JP2017504446A - Analyte concentration warning function for analyte sensor system - Google Patents

Abstract

A system, method and apparatus for providing alerts based on analyte data and acceleration data. An analyte sensor may generate analyte data. An accelerometer may generate acceleration data. A transceiver may convert the analyte data into an analyte concentration value. The transceiver may convert acceleration data into activity information. The transceiver may generate an alert based on the analyte concentration value and activity information. The alert may be communicated to the user by a mobile medical application running on the transceiver and / or a display device (eg, a smartphone) in communication with the transceiver. The mobile medical application may display a plot or graph of analyte concentration values and activity information with respect to time (eg, on a display device display). [Selection] Figure 3

Description

Cross-reference of related applications

  [0001] This application is directed to US Provisional Patent Application No. 61 / 912,103, filed December 5, 2013, and US Provisional Application No. 61 / 922,387, filed December 31, 2013. Claiming the benefit of priority, those applications are incorporated by reference in their entirety. This application is a continuation-in-part of US patent application Ser. No. 14 / 453,078, whose parent application was filed on August 6, 2014, and was filed on August 9, 2013. Provisional Application No. 61 / 864,174, U.S. Provisional Application No. 61 / 865,373 filed on Aug. 13, 2013, and U.S. Provisional Application No. 61/8811, filed on Sep. 24, 2013. Claiming the benefit of priority over 679 and is a continuation-in-part of US patent application Ser. No. 13 / 937,871, whose parent application was filed on July 9, 2013, and US patent application Ser. No. 853/095, the parent application of which was filed on March 29, 2013, and US provisional application 61 / 617,414 filed on March 29, 2012. Priority for issue It claims the benefit, all of which applications are incorporated by reference in their intact.

background

  [0002] Field of the Invention

  [0003] The present invention relates generally to an analyte concentration warning function for an analyte sensor system. Specifically, the present invention relates to a hypoglycemia warning function for a sugar sensor system that generates a warning based on acceleration data.

  [0004] Background considerations

  [0005] Diabetes is a metabolic disease that causes the body's inability to produce any or enough insulin to cause high levels of glucose in the blood. Treatment of diabetes includes oral administration of basal and / or additional insulin and injection or infusion. People with diabetes have an increased risk of hypoglycemia.

  [0006] Hypoglycemia is defined as a condition characterized by abnormally low blood glucose levels, usually less than 70 mg / dL. Hypoglycemia can also include conditions where any individual's blood glucose continues to drop sharply and falls below a certain threshold (eg, 70 mg / dL). The most common reasons leading to hypoglycemia in patients are to inject a dose of insulin (eg, additional pre-meal) and then skip meals, overdosing insulin (eg, through too many injections or insulin pumps) Through) or doing intense activity (eg running or exercising). There are many symptoms (eg, seizures) associated with hypoglycemia. However, many people with diabetes have no symptoms or are otherwise unaware of their hypoglycemia, a condition known as unconscious hypoglycemia. If left untreated, hypoglycemia can lead to fatal situations such as accidents, injuries, loss of consciousness, seizures, coma and possibly death.

  [0007] Typically, hypoglycemia is treated with carbohydrate intake to restore blood sugar to a safe level and prevent progression to severe hypoglycemia. People with diabetes need to keep track of daily carbohydrate intake in order to properly treat their diabetes. Carbohydrate count errors can lead to miscalculated doses of insulin that can then lead to hypoglycemia. In severe cases of hypoglycemia (eg during seizures and / or loss of consciousness), an emergency injection of the hormone glucagon may be required to raise blood glucose to a safe level (ie glucagon emergency).

  [0008] Although some continuous blood glucose monitors (CGM) warn the user when a negative glucose trend is detected and alert the user when blood glucose falls below a user-defined threshold, these alerts It is provided to the user just before hypoglycemia or just before hypoglycemia.

  [0009] There is a current need in the art for a continuous analyte monitor with improved hypoglycemia warning.

Overview

  [0010] One aspect of the present invention may provide a method for alerting against a current or predicted physiological condition or response. In some embodiments, the method includes generating acceleration data corresponding to accelerometer movement, generating activity information based on the acceleration data, and current or predicted physiological based on the activity information. Generating a warning for a particular condition or reaction. In some embodiments, the method can further include displaying a warning. The display of the alert may be by a mobile medical application executed by the processor of the display device, for example. In some embodiments, the display device may be a smartphone, for example. In some embodiments, the accelerometer may be installed in, for example, a transceiver, analyte sensor, and / or activity tracker. In some embodiments, the physiological condition or response may be, for example, hypoglycemia, dehydration and / or hyperglycemia. In some embodiments, the warning may be a predictive warning.

  [0011] In other embodiments, the method can further include receiving galvanic electrical or physiological measurements from a body-mounted or in-body sensor, wherein the activity information includes acceleration data and galvanic data. Generated based on electrical or physiological measurements. In embodiments where the accelerometer is installed in the transceiver, the method can further include receiving activity information from the activity tracker, wherein the alert is in addition to the activity information received from the activity tracker. Is based. In some embodiments, the method can include generating an analyte concentration value based on a data signal received from the analyte sensor, wherein generating the alert includes activity information and an analyte. Generating a warning based on the concentration value.

  [0012] In some embodiments, the method can include displaying a plot of analyte concentration values and activity information over time. In some embodiments, the plot may be generated by a mobile medical application executed by the processor of the display device, and the plot may be displayed on the display of the display device. In some embodiments, the method can include receiving a data signal from an analyte sensor using a transceiver and generating an analyte concentration value using the transceiver. In some embodiments, the method uses a transceiver to communicate a data signal to a display device and generates an analyte concentration value using a mobile medical application executed by the display device processor. Can be included.

  [0013] In some embodiments, generating the activity information based on the acceleration information includes converting the acceleration data into a scalar acceleration value, comparing the scalar acceleration value with an activity threshold, Generating activity information based on the frequency of acceleration values exceeding. In some embodiments, activity information may be used to detect sleep patterns and / or steps. In some embodiments, generating the activity information based on the acceleration information includes converting the acceleration data to a scalar acceleration value, comparing the scalar acceleration value to an activity threshold, and an acceleration value that exceeds the activity threshold. Generating activity information based on the frequency of. In some embodiments, a transceiver may be used to generate activity information.

  [0014] In some embodiments, mobile medical applications executed by a processor of a display device may be used to generate activity information and / or alerts. In some embodiments, a transceiver may be used to receive generated activity information and / or generate an alert.

  [0015] In another aspect of the invention, an accelerometer configured to generate acceleration data corresponding to movement of the accelerometer, and generating or receiving activity information based on the acceleration data and based on the activity information A system can be provided that includes a transceiver configured to generate an alert for a current or predicted physiological condition or response. In some embodiments, the transceiver may comprise an accelerometer. Some embodiments can comprise an analyte sensor, wherein the analyte sensor comprises an accelerometer. In some embodiments, the transceiver receives a data signal from the analyte sensor, generates an analyte concentration value based on the received data signal, and generates an alert based on the analyte concentration value and activity information It is configured to let you.

  [0016] In some embodiments, the system comprises a display configured to display analyte concentration values and activity information with respect to time. In some embodiments, the display is configured to display a plot or graph of analyte concentration values and activity information over time. In some embodiments, the display device generates a display of the alert, analyte concentration value and activity information with a transceiver interface device configured to receive the alert, analyte concentration value and activity information from the transceiver. A processor configured to execute a mobile medical application configured to and a display configured to display the generated display may be included.

  [0017] In some embodiments, to generate activity information based on the acceleration data, the transceiver converts the acceleration data to a scalar acceleration value, compares the scalar acceleration value to an activity threshold, and the activity threshold. The activity information may be generated based on the frequency of acceleration values exceeding. In some embodiments, the system can comprise an activity tracker, where the activity tracker comprises an accelerometer. In some embodiments, the transceiver may comprise an accelerometer and receives activity information from the activity tracker and (i) activity information generated by the transceiver and (ii) received from the activity tracker It may be further configured to generate a warning based on the activity information. In some embodiments, the transceiver receives galvanic or physiological measurements from body-mounted or in-body sensors and is based on acceleration data and galvanic or physiological measurements. It may be further configured to generate activity information.

  [0018] In another aspect of the invention, a sensor interface device configured to receive a data signal from an analyte sensor, and an accelerometer configured to generate acceleration data corresponding to the movement of the accelerometer A network configured to generate an analyte concentration value based on the received data signal, generate activity information based on the acceleration data, and generate a warning based on the analyte concentration value and the activity information; An apparatus can be provided. In some embodiments, the apparatus includes an interface device configured to receive analyte concentration values and activity information, and a network configured to generate a plot of analyte concentration values and activity information with respect to time. And a display configured to display the plot.

  [0019] In another aspect of the invention, a method for alerting to a current or predicted physiological state or response based on informatics generated by accelerometer measurements can be provided.

  [0020] Further variations encompassed within the systems and methods are described below in the detailed description of the invention.

  [0021] The accompanying drawings are incorporated in and constitute a part of this specification and illustrate various non-limiting embodiments of the invention. In the drawings, like reference numbers indicate identical or functionally equivalent elements.

[0022] FIG. 1 is a schematic diagram illustrating an analyte monitoring system that embodies aspects of the invention.

[0023] FIG. 2 is a schematic diagram illustrating a transceiver that embodies aspects of the invention.

[0024] FIG. 3 is a flow chart illustrating a warning process that embodies aspects of the invention.

[0025] FIG. 4 is a flowchart illustrating an activity information generation process that embodies aspects of the present invention.

[0026] FIG. 5 is a graph illustrating scalar acceleration values measured by a system that embodies aspects of the present invention.

[0027] FIG. 6 is a graph illustrating the intensity and duration of a patient's physical activity as measured by a system that embodies aspects of the present invention.

[0028] FIG. 7 is a graph illustrating glucose and activity measurements measured by a system that embodies aspects of the invention.

Detailed Description of the Preferred Embodiment

  [0029] FIG. 1 is a schematic diagram of a continuous analyte monitoring system 120 that embodies aspects of the present invention. In some embodiments, the system 120 can include one or more of the analyte sensor 100, the transceiver 101, the display device 102, and the activity tracker 110. In some embodiments, the sensor 100 and the transceiver 101 are disclosed in U.S. Patent Application Publication No. 2013/0241745, U.S. Patent Application Publication No. 2013/0211213, U.S. Patent Application No. 14 / 453,078, and U.S. Patent Application. One or more of the structural and / or functional features described in one or more of publications 2014/0018644 may be included, all of which are incorporated by reference in their entirety.

  [0030] In some embodiments, the system 120 can include one or more accelerometers (eg, accelerometer 105 and / or accelerometer 111), which can be, for example, 3D accelerometers. Good. In some embodiments, the one or more accelerometers may be configured to generate acceleration data corresponding to the movement of the accelerometer. In some embodiments, the persistent analyte monitoring system 120 can use one or more accelerometers to record, for example, a substantially continuous movement of the user's upper arm, wrist, leg or core. In some embodiments, the one or more accelerometers may be installed in one or more of the analyte sensor 100, the transceiver 101, the display device 102, and the activity tracker 110, or one or more thereof. It may be a part of In some non-limiting embodiments, the transceiver 101 may include an accelerometer 105, as illustrated in FIG. In some non-limiting embodiments, as illustrated in FIG. 1, the system 120 is equipped with an activity tracker 110 (eg, by way of example and without limitation, a body bit such as a fitbit®). Activity tracker), which may include an accelerometer 111 in addition to or as an alternative to the accelerometer 105. In some non-limiting embodiments, analyte sensor 100 and / or display device 102 may additionally or alternatively include an accelerometer. In some embodiments, the transceiver 101 may be configured to generate activity information based on acceleration data generated by one or more accelerometers and one or more based on activity information. A plurality of warnings may be generated. In some embodiments, the transceiver 101 may generate activity information (eg, by the display device 102 or the activity tracker 110) based on acceleration data generated by one or more accelerometers (eg, by the activity tracker 110). It may be configured to receive in addition or instead (from the display device 102 or activity tracker 110). In some embodiments, the transceiver 101 and / or the display device 102 may communicate one or more alerts to the user. In some embodiments, the warning may be a visual, audible and / or vibration warning.

  [0031] In some embodiments, the transceiver 101 may be configured to receive a data signal from the analyte sensor 100 and to generate an analyte concentration value based on the received data signal. It may be configured. In some embodiments, the transceiver 101 may be configured to generate one or more alerts based on analyte concentration values and activity information. In some embodiments, the system 120 can include one or more displays. For example, in one non-limiting embodiment, the system 120 can include a display device 102 that can display one or more of analyte concentration values and activity information (eg, plot or A display 108 configured to display (in a graph) may be included. In some embodiments, the transceiver 101 may additionally or alternatively include a display configured to display one or more of analyte concentration values and activity information with respect to time.

  [0032] In some embodiments, the analyte sensor 100 may include a sensor element 112 and a transceiver interface device 103. The sensor element 112 may also be configured to detect the presence and / or concentration of an analyte (eg, glucose, oxygen, heart marker, low density lipoprotein (LDL), high density lipoprotein (HDL) or triglyceride). Good. In some non-limiting embodiments, the sensor element 112 is configured to receive light from the analyte label, a light source configured to emit excitation light to the analyte label, and the analyte label. One or more of the photodetectors may be included. The amount of light received by the photodetector can indicate the presence or concentration of the analyte. In some embodiments, as described above, the analyte sensor 100 may be an electro-optic sensor, but this is not required, and in some alternative embodiments, the analyte sensor 100 may be, for example and limited to Of course, another type of analyte sensor such as an electrochemical sensor may be used.

  [0033] In some embodiments, the transceiver interface device 103 (i) receives power signals and generates power to power the sensor elements 112 and / or (ii) is generated by the sensor elements 112. May be configured to transmit data signals. In some non-limiting embodiments, the transceiver interface device 103 may be configured to wirelessly transmit data signals, and the transceiver interface device 103 may include inductive elements (eg, antennas or coils). Good. In some alternative embodiments, the transceiver interface device 103 may be configured to communicate data signals to an external device (eg, transceiver 101) via a wired connection, and the transceiver interface device 103 is It may include a wired connection.

  [0034] In some non-limiting embodiments, the analyte sensor 100 may be an implantable sensor or a transdermal sensor. In some embodiments, sensor 100 may be implanted or inserted into a living animal (eg, a living human). The sensor 100 can be implanted or inserted into, for example, the arm, wrist, leg, abdomen, peritoneum, intravenous, or other area of a living animal suitable for sensor implantation or insertion. May be. For example, in one non-limiting embodiment, the sensor 100 may be implanted under the skin (ie, subcutaneously or in peritoneal tissue) such that portions of the sensor 100 do not protrude from the skin, and the transceiver The interface device 103 may wirelessly transmit a data signal. In some embodiments, the analyte sensor 100 may be a fully implantable sensor, but this is not required, and in some alternative embodiments, the sensor 100 has a wired connection to the transceiver 101. A transcutaneous sensor may be used. For example, in some alternative embodiments, sensor 100 may be placed in or on a percutaneous needle (eg, at the tip of the needle). In these embodiments, instead of wirelessly communicating (eg, using an inductive element), the sensor 100 and the transceiver 101 are one or more connected between the transceiver 101 and the percutaneous needle that includes the sensor 100. You may communicate using a some electric wire. As another example, in some alternative embodiments, sensor 100 may be placed on a catheter (eg, for venous blood glucose monitoring) and communicated with transceiver 101 (wirelessly or using electrical wires). May be.

  [0035] In some embodiments, the transceiver 101 communicates with the sensor 100 to power the sensor 100 and / or the data signal from the analyte sensor 100 (eg, a photodetector and / or temperature sensor reading). ) May be an electronic device. In some embodiments, the transceiver 101 may include a sensor interface device 104. The sensor interface device 104 of the transceiver 101 may be configured to receive data signals from the analyte sensor 100 using wireless (eg, inductive) and / or wired communications. In some embodiments where data signals are transmitted wirelessly between the transceiver 101 and the analyte sensor 100, the communication between the transceiver 101 and the analyte sensor 100 is, for example and without limitation, a short range Wireless communication may be used.

  [0036] In some embodiments (eg, embodiments in which sensor 100 is a fully implantable sensor), transceiver 101 is implanted via an inductive magnetic link for one or more of power and data transfer. Passive telemetry for communicating with the mold sensor 100 may be implemented. In some embodiments, the magnetic transceiver-sensor link can be considered a “weakly coupled transformer” type. The magnetic transceiver-sensor link may provide a link for energy and data transfer using amplitude modulation (AM). In some embodiments, data transfer is performed using AM, although other types of modulation may be used in alternative embodiments. In some non-limiting embodiments, the analyte monitoring system can use a frequency of 13.56 MHz, which can achieve high skin penetration and power and / or data transfer. Is a medically approved frequency band for. However, this is not essential, and in other embodiments, one or more different frequencies may be used to power and communicate with the sensor 100.

  [0037] In some non-limiting embodiments, the transceiver 101 may be a portable transceiver or a wearable transceiver (eg, a transceiver held in place by a watch, armband, belt or adhesive). . For example, in some embodiments where the transceiver 101 is a body wearable / wearable device, the transceiver 101 may be a band (eg, armband or wristband) and / or an adhesive (eg, part of a biocompatible patch). And the transceiver 101 communicates a measurement command (ie, a request for measurement information) to the sensor 100 (eg, periodically every two minutes and / or upon user activation). May be. In some embodiments where the transceiver 101 is a portable device, the transceiver 101 is positioned (ie, hovered or traversed / shake / threaded) within the range over the sensor implantation site (ie, in the vicinity of the sensor 100). ) May automatically transmit a measurement command to the sensor 100 to the transceiver 101 and receive an indication from the sensor 100.

  [0038] In some embodiments, the transceiver 101 may calculate an analyte concentration from the analyte data received from the sensor 100. However, it is not necessary for the transceiver 101 to perform the analyte concentration calculation itself, and in some alternative embodiments, the transceiver 101 instead uses the analyte data received from the sensor 100 for the analyte concentration. It may be communicated / relayed to another device (eg, display device 105) for computation (eg, by a mobile medical application executing on display device 105). In some non-limiting embodiments, the analyte concentration calculation may include one or more features described in US Patent Application Publication No. 2014/0018644, the application of which is incorporated by reference in its entirety. Incorporated.

  [0039] In some embodiments, the transceiver 101 includes a display interface device 106 configured to communicate information (eg, alerts and / or analyte concentrations) to one or more display devices 102. But you can. In some embodiments, the display device 102 may be a portable and / or portable device. In some embodiments, the display device 105 may be a smartphone. However, this is not essential, and in alternative embodiments, the display device 102 may be a laptop computer, tablet, notebook computer, personal digital assistant ("PDA"), personal computer or a dedicated analyte monitoring display device. Good. In some embodiments, the display device 102 may include a transceiver interface device 107, which may be configured to communicate with the display interface device 106 of the transceiver 101 through a wired or wireless connection. In some embodiments, the display device 102 may include a processor 109, and the display device 102 may have a mobile medical application installed. In some non-limiting embodiments, the processor 109 may execute a mobile medical application.

  [0040] FIG. 2 is a schematic diagram of a transceiver 101 according to a non-limiting embodiment. In some embodiments, the display interface device 106 of the transceiver 101 may include an antenna and / or connector 902 of a wireless communication integrated circuit (IC) 910. In some non-limiting embodiments, the display interface device 106 may additionally include a wireless communication IC 910 and / or a connector IC 904.

  [0041] In some embodiments, the connector 902 may be, for example, a micro universal serial bus (USB) connector. The connector 902 may enable a wired connection to an external device such as the display device 102 (for example, a smartphone or a personal computer). The transceiver 101 may exchange data to / from external devices through the connector 902 and / or receive power through the connector 902. The connector IC 904 may be a USB-IC, for example, and the USB-IC may control transmission and reception of data through the connector 902. The transceiver 101 may also include a charger IC 906 that receives power via a connector 902 and charges a battery 908 (eg, a lithium polymer battery). In some embodiments, the battery 908 may be rechargeable, may have a short recharge time, and / or may have a small size.

  [0042] In some embodiments, the transceiver 101 may include one or more connectors in addition to (or as an alternative to) the micro USB connector 904. For example, in one alternative embodiment, the transceiver 101 may include a spring-based connector (eg, a pogo pin connector) in addition to (or as an alternative to) the micro USB connector 904, and the transceiver 101 may be A connection established via a spring-based connector may be used to perform wired communication and / or receive power to a display device 105 (eg, a smartphone or personal computer), and then the power In use, for example, the battery 908 may be charged.

  [0043] In some embodiments, the wireless communication IC 910 may allow wireless communication with an external device, such as, for example, one or more display devices 105 (eg, a smartphone or a personal computer). In one non-limiting embodiment, the wireless communication IC 910 may wirelessly transmit data using one or more wireless communication standards. The wireless communication standard utilized may be any suitable wireless communication standard such as the ANT standard, the Bluetooth standard, or the Bluetooth slow energy (BLE) standard (eg, BLE 4.0). In some non-limiting embodiments, the wireless communication IC 910 may be configured to wirelessly transmit data at a frequency greater than 1 gigahertz (eg, 2.4 or 5 GHz). In some embodiments, the wireless communication IC 910 may include an antenna (eg, a Bluetooth antenna).

  [0044] In some embodiments, the transceiver 101 may include a voltage regulator 912 and / or a voltage booster 914. The battery 908 may supply power (via a voltage booster 914) to a radio frequency identification (RFID) reader IC 916 that uses the inductive element 919 to communicate information (eg, commands) to the sensor 100. In addition, information (for example, measurement information) is received from the sensor 100. In some non-limiting embodiments, the sensor 100 and the transceiver 101 may communicate using near field communication (NFC) (eg, at a frequency of 13.56 MHz). In the illustrated embodiment, the inductive element 919 is a planar antenna. In some non-limiting embodiments, the antenna may be flexible. However, the inductive element 919 of the transceiver 101 may be in any configuration that allows sufficient electric field strength to be achieved when brought within sufficient physical proximity of the inductive element 114 of the sensor 100. . In some embodiments, the transceiver 101 may include a power amplifier 918 to amplify the signal to be transmitted to the sensor 100 by the inductive element 919.

  [0045] The transceiver 101 may include a peripheral interface controller (PIC) microcontroller 920 and memory 922 (eg, flash memory), which may be non-volatile and / or electronically erased and / or rewritten. It may be possible. The PIC microcontroller 920 may control the overall operation of the transceiver 101. For example, the PIC microcontroller 920 may control the connector IC 904 or wireless communication IC 910 to transmit data via wired or wireless communication and / or control the RFID reader IC 916 to transmit data via the inductive element 919. May be. The PIC microcontroller 920 may also control the processing of data received via the inductive element 919, the connector 902, or the wireless communication IC 910.

  [0046] In some embodiments, the transceiver 101 may include a sensor interface device, which may allow the transceiver 101 to communicate with the sensor 100. In some embodiments, the sensor interface device may include an inductive element 919. In some non-limiting embodiments, the sensor interface device may additionally include an RFID reader IC 916 and / or a power amplifier 918. However, in some alternative embodiments where a wired connection exists between the sensor 100 and the transceiver 101 (eg, a transdermal embodiment), the sensor interface device may include a wired connection.

  [0047] In some embodiments, the transceiver 101 may include a display 924 (eg, a liquid crystal display and / or one or more light emitting diodes) that is controlled by the PIC microcontroller 920 to provide data ( For example, glucose concentration value) may be displayed. In some embodiments, the transceiver 101 may include a speaker 926 (eg, a beeper) and / or a vibration motor 928, such as an alarm condition (eg, detection of a hypoglycemic or hyperglycemic condition). It may be activated when is satisfied. The transceiver 101 may also include one or more additional sensors 930 that may be used for processing performed by the PIC microcontroller 920, which may include accelerometers (eg, accelerometer 105) and / or temperature. A sensor may be included.

  [0048] In some embodiments, the transceiver 101 may be a wearable transceiver that is a rechargeable external device worn over the sensor implantation or insertion site. The transceiver 101 supplies power to the proximity sensor 100, calculates the analyte concentration from the data received from the sensor 100, and / or displays the calculated analyte concentration on the display device 105 (FIGS. 1A, 1B and 5). Power may be supplied to the sensor 100 through an inductive link (eg, a 13.56 MHz inductive link). In some embodiments, the transceiver 101 may be placed using an adhesive patch or a specially designed strap or belt. The external transceiver 101 may read analyte data measured from the subcutaneous sensor 100 (for example, to a depth of 2 cm or more). The transceiver 101 may read sensor data periodically (eg, every 2 minutes) and calculate analyte concentrations and analyte concentration trends. From this information, the transceiver 101 may also determine whether a warning and / or alarm condition exists, and that condition may be signaled to the user (eg, vibration and / or transmission / reception by the vibration motor 928). LED on display 924 and / or display on display device 105). Information from the transceiver 101 (eg, calculated analyte concentration, calculated analyte concentration trend, warning, alarm and / or notification) is transmitted to the display device 105 (eg, Advanced Encryption Standard (AES) -counter). (Via Bluetooth slow energy with CBC-MAC (CCM) encryption) may be displayed by the mobile medical application on the display device 105. In some non-limiting embodiments, the mobile medical application may provide alerts, alerts and / or notifications in addition to any alerts, alerts and / or notifications received from the transceiver 101. In one embodiment, the mobile medical application may be configured to provide push notifications. In some embodiments, the transceiver 101 has a power button (eg, button 208) to allow the user to turn the device on or off, reset the device, or check the remaining battery life. May be. In some embodiments, the transceiver 101 has a button that may be the same button as the power button or an additional button, and the transceiver 101 is generated by the transceiver 101 in response to detecting a warning or alarm condition. One or more user notification signals (eg, vibration, visual and / or audible) may be suppressed.

  [0049] In some embodiments, the transceiver 101 may provide a wearable alert to the user in a visual, audible, and / or vibrating manner regardless of proximity to the display device 105. In some non-limiting embodiments, as illustrated in FIG. 2, the transceiver 101 may include one or more notification devices (eg, a display 924, a beeper 926) that generate visual, audible and / or vibration alerts. And / or a vibration motor 928). In some embodiments, the transceiver 100 vibrates and / or generates an audio or visual signal, such as an unacceptable analyte, such as a low / high blood sugar warning and alarm when the analyte is glucose. It may be configured to alert the user about the reading.

  [0050] In some embodiments, the transceiver 101 may store measurement information received from the sensor 100 (eg, in the memory 922). Measurement information received from sensor 100 includes: (i) signal channel measurement with light source on; (ii) reference or second signal channel measurement with light source on; (iii) light source current source voltage measurement; (iv) field. One or more of: magnetic current measurement; (v) diagnostic measurement; (vi) ambient signal channel measurement with light source off; (vii) ambient reference or second signal channel measurement with light source off; and (viii) temperature measurement. May be included. In some embodiments, the transceiver 101 may additionally store other data (eg, in the memory 922) along with measurement information received from the sensor 100. In some non-limiting embodiments, the other data includes (i) the analyte concentration calculated by the transceiver 101 from the measurement information (eg, mg / dL, eg 20.0-400.0 mg / dL (Ii) the date and time when the analyte measurement was made, (iii) acceleration taken from the accelerometer (eg, accelerometer 105 of transceiver 101 and / or accelerometer 111 of activity tracker 110). One or more of the measured values (eg, x, y and z) and / or (iv) the temperature of the transceiver 101 measured by the temperature sensor of the transceiver 101 may be included. In some embodiments, the transceiver 101 may keep track of the date and time and may store the date and time with the received analyte measurement information and / or analyte concentration as described above.

  [0051] In embodiments where the transceiver 101 includes an accelerometer, the accelerometer will allow tracking of the activity level of a subject wearing the transceiver 101. This activity level can be included in the event log and incorporated into various algorithms (eg, for analyte concentration calculations, trend determination and / or involvement in potential dose levels for subjects). Good. In some embodiments, the transceiver 101 may store (eg, in the memory 922) any warning and / or alarm conditions that are detected based on the calculated analyte concentration.

  [0052] In some embodiments, the continuous analyte monitoring system 120 can keep track of the analyte concentration (eg, blood glucose concentration) at the user. In some embodiments, the continuous analyte monitoring system provides user input of one or more measurable physiological parameters (eg, insulin and / or pre-meal addition and / or exercise therapy) on a mobile medical application. Can be easily. A mobile medical application may include (a) a transceiver 101 and / or (b) a display device 102 (eg, a smartphone, a receiver, a laptop computer) in communication with the transceiver 101, the analyte sensor 100 and / or the activity tracker 110. , Tablet, notebook computer or personal computer). For example, in one non-limiting embodiment, the mobile medical application may be executed by the processor 109 of the display device 102. In some embodiments having a smartphone or other display device 102 in communication with a transceiver, the communication between the transceiver 101 and the smartphone or other display device 102 is a wireless communication (e.g., Bluetooth wireless communication standard). Use) or wired communication, and the smartphone or other display device 102 may receive information (eg, analyte concentration) from the transceiver 101.

  [0053] In some embodiments, the continuous analyte monitoring system 120 can combine the analyte concentration information with measurable physiological parameters to provide alerts regarding current or predicted physiological conditions. For example, in some embodiments where the analyte is glucose, continuous blood glucose monitoring system 120 fuses glucose concentration information with measurable physiological parameters to provide alerts regarding current or predicted hypoglycemia conditions. Can do. In some embodiments, the alert may include a predictive alert that can be used to prevent a predicted physiological condition. For example, in some non-limiting embodiments, the predictive alert is a hypoglycemic episode (e.g., nocturnal hypoglycemia episode or unconscious hypoglycemia episode) that follows a long duration of activity detected using an accelerometer. Case) can be used to prevent. For example, a continuous analyte monitoring system may trigger a text alert on a smartphone or other display device 102, such as “I have not eaten after a long period of activity. Please take a rest after eating.” Alerts can be provided for medical applications.

  [0054] FIG. 3 is a flowchart illustrating an alerting process 300 that embodies aspects of the present invention. In some embodiments, the alerting process 300 can include generating 301 acceleration data corresponding to accelerometer movement. In some embodiments, acceleration data may be generated by one or more accelerometers (eg, accelerometer 105 and / or accelerometer 111), which may include analyte sensor 100, transceiver 101. , One or more of the display device 102 and the activity tracker 111 may be installed.

  [0055] In some embodiments, the alerting process 300 can include generating 302 activity information based on the acceleration data. In some embodiments, the activity information is sent to and received from the transceiver 101 (eg, by the microcontroller 920 of the transceiver 101), the display device 102 (eg, by a mobile medical application running on the processor 109 of the display device 102), and It may be generated by one or more of the activity trackers 111.

  [0056] In some embodiments, the alerting process 300 can include generating 303 an analyte concentration value based on a data signal received from the analyte sensor 100. In some embodiments, the analyte concentration value is determined by the mobile medical application running on the transceiver 101 (eg, by the microcontroller 920 of the transceiver 101) and the display device 102 (eg, the processor 109 of the display device 102). ). In the embodiment illustrated in FIG. 3, although step 303 of generating an analyte concentration value appears after steps 301 and 302, this is not essential, and in some alternative embodiments, step 303 comprises step It may appear before or during one or more of 301 and 302.

  [0057] In some embodiments, the alerting process 300 generates an alert 304 for a current or predicted physiological condition or response based on one or more of the activity information and the analyte concentration value. Can be included. In some embodiments, the alert is one of the transceiver 101 (eg, by the microcontroller 920 of the transceiver 101) and the display device 102 (eg, by a mobile medical application running on the processor 109 of the display device 102). One or more may be generated.

  [0058] In some embodiments, an accelerometer (eg, accelerometer 105) may be placed inside a printed circuit board (PCB) of the transceiver 101 and the user's body (using the accelerometer ( For example, in an embodiment where the transceiver is worn on the arm, movement of the user's upper body or the core of the user when the transceiver is worn on the stomach may be detected. In some embodiments, the accelerometer output may correspond to acceleration along the X, Y, and Z axes. In some embodiments, the output may be an analog value converted to a digital value by an analog-to-digital converter (ADC). The accelerometer output may be used to interpret and quantify the movement of the user (s) wearing the transceiver.

[0059] FIG. 4 is a flowchart illustrating an activity information generation process 400 that embodies aspects of the present invention. In some non-limiting embodiments, process 400 can be performed at step 302 of warning process 300. In some embodiments, the activity information generation process 400 may include a step 401 of converting acceleration data into scalar acceleration values. In some embodiments, the conversion of step 401 may include converting raw data (eg, a digital value) from the accelerometer to g (m / sec 2). In some embodiments, the conversion of step 401 may include converting the resulting data to a scalar value. In some non-limiting embodiments, the resulting data may be converted to a scalar value using the formula shown below.
AccScalar = sqrt (X * X + Y * Y + Z * Z) (Formula 1)
In some embodiments, the transceiver 101 circuitry (eg, microcontroller 920) may perform conversion of accelerometer raw data to g and from g to scalar values. However, this is not essential, and in other embodiments, some or all of the conversion may be performed by display device 102 (eg, a smartphone or personal computer) and / or activity tracker 110, for example and without limitation. May be performed elsewhere, such as by FIG. 5 is a graph illustrating a non-limiting example of a scalar acceleration value (black line) of an accelerometer over time.

  [0060] In some embodiments, the process 400 can include a step 403 of comparing the scalar acceleration value to one or more activity thresholds. That is, in some embodiments, the persistent analyte monitoring system 120 can use a scalar acceleration value to detect a rapid change in acceleration based on one or more cutoff thresholds. These cases of large changes in acceleration typically correspond to changes in body position and thus activity. Thus, in some non-limiting embodiments, the persistent analyte monitoring system 120 can detect activity by detecting when a scalar acceleration value exceeds a block threshold (ie, an activity threshold). FIG. 5 illustrates detected activity (star) based on an activity threshold of 0.18 in a non-limiting example. Although an activity threshold of 0.18 is used in the example illustrated in FIG. 5, this is not essential and alternative embodiments may use one or more different activity thresholds.

  [0061] In some embodiments, process 400 may include generating 403 activity information based on the frequency of acceleration values that exceed an activity threshold. In some non-limiting embodiments, step 403 uses the detected activity frequency (eg, within a time window) to determine acceleration information activity in three major categories: inactivity / rest, moderate activity. And may be characterized by high activity. FIG. 6 is a graph illustrating an exemplary classification of detected activities of acceleration information into inactivity, medium activity, and high activity categories. Accordingly, FIG. 6 illustrates the intensity and duration of a user's physical activity.

  [0062] In some embodiments, this information about the activity is (i) provided to the user independently as a graph generated by the mobile medical application and displayed on a display (eg, display 108 of display device 102). And / or (ii) fused with analyte data from a continuous analyte monitoring system to provide a predictive warning of the onset of potential health conditions (eg, hypoglycemia onset) before they occur May be. FIG. 7 is a graph illustrating examples of analyte measurements (eg, continuous blood glucose monitoring system (CGMS) measurements) along with activity monitoring data. The graph may be displayed on the display 108 of the display device 102 and / or by the display 924 of the transceiver 101, for example and without limitation.

  [0063] In some embodiments, the persistent analyte monitoring system 120 may additionally or alternatively use activity information to detect sleep patterns and / or steps, and the sleep patterns / steps may be graphed. And / or may be provided to the user using a bar plot. In some non-limiting embodiments, the graphs and / or plots are generated by a mobile medical application running on the processor 109 of the display device 102 and displayed by the display 108 of the display device 102, for example and without limitation. May be.

  [0064] In some non-limiting embodiments, the persistent analyte monitoring system 120 is one or more body-mounted or in-body in connection with acceleration data generated by one or more accelerometers. Galvanic electrical or physiological measurements generated by sensors (eg, heart rate, heart rate and / or sweating) are used to generate activity information and current or predicted physiological state or response A warning may be generated regarding.

  [0065] Embodiments of the present invention have been fully described above with reference to the drawings. While the invention has been described in terms of these preferred embodiments, it will be apparent to those skilled in the art that certain modifications, variations, and alternative constructions may be made to the described embodiments within the spirit and scope of the invention. .

Claims (43)

A method of alerting against a current or predicted physiological state or reaction comprising:
Generating acceleration data corresponding to the movement of the accelerometer;
Generating activity information based on the acceleration data;
Generating a warning for the current or predicted physiological state or reaction based on the activity information;
Including methods.   The method of claim 1, further comprising displaying the warning.   The method of claim 2, further comprising generating the alert display by a mobile medical application executed by a processor of the display device.   The method according to claim 3, wherein the display device is a smartphone.   The method of claim 1, wherein the accelerometer is installed in a transceiver.   The method of claim 1, wherein the accelerometer is installed in an analyte sensor.   The method of claim 1, wherein the accelerometer is installed in an activity tracker.   Receiving galvanic electrical or physiological measurements from a body-mounted or in-body sensor, wherein the activity information is generated based on the acceleration data and the galvanic electrical or physiological measurements. The method of claim 1, wherein:   The accelerometer is installed in a transceiver, and the method further comprises receiving activity information from an activity tracker, and the warning is additionally based on the activity information received from the activity tracker. The method of claim 1.   The method of claim 1, wherein the physiological condition or reaction is hypoglycemia.   The method of claim 1, wherein the physiological condition or reaction is dehydration.   The method of claim 1, wherein the physiological condition or reaction is hyperglycemia. Generating an analyte concentration value based on a data signal received from the analyte sensor;
The method of claim 1, wherein the step of generating the warning comprises generating the warning based on the activity information and the analyte concentration value.   The method of claim 13, further comprising displaying a plot of the analyte concentration value and the activity information over time.   The method of claim 14, wherein the plot is generated by a mobile medical application executed by a processor of a display device, and the plot is displayed on a display of the display device.   The method of claim 13, further comprising receiving the data signal from the analyte sensor using a transceiver.   The method of claim 16, further comprising generating the analyte concentration value using the transceiver. Communicating the data signal to a display device using the transceiver;
Generating the analyte concentration value using a mobile medical application executed by a processor of the display device;
The method of claim 16, further comprising:   The method of claim 1, wherein the warning is a predictive warning.   The method of claim 1, further comprising detecting a sleep pattern using the activity information.   The method of claim 1, further comprising detecting the number of steps using the activity information. Generating the activity information based on the acceleration information;
Converting the acceleration data into a scalar acceleration value;
Comparing the scalar acceleration value to an activity threshold;
Generating activity information based on the frequency of acceleration values exceeding the activity threshold;
The method of claim 1 comprising:   The method of claim 1, further comprising generating the activity information using a transceiver.   The method of claim 1, further comprising generating the activity information using a mobile medical application executed by a processor of a display device.   The method of claim 1, further comprising receiving the generated activity information using a transceiver.   The method of claim 1, further comprising generating the warning using a transceiver.   The method of claim 1, further comprising generating the alert using a mobile medical application executed by a processor of a display device. An accelerometer configured to generate acceleration data corresponding to the movement of the accelerometer;
A transceiver,
Generating or receiving activity information based on the acceleration data;
Generating a warning for a current or predicted physiological state or reaction based on the activity information;
A transceiver configured to perform:
A system comprising:   30. The system of claim 28, wherein the transceiver comprises the accelerometer.   30. The system of claim 28, further comprising an analyte sensor.   32. The system of claim 30, wherein the analyte sensor comprises the accelerometer. The transceiver is
Receiving a data signal from the analyte sensor;
Generating an analyte concentration value based on the received data signal;
Generating the warning based on the analyte concentration value and the activity information;
32. The system of claim 30, wherein the system is configured to perform.   36. The system of claim 32, further comprising a display configured to display the analyte concentration value and the activity information with respect to time.   34. The system of claim 33, wherein the display is configured to display a plot or graph of the analyte concentration value and the activity information over time. A transceiver interface device configured to receive the alert, the analyte concentration value and the activity information from the transceiver;
A processor configured to execute a mobile medical application configured to generate an indication of the alert, the analyte concentration value, and the activity information;
A display configured to display the generated display;
35. The system of claim 32, further comprising a display device comprising: In order to generate the activity information based on the acceleration data, the transceiver
Converting the acceleration data into a scalar acceleration value;
Comparing the scalar acceleration value to an activity threshold;
Generating activity information based on the frequency of acceleration values exceeding the activity threshold;
30. The system of claim 28, wherein the system is configured to perform.   30. The system of claim 28, further comprising an activity tracker.   38. The system of claim 37, wherein the activity tracker comprises the accelerometer. The transceiver comprises the accelerometer, and
Receiving activity information from the activity tracker;
(I) generating the warning based on the activity information generated by the transceiver and (ii) the activity information received from the activity tracker;
38. The system of claim 37, further configured to perform: The transceiver is
Receiving a galvanic electrical or physiological measurement from a body-mounted or in-body sensor;
Generating the activity information based on the acceleration data and the galvanic electrical or physiological measurements;
30. The system of claim 28, further configured to perform: A sensor interface device configured to receive a data signal from an analyte sensor;
An accelerometer configured to generate acceleration data corresponding to the movement of the accelerometer;
A network,
Generating an analyte concentration value based on the received data signal;
Generating activity information based on the acceleration data;
Generating a warning based on the analyte concentration value and the activity information;
A network configured to perform
A device comprising: An interface device configured to receive analyte concentration values and activity information;
Circuitry configured to generate a plot of the analyte concentration value and the activity information with respect to time;
A display configured to display the plot;
A device comprising:   A method of alerting to a current or predicted physiological state or response based on informatics generated by accelerometer measurements.

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