 of the device 30.
  • the look-up table may be either be an additional column in the table described above which contains the set of
  • step U5 If at the step U5 a response message is not received, or if at the step U7 a received response message does not match the interrogation message, the process moves on to a step U9, where a test message table pointer for a new message code sequence is decremented to select a new interrogation message from the table.
  • step U10 it is determined if the decrementing of the test message table pointer results in the end of the table of test messages. If so, the interrogation process ends (unsuccessfully) at a step U11. If the decrementing results in a new interrogation message being selected, the process returns to the step U4 where the new interrogation message is transmitted to the connected glucometer.
  • a plurality of communication protocol data test interrogation messages are selected and transmitted in this way, corresponding to a respective plurality of glucose meter types.
  • each interrogation message is programmed (stored) within the communications device 30 microcontroller and memory module 180.
  • the sequence of these messages are set by the programmable pointer counter (N) that points in turn to each interrogation message allocated for each glucose meter 20 and identified by the content of each communication protocol.
  • the communications device 30 is then ready to Fetch, at a step U12, the acquired biometric (blood glucose) data (and associated time signature/stamp) acquired via the established communication protocol data messages of the glucose meter.
  • the acquisition of the biometric data is complete. If not, the fetch process of the step U12 continues.
  • communications device 30 is ready for the Internet transmission mode via the M2M gateway module 50 as described earlier in relation to Figure 5, and the process therefore progresses to the step S7 of Figure 5.
  • the communications device may initially send an interrogation test message corresponding to the type of glucose meter to which the communications device had been connected at the time it was switched off. There is a high probability that a particular user (associated with the
  • the communications device 30 should preferably only send new glucose measurements (and other biometric data) to the remote server.
  • the communications device 30 reads the glucose measurements from the glucose meter, it reads a time stamp associated with those measurements and compares it with a time stamp retrieved from the remote server which indicates a most recent glucose measurement (for that patient) which is stored at the remote server. If the time stamp associated with the glucose measurements obtained from the glucose meter corresponds to or predates the time stamp retrieved from the remote server, the glucose measurements are not transmitted to the remote server.

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Abstract

La présente invention concerne un dispositif de communication de passerelle de santé mobile de machine à machine intégré (30) pour la surveillance à distance du diabète. Le dispositif de communication (30) peut être connecté à une pluralité de différents types de glucomètre et à Internet. Le dispositif (30) comprend un dispositif de commande, une première interface de communication (70) pour se connecter à un glucomètre, le glucomètre étant l'un d'une pluralité de différents types de glucomètre auquel la première interface de communication peut se connecter, et recevoir des mesures de glycémie à partir du glucomètre connecté, une seconde interface de communication (80) pour se connecter à Internet et transmettre les mesures de glycémie reçues sur Internet à un serveur distant (100), une batterie pour alimenter le dispositif de communication médical, et un capteur de mouvement. Le dispositif de commande est conçu pour activer le dispositif de communication (30) quand le capteur de mouvement détecte un mouvement du dispositif de communication (30). D'autres modes de réalisation permettent une sélection intelligente d'un canal de communication destiné à être utilisé par la seconde interface de communication (80).
PCT/GB2018/052548 2017-09-08 2018-09-07 Dispositif de communication de santé mobile de machine à machine pour surveillance à distance du diabète WO2019048875A1 (fr)

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CN114093489A (zh) * 2021-09-29 2022-02-25 北京华益精点生物技术有限公司 非智能血糖仪的血糖检测时间的确认方法及相关设备
US11363998B2 (en) 2019-06-07 2022-06-21 Teladoc Health, Inc. Managing audio for remote health services

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US20120059673A1 (en) * 2005-06-29 2012-03-08 Medtronic Minimed, Inc. Flexible glucose analysis using varying time report deltas and configurable glucose target ranges
US20110090086A1 (en) * 2007-10-22 2011-04-21 Kent Dicks Systems for personal emergency intervention
WO2012060810A1 (fr) * 2010-11-01 2012-05-10 Loren Robert Larson Glucomètre adaptable conçu pour un usage avec des dispositifs portables et réseau de communication associé
US20140321246A1 (en) * 2013-04-26 2014-10-30 Roche Diagnostics Operations, Inc. BOLUS CALCULATOR TIME KEEPING BETWEEN MOBILE PHONE APPLICATION AND bG METERS

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020247032A1 (fr) * 2019-06-07 2020-12-10 Livongo Health, Inc. Dispositif de santé avec services de santé à distance
US11363998B2 (en) 2019-06-07 2022-06-21 Teladoc Health, Inc. Managing audio for remote health services
CN114093489A (zh) * 2021-09-29 2022-02-25 北京华益精点生物技术有限公司 非智能血糖仪的血糖检测时间的确认方法及相关设备

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