System for blood glucose meter coupled with mobile electronic device

Abstract

The present disclosure provides a mixed analyte test meter, the mixed analyte test meter includes a processor, the processor is operatively connected to a memory, a measurement signal generator, a measurement signal receiver and a short-range wireless transceiver. The processor executes firmware instructions in the memory to: operate the measurement signal generator to apply an electrical signal to a sample placed on an electrochemical test strip via a port; receive a signal measurement value from the measurement signal receiver in response to a predetermined sequence of electrical signals; and use the short-range wireless transceiver to transmit data corresponding to a plurality of signal measurement values ​​to an external computing device, wherein the processor does not identify the measurement value of the analyte in the sample based on the plurality of signal measurement values.

Description

[0001] Priority Claim

[0002] This application claims the benefit of U.S. Provisional Application No. 62 / 916,817, filed on October 18, 2019, entitled “SYSTEM FOR BLOOD GLUCOSE METERCOUPLED WITH MOBILE ELECTRONIC DEVICE,” the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present disclosure relates generally to the field of analyte detection in fluid samples, and more particularly to devices for detecting analytes in fluid samples, including blood glucose meters. Background Art

[0004] Analyte test meters known in the art can analyze body fluid samples provided by users to identify the level of one or more analytes in the user using electronic devices and one or more electrochemical reactions. These analyte meters provide significant benefits for individual users to accurately measure the analyte in fluid (i.e., biological or environmental) samples. The analyte meter applies an electrical signal to a combination of a reagent and a fluid sample, and records the response to the applied electrical signal, and the combination of electronic hardware and software in the analyte test meter implements a detection engine, which detects the level of analytes in the user based on the recorded response to the electrical signal. For example, people with diabetes can benefit from the following: glucose is measured by providing a fluid sample of blood or other body fluids to the reagent formed on the electrochemical test strip, and the electrochemical test strip is electrically connected to a blood glucose meter (BGM). BGM provides the measurement of the blood glucose level of the user, and many BGM devices use disposable electrochemical test strips, which are discarded after each blood glucose measurement. The analyte test meter can also provide benefits for users with heart disease risks by providing the measurement of cholesterol and triglycerides and other analytes. These are just a few examples of the benefits of measuring analytes in biological samples. Advances in medical science have enabled the identification of an increasing number of analytes that can be analyzed electrochemically in fluid samples.

[0005] Although analyte test meters known in the art can provide measurement of a wide range of analytes, existing analyte devices are generally unable to receive software and firmware updates during the life of the analyte device, and the life of the analyte device is generally several years in general practice. Although the analyte test meter can still work properly even without updating, the inability to update the analyte test meter may lead to inefficient operation. For example, as mentioned above, the analyte test meter uses test strips, which are usually discarded after a single use. During the entire life of the meter, the structure and chemical composition of the test strip will not change in any obvious way, because any such changes may reduce the accuracy of the existing analyte test meter. Even relatively small manufacturing differences that may occur between different batches of test strips will have a negative impact on the accuracy of existing analyte test meters, which cannot be dynamically updated to provide accurate measurements from different test strips, even if the test strips themselves are not defective. Many analyte test meters operate as independent devices that cannot receive updates, and especially low-cost analyte test meters are generally unable to receive firmware updates. While some analyte test meters incorporating network connectivity have the technical capability to receive updated firmware data from an online update service, these meters often do not actually receive updates because the same capability that enables legitimate firmware updates also enables unauthorized firmware updates that cause the meter to operate in a manner not authorized by the FDA or other health regulatory agency.

[0006] Another challenge faced by existing analyte test meters is that these test meters are usually operated as independent devices integrated with microprocessors, input devices and output devices and integrated with network devices in some cases, which increases the complexity, price and power consumption of analyte test meters. Even if it is configured to transmit the result to the analyte test meter of external computing device via, for example, Bluetooth or other wireless data links, it is still configured to serve as an independent device during normal operation. Although some removable analyte test meters are configured to serve as independent devices connected to another host device via universal serial bus (USB) or similar connection, such as personal computer (PC), smart phone or other digital devices, these removable analyte test meters still meet complete hardware requirements to realize analyte measurement process, and cannot receive updates on site. In addition, if these removable analyte test meters are still inserted in the device, they usually interfere with the normal operation of the digital device, so the user must connect and disconnect the removable analyte test meter with the host device before each use. Therefore, the improvement of the solution of the above-mentioned challenges of the analyte test meter will be beneficial. Summary of the invention

[0007] In one embodiment, a mixed analyte test meter has been developed. The mixed analyte test meter includes: a memory configured to store firmware instructions; a port configured to receive an electrochemical test strip; a measurement signal generator electrically connected to the port; a measurement signal receiver electrically connected to the port; a short-range wireless transceiver; and a processor operatively connected to the memory, the measurement signal generator, the measurement signal receiver, and the short-range wireless transceiver. The processor is configured to: execute the firmware instructions in the memory to operate the measurement signal generator to apply a predetermined sequence of electrical signals to a sample placed on the electrochemical test strip via the port; receive a plurality of signal measurements from the measurement signal receiver, the measurement signal receiver generating a plurality of measured signals based on a plurality of electrical signals received from the electrochemical test strip in the port in response to the predetermined sequence of electrical signals; and transmit data corresponding to the plurality of signal measurements to an external computing device using the short-range wireless transceiver, wherein the data corresponding to the plurality of signal measurements enables another processor in the external computing device to identify the measurement value of the analyte in the sample.

[0008] In another embodiment, an analyte test meter has been developed. The analyte test meter includes a hybrid analyte test meter and a mobile electronic device. The hybrid analyte test meter includes: a first memory configured to store firmware instructions; a port configured to receive an electrochemical test strip; a measurement signal generator electrically connected to the port; a measurement signal receiver electrically connected to the port; a first short-range wireless transceiver; and a first processor operatively connected to the first memory, the measurement signal generator, the measurement signal receiver, and the first short-range wireless transceiver. The first processor is configured to: execute the firmware instructions in the first memory to operate the measurement signal generator to apply a predetermined sequence of electrical signals to a sample placed on the electrochemical test strip via the port; receive a plurality of signal measurements from the measurement signal receiver, the measurement signal receiver generating a plurality of signal measurements based on a plurality of electrical signals received from the electrochemical test strip in the port in response to the predetermined sequence of electrical signals; and transmit data corresponding to the plurality of signal measurements to the mobile electronic device using the first short-range wireless transceiver. The mobile electronic device includes: a second memory configured to store software instructions; a second short-range wireless transceiver; an output device; and a second processor operatively connected to the second memory, the second short-range wireless transceiver, and the output device. The second processor is configured to: execute the software instructions in the second memory to receive a plurality of signal measurements from a mixed analyte test meter using the second short-range wireless transceiver; execute an analyte detection algorithm to identify the level of an analyte in a sample based on the plurality of signal measurements; and generate an output using the output device to present the level of the analyte in the sample to a user. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] These advantages, effects, features and objects, in addition to those described above, will become more apparent upon consideration of the following detailed description. Such detailed description makes reference to the following drawings, in which:

[0010] Figure 1 A view set is provided for an analyte test meter including a hybrid analyte test meter and an external computing device embodied as a mobile electronic device.

[0011] Figure 2 It is a system that provides network communication services for analyte test instruments. Figure 1 Schematic diagram of an analyte test instrument.

[0012] Figure 3 It is used to operate Figure 1 Analyte test instruments and Figure 2 A block diagram of the system process.

[0013] Figure 4 Is used to update Figure 1 Analyte test instruments and Figure 2 A block diagram of the software and firmware processes in a system. DETAILED DESCRIPTION

[0014] These and other advantages, effects, features and purposes may be better understood from the following description. In the specification, reference is made to the accompanying drawings which form a part hereof and in which are shown by way of illustration and not limitation, embodiments of the inventive concept. Throughout the several views of the drawings, corresponding reference numerals indicate corresponding parts.

[0015] Although the inventive concept is susceptible to various modifications and alternative forms, exemplary embodiments thereof are shown by way of example in the accompanying drawings and described in detail herein. However, it should be understood that the description of the following exemplary embodiments is not intended to limit the inventive concept to the specific form disclosed, but on the contrary, is intended to cover all advantages, effects and features falling within its essence and scope, as defined by the embodiments described herein and the following claims. Therefore, in order to interpret the scope of the inventive concept, reference should be made to the embodiments described herein and the following claims. Therefore, it should be noted that the embodiments described herein may have advantages, effects and features useful for solving other problems.

[0016] The devices, systems and methods will now be described more fully hereinafter with reference to the accompanying drawings, in which some, but not all, embodiments of the inventive concept are shown. Indeed, these devices, systems and methods may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements.

[0017] Likewise, many modifications and other embodiments of the devices, systems, and methods described herein will occur to those skilled in the art having the benefit of the above description and the teachings presented in the associated drawings. Therefore, it should be understood that the devices, systems, and methods are not limited to the specific embodiments disclosed, and variations and other embodiments are intended to be included within the scope of the claims. Although specific terms are employed herein, these terms are used in a general and descriptive sense only and not for purposes of limitation.

[0018] Unless otherwise defined, all scientific and technological terms used herein have the same meaning as commonly understood by those skilled in the art to which the present disclosure belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present method, preferred methods and materials are described herein.

[0019] In addition, referring to an element by the indefinite article "a / an" does not exclude the possibility of the presence of more than one element, unless the context clearly requires that there is one and only one element. Therefore, the indefinite article "a / an" usually means "at least one". Similarly, the terms "have", "comprise" or "include" or any arbitrary grammatical changes thereof are used in a non-exclusive manner. Therefore, these terms can refer to the situation where there are no other features in the entity described in this context except the features introduced by these terms, or the situation where one or more other features are present. For example, expressions such as "A has B", "A contains B" and "A includes B" can refer to the situation where there are no other elements in A except B (i.e., A is only and exclusively composed of B), or the situation where there are one or more other elements in A except B, such as element C, element C and D or even other elements.

[0020] As used herein, the term "mobile electronic device" refers to a portable computing device that provides a user with one or more of each of the following components: an output device, an input device, a memory, and a wireless communication device controlled by one or more processors in the mobile electronic device. Examples of output devices include, but are not limited to, liquid crystal display (LCD) displays, organic or inorganic light emitting diode (LED) displays, and other forms of graphic display devices, audio speakers, and tactile feedback devices. Examples of input devices include, but are not limited to, buttons, keyboards, touch screens, and audio microphones. Examples of memory include, but are not limited to, volatile data storage devices, such as random access memory (RAM); and non-volatile data storage devices, such as magnetic disks, optical disks, solid-state storage devices including EEPROM, NAND flash memory, or other forms of solid-state data storage devices. Examples of wireless communication devices include, but are not limited to, radio transceivers operating using near field communication (NFC) protocols, Bluetooth protocol family (including low-power Bluetooth (BLE)), IEEE 802.11 protocol family ("Wi-Fi"), and cellular data transmission standards ("4G", "5G", etc.). Examples of processors include digital logic devices that implement one or more central processing units (CPUs), graphics processing units (GPUs), digital signal processors (DSPs), field programmable gate arrays (FPGAs), application specific integrated circuits (ASICs), and any other suitable digital logic devices in an integrated device or as a combination of devices that operate together to implement a processor. Common examples of mobile electronic devices include, but are not limited to, smartphones, smart watches, and tablet computing devices.

[0021] Figure 1A rear view 102A, a cross-sectional view 102B, and a front view 102C of the analyte test meter 100 are depicted. The analyte test meter 100 is formed of a hybrid analyte test meter 104 and a mobile electronic device 140, which interact as described herein to provide the functionality of the analyte test meter 100. As used herein, the terms "hybrid analyte test meter" and "hybrid meter" are used interchangeably and refer to an analyte testing device that implements specific hardware and software elements to: generate and apply electrical signals to a sample including an analyte; and record electrical responses to the electrical signals during an electrical current measurement process. However, unlike conventional analyte test meters, the hybrid analyte test meter does not implement hardware and software components that perform a complete analyte measurement process and provide an output of analyte measurement results. Instead, the hybrid meter transmits digital data corresponding to the recorded electrical responses to the electrochemical test sequence to an external computing device, which performs an electrical measurement on the external computing device. Figure 1 embodied as a mobile electronic device 140. The mobile electronic device 140 is configured with hardware and software components that process digital data received from the hybrid meter to perform the following operations: generate a measurement of the analyte level in the sample; provide an output to a user of the measured analyte level; and provide additional services to the user via the mobile electronic device 140 and optionally other computing devices that communicate with the mobile electronic device 140 via one or more data networks. As described below, combining the hybrid meter 104 with the mobile electronic device 140 or another external computing device to form the analyte measurement device 100 provides improvements in the efficiency and functionality of the hardware and software elements that form the analyte measurement device 100.

[0022] As depicted in view 102A, the mixed analyte test meter 104 is mounted to the rear surface of a mobile electronic device 140 that is Figure 1embodied as a smartphone. The housing 126 surrounds both the hybrid meter 104 and the mobile electronic device 140 to hold the hybrid meter 104 in a fixed position relative to the mobile electronic device 140. The hybrid meter 104 includes a port 108 that receives a removable electrochemical test strip 105. The electrochemical test strip 105 includes electrical contacts 106 that form an electrical connection with the hybrid meter 104. The electrical contacts 106 are electrically connected to electrodes in a sample area 107 that supports a chemical reagent in contact with the electrodes. As is known in the art, the reagent includes an enzyme and a mediator that supports a reduction-oxidation (redox) reaction with an analyte in a fluid sample applied to the reagent, and the hybrid meter 104 applies an electric potential to the test strip to detect an electric current, wherein the electric current level is affected by these redox reactions. The port 108 includes a physical opening in the housing of the hybrid meter 104 to receive a portion of the electrochemical test strip 105, the portion including the electrical contacts 106. During operation, the electrical contacts 106 of the electrochemical test strip 105 are inserted into the port 108, while the sample area 107 remains outside the mixing meter 104 and extends outside the housing of the mobile electronic device 140 to enable the user to apply a fluid sample, such as blood, to the reagent in the sample area 107. The mixing meter 104 applies the electrical signals of the test sequence to the electrical contacts 106 and measures the electrical signal responses, which the mixing meter 104 converts to digital data and transmits to the mobile electronic device 140. The electrochemical test strip 105 is representative of electrochemical test strips otherwise known in the art, and the test meter 100 is operable using various forms of electrochemical test strips known in the art without modifying the electrochemical test strips.

[0023] The hybrid meter 104 includes an optional storage compartment 110 that stores consumable supplies for use with the test meter 100, including, for example, one or more of the electrochemical test strips in the supply. Other consumable parts include, for example, a lancet that enables a user to prepare a blood sample for addition to the test strip. In some embodiments, the storage compartment 110 has a moisture-proof door and stores a desiccant that prevents the stored test strips from being contaminated by water before the electrochemical test strips are used.

[0024] Figure 1102B depicts a cross-sectional view of the hybrid meter 104 and the mobile electronic device 140 of the meter 100. As depicted in the cross-sectional view 102B, the hybrid meter 104 extends from the rear surface of the mobile electronic device 140. The hybrid meter 104 is formed to have a thickness of 10 mm or less (in one embodiment, the thickness is approximately 5 mm) to enable a user to conveniently hold and carry the combination of the mobile electronic device 140 and the hybrid meter 104. In addition, the hybrid meter 104 is formed to have a general shape of a rectangular prism with a lower base proximate the mobile electronic device 140 and an upper base engaging the housing 126. The housing 126 provides a beveled edge with rounded corners around the hybrid meter 104 to protect the hybrid meter 104. However, those skilled in the art will recognize that alternative configurations of the hybrid analyte test meter 104 may have different thicknesses or shapes that enable engagement with different types of mobile electronic devices.

[0025] Figure 1 The view 102C in FIG. 1 depicts a front view of the mobile electronic device 140 in the meter 100. The housing 126 surrounds the housing of the mobile electronic device 140 and enables full access to the display 158 and the mechanical interface buttons 159. The display 158 provides a graphical user interface for the functions of the mobile electronic device 140, which functions also include software applications that provide an interface for the user to operate the meter 100 in addition to the standard functions performed by the mobile electronic device 140. As depicted above, the housing 126 and the hybrid meter 104 do not interfere with the user's access to the display 158 or a wired connection in the mobile electronic device 140, such as a USB connection or other wired connection. More generally, the hybrid meter 104 provides minimal interference with the operation of the mobile electronic device 140 for use outside of performing analyte measurement operations for the user, while the entire meter device 100 also integrates the hybrid meter 104 so that the hybrid meter 104 remains attached to the mobile electronic device 140 during normal use and can be used at any time when the user contacts the mobile electronic device 140.

[0026] like Figure 1 As depicted, housing 126 secures hybrid analyte test meter 104 to mobile electronic device 140. Housing 126 surrounds at least a portion of hybrid meter 104 and at least a portion of mobile electronic device 140. Figure 1In the embodiment of the present invention, the housing 126 includes a first cavity for accommodating the hybrid analyte test meter 104 and a second cavity for accommodating the mobile electronic device 140. In this embodiment, the housing 126 is formed of rubber, plastic, or another flexible material, which holds the hybrid meter 104 in a position close to the rear surface of the mobile electronic device 140 and surrounds the edges of the mobile electronic device 140, while providing openings for the display 158 and interface buttons 159. Although not shown in greater detail, the housing 126 can provide additional openings for a camera lens, a socket for a wired connection such as a USB port, or other components in the mobile electronic device 140. The housing 126 also provides an opening for the electrochemical test strip port 108 in the hybrid meter 104, and, if desired, an opening to provide access to the storage compartment 110. The housing 126 holds the hybrid meter 104 in a fixed position with the mobile electronic device 140 so that the user can hold and operate the two devices as a single unit. Of course, since different mobile electronic devices come in a wide variety of shapes and sizes, different housing designs may be used to hold the hybrid meter 104 with a variety of mobile electronic devices without requiring modification to the hybrid meter 104. For example, if a user obtains a different smartphone or other mobile electronic device to use with the hybrid meter 104, the hybrid meter 104 can be transferred to a different situation. The housing 126 also provides a degree of damage protection for both the hybrid meter 104 and the mobile electronic device 140, such as providing some damage protection from being dropped. In other embodiments, the hybrid meter 104 is attached to the exterior of the mobile electronic device using an adhesive coupling, a magnetic coupling, or a mechanical connection.

[0027] Figure 2 2 is a schematic diagram of a system 200 including an analyte test meter 100 that utilizes a data network 280 to communicate with a networked server that provides a software and firmware update service 284 and a healthcare service 288. As described above, the analyte test meter 100 combines a hybrid meter 104 and a mobile electronic device 140. In the system 200, the software and firmware update service is a commercially available service, such as a so-called "app store" or other online service that provides a mechanism to update the software in the mobile electronic device 140 and Figure 2 In certain configurations of the present invention, the firmware of the hybrid meter 104 is updated via the mobile electronic device 140. The healthcare service 288 represents an online system that receives analyte measurements and other user data from the analyte test meter 100. The healthcare service 288 optionally provides health information and treatment recommendations to the user of the analyte test meter 100, and in some embodiments, the healthcare service 288 also enables a healthcare provider (HCP) to access the user's analyte level history as part of providing healthcare services to the user. Figure 2The internal components and configuration of the analyte test meter 100 are further depicted in greater detail.

[0028] like Figure 2 As depicted, the hybrid meter 104 includes a first processor 112 operatively connected to a first memory 116, a first short-range wireless transceiver 128, and to a port 108 via a measurement signal generator 120 and a measurement signal receiver 124. A battery or capacitor 132 provides power to operate these components in the hybrid meter 104. The mobile electronic device 140 includes a second processor 144 operatively connected to a second memory 148, a second short-range wireless transceiver 152, an input / output (I / O) device 156, and a wireless network transceiver 160. During operation, the processor 144 in the mobile electronic device 140 executes application software 168 to: provide an interface to a user of the analyte test meter 100; control the hybrid meter 104; and analyze measurement data received from the hybrid meter 104 to identify the level of one or more analytes in a sample on an electrochemical test strip provided to the hybrid meter 104. The battery 164 provides power to operate these components in the mobile electronic device 140.

[0029] Referring to the hybrid analyte test meter 104 in more detail, the memory 116 includes a non-volatile storage device, such as an EEPROM, NAND, or other suitable data storage device for long-term storage of firmware data 118 and firmware authentication keys 119. The memory 116 further includes a volatile RAM that stores data, such as recorded signal measurement data and any other data generated and stored in the memory 116 during operation of the hybrid meter 104. The firmware 118 is embodied as binary data that includes operating instructions for controlling the operation of the processor 112 and parameter data used by the processor 112 to control the operation of the measurement signal generator 120 and the measurement signal receiver 124. For example, the processor 112 executes instructions in the firmware 118 to operate the measurement signal generator 120, and the processor 112 uses parameters in the firmware 118 to specify the operating voltage levels and durations of the AC and DC signals that the measurement signal generator 120 applies to the electrodes of the test strip via the port 108. Similarly, the processor 112 executes instructions in the firmware 118 to process and record analog or digitized signal measurement data received by the measurement signal receiver 124 from the test strip in the port 108. The processor 112 also executes firmware instructions to perform communications with the mobile electronic device 140 using the short-range wireless transceiver 128. As described in further detail below, as part of a software update, the hybrid meter 104 receives updated firmware received by the mobile electronic device 140. The processor 112 uses the authentication key 119, which in one embodiment is a cryptographic public key of a trusted publisher, to verify the authenticity of the updated firmware image before using the updated firmware.

[0030] The measurement signal generator 120 includes a modulator, an amplifier, a smoothing filter, and other circuits to implement a waveform generator that can be configured to generate both direct current (DC) signals and alternating current (AC) signals within a predetermined operating range of voltage, power, and frequency. For example, in one configuration, the measurement signal generator 120 can generate an AC voltage and a DC voltage with a relative potential difference of up to 1.0V (e.g., +0.5V to -0.5V) between a counter electrode and a reference electrode in a test strip, with a frequency of 0Hz (DC) to 100kHz AC, wherein various waveforms include sinusoidal and triangular AC waveforms and square or trapezoidal pulsed DC waveforms. A digital-to-analog converter (DAC) integrated in the processor 112 or the measurement signal generator enables the processor 112 to generate a digital data output that generates various analog voltage measurement signals from the measurement signal generator 120. The measurement signal receiver 124 includes one or more signal amplifiers and filters that enable detection of the current signal generated between the counter electrode and the reference electrode in the test strip 105 in response to the measurement signal from the measurement signal generator 120. The analog-to-digital signal converter integrated in the processor 112 or the measurement signal generator 120 enables the mixed analyte test meter 104 to generate discrete digital sample values ​​of the measured current for further processing by the digital logic device in the mixed meter 104 and the mobile electronic device 140. In some embodiments, one or both of the measurement signal generator 120 and the measurement signal receiver 124 are fully or partially integrated with the processor 112. For example, the processor 112 optionally integrates components such as DAC and ADC, modulators, amplifiers, and filter circuits. In other embodiments, the measurement signal generator 120 and the measurement signal receiver 124 are implemented using external components, wherein the processor 112 generates a control signal to operate the signal generator 120, and the processor 112 receives signal measurement data from the measurement signal receiver 124.

[0031] exist Figure 2In some embodiments, the short-range wireless transceiver 128 includes at least one antenna and at least one device that provides short-range wireless communication with the mobile electronic device 140. In some embodiments, the short-range wireless transceiver 128 further includes circuitry that enables the mobile electronic device 140 to provide power to the hybrid meter 104 via inductive coupling without requiring a wired electrical connection between the two devices. In one embodiment, the short-range wireless transceiver 128 includes a near field communication (NFC) wireless transceiver that is connected to a coil antenna formed in the hybrid analyte test meter 104 and is configured to receive digital data from the processor 112 for transmission to the mobile electronic device 140 and to receive and decode transmissions from the mobile electronic device 140 to provide a digital data representation of the received signal to the processor 112. The hybrid meter 104 incorporates the coil antenna as a conductive trace formed in a printed circuit board, or employs other conductive coils in the hybrid analyte test meter 104. The antenna receives data from the mobile electronic device 140 that is encoded in an electromagnetic signal transmitted by a corresponding short-range wireless transceiver 152 in the mobile electronic device 140 , and a receiver in the short-range wireless transceiver 128 decodes the data for use by the processor 112 .

[0032] exist Figure 2In an embodiment of the present invention, the short-range wireless transceiver 128 incorporates an NFC transceiver that provides an energy-efficient wireless communication channel that communicates with a corresponding NFC transceiver in the short-range wireless transceiver 152 of the mobile electronic device 140. The NFC transceiver operates over a short range (typically about 5 cm or less), and the physical configuration of the analyte test meter 100 that places the hybrid analyte test meter 104 near the mobile electronic device 140 enables efficient use of the NFC transceiver to provide communication. In addition, many mobile electronic devices also include other wireless transceivers, such as IEEE 802.11 "Wi-Fi", Bluetooth, and cellular data (e.g., 4G, 5G, etc.), which are substantially unaffected by the use of a short-range wireless transceiver (such as an NFC transceiver), which enables the mobile electronic device 140 to operate in general use other than communicating with the hybrid meter without interference from the hybrid meter 104. The short-range wireless transceivers 128 and 152 typically operate at lower power levels than other wireless networking standards such as Bluetooth or IEEE 802.11 ("Wi-Fi"). In addition, because the housing 126 holds the mixed analyte test meter 104 close to the mobile electronic communication device 140 to achieve inductive coupling between the coil antennas in the two devices, the short-range wireless transceivers 128 and 152 can communicate with each other with minimal interference from external radio transmitters, which avoids known connection problems that affect long-range wireless transmission protocols in environments with a large number of transmitting devices. Other embodiments of the short-range wireless transceiver use a radio frequency identification (RFID) transceiver or similar short-range wireless technology that will not interfere with the operation of additional wireless network transceivers in the mobile electronic device 140.

[0033] As described above, the short-range wireless transceivers 128 and 152 provide wireless data communication between the hybrid meter 104 and the mobile electronic device 140. In addition, some embodiments of the hybrid meter 104 use the short-range wireless transceiver 128 to receive power from the mobile electronic device 140, which charges the capacitor 132 or recharges the battery 132 to provide power to components in the hybrid meter 104. In one embodiment incorporating an NFC transceiver, the mobile electronic device 140 transmits a power signal that provides power to the NFC transceiver in the short-range wireless transceiver 128, which then provides power to charge the capacitor 132 or recharge the battery 132. As is known in the art, the NFC power signal is transmitted as an alternating current (AC) signal at a predetermined frequency (e.g., 13.56 MHz), and the coil antennas in both the hybrid meter 104 and the mobile electronic device 140 enable inductive coupling to generate power in the hybrid meter 104. The hybrid meter 104 includes a rectifier that converts the AC power signal into a direct current (DC) charging current to provide power to the capacitor or rechargeable battery 132. While some NFC transceiver configurations can implement the power transfer operations described above, other embodiments employ different charging circuits that provide inductive coupling between the hybrid meter 104 and the coil antennas of the mobile electronic device 140, which can use different AC power signal frequencies (e.g., 50 Hz or 60 Hz). As described above, embodiments that provide wireless power transfer from the mobile electronic device 140 to the hybrid meter 104 are optional, and other embodiments of the hybrid meter 104 employ commercially available non-rechargeable batteries, such as button batteries or other suitable batteries, to provide power.

[0034] The battery or capacitor 132 stores electrical energy that provides power to operate the mixed analyte test meter 104, more specifically, the processor 112, the memory 116, the measurement signal generator 120, the measurement signal receiver 124, and the short-range wireless transceiver 128. In an embodiment using the battery 132, the mixed analyte test meter 104 can be activated at any time. For example, the mixed analyte test meter 104 can be activated via an electrical switch (such as a switch that is closed when the port 108 receives the test strip), or via a wireless activation signal received from the mobile electronic device 140. In an embodiment using the capacitor 132, the capacitor 132 only maintains the charge for a relatively short period of time (e.g., about several minutes), and the mixed analyte test meter 104 is activated in response to an external charging signal generated by the mobile electronic device 140 to charge the capacitor 132 via inductive coupling through the short-range wireless transceiver. Once the capacitor 132 reaches a predetermined charge level, the capacitor 132 provides the power required to activate the components in the mixed analyte test meter. In this embodiment, the user activates the hybrid analyte test meter 104 via a user interface, such as a graphical icon or other input presented to the user by the mobile electronic device 140 as part of the user interface 172 in the application software 168. In one configuration, the mobile electronic device 140 continues to deliver power to the hybrid meter 104 during operation of the hybrid meter 104, while in another embodiment, the capacitor 132 receives sufficient charge to analyze a single fluid sample applied to a test strip prior to operation of the hybrid meter 104. The charging process generally enables the hybrid meter 104 to generate signal measurement data for a single fluid sample, and the mobile electronic device 140 provides additional power for each test operation.

[0035] Referring to the mobile electronic device 140 in more detail, Figure 2 A second processor 144 is depicted that is operatively connected to a second memory 148, a short-range wireless transceiver 152, input and output devices 156, and a wireless network transceiver 160. A battery 164, such as a lithium-ion battery or other suitable battery, provides power to operate the processor 144, the memory 148, the second short-range wireless transceiver 152, the input and output devices 156, the wireless network transceiver 160, and as described above, in some embodiments, the battery 164 provides power to the hybrid meter 104 via the second short-range wireless transceiver 152. Since the mobile electronic device 140 is a typical general-purpose digital electronic device, such as a smartphone, a tablet computer, or a wearable device, the mobile electronic device 140 includes commercially available hardware components, and the precise configuration of the mobile electronic device 140 varies based on the manufacturer. Typically, the processor 144 is a system on a chip (SoC) that includes a CPU having one or more cores and a processor and a processor that are connected via a processor. Figure 1The processor 144 optionally includes a digital signal processor for audio input and output and other specialized computing units (including, for example, an image processor and a neural network accelerator). Other components in the mobile electronic device 140 (including sensors such as accelerometers, gyroscopes, temperature sensors, humidity sensors, etc.) are either integrated with the processor 144 or operatively connected to the processor 144 and are described herein as part of the processor 144.

[0036] In the mobile electronic device 140, the memory 148 includes one or more non-volatile and volatile data storage devices. Figure 2 In the configuration of , the memory 148 stores application software 168 and operating system software 188 , both of which comprise instructions that are executed by the mobile electronic device processor 144 .

[0037] The application software 168 further includes executable program code, configuration data, a record of stored user preferences and a log of user data, and other digital assets such as graphical user interface (GUI) elements for the user interface 172, the analyte detection algorithm 176, the communication stack 180, stored user data 184, and the measurement signal data 186. Figure 1 104 as part of a software update process, the application software 168 is also depicted as including a copy of the firmware 118 used by the hybrid analyte test meter 104. The user interface 172 includes software instructions and other graphical assets that enable the application software 168 to receive input from a user to control the analyte test meter 100 and display the results of the analyte test and other health-related information of the user. The analyte detection algorithm 176 includes software instructions and profile and parameter data that enable the processor 144 to process the measurement signal data 186 received from the hybrid meter 104 to generate a measurement of the analyte level in the fluid sample. In some embodiments, the analyte detection algorithm 176 also enables the processor 144 to execute a failsafe protocol to detect contamination in the fluid sample or a fault in the test strip. The communication software 180 interfaces with services provided by the operating system software 188 to send and receive data using both the short-range wireless transceiver 152 that provides communications to the hybrid meter 104 and the wireless network transceiver 160 that enables the mobile electronic device 140 to send analyte level measurements to the healthcare service 288 for additional analysis. The stored user data 184 includes user-specific preference and configuration data and a history of one or more analyte measurements and, optionally, other information about the user's activities including meal times and activity data.

[0038] The operating system (OS) software 188 includes a software kernel, drivers, libraries, and other system software associated with a standard commercially available operating system. The OS software 188 provides standardized services, such as a network stack and a graphics stack, a file system for data storage and management, software access to the I / O devices 156, etc. For purposes of explanation, the OS software 188 is also described herein as including other software applications in addition to the application software 168, particularly a software update service that enables the mobile electronic device 140 to receive updates to the software 168 and firmware 118 for the hybrid meter 104 from the software and firmware update service 284, even though these software programs are not strictly considered to be part of the "operating system" in the academic sense.

[0039] As described above, the processor 112 in the mixed analyte test meter 104 executes program instructions stored in the firmware 118, and the processor 144 in the mobile electronic device 140 executes stored software instructions that implement the operating system software 188 and the application software 168. Of course, those skilled in the art recognize that the terms "firmware" and "software" both refer to stored program instructions and other data, such as parameter data that is stored in a non-volatile memory and controls the operation of the processor that executes the stored instructions. Both firmware and software can implement the functions described herein, and both firmware and software can be updated during the operation of the mixed analyte test meter 104 and the mobile electronic device 140. In the context of the present disclosure, the terms "firmware" and "software" are used to provide a clear distinction between the operation of the mixed analyte test meter 104 and the mobile electronic device 140, and these terms do not otherwise limit the scope of the present disclosure.

[0040] In the mobile electronic device 140, the I / O devices 156 include, for example, input devices such as touch-sensitive inputs in the display screen 158, mechanical buttons 159 or other mechanical controls, voice inputs, tactile inputs, etc. Output devices include, for example, graphical outputs such as the display screen 158, indicator lights, audio outputs via speakers, or headphone outputs, etc.

[0041] In the mobile electronic device 140, the short-range wireless transceiver 152 includes components that are compatible with the short-range wireless transceiver 128 in the hybrid meter 104, such as the NFC transceiver described above or other short-range wireless transceivers and antennas, such as a second coil antenna, that enable wireless data communication and optional power transfer via inductive coupling between the mobile electronic device 140 and the hybrid meter 104. The wireless network transceiver 160 is a separate wireless device that communicates over a larger range (such as approximately a few meters for Bluetooth or IEEE 802.11 "Wi-Fi" connections and up to several kilometers for cellular data transceivers) for communicating with software and firmware update services 284, healthcare services 288, or other external computing systems via the network 280. In addition, the wireless network transceiver 160 is generally capable of using Figure 2 The intermediate data network such as network 280 communicates with multiple devices including remote computing systems, and Figure 2 The short-range wireless transceivers 128 and 152 are generally configured for direct point-to-point communication between two devices, such as the hybrid analyte meter 104 and the mobile electronic device 140 .

[0042] Figure 3 A process 300 is depicted for measuring an analyte in a test sample using an analyte test meter that includes a hybrid analyte test meter and a mobile electronic device. In the following description, references to the process 300 to perform a function or action refer to operating one or more processors in at least one of the hybrid analyte test meter or the mobile electronic device to execute stored program instructions to perform the function or action in conjunction with other components in the analyte test meter. For purposes of illustration, the process 300 is described in conjunction with the mobile electronic device. Figure 1 and Figure 2 Process 300 is described with reference to analyte test meter 100 and system 200 that implement an amperometric measurement process to measure the level of a glucose analyte in a blood sample of a user who is a person with diabetes.

[0043] The process 300 begins with the activation of the hybrid meter 104 (block 304). In one configuration, the user executes the application software 168 by using a touch screen, voice input, or other suitable input device 156 in the mobile electronic device 140. The processor 144 in the mobile electronic device 140 activates the short-range wireless transceiver 152 to transmit an activation or "wake-up" signal to the corresponding short-range wireless transceiver 128 in the hybrid meter 104. The processor 112 in the hybrid meter 104 is activated from a deactivated or low-power standby operating mode in response to the activation signal. In an embodiment where the hybrid meter 104 stores electrical energy in a capacitor 132 without using a battery, the activation signal from the mobile electronic device 140 charges the capacitor 132 to provide sufficient power to activate the hybrid analyte test meter 104. In addition, as part of the activation process, if the user has not inserted a test strip into the port 108, the mobile electronic device 140 generates a graphical or audio output to instruct the user to insert a test strip. In another configuration, the hybrid analyte test meter 104 is activated when the test strip is inserted into the port 108. The electrodes in the test strip close the circuit to enable activation of the meter processor 112, which receives power from the battery 132 or the previously charged capacitor 132. In this configuration, the meter processor 112 optionally uses the short-range wireless transceiver 128 to transmit an activation signal to the mobile electronic device 140. The mobile electronic device processor 144 executes the application software 168 in response to receiving the activation signal without requiring additional input from the user other than the insertion of the test strip. Alternatively, the user manually operates the mobile electronic device 140 to execute the application software 168.

[0044] The process 300 continues as the mixing meter 104 applies the electrical signal test sequence to the test strip to which the fluid sample has been added (block 308). Figure 3 In an exemplary embodiment of the present invention, the electrical signal test sequence is capable of detecting the glucose level in a blood sample applied to a test strip. In one embodiment, the test sequence is a predetermined sequence of electrical signals, including a plurality of alternating current (AC) signals and a subsequent plurality of direct current (DC) signals, which are applied by the measurement signal generator 120 to a sample placed on an electrochemical test strip via port 108. In order to detect blood glucose in a blood sample, the measurement signal generator 120 generates an AC waveform and a subsequent series of pulsed DC signals, which are applied to at least one circuit formed by a working electrode connected to a counter electrode via a chemical reagent that has received a dose of the fluid sample. Although not described in further detail herein, the mixing meter 104 optionally performs a sufficient dose process that detects the application of a fluid sample (such as a blood sample) to the test strip by measuring the level of electrical impedance between one or more pairs of electrodes to ensure that the test strip has received the fluid sample before applying the electrical test signal sequence to the test strip.

[0045] In one configuration of the predetermined sequence of AC and DC electrical signals, the measurement signal generator 120 generates an AC signal having a sinusoidal waveform at a single frequency in the range of about 1 kHz to 100 kHz or in a range of frequencies in various time periods, such as a series of time periods in which the measurement signal generator 120 generates an AC signal having a frequency of 10 kHz [in the first section], 20 kHz, 10 kHz [in the second section], 2 kHz, and 1 kHz, although other frequency series may also be used. The measurement signal generator 120 generates an AC signal having a voltage amplitude of about ±0.05 V (peak-to-peak amplitude of 0.1 V), where this voltage level and other voltage levels in this example refer to the relative potential difference between the working electrode and the counter electrode in a test strip (such as the test strip 105) because the test strip does not include a separate reference electrode. The measurement signal generator 120 then generates a series of pulsed DC signals having a square or trapezoidal waveform over a period of about 1.5 seconds. In one configuration, each DC pulse has a duration of approximately 100 milliseconds, with a corresponding 100 millisecond relaxation period between pulses corresponding to a 50% duty cycle within a 200 millisecond period before starting the next pulse, although the duration of each pulse can vary between, for example, 50 milliseconds and 500 milliseconds, and the duty cycle can be greater than or less than 50%. The measurement signal generator 120 generates each DC pulse with a voltage of approximately 0.45V, which is greater than the 0.1V peak-to-peak amplitude of the AC signal. In this test sequence, the predetermined sequence of electrical signals including AC and DC signals has a duration of approximately 3 seconds, and more generally, the test sequence typically has a duration in the range of 1 second to 10 seconds. The measurement signal generator 120 operates a switch during each relaxation period to create a short circuit (0V potential) between electrodes in the test strip, and opens the switch during each DC pulse to ensure that the DC pulse is applied in the circuit path, which includes the reagent with the liquid sample.

[0046] The foregoing examples are non-limiting examples of predetermined sequences of electrical signals effective for measuring blood glucose values, and the frequency, amplitude, duration, and generation order of the signals can be adjusted in alternative configurations. In addition, alternative configurations can use different sequences of AC and DC signals, or only use AC or DC signals to measure blood glucose or other analytes. For example, an alternative embodiment uses a DC pre-processing signal at the beginning of a predetermined sequence of electrical signals, followed by the above sequence or only a sequence of pulsed DC electrical signals. Another alternative configuration generates a series of AC signals with a triangular waveform and a higher voltage amplitude (e.g., 0.45V) after the series of pulsed DC signals, and the response to these AC signals provides input data for a fault protection algorithm for detecting potential faults in one or more test strips or contamination of a liquid sample, which potential faults or contamination can hinder accurate measurement of blood glucose.

[0047] During the process 300, the hybrid meter 300 records a plurality of signal measurements received from the test strip in response to a plurality of signals in the electrical test sequence (box 312), and generates digital data corresponding to the recorded signal measurements (box 316) for further processing using one or more digital logic devices. In the embodiment described herein, the analyte test meter 100 performs a current measurement analyte detection process to detect glucose analytes in a blood sample. The measurement signal receiver 124 records the signal measurement results of the current generated in the test strip in response to the predetermined sequence of electrical signals generated by the measurement signal generator 120 during the processing of the above-mentioned box 308. Although the signal generator 120 is generally operated with a predetermined voltage distribution to generate a predetermined sequence of electrical signals in the test sequence, the measurement signal receiver 124 generally records the level of the current flowing through the circuit formed by the electrodes in the test strip and the added reagents. The levels of these currents are affected by the redox reaction between the chemical substances (including the analyte) in the fluid sample and the reagents formed on the test strip. In addition, the current changes with time based on the changes in the electrical signals of the test sequence and the progress of the chemical reaction between the fluid sample and the reagents over time. Those skilled in the art will recognize that the measurement signal receiver 124 records signal measurements in response to a predetermined sequence of electrical signals during and after generation of the signals by the measurement signal generator 120. For example, the measurement signal receiver 124 records current measurements in response to the AC signal during application of the AC signal, during application of the pulsed DC signal, and during a relaxation period following each DC pulse as the current decays, and in some embodiments, temporarily reverses direction to produce a small negative current measurement through the circuit in the test strip during at least a portion of each relaxation period.

[0048] During process 300, the measurement signal receiver 124 generates signal measurements by sampling the current over time at a Nyquist rate of two or more times the highest frequency component of the signal in the test sequence, which in the above example is at least 40 kHz, although the sampling rate may be higher or lower to maintain at least twice the sampling rate of the highest frequency component of the test signal. Each signal measurement provides an analog measurement of the current within a predetermined measurement range (e.g., a range of ±50 μA in one embodiment), and an analog-to-digital converter in the measurement signal receiver 124 or hybrid meter processor 112 converts each analog signal measurement to a digital data representation for further processing in the mobile electronic device 140. The hybrid meter processor 112 optionally buffers the digital data corresponding to the plurality of signal measurements in the meter memory 116 prior to transmission to the mobile electronic device 140, as will be described in further detail below.

[0049] In addition to the digital value of each signal measurement, the hybrid meter processor 112 also optionally generates a series of time stamp values ​​and associates both the measurement signal data corresponding to the measured current response and the voltage level value corresponding to the voltage generated by the measurement signal generator 120. The time stamp and the associated signal measurement and voltage value data enable the processor 144 in the mobile electronic device 140 to identify the time relationship between each signal measurement and the corresponding voltage signal applied to the test strip by the signal measurement generator 124 during the process 300. For example, these data enable the detection of phase differences between the electrical signal in the test sequence and the generated measurement signal of the current value, which occurs at least during the above-mentioned AC signal generation sequence. In another configuration, the hybrid meter 104 transmits only data corresponding to the measurement signal to the mobile electronic device 140. In this configuration, the mobile electronic device 140 stores the time and voltage profiles of the predetermined sequence of electrical signals in the test sequence as part of the analyte detection algorithm data 176. The processor 144 in the mobile electronic device associates the profile data with the corresponding signal measurement value based on the order in which the hybrid meter 104 generates data corresponding to the signal measurement samples during the test sequence.

[0050] The process 300 continues as the hybrid meter 104 transmits digital data corresponding to the plurality of signal measurements and optionally the timestamps and voltage values ​​of the electrical signals in the test sequence to the mobile electronic device 140 (block 320). In the analyte test meter 100, the hybrid meter processor 112 operates the short-range wireless transceiver 128 to transmit the data to the corresponding short-range wireless transceiver 152 in the mobile electronic device. In one configuration, the hybrid analyte test meter 104 temporarily stores the digital data corresponding to the signal measurements in the meter memory 116 and transmits the stored digital data after completing the recording of the digital representations of all signal measurements during the process 300. In another configuration, the hybrid analyte test meter 104 begins transmitting the digital representations of all signal measurements after generating at least one digital data but before completing the recording of the digital data for the entire test sequence. The processor 144 in the mobile electronic device 140 temporarily stores the digital measurement signal data 186 in the memory 168 for additional processing to detect the level of the analyte in the fluid sample. In embodiments where the hybrid meter 104 transmits the timestamp and signal voltage data along with the digital measurement signal data 186 to the mobile electronic device 140 , the mobile electronic device 140 also stores these data together.

[0051] The process 300 continues (block 324) as the processor 144 in the mobile electronic device 140 executes the stored program instructions of the analyte detection algorithm 176 in the application software 168 to generate a measurement of the analyte level based on the digital measurement signal data that the mobile electronic device 140 has received from the hybrid meter 104. The measurement of the analyte level includes a general measurement based on the current measured during one or more of the DC pulses, identification and correction of confounding factors (such as temperature levels and hematocrit levels in the blood sample, which are corrected to improve the accuracy of the analyte measurement), and possible triggering of a failsafe (if the processor 144 detects contamination of the fluid sample or a fault in the test strip). Although algorithms for performing the analyte measurement process are known in the art and these algorithms are not described in detail herein, generally, the current level measured in the signal measurement data in response to the pulsed DC signal is positively correlated with the level of glucose in the sample, which enables the analyte detection algorithm to generate a measurement of the glucose level using a predetermined distribution that maps the digital values ​​of one or more of the signal measurements to the glucose level. While the level of glucose in the blood sample affects the current level in the signal measurement, other factors, including the temperature and hematocrit level in the blood sample, also affect the current level in the signal measurement, and these variables are referred to as "confounding factors." The meter processor 144 identifies characteristics of the signal measurement data (such as the phase difference between the generation of the AC voltage signal in a predetermined signal sequence and the corresponding current response) to use as inputs to correction functions in the analyte detection algorithm 176. These inputs reduce or eliminate the spurious effects of the temperature and hematocrit variables, which improves the accuracy of the final blood glucose measurement.

[0052] During process 300, the mobile electronic device processor 144 also performs a failsafe detection as part of the analyte detection algorithm 176. While the analyte detection algorithm 176 corrects for confounding factors to improve the accuracy of the glucose level measurement, the failsafe function of the analyte detection algorithm 176 detects certain external factors that prevent accurate detection of glucose levels. An example of a failsafe is to detect the presence of elevated levels of antioxidants in a blood sample, where ascorbic acid (vitamin C) is an example of an antioxidant that may contaminate (which would produce inaccurate glucose measurements) a blood sample. Another failsafe occurs if one or more of the electrodes in the test strip are damaged (which may result in the detection of no current or interruption of current when the damaged electrode has only intermittent electrical continuity). In the event that the failsafe is triggered (box 328), the meter processor 144 does not generate a final glucose measurement. Instead, the meter processor 144 operates the user interface 172 in the application software 168 to generate a visual or audio output using the output device 156 to alert the user that the test failed and request a new measurement (box 332). In one embodiment, the output instructs the user to wash their hands to reduce the possibility of contamination and to replace the test strip before repeating process 300 with a new test strip.

[0053] If the analyte measurement process is completed without triggering the failsafe (block 328), the process 300 continues as the processor 144 in the mobile device 140 generates an output using an output device to present the level of the analyte in the sample to the user and optionally stores a record of the measurement with the stored user data 184 for long-term analysis (block 336). In one embodiment, the meter processor 144 operates the user interface 172 in the application software 168 to generate a visual or audio output of a digital measurement of the measured glucose level (e.g., in milligrams of glucose per deciliter of blood, such as 100 mg / dL) via the display device 158. In addition to the digital output, the mobile electronic device 140 optionally generates an additional output with a history of blood glucose measurements or recommendations for managing blood glucose levels if the measured glucose level is above or below a recommended range.

[0054] In the system 200, the analyte test meter 100 stores the measured blood glucose level of the user in association with the stored user data 184 in the mobile electronic device memory 148. The memory 148 stores the blood glucose measurement results in association with the date and time when the measurement results are generated. In addition to being stored in the memory 148, the mobile electronic device 140 also optionally executes the communication software 180 to use the wireless network transceiver 160 to transmit the glucose measurement results and the associated user data to the health care service system 288 for long-term storage and additional analysis. The associated user data may include other information from the user (such as manual input indicating the most recent time the user ate food before the blood glucose measurement) and automated data (such as the location of the mobile electronic device 140 at the time of the blood glucose measurement), as well as accelerometer data that can indicate the user's activity level before the blood glucose measurement. As described above, the health care service system 288 performs additional analysis on the long-term trends of the user's blood glucose level and other health parameters, and each blood glucose measurement provides additional input data to the health care service 288. Transmitting the blood glucose level to the healthcare service 288 does not require manual input on the part of the user, which enables efficient automatic tracking of the user's blood glucose level over time for viewing by the user and an authorized healthcare provider. After the process 300 is completed, the user removes and disposes of the test strip 105, and the mixed analyte test meter 104 optionally includes a mechanical ejection mechanism to facilitate the removal of the test strip 105. The mixed analyte test meter 104 is deactivated until the user begins the process 300 again, and the processor 144 in the mobile electronic device 140 can execute other software applications in the operating system software 188 without disconnecting the mixed analyte test meter 104. The mixed analyte test meter 104 remains fixed to the mobile electronic device 140 in the housing 126 and does not interfere with the operation of the mobile electronic device 140 for general use when the mixed analyte test meter 104 is deactivated.

[0055] As described above, the analyte test meter 100 incorporates a hybrid meter 104 and a specially reconfigured mobile electronic device 140 to enable measurement of analytes in fluid samples, such as glucose in blood samples. In addition to the advantages described above over prior art analyte measurement devices, the analyte test meter 100 further enables dynamic software and firmware updates that can dynamically modify and improve the operation of the analyte test meter 100 without having to replace the hybrid meter 104 or the mobile electronic device 140.

[0056] Figure 4A process 400 is depicted for operating the analyte meter 100 to update one or both of the application software 168 in the mobile electronic device 140 and the firmware 118 in the hybrid meter 104. In the following description, references to the process 400 to perform a function or action refer to operating one or more processors in at least one of the hybrid analyte test meter or the mobile electronic device to execute stored program instructions to perform the function or action in conjunction with other components in the analyte test meter. For purposes of illustration, the process 400 is described in conjunction with the mobile electronic device. Figure 1 and Figure 2 The process 400 is described with reference to the analyte test meter 100 and the system 200 .

[0057] The process 400 begins (block 404) as the mobile electronic device 140 receives an updated software package from the online software and update service 284. In the system 200, the processor 144 in the mobile electronic device 140 executes a software update program in the operating system software 188, which retrieves the software package from the online software and update service 284 via the network 280 using the wireless network transceiver 160. The mobile electronic device 140 optionally uses a software update service, which is also referred to as an "application store" that provides software updates for mobile electronic devices. In one configuration, the software package includes updated replacements for the executable software instruction code of the analysis software 168, configuration file data including parameter data used by the application software during the analyte detection process, various graphical assets used to generate a user interface, and additional firmware code, which the mobile electronic device 140 receives for subsequent transmission to the hybrid meter 104. As part of process 400, the processor 144 in the mobile electronic device 140 extracts files and other data structures from the software package and stores them in the memory 148, although a copy of the previously installed version of the application software 168 remains in the memory in the event that the update process fails during a firmware update operation, which is described in more detail below.

[0058] In another configuration where the mobile electronic device 140 and the hybrid meter 104 are already configured with previous versions of the application software 168 and firmware 118, the software package includes only the set of files that include the changes to the existing software 168 and firmware 118, while other portions of the software remain unchanged. For example, one type of update includes changes to parameters used in a glucose detection algorithm or a fail-safe detection process, but does not affect the executable instructions in the application software 168 or firmware 118, and the software package only includes the relevant changes to the parameter data without requiring a complete replacement of the entire software and firmware.

[0059] The process 400 continues (block 408) as the mobile electronic device 140 transmits the updated firmware data to the hybrid analyte test meter 104. The software package includes a copy of the firmware 118, and the processor 144 operates the short-range wireless transceiver 152 to transmit the firmware 118 to the hybrid meter 104, where the processor 112 in the hybrid meter 104 stores the firmware data in the meter memory 116. The meter memory 116 includes sufficient capacity to store at least two copies of the firmware data 118, which enables the hybrid meter 104 to maintain use of the existing firmware 118 until the updated firmware has been fully verified before using the updated firmware. As described above, in some configurations, the software update may not include an update to the firmware for the hybrid analyte test meter 104, and thus the firmware update process may not occur during every software update, but the analyte test meter 100 is configured to perform a firmware update when the update is included as part of the software update.

[0060] The process 400 continues (block 412) as the hybrid meter 104 authenticates the firmware data that has been received from the mobile electronic device 140. During the authentication process, the meter processor 112 uses the authentication key 119 that was stored in the meter memory 116 at the time of manufacture and is separate from the firmware data 118 to verify the authenticity of the firmware data received from the mobile electronic device 140 based on a cryptographic signature that the mobile electronic device 140 received from the software and firmware update service 284 as part of or in conjunction with the updated firmware data, and that the hybrid analyte test meter 104 also stores in the meter memory 116.

[0061] In one embodiment, the authentication key 119 is a public key associated with a private key known only to an authorized party, such as a device manufacturer of the hybrid analyte test meter 104, which has obtained regulatory approval to distribute a version of the firmware. The authorized party's computing system performs a signing operation that generates a cryptographic hash value of the updated firmware data using, for example, SHA-3 or other suitable cryptographically secure hashing algorithm, and then generates a cryptographic signature by using the private key to encrypt the hash value using an asymmetric cryptographic algorithm for later decryption using the public authentication key 119. Although the authentication key 119 in the memory 116 of the hybrid meter 104 need not be secret and can be made public, the private key is not disclosed to the analyte test device 100 or any other computing system in the system 200. Of course, those skilled in the art will recognize that the encryption described in the context of the cryptographic signing and authentication process does not make the SHA-3 value in the signature secret, because the publicly available authentication key 119 can decrypt the value. Instead, the meter processor 112 uses the authentication key 119 to decrypt the cryptographic hash value that can only be generated using the corresponding private signature key and cannot be forged in a practical manner. The meter processor 112 also generates another cryptographic hash value of the updated firmware data using the same cryptographically secure hash algorithm used to generate the decrypted cryptographic hash value (e.g., SHA-3). The meter processor 112 compares the calculated cryptographic hash value of the updated firmware data with the decrypted cryptographic hash value from the signature. If the processor 112 verifies that the two values ​​match, then the meter processor 112 successfully authenticates the digital signature and the firmware data because only a party with the private key can actually generate a signature that matches the cryptographic hash value of the firmware data. However, if the processor 112 verifies that the cryptographic hash value does not match the cryptographic hash value decrypted from the cryptographic signature, then the authentication process has failed because the hybrid meter 104 has determined that one or both of the received firmware data and the cryptographic signature are not authentic.

[0062] During process 400, even though the software and firmware update service 284 is not under the direct control of the device manufacturer, and this is expected to be the case in most practical embodiments of the system 200, the operator of the software and firmware update service 284 or a malicious third party cannot effectively modify the firmware 118 in a manner that avoids detection by the hybrid analyte test meter 104, which prevents an unauthorized party from loading unapproved firmware in the hybrid meter 104. In some embodiments, each firmware image includes a version number that is part of the signed firmware data and cannot be changed without detection, and the meter processor 112 also confirms that the version of the updated firmware is newer (e.g., a larger version number) than the currently installed firmware. This can prevent an unauthorized third party from successfully loading an otherwise valid but outdated firmware, even if the outdated firmware has a valid signature. In addition, the authorization process also ensures that the firmware received from the mobile electronic device 140 is not corrupted due to data transmission or other hardware errors.

[0063] Reference again Figure 4 , if the authentication of the firmware is successful (block 416), the hybrid meter 104 and the mobile electronic device 140 complete the software update process (block 420). In one embodiment, the meter processor 112 either deactivates the hybrid meter 104 to wait for a future start during the process 300, or immediately restarts and uses the newly updated firmware data stored in the hybrid meter memory 116 as the new meter firmware 118. After a successful update, the meter processor 112 optionally deletes the old firmware data from the memory 116. The meter processor 112 also sends a message to the mobile electronic device 140 using a short-range wireless transceiver to indicate that the authentication was successful before or after the firmware update process is completed. In the mobile electronic device 140, the processor 144 completes the update of the application software data to the new version in response to receiving a message from the hybrid meter 104 indicating that the firmware has been successfully updated. The mobile electronic device processor 144 typically restarts the application software program 168 to use the updated version and optionally deletes the old version of the application data 168 from the mobile electronic device memory 148. Although not described in further detail herein, the mobile electronic device 140 optionally uses additional cryptographic signatures to authenticate the validity of components in the application software 168 in a manner similar to the firmware authentication described above, although the mobile electronic device 140 optionally uses a more complex process involving chained certificates that are authenticated in a system such as the Transport Layer Security (TLS) protocol based on a trusted public key from a certificate authority in a manner known in the art. After completing the update of the application software 168 and the firmware 118, the analyte test meter 100 can use the newly updated software to perform the process 300 and other functions.

[0064] Reference again Figure 4During process 400, if the authentication of the firmware is unsuccessful (block 416), the software and firmware update process is canceled (block 424). In the hybrid meter 104, the meter processor 112 uses the short-range wireless transceiver 128 to send a message to the mobile electronic device 140 indicating that the authentication process failed. The meter processor 112 continues to use the previous version of the firmware 118 and optionally deletes the firmware data and cryptographic signature that failed the authentication process from the meter memory 116. The mobile electronic device processor 144 also continues to use the previous version of the application software 168 and does not execute the updated version of the application software data. In response to the failure of the authentication process, the mobile electronic device processor 144 optionally deletes the updated application software data from the memory 148. The mobile electronic device processor 144 optionally generates an error output message to notify the user via the user interface 172 and the I / O device 156 why the software update failed due to the authentication failure (block 428).

[0065] As described above, process 400 enables dynamic updates to both the application software 168 in the mobile electronic device 140 and the firmware 118 in the hybrid analyte test meter 104. A non-limiting list of technical advantages provided by the embodiments described herein over the prior art include the ability to: change parameters used for analyte detection and fail-safe condition detection; change a predetermined sequence of electrical signals that the hybrid meter 104 applies to the test strip during a test sequence; and change the analyte detection and fail-safe algorithms used by the mobile electronic device 140 to detect analyte levels and trigger fail-safes when necessary.

[0066] The present disclosure has been described in conjunction with what are believed to be the most practical and preferred embodiments. However, these embodiments have been presented by way of illustration, and are not intended to be limited to the disclosed embodiments. Therefore, those skilled in the art will recognize that the present disclosure encompasses all modifications and alternative arrangements as set forth in the following claims and within the spirit and scope of the present disclosure.

Claims

1. A mixed analyte test meter, comprising: a memory configured to store firmware instructions; a port configured to receive an electrochemical test strip; a measurement signal generator electrically connected to the port; a measurement signal receiver electrically connected to the port; Short-range wireless transceivers; as well as a processor operatively connected to the memory, the measurement signal generator, the measurement signal receiver, and the short-range wireless transceiver, the processor being configured to execute the firmware instructions in the memory to: operating the measurement signal generator to apply a predetermined sequence of electrical signals to a sample placed on the electrochemical test strip via the port; receiving a plurality of signal measurements from the measurement signal receiver, the measurement signal receiver generating a plurality of measured signals based on a plurality of electrical signals received from the electrochemical test strip in the port in response to the predetermined sequence of electrical signals; as well as Data corresponding to the plurality of signal measurements are transmitted to an external computing device using the short-range wireless transceiver, wherein the data corresponding to the plurality of signal measurements enables another processor in the external computing device to identify a measurement of an analyte in the sample by executing an analyte detection algorithm.

2. The mixed analyte test meter of claim 1, wherein the short-range wireless transceiver further comprises: Near Field Communication (NFC) transceiver.

3. The mixed analyte test meter of claim 1, further comprising: a capacitor configured to provide power to the memory, the measurement signal generator, the measurement signal receiver, the short-range wireless transceiver, and the processor; as well as A coil antenna is electrically connected to the short-range wireless transceiver and the capacitor, wherein the coil antenna is configured to inductively couple with another coil antenna in the external computing device to charge the capacitor using power received from the external computing device.

4. The mixed analyte test meter of claim 3, wherein the memory, the measurement signal generator, the measurement signal receiver, and the processor are activated in response to the capacitor reaching a predetermined charge level.

5. The mixed analyte test meter of claim 1, further comprising: A battery configured to provide power to the memory, the measurement signal generator, the measurement signal receiver, the short-range wireless transceiver, and the processor, wherein the memory, the measurement signal generator, the measurement signal receiver, the short-range wireless transceiver, and the processor are activated in response to the electrochemical test strip being inserted into the port using power received from the battery.

6. The mixed analyte test meter of claim 1, wherein the memory is further configured to store: an authentication key; and The processor is further configured to execute the firmware instructions in the memory to: receiving updated firmware data and a cryptographic signature corresponding to the updated firmware data from the external computing device using the short-range wireless transceiver; storing the updated firmware data and the cryptographic signature in the memory; generating a hash value of the updated firmware data using a cryptographically secure hash function; as well as Instructions stored in the updated firmware data are executed only in response to verifying, using the authentication key, that the hash value matches an output of a decryption of the cryptographic signature.

7. The mixed analyte test meter of claim 6, wherein the processor is further configured to execute the firmware instructions in the memory to: In response to verifying, using the authentication key, that the hash value does not match the output of the decryption of the cryptographic signature, deleting the updated firmware data from the memory.

8. The mixed analyte test meter of claim 1 , wherein the processor is further configured to execute the firmware instructions in the memory to: The measurement signal generator is operated to apply a predetermined sequence of electrical signals including a plurality of alternating current (AC) signals followed by a plurality of direct current (DC) signals to the sample placed on the electrochemical test strip via the port.

9. The mixed analyte test meter of claim 1, further comprising: A container is configured to store a plurality of the electrochemical test strips.

10. An analyte testing instrument, comprising: A mixed analyte test meter and a mobile electronic device, the mixed analyte test meter comprising: a first memory configured to store firmware instructions; a port configured to receive an electrochemical test strip; a measurement signal generator electrically connected to the port; a measurement signal receiver electrically connected to the port; a first short-range wireless transceiver; and a first processor operatively connected to the first memory, the measurement signal generator, the measurement signal receiver, and the first short-range wireless transceiver, the first processor being configured to execute the firmware instructions in the first memory to: operating the measurement signal generator to apply a predetermined sequence of electrical signals to a sample placed on the electrochemical test strip via the port; receiving a plurality of signal measurements from the measurement signal receiver, the measurement signal receiver generating the plurality of signal measurements based on a plurality of electrical signals received from the electrochemical test strip in the port in response to the predetermined sequence of electrical signals; and transmitting data corresponding to the plurality of signal measurements to the mobile electronic device using the first short-range wireless transceiver; and The mobile electronic device comprises: a second memory configured to store software instructions; a second short-range wireless transceiver; output device; and a second processor operatively connected to the second memory, the second short-range wireless transceiver, and the output device, the second processor being configured to execute the software instructions in the second memory to: receiving the plurality of signal measurements from the mixed analyte test meter using the second short-range wireless transceiver; executing an analyte detection algorithm to identify the level of an analyte in the sample based on the plurality of signal measurements; and An output is generated using the output device to present the level of the analyte in the sample to a user.

11. The analyte test meter of claim 10, wherein the first short-range wireless transceiver is a first near field communication (NFC) transceiver and the second short-range wireless transceiver is a second NFC transceiver.

12. The analyte test meter of claim 10, further comprising: a capacitor configured to provide power to the first memory, the measurement signal generator, the measurement signal receiver, the first short-range wireless transceiver, and the first processor; as well as a first coil antenna electrically connected to the first short-range wireless transceiver and the capacitor; and The mobile electronic device further comprises: Battery; as well as a second coil antenna electrically connected to the second short-range wireless transceiver and the battery, wherein the first coil antenna in the mixed analyte test meter is configured to inductively couple with the second coil antenna in the mobile electronic device to charge the capacitor using power received from the battery in the mobile electronic device.

13. The analyte test meter of claim 12, the mobile electronic device further comprising: Input device; and The second processor is operatively connected to the input device and is further configured to execute the software instructions in the second memory to: receiving an input request using the input device to activate the mixed analyte test meter; as well as The second short-range wireless transceiver is activated to transfer power from the battery to the capacitor in the mixed analyte test meter to charge the capacitor to a predetermined level for activating the mixed analyte test meter.

14. The analyte test meter of claim 12, wherein the first memory, the measurement signal generator, the measurement signal receiver, and the first processor in the mixed analyte test meter are activated in response to the capacitor reaching a predetermined charge level.

15. The analyte test meter of claim 12, wherein the second processor is configured to execute the analyte detection algorithm to identify a level of glucose in a blood sample based on the plurality of signal measurements.

16. The analyte test meter of claim 10, further comprising: A battery configured to provide power to the memory, the measurement signal generator, the measurement signal receiver, the short-range wireless transceiver, and the processor, wherein the memory, the measurement signal generator, the measurement signal receiver, the short-range wireless transceiver, and the processor are activated in response to the electrochemical test strip being inserted into the port using power received from the battery.

17. The analyte test meter of claim 10, wherein the first memory in the mixed analyte test meter is further configured to store: an authentication key; and The first processor in the mixed analyte test meter is further configured to execute the firmware instructions in the memory to: receiving updated firmware data and a cryptographic signature corresponding to the updated firmware data from an external computing device using the first short-range wireless transceiver; storing the updated firmware data and the cryptographic signature in the first memory; generating a hash value of the updated firmware data using a cryptographically secure hash function; as well as Instructions stored in the updated firmware data are executed only in response to verifying, using the authentication key, that the hash value matches an output of a decryption of the cryptographic signature.

18. The analyte test meter of claim 17, the first processor in the mixed analyte test meter further configured to execute the firmware instructions in the memory to: In response to verifying, using the authentication key, that the hash value does not match the output of the decryption of the cryptographic signature, deleting the updated firmware data from the memory.

19. The analyte test meter of claim 10, wherein the first processor in the mixed analyte test meter is further configured to execute the firmware instructions in the memory to: The measurement signal generator is operated to apply a predetermined sequence of electrical signals including a plurality of alternating current (AC) signals followed by a plurality of direct current (DC) signals to the sample placed on the electrochemical test strip via the port.

20. The analyte test meter of claim 10, further comprising: A container is configured to store a plurality of the electrochemical test strips.

21. The analyte test meter of claim 10, further comprising: A housing includes a first cavity for receiving the mixed analyte test meter and a second cavity for receiving the mobile electronic device, wherein the housing holds the mixed analyte test meter in a position proximate a rear surface of the mobile electronic device.

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