Patent Description:
The detection and/or monitoring of analyte levels, such as glucose, ketones, lactate, oxygen, hemoglobin AIC, or the like, can be vitally important to the health of an individual having diabetes Diabetics generally monitor their glucose levels to ensure that they are being maintained within a clinically safe range, and may also use this information to determine if and/or when insulin is needed to reduce glucose levels in their bodies or when additional glucose is needed to raise the level of glucose in their bodies.

Growing clinical data demonstrates a strong correlation between the frequency of glucose monitoring and glycemic control. Despite such correlation, many individuals diagnosed with a diabetic condition do not monitor their glucose levels as frequently as they should due to a combination of factors including convenience, testing discretion, pain associated with glucose testing, and cost.

Analyte monitoring systems have been developed that assist individuals to more frequently monitor their glucose and/or other analyte levels. These systems typically utilize a device that resides in or on the patient's body and have a sensor that measures the patient's glucose levels continuously or repeatedly over the course of the sensor's lifetime. This device can communicate the measured information wirelessly to another device, typically a smart device, computing device, or other type of glucose information reader. The wireless communication adds to the convenience and user-friendly nature of the system. However, challenges can arise when the wireless communication is performed according to a protocol that
has timing requirements that do not take into account the processing and other delays that may be present in the analyte monitoring system.

<CIT> and <CIT> disclose monitoring systems in which data is communicated. <CIT> discloses a storage device and a controller configured to read data from the storage device, <CIT> discloses an electronic information storage medium that can establish communication with an external apparatus.

For these and other reasons, needs exist for analyte monitoring systems, devices, and methods capable of maintaining compliance with wireless protocol requirements.

Example embodiments of systems, devices, and methods are described herein for communication in an analyte monitoring system in accordance with an applicable communication protocol. In many embodiments, a first device of the system may transmit a command to a second device of the system and the second device may encounter a processing delay in preparing data responsive to the command. In these or other cases the second device may transmit dummy data to the first device in order to maintain compliance with the communication protocol until such time that the second device is ready to transmit data responsive to the command. Numerous different embodiments for incorporating and/or accommodating the presence of dummy data in a communication hierarchy are provided.

Other systems, devices, methods, features and advantages of the subject matter described herein will be or will become apparent to one with skill in the art upon examination of the following figures and detailed description. It is intended that all such additional systems, methods, features and advantages be included within this description, be within the scope of the subject matter described herein, and be protected by the accompanying claims. In no way should the features of the example embodiments be construed as limiting the appended claims, absent express recitation of those features in the claims.

The details of the subject matter set forth herein, both as to its structure and operation, may be apparent by study of the accompanying figures, in which like reference numerals refer to like parts. The components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the subject matter. Moreover, all illustrations are intended to convey concepts, where relative sizes, shapes and other detailed attributes may be illustrated schematically rather than literally or precisely.

Before the present subject matter is described in detail, it is to be understood that this disclosure is not limited to the particular embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present disclosure will be limited only by the appended claims.

Generally, embodiments of the present disclosure are used with systems, devices, and methods for detecting at least one analyte, such as glucose, in a bodily fluid (e.g., subcutaneously within the interstitial fluid ("ISF") or blood, within the dermal fluid of the dermal layer, or otherwise). Accordingly, many embodiments include in vivo analyte sensors structurally configured so that at least a portion of the sensor is, or can be, positioned in the body of a user to obtain information about at least one analyte of the body. However, the embodiments disclosed herein can be used with in vivo analyte monitoring systems that incorporate in vitro capability, as well as purely in vitro or ex vivo analyte monitoring systems, including those systems that are entirely non-invasive.

Furthermore, the embodiments described herein can be used with devices that sense biometrics other than analyte data, such as heart rate, blood pressure, body temperature, perspiration, intraocular pressure, and others. The embodiments described herein can be used with devices that sense movement and/or activity level alone or in combination with any other metric. The embodiments described herein are thus not limited to medical applications and can be used with other, non-medical systems, where RF communication between devices is employed.

Before describing the embodiments in detail, however, it is first desirable to describe examples of devices that can be present within, for example, an in vivo analyte monitoring system, as well as examples of their operation, all of which can be used with the embodiments described herein.

In vivo monitoring systems can include a sensor that, while positioned in vivo, makes contact with the bodily fluid of the user and senses the analyte levels contained therein. The sensor can be part of a OBD that resides on the body of the user and contains the electronics and power supply that enable and control the analyte sensing. The on body device, and variations thereof, can also be referred to as a "sensor device," an "on-body electronics device," a "sensor control device," or a "sensor communication device," to name a few. As used herein, these terms are not limited to devices with in vivo analyte sensors, and encompass devices that have ex vivo sensors of other types, whether biometric (e.g., photonic analyte sensors, heart rate sensors, temperature sensors, etc.) or non-biometric. The term "on body" encompasses devices that reside directly on the body (e.g., attached to the skin), are wholly within the body (e.g., a fully implanted device), or are in close proximity to the body, such as a wearable device (e.g., glasses, watch, wristband or bracelet, neckband or necklace, etc.) or a device in a pocket, etc..

In vivo monitoring systems can also include one or more reader devices that read information about a sensed level from the on body device. These reader devices can process and/or display the sensed analyte information, in any number of forms, to the user. These devices, and variations thereof, can be referred to as "handheld reader devices," "readers," "handheld electronics" (or handhelds), "portable data processing" devices or units, "information receivers," "receiver" devices or units (or simply receivers), "relay" devices or units, or "remote" devices or units, to name a few.

In vivo analyte monitoring systems can be differentiated from "in vitro" systems that contact a biological sample outside of the body, and "ex vivo" systems that gain information about the body or a substance within the body but that do so while remaining wholly outside the body without extracting a biological sample from inside the body. In vitro systems can include a meter device that has a port for receiving an analyte test strip carrying a bodily fluid of the user, which can be analyzed to determine the user's analyte level. As mentioned, the embodiments described herein can be used with in vivo systems, ex vivo systems, in vitro systems, and combinations thereof.

The embodiments described herein can be used to monitor and/or process information regarding any number of one or more different analytes. Analytes that may be monitored include, but are not limited to, acetyl choline, amylase, bilirubin, cholesterol, chorionic gonadotropin, glycosylated hemoglobin (HbAlc), creatine kinase (e.g., CK-MB), creatine, creatinine, DNA, fructosamine, glucose, glucose derivatives, glutamine, growth hormones, hormones, ketones, ketone bodies, lactate, peroxide, prostate-specific antigen, prothrombin, RNA, thyroid stimulating hormone, and troponin. The concentration of drugs, such as, for example, antibiotics (e.g., gentamicin, vancomycin, and the like), digitoxin, digoxin, drugs of abuse, theophylline, and warfarin, may also be monitored. In embodiments that monitor more than one analyte, the analytes may be monitored at the same or different times.

Example embodiments of in vivo analyte monitoring systems can include one or more on body devices, one or more reader devices, and one or more computer systems capable of communicating in a highly interconnected fashion. <FIG> is an illustrative and block diagram depicting an example embodiment of an in vivo analyte monitoring system <NUM> having an on body device (OBD) <NUM>, a first reader device <NUM>-<NUM>, a second reader device <NUM>-<NUM>, a local or remote computer system <NUM>, and a trusted computer system <NUM> (e.g., a server), each of which can be configured to communicate over a communications network <NUM>. References to reader device <NUM> herein refer to both reader device <NUM>-<NUM> and <NUM>-<NUM>.

OBD <NUM> can communicate with reader device <NUM> over two or more wireless communication paths, links, or channels <NUM> and <NUM>, which can be uni-directional or bi-directional. Links <NUM> and <NUM> are formed by communication circuitry and one or more antennas present in OBD <NUM> and reader device <NUM>. In some embodiments, the capability for devices <NUM> and <NUM> to communicate over an additional wired communication path, such as a universal serial bus (USB) cable (not shown), can be implemented.

Wireless communication link <NUM> can have various implementations. In some embodiments, communication link <NUM> uses near field electromagnetic induction to communicate Such links are sometimes referred to as close proximity communications as they require the transmitting and receiving devices to be in relatively close proximity as compared to far field (or transition zone) communications. Communication using electromagnetic induction generally occurs within a two wavelength distance, more typically within one wavelength distance between the transmitting and receiving devices. In many embodiments, electromagnetic induction-based communications occur only within one foot (<NUM> inches) of range or shorter, dependent upon frequency and power of transmission, among others. Examples include "Near Field Communication" (NFC) protocols, which refer to a number of protocols (or standards) that set forth operating parameters, modulation schemes, coding, transfer speeds, frame format, and command definitions for NFC devices. Some examples of NFC devices operate at <NUM> Megahertz (Mhz) The following is a non-exhaustive list of examples of these protocols: ECMA-<NUM>, ECMA-<NUM>, ISO/IEC <NUM>, ISO/IEC <NUM>, ISO/IEC <NUM>-<NUM>, ISO/IEC <NUM>, and ISO/IEC <NUM>. Examples also include Radio Frequency Identification (RFID) protocols.

Responsive communications using electromagnetic induction can be passively generated, where power conveyed by a transmission from a first device is captured by the receiving second device and used to power transmission of a response by the second device back to the first device. Responsive communications using electromagnetic induction can be actively generated, such that the receiving second device uses power from its own power source alone, or in combination with power captured from the received transmission, to power transmission of the responsive communication back to the first device.

The sending of a transmission, e.g., a request for analyte data, from reader device <NUM> to OBD <NUM> can cause OBD <NUM> to respond with a transmission of its own, e.g., analyte data obtained or derived from a measurement made by sensor <NUM>. This process of transmitting from reader <NUM> to OBD <NUM> and receiving a response from OBD <NUM> can be referred to as "scanning" or conducting a "scan" of OBD <NUM>. In many embodiments, OBD <NUM> is configured as a passive device where the power from a transmission from reader device <NUM> received over link <NUM> is captured and used to power transmission of the responsive communication from OBD <NUM> back to reader device <NUM>. This can be referred to as a "passive scan. " In such embodiments, OBD <NUM> can power transmissions without using power from a power source (e.g., a coin cell battery) internal to OBD <NUM>. In other embodiments, OBD <NUM> can be configured as an active device where the power from a transmission from reader device <NUM> received over link <NUM> is or is not captured, and the power used to transmit the responsive communication from OBD <NUM> back to reader device <NUM> is generated entirely or in part by the power source internal to OBD <NUM>. This can be referred to as an "active scan.

Wireless communication link <NUM> utilizes communication protocols other than those used by link <NUM> and relies primarily on the longer range far field characteristics of electromagnetic transmission, where transmission does not occur only through inductive coupling. Link <NUM> can communicate over the same close proximity communication range as link <NUM> and substantially farther. Link <NUM> can also have various implementations. To form link <NUM>, OBD <NUM> and reader <NUM> can include communication circuitry and one or more antennas configured to communicate over standardized or proprietary protocols and formats. For example, link <NUM> can be formed using a Bluetooth (e.g., traditional Bluetooth or Bluetooth Low Energy (BLE)) frequency and protocol. Link <NUM> can also be formed in other frequency bands and using other protocols, such as an ultra-high frequency (UHF) band (for example, between <NUM>-<NUM> Megahertz) and proprietary protocol, a Wi-Fi protocol in various frequencies, other proprietary protocol, or the like, including those communication protocols in existence as of the date of this filing or their later developed variants. While both links <NUM> and <NUM> can utilize various protocols and frequencies, for ease of differentiation they can be referred to herein as NFC link <NUM> and Bluetooth (BT) link <NUM>. In some embodiments, NFC link <NUM> is used to initiate and activate the on body device <NUM>, while analyte data is communicated only over BT link <NUM>.

OBD <NUM> can be configured to communicate with multiple reader devices <NUM> over different instances of links <NUM> and <NUM>. This is shown in <FIG> by the presence of first reader device <NUM>-<NUM> capable of communication with OBD <NUM> over NFC link <NUM>-<NUM> and BT link <NUM>-<NUM>, and by the presence of second reader device <NUM>-<NUM> capable of communication with OBD <NUM> over NFC link <NUM>-<NUM> and BT link <NUM>-<NUM>. Additional reader devices <NUM> can also be present.

Reader device <NUM> can communicate with multiple OBDs <NUM>. For example, each reader device <NUM> can communicate with a first OBD <NUM> on the body of a user over the first OBD's operating lifetime, and then that OBD <NUM> can be discarded and replaced with a second OBD <NUM> on the body of the user, which the same reader device <NUM> can again communicate with. In some embodiments, a particular reader device <NUM> can communicate with multiple OBDs concurrently, located on the same or different users.

Reader device <NUM> is also capable of wired, wireless, or combined communication with other devices. <FIG> depicts reader device <NUM>-<NUM> in communication with computer system <NUM> (e.g., a local or remote computer system) over communication link, path, or channel <NUM>, and also in communication with a network <NUM>, such as the internet or the cloud, over communication link, path, or channel <NUM>. (Reader device <NUM>-<NUM> can also communicate with these devices in like fashion, but those connections are not shown for ease of illustration. ) Reader device <NUM>-<NUM> can communicate with a trusted computer system ISO by way of network <NUM> using link <NUM>. Trusted computer system <NUM> can communicate with computer system <NUM> over communication link, path, or channel <NUM>. For example, trusted computer system <NUM> can be a server that serves analyte analytics software to reader device <NUM>-<NUM> and/or computer system <NUM>, for example, in the form of a downloadable software application or "app" or as an internet browser accessible web page.

Communication links <NUM>, <NUM>, and <NUM> can be wireless, wired, or both, can be uni directional or bi-directional, and can be part of a telecommunications network, such as a Wi-Fi network, a local area network (LAN), a wide area network (WAN), the internet, or other data network. In some cases, communication paths <NUM> and <NUM> can be, at least in part, the same path (e.g., such as when communicating over Wi-Fi). All communications over the various paths can be encrypted and OBD <NUM>, reader device <NUM>-<NUM>, reader device <NUM>-<NUM>, computer system <NUM>, and trusted computer system <NUM> can each be configured to encrypt and decrypt those communications sent and received.

Variants of devices <NUM> and <NUM>, as well as other components of an in vivo-based analyte monitoring system that are suitable for use with the system, device, and method embodiments set forth herein, are described in <CIT>(the'<NUM> Publication).

Referring again to <FIG>, OBD <NUM> can include a housing <NUM> containing analyte monitoring circuitry and a power source. In this embodiment, the analyte monitoring circuitry is electrically coupled with an analyte sensor <NUM> that extends through an adhesive patch <NUM> and projects away from housing <NUM>. Adhesive patch <NUM> contains at least one adhesive layer (not shown) for attachment to a skin surface of the body of the user, and optionally a second adhesive layer on the opposite surface for attachment to housing <NUM>. Other forms of attachment to the body and/or housing <NUM> may be used, in addition to or instead of adhesive.

Analyte sensor <NUM> is adapted to be at least partially inserted into the body of the user, where it can make fluid contact with that user's bodily fluid (e.g., ISF, dermal fluid, or blood) and be used, along with the analyte monitoring circuitry, to measure analyte-related data of the user. Sensor <NUM> and any accompanying sensor electronics can be applied to the body in any desired manner. For example, an insertion device (not shown) can be used to position all or a portion of analyte sensor <NUM> through an external surface of the user's skin and into contact with the user's bodily fluid. In doing so, the insertion device can also position OBD <NUM> with adhesive patch <NUM> onto the skin. In other embodiments, the insertion device can position sensor <NUM> first, and then accompanying electronics (e g. , wireless transmission circuitry and/or data processing circuitry, and the like) can be coupled with sensor <NUM> afterwards, either manually or with the aid of a mechanical device. Examples of insertion devices are described in <CIT>, <CIT>, <CIT>, <CIT>, and <CIT>.

After collecting raw analog data from the user's body, OBD <NUM> can optionally apply analog signal conditioning to the data and convert the analog data into a digital form of the conditioned raw data. In some embodiments, this digital raw data can be encoded for transmission to another device, e.g., reader device <NUM>, which then algorithmically processes that digital raw data into a final form representative of the user's measured biometric (e.g., a form readily made suitable for display to the user). This algorithmically processed data can then be formatted or graphically processed for digital display to the user. In other embodiments, OBD <NUM> itself can algorithmically process the digital raw data into the final form that is representative of the user's measured biometric (e.g., analyte level) and then encode and wirelessly communicate that data to reader device <NUM>, which in turn can format or graphically process the received data for digital display to the user. In other embodiments, OBD <NUM> can graphically process the final form of the data such that it is ready for display, and display that data on a display of OBD <NUM> or transmit the data to reader device <NUM>. In some embodiments, the final form of the biometric data (prior to graphic processing) is used by the system (e.g., incorporated into a diabetes monitoring regime) without processing for display to the user. In some embodiments, OBD <NUM> and reader device <NUM> transmit the digital raw data to another computer system for algorithmic processing and display. The transmissions of these various forms of data can occur over either or both of links <NUM> and <NUM>.

Each reader device <NUM> within system <NUM> can include a display <NUM> to output information to the user and/or to accept an input from the user, and an optional input component <NUM> (or more), such as a button, actuator, touch sensitive switch, capacitive switch, pressure sensitive switch, jog wheel or the like, to input data, commands, or otherwise control the operation of reader device <NUM>. In certain embodiments, display <NUM> and input component <NUM> may be integrated into a single component, for example, where the display can detect the presence and location of a physical contact touch upon the display, such as a touch screen user interface. In certain embodiments, input component <NUM> of reader device <NUM> may include a microphone and reader device <NUM> may include software configured to analyze audio input received from the microphone, such that functions and operation of the reader device <NUM> may be controlled by voice commands. In certain embodiments, an output component of reader device <NUM> includes a speaker (not shown) for outputting information as audible signals. Similar voice responsive components such as a speaker, microphone and software routines to generate, process and store voice driven signals may be included in OBD <NUM>.

Reader device <NUM> can also include one or more data communication ports <NUM> for wired data communication with external devices such as computer system <NUM> or OBD <NUM>. Example data communication ports include all types of serial or parallel connectors, including all variants of USB ports, RS-<NUM> ports, Ethernet ports, Firewire ports, or other similar data communication ports configured to connect to the compatible data cables. Reader device <NUM> may also include an integrated or attachable in vitro glucose meter, including an in vitro test strip port (not shown) to receive an in vitro glucose test strip for performing in vitro blood glucose measurements.

Reader device <NUM> can display the measured biometric data wirelessly received from OBD <NUM> and can also be configured to output alarms, alert notifications, glucose values, etc., which may be visual, audible, tactile, or any combination thereof. Further details and other display embodiments can be found in, e.g., <CIT>.

Reader device <NUM> can function as a data conduit or relay to transfer the measured data from OBD <NUM> to computer system <NUM> or trusted computer system <NUM>. In certain embodiments, the data received from OBD <NUM> may be stored (permanently or temporarily) in one or more memories of reader device <NUM> prior to uploading to system <NUM>, <NUM> or network <NUM>.

Computer system <NUM> may be a personal computer, a server terminal, a laptop computer, a tablet, or other suitable data processing device. Computer system <NUM> can be (or include) software for data management and analysis and communication with the components in analyte monitoring system <NUM>. Computer system <NUM> can be used by the user or a medical professional to display and/or analyze the biometric data measured by OBD <NUM>. In some embodiments, OBD <NUM> can communicate the biometric data directly to computer system <NUM> without an intermediary such as reader device <NUM>, or indirectly using an internet connection (also optionally without first sending to reader device <NUM>). Operation and use of computer system <NUM> is further described in the'<NUM> Publication. Analyte monitoring system <NUM> can also be configured to operate with a data processing module (not shown), also as described in the '<NUM> Publication.

Trusted computer system <NUM> can be within the possession of the manufacturer or distributor of OBD <NUM>, either physically or virtually through a secured connection, and can be used to perform authentication of OBD <NUM>, for secure storage of the user's biometric data, and/or as a server that serves a data analytics program (e.g., accessible via a web browser) for performing analysis on the user's measured data.

Reader device <NUM> can be a dedicated reader device that is custom manufactured for the purpose of interfacing with OBD <NUM>. Reader device <NUM> can also be a mobile communication device such as a mobile telephone including, but not limited to, a Wi-Fi or internet enabled smart phone, tablet, or personal digital assistant (PDA). Reader device <NUM> can also be configured as a mobile smart wearable electronics assembly, such as a smart glass or smart glasses, or a smart watch or wristband.

<FIG> is a block diagram of an example embodiment of a reader device <NUM> (e.g., a dedicated reader, a smart phone, etc.). Here, reader device <NUM> includes input component <NUM>, display <NUM>, and processor or processing circuitry <NUM> with memory <NUM>, first communication circuitry <NUM> coupled with a first antenna <NUM>, second communication circuitry <NUM> coupled with an optional second antenna <NUM>, a memory <NUM>, a power supply <NUM>, and power management circuitry <NUM>.

Reader <NUM> can be implemented in a highly interconnected fashion, where power supply <NUM> is coupled with each component shown in <FIG> and where those components that communicate or receive data, information, or commands (e.g., processor <NUM>, memory <NUM>, memory <NUM>, power management circuitry <NUM>, input component <NUM>, display <NUM>, first communication circuitry <NUM>, and second communication circuitry <NUM>), can be communicatively coupled with every other such component over, for example, one or more communication connections or buses <NUM>. <FIG> is an abbreviated representation of the typical hardware and functionality that resides within a dedicated reader and those of ordinary skill in the art will readily recognize that other hardware and functionality (e.g., codecs, drivers, glue logic, global positioning system (GPS) circuitry, a crystal oscillator, phase-locked loop (PLL), etc.) can also be included.

First communication circuitry <NUM> and antenna <NUM> are configured for communication (transmission and/or reception) over communication link <NUM>, and second communication circuitry <NUM> and antenna <NUM> are configured for communication over communication link <NUM>. In some embodiments, antenna <NUM> and antenna <NUM> can be a single shared antenna (e.g., capable of transmission and reception over NFC and BT frequencies). Communication circuitry <NUM> and <NUM> can be implemented as one or more chips and/or components (e.g., transmitter, receiver, transceiver, encoder, decoder, and/or other communication circuitry) that perform the functions for communications over the respective communications links <NUM> and <NUM>.

Antennas <NUM> and <NUM> can be configured according to the needs of the application and communication protocol. Antennas <NUM> and <NUM> can have the same or different configuration and can be, for example, a printed circuit board (PCB) trace antenna, a ceramic antenna, or a discrete metallic antenna. Antennas <NUM> and <NUM> can be configured as a monopole antenna, a dipole antenna, an F-type antenna, a loop antenna, and others.

Processor <NUM> can include one or more processors, microprocessors, controllers, and/or microcontrollers, each of which can be a discrete chip or distributed amongst (and a portion of) a number of different chips. Here, processor <NUM> includes on-board memory <NUM>. Processor <NUM> can interface with communication circuitry <NUM> and <NUM> and perform analog-to-digital conversions, encoding and decoding, digital signal processing and other functions that facilitate the conversion of data signals into a format (e.g., in-phase and quadrature) suitable for provision to communication circuitry <NUM> and <NUM>, which can then transmit the signals wirelessly. Processor <NUM> can also interface with communication circuitry <NUM> and <NUM> to perform the reverse functions necessary to receive a wireless transmission and convert it into digital data or information.

Processor <NUM> can execute software instructions stored in memory <NUM> or <NUM>. These instructions can cause processor <NUM> to cause communication circuitry <NUM> and <NUM> to transmit, can cause processor <NUM> to read and act on received transmissions, can cause processor <NUM> to read input from input component <NUM>, to display data or information on display <NUM>, to read input from display <NUM> when implemented as a touchscreen, to process data or information received from other devices (e.g., analyte data, calibration information, synchronization information received from OBD <NUM>, and others), to perform tasks to maintain synchronization with OBD <NUM>, and others.

Memory <NUM> can be shared by one or more of the various functional units present within reader device <NUM>, or can be distributed amongst two or more of them (e.g., as separate memories present within different chips). Memory <NUM> can also be a separate chip of its own. Memories <NUM> and <NUM> are non-transitory, and can be volatile (e.g., RAM, etc.) and/or non-volatile memory (e.g., ROM, flash memory, F-RAM, etc.).

Power supply <NUM> can include one or more batteries, which can be rechargeable or single-use disposable batteries. Power management circuitry <NUM> can regulate battery charging and monitor usage of power supply <NUM>, boost power, perform DC conversions, and the like.

Reader device <NUM> can also include or be integrated with a drug (e.g., insulin, etc.) delivery device such that they, e.g., share a common housing. Examples of such drug delivery devices can include medication pumps having a cannula that remains in the body to allow infusion over a multi-hour or multi-day period (e.g., wearable pumps for the delivery of basal and bolus insulin). Reader device <NUM>, when combined with a medication pump, can include a reservoir to store the drug, a pump connectable to transfer tubing, and an infusion cannula. The pump can force the drug from the reservoir, through the tubing and into the diabetic's body by way of the cannula inserted therein. Other examples of drug delivery devices that can be included with (or integrated with) reader device <NUM> include portable injection devices that pierce the skin only for each delivery and are subsequently removed (e.g., insulin pens). A reader device <NUM>, when combined with a portable injection device, can include an injection needle, a cartridge for carrying the drug, an interface for controlling the amount of drug to be delivered, and an actuator to cause injection to occur. The device can be used repeatedly until the drug is exhausted, at which point the combined device can be discarded, or the cartridge can be replaced with a new one, at which point the combined device can be reused repeatedly. The needle can be replaced after each injection.

The combined device can function as part of a closed-loop system (e.g., an artificial pancreas system requiring no user intervention to operate), semi-closed loop system (e.g., an insulin loop system requiring seldom user intervention to operate, such as to confirm changes in dose), or an open loop system. For example, the diabetic's analyte level can be monitored in a repeated automatic fashion by OBD <NUM>, which can then communicate that monitored analyte level to reader device <NUM>, and the appropriate drug dosage to control the diabetic's analyte level can be automatically determined and subsequently delivered to the diabetic's body. Software instructions for controlling the pump and the amount of insulin delivered can be stored in memory <NUM> and/or <NUM> of reader device <NUM> and executed by processing circuitry <NUM>. These instructions can also cause calculation of drug delivery amounts and durations (e.g., a bolus infusion and/or a basal infusion profile) based on the analyte level measurements obtained directly or indirectly from OBD <NUM>. In some embodiments OBD <NUM> can determine the drug dosage and communicate that to reader device <NUM>.

<FIG> is a block diagram depicting an example embodiment of OBD <NUM> having analyte sensor <NUM> and sensor electronics (including analyte monitoring circuitry). The sensor electronics can be implemented in one or more semiconductor chips, such as application specific integrated circuits (ASICs), off-the-shelf (OTS) chips, programmable devices (e.g., a PGA or FPGA, etc.), or others. OBD <NUM> includes certain high-level functional units, including an analog front end (AFE) <NUM>, power management (or control) circuitry <NUM>, processor or processing circuitry <NUM>, memory <NUM>, first communication circuitry <NUM>, and second communication circuitry <NUM>. In this embodiment, both AFE <NUM> and processor <NUM> are used as analyte monitoring circuitry, but in other embodiments either circuit (or others) can perform the analyte monitoring function.

OBD <NUM> can be implemented in a highly interconnected fashion, where power supply <NUM> is coupled with each component shown in <FIG> and where those components that communicate or receive data, information, or commands (e.g., AFE <NUM>, power management circuitry <NUM>, processor <NUM>, memory <NUM>, first communication circuitry <NUM>, and second communication circuitry <NUM>), can be communicatively coupled with every other such component over, for example, one or more communication connections or buses <NUM>. <FIG> is an abbreviated representation of the typical hardware and functionality that resides within an OBD <NUM> and those of ordinary skill in the art will readily recognize that other hardware and functionality (e.g., codecs, drivers, glue logic, crystal oscillator, phase-locked loop (PLL)) can also be included.

Communication circuitry <NUM> and <NUM> can be coupled to antennas <NUM> and <NUM>, respectively, which can be on chip or off chip (as shown here). First communication circuitry <NUM> and antenna <NUM> are configured for communication (transmission and/or reception) over communication link <NUM>, and second communication circuitry <NUM> and antenna <NUM> are configured for communication over communication link <NUM>. In some embodiments, antenna <NUM> and antenna <NUM> can be a single shared antenna (e.g., capable of transmission and reception over NFC and BT frequencies). Communication circuitry <NUM> and <NUM> can be implemented as one or more components (e.g., transmitter, receiver, transceiver, passive circuit, encoder, decoder, and/or other communication circuitry) that perform the functions for communications over the respective communications links <NUM> and <NUM>.

Although not limited to such, in some embodiments, communication circuitry <NUM> is passive and only uses power harvested from a transmission received from a second device (e.g., reader <NUM>) to generate and propagate a response transmission back to the second device (such as when link <NUM> is an NFC link). In these and other embodiments, communication circuitry <NUM> can be active and can use power from OBD power source <NUM> to generate and propagate a transmission to a second device. The active communication circuitry <NUM> permits OBD <NUM> to generate a transmission spontaneously and with prompting from another device (e.g., without first receiving a request, polling signal, timing signal, and the like from the second device).

Processor <NUM> can include one or more processors, microprocessors, controllers, and/or microcontrollers, each of which can be a discrete chip or distributed amongst (and a portion of) a number of different chips. Processor <NUM> can interface with communication circuitry <NUM> and <NUM> and perform analog-to-digital conversions, encoding and decoding, digital signal processing and other functions that facilitate the conversion of data signals into a format (e.g., in-phase and quadrature) suitable for provision to communication circuitry <NUM> and <NUM>, which can then transmit the signals wirelessly. Processor <NUM> can also interface with communication circuitry <NUM> and <NUM> to perform the reverse functions necessary to receive a wireless transmission and convert it into digital data or information.

Processor <NUM> can execute software instructions stored in memory <NUM>. These instructions can cause processor <NUM> to cause communication circuitry <NUM> and <NUM> to transmit a communication generated by processor <NUM>, can cause processor <NUM> to read and act on received transmissions, to adjust the timing of timing circuitry <NUM>, to collect temperature information from a temperature sensor, to record and/or process a measurement from analyte sensor <NUM>, to monitor collected analyte data for actual or potential alarm conditions, to generate and cause the transmission of an alarm indication using communication circuitry <NUM>, to process data or information received from other devices (e.g., reader <NUM>), to perform tasks to maintain synchronization with reader <NUM>, and others.

Memory <NUM> can be shared by the various components present within OBD <NUM>, or can be distributed amongst two or more of them. Memory <NUM> can also be a separate chip. Memory <NUM> is non-transitory and can be volatile and/or non-volatile memory. OBD <NUM> can include an optional temperature (or other environmental factor) sensor (not shown) and power source <NUM>, which can be a coin cell battery, or the like. AFE <NUM> interfaces with in vivo analyte sensor <NUM> and receives measurement data therefrom, converts to digital form and outputs to processor <NUM> which in turn can, in some embodiments, process in any of the manners described elsewhere herein. This data can then be provided to communication circuitry <NUM> and <NUM> for sending, by way of antennas <NUM> and <NUM>, to reader device <NUM> (not shown), for example, where minimal further processing is needed by the resident software application to display the data. Antennas <NUM> and <NUM> can be configured according to the needs of the application and communication protocol. Antennas <NUM> and <NUM> can have the same or different configuration and can be, for example, a printed circuit board (PCB) trace antenna, a ceramic antenna, or a discrete metallic antenna. Antennas <NUM> and <NUM> can be configured as a monopole antenna, a dipole antenna, an F-type antenna, a loop antenna, and others.

<FIG> is a block diagram depicting another example embodiment of OBD <NUM>. Here, OBD <NUM> includes two semiconductor chips <NUM> and <NUM>. Chip <NUM> is an ASIC including AFE <NUM> and communication circuitry <NUM> for NFC link <NUM>. Chip <NUM> is a chip including processor <NUM>, memory <NUM>, communication circuitry <NUM> for BT link <NUM>, and power management circuitry <NUM>. Communication interface <NUM> can be configured in any manner desired. In one embodiment chip <NUM> is a Bluetooth or BLE radio chip and communication interface <NUM> is a serial interface, such as a serial peripheral interface (SPI). In other embodiments interface <NUM> is a parallel interface.

While <FIG> depict embodiments of OBD <NUM> capable of forming multiple communication links <NUM> and <NUM>, all the embodiments described herein can be practiced with implementations of OBD <NUM> capable of forming only one communication link.

Communications received by OBD <NUM> can include one or more commands for OBD <NUM> to take an action, such as to connect a power source to the internal circuitry or otherwise transition from a zero power or low-power state to a relatively higher power state, to activate sensor <NUM> (e.g., such as by applying a bias voltage to one or more electrodes), to perform an analyte data measurement, to read out data stored in memory <NUM> (e.g., measured analyte data, data identifying OBD <NUM> (e.g., software version, serial number, etc.)), to perform a diagnostic, to set up a Bluetooth pairing, or others. These commands can be initiated by the user or can be automatically transmitted by the sending device as part of a software routine. The command can be specified in the applicable standard, or can be a custom command that requires a custom response.

The received communication often requires transmission of a response back to reader <NUM>. If the commands are sent over NFC link <NUM> than the sending device will be in close proximity to OBD <NUM>. Otherwise the sending device will be in range of OBD <NUM>. For ease of discussion, the sending device will be described herein as reader <NUM>.

After receiving the one or more commands, OBD <NUM> will utilize its internal hardware, software, or a combination thereof to generate a response for transmission back to reader <NUM>. In some embodiments OBD <NUM> can even communicate with other devices on or near the user's body, or even remote to the user, as part of the process to collect the information requisite to generate the response. The amount of time necessary for OBD <NUM> to generate the response is dependent on a number of factors such as the amount of processing required to generate the response, the speed of the hardware and/or software responsible for generating the response, the amount of data required for the response, and others.

Certain communication protocols have a timing constraint or requirement that allocates a finite amount of time for the receiving device to respond. These protocols can be industry-standard protocols or custom protocols. For example, in embodiments where communications transmitted over NFC link <NUM> is compliant with the ISO15693 standard, then those communications must be sent within the maximum amount of time allotted by the standard for the receiving device to respond. For example, a majority of the NFC commands, including the Read Multiple Block command, Reade Single Block command, custom commands and proprietary commands, must be responded to within a set time limit. In one example ISO15693 specifies the command be responded to within <NUM> microseconds (µs) from the time that the receiving device received the command. Other standards may set other time limits, or this ISO <NUM> standard may be revised to allocate a different time limit.

In certain scenarios OBD <NUM> may require more time than the set time limit to generate and send a response. This processing delay can result in violation of the set time limit, and noncompliance with the standard. This may present particular problems when reader <NUM> is a commercial smart phone, as the smart phone may treat this violation as an error or failure preventing communication from being completed.

Example embodiments disclosed here can compensate for this processing delay and maintain compliance by transmitting one or more responses including dummy data, which is data that is sent for the purpose of maintaining compliance but does not constitute data that is wholly or partly responsive to the command. This data can be a predetermined sequence of bits that is programmed into or otherwise recognizable by the reader as representing dummy data. This data can alternatively be pseudorandom data that is generated according to an algorithm or code that signifies dummy data, such that when the pseudorandom data is decoded by the reader it is recognized as such. In another embodiment, the data can be predetermined or random and its status as dummy data can be indicated by a flag located in, for example, a payload header, whereupon the reader <NUM> can discard the data after recognizing the presence of the flag.

<FIG> is a flow diagram depicting an example embodiment of a method <NUM> of communication by a receiving device, which will be described here as OBD <NUM>. At <NUM>, OBD <NUM> receives a transmission including a command from a sending device, such as reader <NUM>. At <NUM>, OBD <NUM> processes the received command. This can include any steps necessary to decrypt, decode, and/or validate the received command, as well as any steps necessary to generate the information or data responsive to the command (the responsive data) for transmission back to reader <NUM>. In this embodiment, it is assumed that step <NUM> requires more time than is allocated by the communication protocol to transmit the response back to reader <NUM>. As such, at <NUM> OBD <NUM> transmits dummy data in a response to reader <NUM>. This occurs prior to expiration of the set time limit for response so as to maintain compliance. The set time limit then resets and begins a new (second) time period for response. Prior to expiration of the second time period, OBD <NUM> transmits another response, which can include the responsive data if ready. If not ready, then OBD <NUM> can again transmit dummy data to reader <NUM>, which again resets the set time limit in the process can repeat iteratively until the responsive data is ready for transmission. At <NUM>, responsive data is transmitted back to reader <NUM> in one or more transmissions depending upon the size of the payload and constraints of the protocol etc. the completion of the response can be indicated by transmission of such an indication to reader <NUM>, such as an end of frame (EOF) sequence.

<FIG> is a flow diagram depicting an example embodiment of a method <NUM> of communication by the sending device, which will be described here as reader <NUM>. At <NUM>, reader <NUM> sends a command to OBD <NUM>. At <NUM>, reader <NUM> receives a response from OBD <NUM> within the time allocated by the protocol. At <NUM>, reader <NUM> reads the received response and determines if it is dummy data or responsive data. In embodiments where the dummy data is a predetermined sequence or code (e.g., AAAA, FFFF, or others), then this determination can be made by comparing the received response to the known predetermined sequence or code to identify whether it matches and thus constitutes dummy data. If the received response does not match, and satisfies the other criteria for being valid data (such as satisfaction of a cyclic redundancy check, presence in the proper format, etc.), then the received response can be determined to be responsive data. In embodiments where the dummy data is indicated according to other techniques, such as generation according to a dummy data algorithm or indication as dummy data by a flag in the header, then reader <NUM> can apply that appropriate technique to verify whether or not the received response is dummy data or responsive data.

If the received response is responsive data then reader <NUM> acts upon it accordingly at <NUM>. This can include storing the responsive data, displaying the responsive data to a user, communicating the responsive data to another device or any number of other actions apparent to those of ordinary skill in the art. If the received response is dummy data, then method <NUM> can return and wait for another response at step <NUM>. The dummy data can be discarded or ignored by reader <NUM>. The process of receiving a response at step <NUM> and determining whether the received response is dummy data or responsive data at <NUM> can repeat indefinitely until responsive data is received, and overall time period for completion of the sequential exchange of communications is reached, system <NUM> times out, or another event that terminates method <NUM> occurs.

<FIG> is a flow diagram depicting another example embodiment of a method <NUM> of communication by the sending device, which will be described here as reader <NUM>. At <NUM>, reader <NUM> sends a command to OBD <NUM>. At <NUM>, reader <NUM> receives N sequential responses from OBD <NUM>, each sequential response being within the time allocated by the protocol. For example, if the protocol sets the time limit as being one millisecond, then each sequential response is received within a millisecond of the prior response. In this embodiment, reader <NUM> does not independently determine whether every received response is dummy data or responsive data, but rather is programmed to recognize the proper number of responses that should be received in order to constitute a holy responsive set of communications from OBD <NUM>. For example, reader <NUM> can be programmed to recognize or expect that a certain command XYZ sent by reader <NUM> to OBD <NUM> should result in E individual responses received back from OBD <NUM>, where E is greater than or equal to one. At <NUM>, reader <NUM> determines if the number of received responses N is equal to the number of expected responses E. If so, then reader <NUM> can treat the E responses as being responsive data (assuming the responses satisfy all other validation criteria) and act accordingly at <NUM> (e.g., store the data, display the data, etc.).

If the number of received responses N is greater than the number of expected responses E, then reader <NUM> can treat the first N minus E (N-E) responses as being dummy data at <NUM>. This can include ignoring or discarding the first N-E responses. This can also optionally include reading the first N-E responses and verifying that each is dummy data according to the dummy data criterion for the individual implementation, e.g., comparison to the known dummy data code, reference to a dummy data flag, etc. With E responses remaining, reader <NUM> can proceed to step <NUM> and treat the remaining E responses as responsive data, again assuming other validation criteria are satisfied, and act accordingly.

<FIG> is a flow diagram of another example embodiment of a method <NUM> of communication between a sending device and a receiving device, which will be described here as reader <NUM> and OBD <NUM>, respectively. At <NUM>, reader <NUM> sends a command to OBD <NUM>, which receives it and begins processing it at <NUM>. In this embodiment, OBD <NUM> is programmed to transmit a predetermined number (P) of dummy data responses back to reader <NUM> prior to transmitting the responsive data in the P+1th (and any subsequent) responses. The predetermined number of dummy data responses is determined based on the expected amount of time necessary for OBD to generate responsive data. This predetermined number can be determined and verified through testing during the system's development process. For example, if the set time period for responses one millisecond (ms), and it is determined that the maximum time necessary for OBD <NUM> to generate responsive data is <NUM>, then P can be preset to four and OBD <NUM> can be programmed to transmit four responses containing dummy data and began transmission of responsive data in the fifth response. Likewise, reader <NUM> can be programmed to expect four responses containing dummy data prior to receiving responsive data in the fifth response.

Referring to <FIG>, at <NUM> OBD <NUM> sends N responses to reader <NUM>, which receives them at <NUM>. At <NUM>, reader <NUM> can treat the first P responses as dummy data and the remaining N minus P (N-P) responses as responsive data. This can include ignoring or discarding the first P responses. It can also optionally include reading the first P responses to verify they are dummy data. Reader <NUM> can read the P+1th response as being the first response containing responsive data, and continue through any remaining N-P responses. Assuming the responsive data meets the other validation criteria, then reader <NUM> can act upon it accordingly as described herein.

In some embodiments, system <NUM> can be configured such that different commands have different numbers of predetermined responses that are utilized, for example, based on different processing times for different commands. For example, a first command may correspond to three predetermined dummy data responses whereas a second command may correspond to four predetermined dummy data responses, and so forth. In these embodiments, both of the reader device and on body devices are preferably preprogrammed to know the proper number of predetermined responses to use for each command and the on body device can be programmed to read the received command and determine the appropriate number of predetermined responses to send for that command. Such configurations allow for more efficient use of communication bandwidth.

The embodiments described with respect to <FIG> are performed in systems where the time for processing the received command can exceed the time allocated for response by the protocol or standard. These embodiments can be utilized with any system that may encounter these extensive processing delays, regardless of the reason for the processing delay. The following embodiments are intended to serve as non-exhaustive examples of topologies or situations where the processing delay can exceed the allocated time, and many other examples are possible and within the scope of the subject matter described herein.

Referring back to the embodiment of <FIG> where link <NUM> is an NFC link, in certain examples some NFC communications received by communication circuitry <NUM> can be processed and responded to directly by ASIC <NUM>, without interaction of chip <NUM>. Some commands, however, may require a response generated by a more robust entity such as processor <NUM>. In those instances, ASIC <NUM> can transfer the relevant portion of the received communication to chip <NUM> for generation of a response. Chip <NUM> can then generate the responsive data and, once available, output the responsive data back to ASIC <NUM> for transmission as one or more responses from OBD <NUM> over NFC link <NUM>.

Reader <NUM> can be programmed or configured to recognize responses where the payload contains byte values (e.g., ABCD, FFFF) matching this predetermined payload as dummy data, and subsequently ignore those responses (e.g., not store in memory) and continue monitoring NFC link <NUM> for a response transmission including payload data other than the dummy data.

<FIG> is an information flow diagram depicting an example embodiment <NUM> for handling wireless communications to avoid violation of the set time limit for response. This embodiment <NUM> will be described in the context of an OBD <NUM> configured similar to <FIG>, although this embodiment <NUM> is not limited to such. The arrows in <FIG> depict wireless transmissions from reader <NUM> to chip <NUM> of OBD <NUM> and back to reader <NUM>, as well as internal wired communication within OBD <NUM> from chip <NUM> to chip <NUM> and back that may, e.g., be communicated over interface <NUM> configured as an SPI.

At <NUM> a custom command is transmitted from reader device <NUM> and received at chip <NUM> of OBD <NUM>. At <NUM>, the received custom command (e.g., relevant portion thereof or information representative of the received command) is then transferred from chip <NUM> to chip <NUM> over interface <NUM>. Chip <NUM> then reads the command and begins the process of generating and outputting the appropriate responsive data at <NUM>. This may include the execution of algorithms, retrieval of data from memory, and/or other functions.

Concurrently, chip <NUM> prepares a response transmission, such as by using circuitry on chip <NUM> (e.g., ASIC circuitry). At <NUM> chip <NUM> causes transmission of a response including a start of frame (SOF) indication back to reader <NUM> over link <NUM>. Also transmitted back to reader <NUM> are any flags (at <NUM>) and/or other parameters (at <NUM>) for the response packet header that can be readily determined with the set time limit for response transmission.

Assuming that chip <NUM> has not yet generated a response to the custom command with the expiration of the set time limit approaching, then at <NUM> chip <NUM> sends dummy data to reader <NUM>. This process continues, where prior to the expiration of each subsequent set time limit a payload including dummy data is transmitted to reader <NUM>. This loop can continue repeatedly until <NUM>, when chip <NUM> outputs the response data payload to chip <NUM>. Receipt of the response data payload is recognized by chip <NUM>, which then causes this response data payload to be transmitted to reader <NUM> at <NUM> (utilizing as many sequential response packets as necessary and permitted to complete transmission). At <NUM> chip <NUM> transmits error detection bits (e.g., a cyclic redundancy check (CRC)) followed by an end of frame (EOF) indication at <NUM>.

<FIG> is an information flow diagram depicting an example embodiment <NUM> for handling wireless communications to avoid violation of the set time limit for response. This embodiment <NUM> will be described in the context of an OBD <NUM> configured similar to <FIG>, although this embodiment <NUM> is not limited to such.

At <NUM> a custom command is transmitted from reader device <NUM> and received at chip <NUM> of OBD <NUM>. At <NUM>, chip <NUM> requests information necessary to formulate responsive data from chip <NUM>. For example, the requested information may be a random number created by a random number generator in chip <NUM> for the purpose of encrypting the responsive data prior to transmission back to reader <NUM>. At <NUM> chip <NUM> processes the requested information and at <NUM> chip <NUM> provides the requested information to chip <NUM>. At <NUM> chip <NUM> receives the requested information from chip <NUM> and <NUM> chip <NUM> begins processing the responsive data. In other embodiments, the dummy data can be encrypted prior to transmission as well.

Assuming that chip <NUM> has not yet generated a response to the custom command with the expiration of the set time limit approaching, then at <NUM> chip <NUM> sends dummy data to reader <NUM>. This process continues, where prior to the expiration of each subsequent set time limit a payload including dummy data is transmitted to reader <NUM>. This loop can continue repeatedly until <NUM>, when chip <NUM> completes processing (e.g., generation of responsive data and encryption of the same) and the responsive data is ready for transmission. Chip <NUM> then causes this responsive data payload to be transmitted to reader <NUM> at <NUM> (utilizing as many sequential responsive packet transmissions as necessary and permitted to complete transmission). At <NUM> chip <NUM> transmits error detection bits (e.g., a cyclic redundancy check (CRC)) followed by an end of frame (EOF) indication at <NUM>.

In addition to the variance described above, in any and all embodiments described herein, responses containing dummy data can be responses that contain only dummy data within the payload portion of the response. This can be indicated by the sequence of bits contained within the payload corresponding to a predetermined code (e.g., AAAA, FFFF, ABCD, and others), or by a flag in the header section of the data frame that indicates that the data within the payload is dummy data or only dummy data.

Various aspects of the present subject matter are set forth below, in review of, and/or in supplementation to, the embodiments described thus far, with the emphasis here being on the interrelation and interchangeability of the following embodiments. In other words, an emphasis is on the fact that each feature of the embodiments can be combined with each and every other feature unless explicitly stated otherwise or logically implausible.

In many embodiments, a method of communication in an analyte monitoring system including an on body device and a reader device is provided, the method including: wirelessly receiving, by the on body device, a command from the reader device; wirelessly transmitting at least one first response to the reader device, where the at least one first response includes dummy data; and wirelessly transmitting at least one second response to the reader device, where the at least one second response includes data responsive to the command.

In some embodiments, the method further includes processing the received command while transmitting the at least one first response to the reader device. Processing the received command can include: generating the data responsive to the command; and encrypting the data responsive to the command. The at least one second response transmitted to the reader device can include data responsive to the command in an encrypted form. The at least one first response transmitted to the reader device can include dummy data in an encrypted form.

In some embodiments, the method further includes determining whether data responsive to the command is ready for transmission prior to expiration of a set time limit for response. The method can further include transmitting a first response to the reader device if it is determined that data responsive to the command is not ready for transmission prior to expiration of the set time limit for response. The method can further include transmitting a second response to the reader device if it is determined that data responsive to the command is ready for transmission prior to expiration of the set time limit for response.

In some embodiments, the method can further include transmitting a plurality of first responses to the reader device, where each first response includes dummy data, and where each first response is transmitted prior to expiration of a set time limit for response.

In some embodiments, the dummy data can be a predetermined code, can be indicated by a flag in a header of the at least one first response, or can be pseudorandom data.

In some embodiments, the method can further include generating the dummy data according to a dummy data algorithm.

In some embodiments, the on body device can include a first semiconductor device and a second semiconductor device communicatively coupled to the first semiconductor device with a communication interface. The communication interface can be a serial peripheral interface. The method can further include: outputting a request for responsive data from the first semiconductor device to the second semiconductor device over the communication interface; generating the responsive data by the second semiconductor device; and outputting the responsive data from the second semiconductor device to the first semiconductor device over the communication interface, prior to transmitting the at least one second response to the reader device. The first semiconductor device can be configured to format data according to a near field communication (NFC) protocol. The second semiconductor device can be configured to format data according to a Bluetooth communication protocol.

In some embodiments, the method can further include: processing the received command; and wirelessly transmitting at least one third response to the reader device prior to wirelessly transmitting the at least one first response to the reader device. The at least one third response can include at least one of a start of frame indication, a flag, or a communication parameter. The method can further include wirelessly transmitting at least one fourth response after wirelessly transmitting the at least one second response. The at least one fourth response can include error detection information or an end of frame indication.

In some embodiments, wireless communication between the on body device and the reader device is in accordance with a near field communication (NFC) protocol.

In many embodiments, an on body device of an analyte monitoring system is provided, the on body device including: communication circuitry configured to wirelessly receive a command and wirelessly transmit one or more responses; and processing circuitry configured to generate dummy data and data responsive to the command, where the on body device is configured to wirelessly transmit at least one first response including the dummy data and at least one second response including the data responsive to the command.

In some embodiments, the on body device can be configured such that the processing circuitry processes the received command while the communication circuitry transmits the at least one first response. The processing circuitry can be configured to encrypt the data responsive to the command and output the encrypted responsive data to the communication circuitry. The processing circuitry can be configured to encrypt the dummy data and output the encrypted dummy data to the communication circuitry.

In some embodiments, the on body device can be configured to determine whether data responsive to the command is ready for transmission prior to expiration of a set time limit for response.

In some embodiments, the processing circuitry can be configured to cause transmission of the first response prior to expiration of a set time limit for response, after determination that data responsive to the command is not ready for transmission.

In some embodiments, the processing circuitry can be configured to cause transmission of the second response prior to expiration of the set time limit for response, after determination that data responsive to the command is ready for transmission.

In some embodiments, the on body device can be configured to transmit a plurality of first responses, where each first response includes dummy data, and where each first response is transmitted prior to expiration of a set time limit for response.

In some embodiments, the dummy data can be: a predetermined code, indicated by a flag in a header of the at least one first response, pseudorandom data, or generated according to a dummy data algorithm.

In some embodiments, the on body device can include a first semiconductor device and a second semiconductor device communicatively coupled to the first semiconductor device with a communication interface. The communication interface can be a serial peripheral interface. A first portion of the processing circuitry can be located on the first semiconductor device and a second portion of the processing circuitry is located on the second semiconductor device. The first semiconductor device can be configured to output a request for responsive data over the communication interface to the second semiconductor device. The second semiconductor device can be configured to generate the responsive data and output the responsive data to the first semiconductor device over the communication interface. The first semiconductor device can be configured to format data according to a near field communication (NFC) protocol. The second semiconductor device can be configured to format data according to a Bluetooth communication protocol.

In some embodiments, the communication circuitry is configured to wirelessly receive and transmit in accordance with a near field communication (NFC) protocol.

In some embodiments, the processing circuitry is communicatively coupled with memory, and where the memory stores a plurality of instructions executable by the processing circuitry.

In many embodiments, a method of communication in an analyte monitoring system including an on body device and a reader device is provided, the method including: wirelessly transmitting, by the reader device, a command to the on body device; wirelessly receiving at least one first response from the on body device, where the at least one first response includes dummy data; and wirelessly receiving at least one second response from the on body device, where the at least one second response includes data responsive to the command.

In some embodiments, the method can further include determining, by the reader device, whether each of the at least one first responses includes dummy data.

In some embodiments, the method can further include determining, by the reader device, whether each of the at least one second responses includes data responsive to the command.

In some embodiments, the method can further include acting upon the data responsive to the command by the reader device. Acting upon the data responsive to the command can include storing the data responsive to the command or displaying the data responsive to the command.

In some embodiments, the method can further include determining, by the reader device, whether a total number (N) of received at least one first responses and at least one second responses is greater than an expected number (E) of responses. The method can further include: treating, by the reader device, the first N-E responses as dummy data; and treating, by the reader device, the remaining E responses as including data responsive to the command. The method can further include reading, by the reader device, the first N-E responses to confirm they comprise dummy data. The method can include decrypting, by the reader device, the received at least one second response. The method can further include decrypting, by the reader device, the received at least one first response. The dummy data can be: a predetermined code, indicated by a flag in a header of the at least one first response, pseudorandom data, or generated according to a dummy data algorithm.

In some embodiments, the reader device is communicating with an on body device.

In some embodiments, the reader device wirelessly receives and transmits in accordance with a near field communication (NFC) protocol. The method can further include wirelessly receiving data from an on body device according to a Bluetooth protocol.

In many embodiments, a reader device of an analyte monitoring system is provided, the reader device including: communication circuitry configured to wirelessly transmit a command and wirelessly receive one or more responses; and processing circuitry configured to determine whether each received response includes dummy data or data responsive to the command.

In some embodiments, the processing circuitry is configured to act upon the data responsive to the command.

In some embodiments, the processing circuitry is configured to store or display the data responsive to the command.

In some embodiments, the processing circuitry is configured to ignore or discard the dummy data.

In some embodiments, the processing circuitry is configured to decrypt each received response.

In some embodiments, the reader device is configured to communicate with an on body device.

In some embodiments, the communication circuitry is configured to wirelessly transmit and receive in accordance with a near field communication (NFC) protocol. The communication circuitry is first communication circuitry and the reader device includes second communication circuitry configured to wirelessly transmit and receive according to a Bluetooth protocol.

In many embodiments, a reader device of an analyte monitoring system, the reader device including: communication circuitry configured to wirelessly transmit a command and wirelessly receive one or more responses; and processing circuitry configured to determine whether a total number (N) of received responses is greater than an expected number (E) of responses.

In some embodiments, the processing circuitry can be configured to treat the first N-E responses as dummy data and treat the remaining E responses as including data responsive to the command. The processing circuitry can be configured to read the first N-E responses to confirm they comprise dummy data. The processing circuitry can be configured to act upon the data responsive to the command. The processing circuitry can be configured to store or display the data responsive to the command. The processing circuitry can be configured to ignore or discard the first N-E responses without confirming the first N-E responses comprise dummy data. The processing circuitry can be configured to decrypt each received response.

In some embodiments, the communication circuitry is configured to wirelessly transmit and receive in accordance with a near field communication (NFC) protocol. The communication circuitry can be first communication circuitry and the reader device can include second communication circuitry configured to wirelessly transmit and receive according to a Bluetooth protocol.

In many embodiments, a method of communication in an analyte monitoring system including an on body device and a reader device is provided, the method including: wirelessly receiving, by the on body device, a command from the reader device; wirelessly transmitting a predetermined number (P) of first responses from the on body device to the reader device, where each first response includes dummy data; and wirelessly transmitting at least one second response from the on body device to the reader device, where the at least one second response includes data responsive to the command.

In some embodiments, the method can further include processing the received command while transmitting the predetermined number of first responses to the reader device.

In some embodiments, processing the received command can include: generating the data responsive to the command; and encrypting the data responsive to the command. The at least one second response transmitted to the reader device can include data responsive to the command in an encrypted form. Each of the predetermined number of first responses transmitted to the reader device can include dummy data in an encrypted form.

In some embodiments, the method further includes counting, by the reader device, the number of responses received from the on body device. The method can further include treating the P+1th response as including data responsive to the command. The method can further include not confirming the first P received responses comprise dummy data.

In some embodiments, the method can further include reading, by the on body device, the received command and wirelessly transmitting a predetermined number (P) of first responses that corresponds to the received command. The received command is one of a plurality of commands, and where the reader device and on body device are programmed to identify the correct number of predetermined responses based on the command.

In some embodiments, the wireless communication between the on body device and the reader device is in accordance with a near field communication (NFC) protocol.

In many embodiments, an analyte monitoring system is provided, including: an on body device including communication circuitry and processing circuitry, and a reader device including communication circuitry and processing circuitry, where the on body device is configured to wirelessly receive a command from the reader device, wirelessly transmit a predetermined number (P) of first responses to the reader device, where each first response includes dummy data, and wirelessly transmit at least one second response to the reader device, where the at least one second response includes data responsive to the command.

In some embodiments, the on body device is configured to process the received command while transmitting the predetermined number of first responses to the reader device. The processing circuitry of the on body device can be configured to generate the data responsive to the command and encrypt the data responsive to the command. The processing circuitry of the on body device can be configured to encrypt the dummy data and transmit the dummy data in encrypted form.

In some embodiments, the processing circuitry of the reader device can be configured to account the number of responses received from the on body device. The processing circuitry of the reader device can be configured to treat the P+1th response as including data responsive to the command. The processing circuitry of the reader device can be configured to ignore or discard the first P received responses without performance of a confirmation that the first P received responses each comprise dummy data.

In some embodiments, the processing circuitry of the on body device is configured to read the received command and wirelessly transmit a predetermined number (P) of first responses that corresponds to the received command.

In some embodiments, the received command is one of a plurality of commands, and where the reader device and on body device are programmed to identify the correct number of predetermined responses based on the command.

In some embodiments, the communication circuitry of the on body device and the communication circuitry of the reader device are each configured to communicate in accordance with a near field communication (NFC) protocol.

In many embodiments, a method of communication in an analyte monitoring system including an on body device and a reader device is provided, the method including: receiving, at the on body device, a transmission including a custom command from the reader device, where the transmission is formatted according to a first communication protocol; communicating the custom command from a first semiconductor chip of the on-body device to a second semiconductor chip of the on-body device, where the first semiconductor chip includes communication circuitry adapted for communication over the first communication protocol and the second semiconductor chip includes a processor; causing transmission of a first data payload including dummy data from the on body device to the reader device within a set time limit for response according to the first communication protocol; communicating a response data payload from the second semiconductor chip to the first semiconductor chip; and causing transmission of the response data payload from the on body device to the reader device.

For each and every embodiment of a method disclosed herein, systems and devices capable of performing each of those embodiments are covered within the scope of the present disclosure. For example, embodiments of OBDs are disclosed and these devices can have one or more sensors, analyte monitoring circuits (e.g., an analog circuit), memories (e.g., for storing instructions), power sources, communication circuits, transmitters, receivers, processors and/or controllers (e.g., for executing instructions) that can perform any and all method steps or facilitate the execution of any and all method steps. These OBD embodiments can be used and can be capable of use to implement those steps performed by a OBD from any and all of the methods described herein.

For all the aforementioned embodiments, the actions carried out by the on body device can be performed, or caused to be performed, by processing circuitry of the on body device executing one or more instructions stored on memory of the on body device. Similarly for all the aforementioned embodiments, the actions carried out by the reader device can be performed, or cause to be performed, by processing circuitry of the reader device executing one or more instructions stored on memory of the reader device.

Computer program instructions for carrying out operations in accordance with the described subject matter can be stored on any non-transitory memory described herein and executed by processing circuitry communicatively coupled thereto. The computer program instructions can be written in any combination of one or more programming languages, including an object oriented programming language such as Java, JavaScript, Smalltalk, C++, C#, Transact-SQL, XML, PHP or the like and conventional procedural programming languages, such as the "C" programming language or similar programming languages. The program instructions may execute entirely on the user's computing device, partly on the user's computing device, as a stand-alone software package, partly on the user's computing device and partly on a remote computing device or entirely on the remote computing device or server. In the latter scenario, the remote computing device may be connected to the user's computing device through any type of network, including a local area network (LAN) or a wide area network (WAN), or the connection may be made to an external computer (for example, through the Internet using an Internet Service Provider).

It should be noted that all features, elements, components, functions, and steps described with respect to any embodiment provided herein are intended to be freely combinable and substitutable with those from any other embodiment. If a certain feature, element, component, function, or step is described with respect to only one embodiment, then it should be understood that that feature, element, component, function, or step can be used with every other embodiment described herein unless explicitly stated otherwise. This paragraph therefore serves as antecedent basis and written support for the introduction of claims, at any time, that combine features, elements, components, functions, and steps from different embodiments, or that substitute features, elements, components, functions, and steps from one embodiment with those of another, even if the following description does not explicitly state, in a particular instance, that such combinations or substitutions are possible. It is explicitly acknowledged that express recitation of every possible combination and substitution is overly burdensome, especially given that the permissibility of each and every such combination and substitution will be readily recognized by those of ordinary skill in the art.

To the extent the embodiments disclosed herein include or operate in association with memory, storage, and/or computer readable media, then that memory, storage, and/or computer readable media are non-transitory. Accordingly, to the extent that memory, storage, and/or computer readable media are covered by one or more claims, then that memory, storage, and/or computer readable media is only non-transitory.

Claim 1:
A method of communication in an analyte monitoring system (<NUM>) comprising an on body device (<NUM>) and a reader device (<NUM>-<NUM>, <NUM>-<NUM>), the method comprising:
wirelessly receiving (<NUM>), by the on body device, a command from the reader device;
the method comprising wirelessly transmitting (<NUM>) at least one first response to the reader device based on determining that data responsive to the command is not ready for transmission prior to expiration of a set time limit for response, wherein the at least one first response comprises dummy data; and
wirelessly transmitting (<NUM>) at least one second response to the reader device, wherein the at least one second response comprises data responsive to the command.