Patent Description:
The present invention relates to calculating and correcting levels in a first medium using measurements from a second medium. More specifically, aspects of the present invention relate to correcting first medium levels when new information becomes available. Even more specifically, aspects of the present invention relate to calculating blood analyte levels using measurements of interstitial fluid analyte levels and correcting the calculated blood analyte levels when one or more new measurements of interstitial fluid analyte levels become available.

Analyte monitoring systems may be used to monitor analyte levels, such as analyte concentrations. One type of analyte monitoring system is a continuous glucose monitoring (CGM) system. A CGM system measures glucose levels throughout the day and can be very useful in the management of diabetes. Some analyte monitoring systems use measurements indicative of analyte levels in interstitial fluid ("ISF") to calculate ISF analyte levels and then convert the ISF analyte levels to blood analyte levels. The analyte monitoring systems may display the blood analyte levels to a user. However, because ISF analyte levels lag behind blood analyte levels, accurate conversion of ISF analyte levels to blood analyte levels is difficult. <CIT> discloses a method and system for the calibration of analyte sensors to reduce errors in the sensor measurements. <CIT> discloses a method and system for dynamically updating calibration parameters for an analyte sensor.

Aspects of the present invention relate to improving the accuracy of levels displayed to a user.

One aspect of the invention may provide an analyte monitoring system including an analyte sensor and a transceiver. The analyte sensor may include an indicator element that exhibits one or more detectable properties based on an amount or concentration of an analyte in proximity to the indicator element. The transceiver is configured to receive first sensor data from the analyte sensor. The transceiver may be configured to calculate a first interstitial fluid analyte level using at least the first sensor data; calculate a first interstitial fluid analyte level rate of change using at least the first interstitial fluid analyte level and one or more past interstitial fluid analyte levels. The transceiver may be configured to calculate a first blood analyte level using at least the first interstitial fluid analyte level and the first interstitial fluid analyte level rate of change. The transceiver is configured to, after receiving the first sensor data, receive second sensor data from the analyte sensor. The transceiver may be configured to calculate a second interstitial fluid analyte level using at least the second sensor data. The transceiver may be configured to calculate an updated first interstitial fluid analyte level rate of change using at least the first interstitial fluid analyte level, the second interstitial fluid analyte level, and the one or more past interstitial fluid analyte levels. The transceiver may be configured to calculate a corrected first blood analyte level using at least the first interstitial fluid analyte level and the first interstitial fluid analyte level rate of change.

In some embodiments, the transceiver may be further configured to: calculate a second interstitial fluid analyte level rate of change using at least the first and second interstitial fluid analyte levels; and calculate a second blood analyte level using at least the second interstitial fluid analyte level and the second interstitial fluid analyte level rate of change. The system includes a display device which may be configured to: receive and display the first blood analyte level; receive and display the second blood analyte level; and receive and display the corrected first blood analyte level.

The system includes a display device which may be configured to: receive and display the first blood analyte level; and receive and display the corrected first blood analyte level. In some embodiments, the display device may be configured to: display the first blood analyte level until the corrected first blood analyte level is received; and, after receiving the corrected first blood analyte level, display the corrected first blood analyte level instead of the first blood analyte level.

One aspect of the invention may provide a method of calculating and correcting blood analyte levels. The method includes using a transceiver to receive first sensor data from an analyte sensor. The method may include using the transceiver to calculate a first interstitial fluid analyte level based on at least the first sensor data. The method may include using the transceiver to calculate a first interstitial fluid analyte level rate of change based on at least the first interstitial fluid analyte level and one or more past interstitial fluid analyte levels. The method may include using the transceiver to calculate a first blood analyte level based on at least the first interstitial fluid analyte level and the first interstitial fluid analyte level rate of change. The method includes, after receiving the first sensor data, using the transceiver to receive second sensor data from the analyte sensor. The method may include using the transceiver to calculate a second interstitial fluid analyte level based on at least the second sensor data. The method may include using the transceiver to calculate an updated first interstitial fluid analyte level rate of change based on at least the first interstitial fluid analyte level, the second interstitial fluid analyte level, and the one or more past interstitial fluid analyte levels. The method may include using the transceiver to calculate a corrected first blood analyte level based on at least the first interstitial fluid analyte level and the first interstitial fluid analyte level rate of change.

The transceiver may include a sensor interface device and a processor. The sensor interface device may be configured to convey a power signal to an analyte sensor, receive first sensor data from the analyte sensor, and, after receiving the first sensor data, receive second sensor data. The processor may be configured to: calculate a first interstitial fluid analyte level using at least the first sensor data; calculate a first interstitial fluid analyte level rate of change using at least the first interstitial fluid analyte level and one or more past interstitial fluid analyte levels; calculate a first blood analyte level using at least the first interstitial fluid analyte level and the first interstitial fluid analyte level rate of change; calculate a second interstitial fluid analyte level using at least the second sensor data; calculate an updated first interstitial fluid analyte level rate of change using at least the first interstitial fluid analyte level, the second interstitial fluid analyte level, and the one or more past interstitial fluid analyte levels; and calculate a corrected first blood analyte level using at least the first interstitial fluid analyte level and the first interstitial fluid analyte level rate of change.

One aspect of the invention may provide a method according to claim <NUM>.

In some embodiments, the method may include using the transceiver to calculate a subsequent second medium level rate of change based on at least the initial and subsequent second medium levels. In some embodiments, the method may include using the transceiver to calculate a subsequent first medium level based on at least the subsequent second medium level and the subsequent second medium level rate of change. In some embodiments, the method may include using the transceiver to convey the subsequent second medium level to the display device.

The method includes using the transceiver to convey the first medium level to a display device; and using the transceiver to convey the corrected first medium level to the display device. The method includes using the display device to receive and display the first medium level; and using the display device to receive and display the corrected first medium level. The method includes using the display device to display the first medium level until display device receives the corrected first medium level; and using the display device to, after receiving the corrected first medium level, display the corrected first medium level instead of the first medium level.

In some embodiments, the first medium may be blood. In some embodiments, the second medium may be interstitial fluid. In some embodiments, the initial second medium level may be an initial interstitial fluid analyte level.

One aspect of the invention may provide a monitoring system according to claim <NUM>.

In some embodiments, the transceiver may be further configured to calculate a subsequent second medium level rate of change based on at least the initial and subsequent second medium levels and may be further configured calculate a subsequent first medium level based on at least the subsequent second medium level and the subsequent second medium level rate of change. In some embodiments, the transceiver may be further configured to convey the subsequent second medium level to the display device.

The transceiver is further configured to convey the first medium level to a display device and further configured to convey the corrected first medium level to the display device. The system further comprises the display device, and the display device is configured to: receive and display the first medium level; and receive and display the corrected first medium level. The display device is further configured to: display the first medium level until display device receives the corrected first medium level; and after receiving the corrected first medium level, display the corrected first medium level instead of the first medium level.

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

The accompanying drawings, which are incorporated herein and form part of the specification, illustrate various, non-limiting embodiments of the present invention. In the drawings, like reference numbers indicate identical or functionally similar elements.

<FIG> is a schematic view of an exemplary analyte monitoring system <NUM> embodying aspects of the present invention. The analyte monitoring system <NUM> may be a continuous analyte monitoring system (e.g., a continuous glucose monitoring system). The analyte monitoring system <NUM> includes an analyte sensor <NUM>, a transceiver <NUM>, and a display device <NUM>. In some embodiments, the sensor <NUM> may be small, fully subcutaneously implantable sensor measures analyte (e.g., glucose) concentrations in a medium (e.g., interstitial fluid) of a living animal (e.g., a living human). However, this is not required, and, in some alternative embodiments, the sensor <NUM> may be a partially implantable (e.g., transcutaneous) sensor or a fully external sensor. In some embodiments, the transceiver <NUM> may be an externally worn transceiver (e.g., attached via an armband, wristband, waistband, or adhesive patch). In some embodiments, the transceiver <NUM> may remotely power and/or communicate with the sensor to initiate and receive the measurements (e.g., via near field communication (NFC)). However, this is not required, and, in some alternative embodiments, the transceiver <NUM> may power and/or communicate with the sensor <NUM> via one or more wired connections. In some non-limiting embodiments, the transceiver <NUM> may be a smartphone (e.g., an NFC-enabled smartphone). In some embodiments, the transceiver <NUM> may communicate information (e.g., one or more analyte concentrations) wirelessly (e.g., via a Bluetooth™ communication standard such as, for example and without limitation Bluetooth Low Energy) to a hand held application running on a display device <NUM> (e.g., smartphone). In some embodiments, the analyte monitoring system <NUM> may include a web interface for plotting and sharing of uploaded data.

In some embodiments, as illustrated in <FIG>, the transceiver <NUM> may include an inductive element <NUM>, such as, for example, a coil. The transceiver <NUM> may generate an electromagnetic wave or electrodynamic field (e.g., by using a coil) to induce a current in an inductive element <NUM> of the sensor <NUM>, which powers the sensor <NUM>. The transceiver <NUM> may also convey data (e.g., commands) to the sensor <NUM>. For example, in a non-limiting embodiment, the transceiver <NUM> may convey data by modulating the electromagnetic wave used to power the sensor <NUM> (e.g., by modulating the current flowing through a coil <NUM> of the transceiver <NUM>). The modulation in the electromagnetic wave generated by the transceiver <NUM> may be detected/extracted by the sensor <NUM>. The transceiver <NUM> receives sensor data (e.g., measurement information) from the sensor <NUM>. For example, in a non-limiting embodiment, the transceiver <NUM> may receive sensor data by detecting modulations in the electromagnetic wave generated by the sensor <NUM>, e.g., by detecting modulations in the current flowing through the coil <NUM> of the transceiver <NUM>.

The inductive element <NUM> of the transceiver <NUM> and the inductive element <NUM> of the sensor <NUM> may be in any configuration that permits adequate field strength to be achieved when the two inductive elements are brought within adequate physical proximity.

In some non-limiting embodiments, as illustrated in <FIG>, the sensor <NUM> may be encased in a sensor housing <NUM> (i.e., body, shell, capsule, or encasement), which may be rigid and biocompatible. The sensor <NUM> may include an analyte indicator element <NUM>, such as, for example, a polymer graft coated, diffused, adhered, or embedded on or in at least a portion of the exterior surface of the sensor housing <NUM>. The analyte indicator element <NUM> (e.g., polymer graft) of the sensor <NUM> may include indicator molecules <NUM> (e.g., fluorescent indicator molecules) exhibiting one or more detectable properties (e.g., optical properties) based on the amount or concentration of the analyte in proximity to the analyte indicator element <NUM>. In some embodiments, the sensor <NUM> may include a light source <NUM> that emits excitation light <NUM> over a range of wavelengths that interact with the indicator molecules <NUM>. The sensor <NUM> may also include one or more photodetectors <NUM>, <NUM> (e.g., photodiodes, phototransistors, photoresistors, or other photosensitive elements). The one or more photodetectors (e.g., photodetector <NUM>) may be sensitive to emission light <NUM> (e.g., fluorescent light) emitted by the indicator molecules <NUM> such that a signal generated by a photodetector (e.g., photodetector <NUM>) in response thereto that is indicative of the level of emission light <NUM> of the indicator molecules and, thus, the amount of analyte of interest (e.g., glucose). In some non-limiting embodiments, one or more of the photodetectors (e.g., photodetector <NUM>) may be sensitive to excitation light <NUM> that is reflected from the analyte indicator element <NUM> as reflection light <NUM>. In some non-limiting embodiments, one or more of the photodetectors may be covered by one or more filters that allow only a certain subset of wavelengths of light to pass through (e.g., a subset of wavelengths corresponding to emission light <NUM> or a subset of wavelengths corresponding to reflection light <NUM>) and reflect the remaining wavelengths. In some non-limiting embodiments, the sensor <NUM> may include a temperature transducer <NUM>. In some non-limiting embodiments, the sensor <NUM> may include a drug-eluting polymer matrix that disperses one or more therapeutic agents (e.g., an anti-inflammatory drug).

In some embodiments, as illustrated in <FIG>, the sensor <NUM> may include a substrate <NUM>. In some embodiments, the substrate <NUM> may be a circuit board (e.g., a printed circuit board (PCB) or flexible PCB) on which circuit components (e.g., analog and/or digital circuit components) may be mounted or otherwise attached. However, in some alternative embodiments, the substrate <NUM> may be a semiconductor substrate having circuitry fabricated therein. The circuitry may include analog and/or digital circuitry. Also, in some semiconductor substrate embodiments, in addition to the circuitry fabricated in the semiconductor substrate, circuitry may be mounted or otherwise attached to the semiconductor substrate <NUM>. In other words, in some semiconductor substrate embodiments, a portion or all of the circuitry, which may include discrete circuit elements, an integrated circuit (e.g., an application specific integrated circuit (ASIC)) and/or other electronic components (e.g., a non-volatile memory), may be fabricated in the semiconductor substrate <NUM> with the remainder of the circuitry is secured to the semiconductor substrate <NUM> and/or a core (e.g., ferrite core) for the inductive element <NUM>. In some embodiments, the semiconductor substrate <NUM> and/or a core may provide communication paths between the various secured components.

In some embodiments, the one or more of the sensor housing <NUM>, analyte indicator element <NUM>, indicator molecules <NUM>, light source <NUM>, photodetectors <NUM>, <NUM>, temperature transducer <NUM>, substrate <NUM>, and inductive element <NUM> of sensor <NUM> may include some or all of the features described in one or more of <CIT>, <CIT>, and <CIT>. Similarly, the structure and/or function of the sensor <NUM> and/or transceiver <NUM> may be as described in one or more of<CIT>, <CIT>, and <CIT>.

Although in some embodiments, as illustrated in <FIG>, the sensor <NUM> may be an optical sensor, this is not required, and, in one or more alternative embodiments, sensor <NUM> may be a different type of analyte sensor, such as, for example, an electrochemical sensor, a diffusion sensor, or a pressure sensor. Also, although in some embodiments, as illustrated in <FIG> and <FIG>, the analyte sensor <NUM> may be a fully implantable sensor, this is not required, and, in some alternative embodiments, the sensor <NUM> may be a transcutaneous sensor having a wired connection to the transceiver <NUM>. For example, in some alternative embodiments, the sensor <NUM> may be located in or on a transcutaneous needle (e.g., at the tip thereof). In these embodiments, instead of wirelessly communicating using inductive elements <NUM> and <NUM>, the sensor <NUM> and transceiver <NUM> may communicate using one or more wires connected between the transceiver <NUM> and the transceiver transcutaneous needle that includes the sensor <NUM>. For another example, in some alternative embodiments, the sensor <NUM> may be located in a catheter (e.g., for intravenous blood glucose monitoring) and may communicate (wirelessly or using wires) with the transceiver <NUM>.

In some embodiments, the sensor <NUM> may include a transceiver interface device. In some embodiments where the sensor <NUM> includes an antenna (e.g., inductive element <NUM>), the transceiver interface device may include the antenna (e.g., inductive element <NUM>) of sensor <NUM>. In some of the transcutaneous embodiments where there exists a wired connection between the sensor <NUM> and the transceiver <NUM>, the transceiver interface device may include the wired connection.

<FIG> and <FIG> are cross-sectional and exploded views, respectively, of a non-limiting embodiment of the transceiver <NUM>, which may be included in the analyte monitoring system illustrated in <FIG>. As illustrated in <FIG>, in some non-limiting embodiments, the transceiver <NUM> may include a graphic overlay <NUM>, front housing <NUM>, button <NUM>, printed circuit board (PCB) assembly <NUM>, battery <NUM>, gaskets <NUM>, antenna <NUM>, frame <NUM>, reflection plate <NUM>, back housing <NUM>, ID label <NUM>, and/or vibration motor <NUM>. In some non-limiting embodiments, the vibration motor <NUM> may be attached to the front housing <NUM> or back housing <NUM> such that the battery <NUM> does not dampen the vibration of vibration motor <NUM>. In a non-limiting embodiment, the transceiver electronics may be assembled using standard surface mount device (SMD) reflow and solder techniques. In one embodiment, the electronics and peripherals may be put into a snap together housing design in which the front housing <NUM> and back housing <NUM> may be snapped together. In some embodiments, the full assembly process may be performed at a single external electronics house. However, this is not required, and, in alternative embodiments, the transceiver assembly process may be performed at one or more electronics houses, which may be internal, external, or a combination thereof. In some embodiments, the assembled transceiver <NUM> may be programmed and functionally tested. In some embodiments, assembled transceivers <NUM> may be packaged into their final shipping containers and be ready for sale.

In some embodiments, as illustrated in <FIG> and <FIG>, the antenna <NUM> may be contained within the housing <NUM> and <NUM> of the transceiver <NUM>. In some embodiments, the antenna <NUM> in the transceiver <NUM> may be small and/or flat so that the antenna <NUM> fits within the housing <NUM> and <NUM> of a small, lightweight transceiver <NUM>. In some embodiments, the antenna <NUM> may be robust and capable of resisting various impacts. In some embodiments, the transceiver <NUM> may be suitable for placement, for example, on an abdomen area, upper-arm, wrist, or thigh of a patient body. In some non-limiting embodiments, the transceiver <NUM> may be suitable for attachment to a patient body by means of a biocompatible patch. Although, in some embodiments, the antenna <NUM> may be contained within the housing <NUM> and <NUM> of the transceiver <NUM>, this is not required, and, in some alternative embodiments, a portion or all of the antenna <NUM> may be located external to the transceiver housing. For example, in some alternative embodiments, antenna <NUM> may wrap around a user's wrist, arm, leg, or waist such as, for example, the antenna described in <CIT>.

<FIG> is a schematic view of an external transceiver <NUM> according to a non-limiting embodiment. In some embodiments, the transceiver <NUM> may have a connector <NUM>, such as, for example, a Micro-Universal Serial Bus (USB) connector. The connector <NUM> may enable a wired connection to an external device, such as a personal computer (e.g., personal computer <NUM>) or a display device <NUM> (e.g., a smartphone).

The transceiver <NUM> may exchange data to and from the external device through the connector <NUM> and/or may receive power through the connector <NUM>. The transceiver <NUM> may include a connector integrated circuit (IC) <NUM>, such as, for example, a USB-IC, which may control transmission and receipt of data through the connector <NUM>. The transceiver <NUM> may also include a charger IC <NUM>, which may receive power via the connector <NUM> and charge a battery <NUM> (e.g., lithium-polymer battery). In some embodiments, the battery <NUM> may be rechargeable, may have a short recharge duration, and/or may have a small size.

In some embodiments, the transceiver <NUM> may include one or more connectors in addition to (or as an alternative to) Micro-USB connector <NUM>. For example, in one alternative embodiment, the transceiver <NUM> may include a spring-based connector (e.g., Pogo pin connector) in addition to (or as an alternative to) Micro-USB connector <NUM>, and the transceiver <NUM> may use a connection established via the spring-based connector for wired communication to a personal computer (e.g., personal computer <NUM>) or a display device <NUM> (e.g., a smartphone) and/or to receive power, which may be used, for example, to charge the battery <NUM>.

In some embodiments, the transceiver <NUM> may have a wireless communication IC <NUM>, which enables wireless communication with an external device, such as, for example, one or more personal computers (e.g., personal computer <NUM>) or one or more display devices <NUM> (e.g., a smartphone). In one non-limiting embodiment, the wireless communication IC <NUM> may employ one or more wireless communication standards to wirelessly transmit data. The wireless communication standard employed may be any suitable wireless communication standard, such as an ANT standard, a Bluetooth standard, or a Bluetooth Low Energy (BLE) standard (e.g., BLE <NUM>). In some non-limiting embodiments, the wireless communication IC <NUM> may be configured to wirelessly transmit data at a frequency greater than <NUM> gigahertz (e.g., <NUM> or <NUM>). In some embodiments, the wireless communication IC <NUM> may include an antenna (e.g., a Bluetooth antenna). In some non-limiting embodiments, the antenna of the wireless communication IC <NUM> may be entirely contained within the housing (e.g., housing <NUM> and <NUM>) of the transceiver <NUM>. However, this is not required, and, in alternative embodiments, all or a portion of the antenna of the wireless communication IC <NUM> may be external to the transceiver housing.

In some embodiments, the transceiver <NUM> may include a display interface device, which may enable communication by the transceiver <NUM> with one or more display devices <NUM>. In some embodiments, the display interface device may include the antenna of the wireless communication IC <NUM> and/or the connector <NUM>. In some non-limiting embodiments, the display interface device may additionally include the wireless communication IC <NUM> and/or the connector IC <NUM>.

In some embodiments, the transceiver <NUM> may include voltage regulators <NUM> and/or a voltage booster <NUM>. The battery <NUM> may supply power (via voltage booster <NUM>) to radiofrequency identification (RFID) reader IC <NUM>, which uses the inductive element <NUM> to convey information (e.g., commands) to the sensor <NUM> and receive information (e.g., measurement information) from the sensor <NUM>. In some non-limiting embodiments, the sensor <NUM> and transceiver <NUM> may communicate using near field communication (NFC) (e.g., at a frequency of <NUM>). In the illustrated embodiment, the inductive element <NUM> is a flat antenna. In some non-limiting embodiments, the antenna may be flexible. However, as noted above, the inductive element <NUM> of the transceiver <NUM> may be in any configuration that permits adequate field strength to be achieved when brought within adequate physical proximity to the inductive element <NUM> of the sensor <NUM>. In some embodiments, the transceiver <NUM> may include a power amplifier <NUM> to amplify the signal to be conveyed by the inductive element <NUM> to the sensor <NUM>.

The transceiver <NUM> may include a peripheral interface controller (PIC) microcontroller <NUM> and memory <NUM> (e.g., Flash memory), which may be non-volatile and/or capable of being electronically erased and/or rewritten. The PIC microcontroller <NUM> may control the overall operation of the transceiver <NUM>. For example, the PIC microcontroller <NUM> may control the connector IC <NUM> or wireless communication IC <NUM> to transmit data via wired or wireless communication and/or control the RFID reader IC <NUM> to convey data via the inductive element <NUM>. The PIC microcontroller <NUM> may also control processing of data received via the inductive element <NUM>, connector <NUM>, or wireless communication IC <NUM>.

In some embodiments, the transceiver <NUM> may include a sensor interface device, which may enable communication by the transceiver <NUM> with a sensor <NUM>. In some embodiments, the sensor interface device may include the inductive element <NUM>. In some non-limiting embodiments, the sensor interface device may additionally include the RFID reader IC <NUM> and/or the power amplifier <NUM>. However, in some alternative embodiments where there exists a wired connection between the sensor <NUM> and the transceiver <NUM> (e.g., transcutaneous embodiments), the sensor interface device may include the wired connection.

In some embodiments, the transceiver <NUM> may include a display <NUM> (e.g., liquid crystal display and/or one or more light emitting diodes), which PIC microcontroller <NUM> may control to display data (e.g., analyte concentration values). In some embodiments, the transceiver <NUM> may include a speaker <NUM> (e.g., a beeper) and/or vibration motor <NUM>, which may be activated, for example, in the event that an alarm condition (e.g., detection of a hypoglycemic or hyperglycemic condition) is met. The transceiver <NUM> may also include one or more additional sensors <NUM>, which may include an accelerometer and/or temperature sensor, that may be used in the processing performed by the PIC microcontroller <NUM>.

In some embodiments, the transceiver <NUM> may be a body-worn transceiver that is a rechargeable, external device worn over the sensor implantation or insertion site. The transceiver <NUM> may supply power to the proximate sensor <NUM>, calculate analyte concentrations from data received from the sensor <NUM>, and/or transmit the calculated analyte concentrations to a display device <NUM> (see <FIG>). Power may be supplied to the sensor <NUM> through an inductive link (e.g., an inductive link of <NUM>). In some embodiments, the transceiver <NUM> may be placed using an adhesive patch or a specially designed strap or belt. The external transceiver <NUM> may read measured analyte data from a subcutaneous sensor <NUM> (e.g., up to a depth of <NUM> or more). The transceiver <NUM> may periodically (e.g., every <NUM>, <NUM>, or <NUM> minutes) read sensor data and calculate an analyte concentration and an analyte concentration trend. From this information, the transceiver <NUM> may also determine if an alert and/or alarm condition exists, which may be signaled to the user (e.g., through vibration by vibration motor <NUM> and/or an LED of the transceiver's display <NUM> and/or a display of a display device <NUM>). The information from the transceiver <NUM> (e.g., calculated analyte concentrations, calculated analyte concentration trends, alerts, alarms, and/or notifications) may be transmitted to a display device <NUM> (e.g., via Bluetooth Low Energy with Advanced Encryption Standard (AES)-Counter CBC-MAC (CCM) encryption) for display by a mobile medical application (MMA) being executed by the display device <NUM>. In some non-limiting embodiments, the MMA may provide alarms, alerts, and/or notifications in addition to any alerts, alarms, and/or notifications received from the transceiver <NUM>. In one embodiment, the MMA may be configured to provide push notifications. In some embodiments, the transceiver <NUM> may have a power button (e.g., button <NUM>) to allow the user to turn the device on or off, reset the device, or check the remaining battery life. In some embodiments, the transceiver <NUM> may have a button, which may be the same button as a power button or an additional button, to suppress one or more user notification signals (e.g., vibration, visual, and/or audible) of the transceiver <NUM> generated by the transceiver <NUM> in response to detection of an alert or alarm condition.

In some embodiments, the transceiver <NUM> of the analyte monitoring system <NUM> may receive raw signals indicative of an amount or concentration of an analyte in the interstitial fluid ("ISF") in proximity to the analyte indicator element <NUM> of the analyte sensor <NUM>. In some embodiments, the transceiver <NUM> may receive the raw signals from the sensor <NUM> periodically (e.g., every <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> minutes). In some embodiments, the raw signals may include one or more measurements (e.g., one or more measurements indicative of the level of emission light <NUM> from the indicator molecules <NUM> as measured by the photodetector <NUM>, one or more measurements indicative of the level of reference light <NUM> as measured by photodetector <NUM>, and/or one or more temperature measurements as measured by the temperature transducer <NUM>). In some embodiments, the transceiver <NUM> may use the received raw signals to calculate an ISF analyte level.

In some embodiments, the transceiver <NUM> may use the calculated ISF analyte level and one or more previously calculated ISF analyte levels to calculate a rate of change of the interstitial fluid analyte level ("ISF_ROC"). In some non-limiting embodiments, to calculate ISF_ROC, the transceiver <NUM> may use just the calculated ISF analyte level and the most recent previously calculated ISF analyte level and determine ISF_ROC as the difference between the calculated ISF analyte level and most recent previously calculated ISF analyte level divided by the time difference between a time stamp for the calculated ISF analyte level and a time stamp for the most recent previously calculated ISF analyte level. In some alternative embodiments, to calculate ISF_ROC, the transceiver <NUM> may use the calculated ISF analyte level and a plurality of the most recent previously calculated ISF analyte levels. In some non-limiting embodiments, the plurality of the most recent previously calculated ISF analyte levels may be, for example and without limitation, the previous two calculated ISF analyte levels, the previous <NUM> calculated ISF analyte levels, or any number of previously calculated ISF analyte levels in between (e.g., the previous <NUM> calculated analyte levels). In other alternative embodiments, to calculate ISF_ROC, the transceiver <NUM> may use the calculated ISF analyte level and the previously calculated ISF analyte levels that were calculated during a time period. In some non-limiting embodiments, the time period may be, for example and without limitation, the last one minute, the last <NUM> minutes, or any amount of time in between (e.g., the last <NUM> minutes). In some embodiments where the transceiver <NUM> uses the calculated ISF analyte level and more than one previously calculated ISF analyte levels to calculate ISF_ROC, the transceiver <NUM> may use, for example, linear or non-linear regression to calculate ISF_ROC.

In some embodiments, the transceiver <NUM> may convert the calculated ISF analyte level into a blood analyte level by performing a lag compensation, which compensates before the lag between blood analyte level and an ISF analyte level. In some embodiments, the transceiver <NUM> may calculate the blood analyte level using at least the calculated ISF analyte level and the calculated ISF_ROC. In some non-limiting embodiments, the transceiver <NUM> may calculate the blood analyte level as ISF_ROC/p<NUM> + (<NUM>+p<NUM>/p<NUM>)*ISF_analyte, where p<NUM> is analyte diffusion rate, p<NUM> is the analyte consumption rate, and ISF_analyte is the calculated ISF analyte level.

In some embodiments, the transceiver <NUM> may store one or more of the calculated ISF analyte level, calculated ISF_ROC, and calculated blood analyte level (e.g., in memory <NUM>). In some embodiments, the transceiver <NUM> may convey the calculated blood analyte level to the display device <NUM>, and the display device <NUM> may display the calculated blood analyte level. However, for real-time display of blood analyte levels, only the current calculated ISF analyte level and one or more past ISF analyte levels can be used to estimate the ISF_ROC because subsequent/future ISF analyte levels are not yet available. Accordingly, in some embodiments, after one or more subsequent ISF analyte levels are calculated, the transceiver <NUM> may use the one or more subsequent ISF analyte levels to correct the calculated blood analyte level. That is, at a later time, both past and future ISF analyte values are available, and the transceiver <NUM> may use past and future ISF analyte values to update the ISF_ROC and calculate a corrected blood analyte value, which may be more accurate than the uncorrected, lag-compensated blood analyte value. In addition, corrected blood analyte values may be smoother than uncorrected, lag-compensated blood analyte values when shown over time.

In some embodiments, the transceiver <NUM> may calculate the updated ISF_ROC using one or more past ISF analyte values, the calculated ISF analyte value, and one or more subsequent ISF analyte values. In some non-limiting embodiments, the transceiver <NUM> may use, for example, linear or non-linear regression to calculate the updated ISF_ROC. In some embodiments, the transceiver <NUM> may calculate the corrected blood analyte value using the updated ISF_ROC instead of the original ISF_ROC. In some non-limiting embodiments, the transceiver <NUM> may calculate the corrected blood analyte value as updated_ISF_ROC/p<NUM> + (<NUM>+p<NUM>/p<NUM>)*ISF_analyte, where p<NUM> is analyte diffusion rate, p<NUM> is the analyte consumption rate, updated_ISF_ROC is the calculated updated ISF_ROC, and ISF_analyte is the calculated ISF analyte level.

In some embodiments, the transceiver <NUM> may store one or more of the updated ISF_ROC and the corrected blood analyte level (e.g., in memory <NUM>). In some embodiments, the transceiver <NUM> may convey the corrected blood analyte level to the display device <NUM>, and the display device <NUM> may display the corrected blood analyte level. In some embodiments, the display device may be configured to display an uncorrected, lag-compensated blood analyte value until the display device <NUM> receives the corrected blood analyte level and, after receiving the corrected blood analyte level, display the corrected blood analyte level instead of the uncorrected blood analyte level. In some embodiments, the display device <NUM> may be configured to display uncorrected, lag-compensated blood analyte value for real-time display. In some embodiments, the display device <NUM> may be configured to also display uncorrected, lag-compensated blood analyte value for historical blood analyte level display (e.g., a display of blood analyte levels over time) but only until the display device <NUM> receives the corrected blood analyte level.

<FIG> show an example in which ISF glucose levels within time range from <NUM> minutes into the future to <NUM> minutes into the past are used to calculate updated ISF_ROC values and correct blood glucose ("BG") levels. <FIG> shows ISF glucose levels over time. <FIG> shows original and updated ISF _ROC values over time. <FIG> shows uncorrected, lag-compensated BG levels and lag-corrected BG levels over time. In the example illustrated in <FIG>, the transceiver <NUM> may (i) calculate an original ISF_ROC using an ISF glucose level and one or more ISF glucose levels in a <NUM>-minute window into the past, (ii) calculate a lag-compensated BG level using the ISF glucose level, and (iii) convey the lag-compensated BG level to the display device <NUM> for real-time and historical BG display. Then, after a <NUM>-minute delay, the transceiver <NUM> may (i) calculate an updated ISF_ROC using the ISF glucose level, the one or more ISF glucose levels in the <NUM>-minute window into the past, and one or more ISF glucose levels during the <NUM>-minute delay, (ii) calculate a corrected BG level using the ISF glucose level and the updated ISF_ROC, and (iii) convey the corrected BG level to the display device <NUM> to update the historical BG display. In the example illustrated in <FIG>, the sampling period for sensor measurement is <NUM> minutes. That is, the transceiver <NUM> receives sensor data from the analyte sensor <NUM> every <NUM> minutes, the <NUM>-minute window into the past includes <NUM> previous ISF glucose measurements, and the <NUM>-minute window into the future includes <NUM> subsequent measurements.

<FIG> is a flow chart illustrating an iterative process <NUM> for calculating and correcting blood analyte levels. In some embodiments, one or more steps of the process <NUM> may be performed by an analyte monitoring system, such as, for example, the analyte monitoring system <NUM>. Steps of the process <NUM> are performed by a transceiver, such as, for example, the transceiver <NUM>. In some non-limiting embodiments, one or more steps of the process <NUM> may be performed by a processor, such as, for example, the PIC microcontroller <NUM> of the transceiver <NUM>.

In some embodiments, the process <NUM> may include a step <NUM> in which the transceiver <NUM> determines whether the transceiver <NUM> has received sensor data from the sensor <NUM>. The sensor data include one or more sensor measurements, such as, for example and without limitation, one or more light measurements and/or one or more temperature measurements. In some embodiments, the transceiver <NUM> may receive the sensor data after conveying a command (e.g., a measurement command or a read sensor data command) to the sensor <NUM>. However, this is not required, and, in some alternative embodiments, the sensor <NUM> may control when sensor data is conveyed to the transceiver <NUM>, or the sensor <NUM> may continuously convey sensor data to the transceiver <NUM>. In some non-limiting embodiments, the transceiver <NUM> may receive the sensor data periodically (e.g., every <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> minutes).

In some embodiments, the transceiver <NUM> may receive the sensor data wirelessly. For example and without limitation, in some non-limiting embodiments, the transceiver <NUM> may receive the sensor data by detecting modulations in an electromagnetic wave generated by the sensor <NUM>, e.g., by detecting modulations in the current flowing through the coil <NUM> of the transceiver <NUM>. However, this is not required, and, in some alternative embodiments, the transceiver <NUM> may receive the sensor data via a wired connection to the sensor <NUM>.

In some embodiments, the sensor data may be associated with a time stamp. In some non-limiting embodiments, the transceiver <NUM> may receive the time stamp from the sensor <NUM>. In some non-limiting embodiments, the received sensor data may include the time stamp. In some embodiments, the time stamp may reflect the time at which one or more sensor measurements included in the sensor data were taken. However, it is not required that the transceiver <NUM> receive the time stamp from the sensor <NUM>. For example, in some alternative embodiments, the transceiver <NUM> may assign the time stamp to the sensor data after receiving the sensor data. In these embodiments, the time stamp may reflect when the transceiver <NUM> received the sensor data.

In some non-limiting embodiments, if the sensor <NUM> has received sensor data, the process <NUM> may proceed from step <NUM> to an ISF analyte level calculation step <NUM>. In some non-limiting embodiments, if the transceiver <NUM> has not received sensor data, the process <NUM> may return to step <NUM>.

The process <NUM> includes the step <NUM> in which the transceiver <NUM> calculates an ISF analyte level using the received sensor data. In some embodiments, the ISF analyte level may be a measurement of the amount or concentration of the analyte in the interstitial fluid in proximity to the analyte indicator element <NUM>. In some non-limiting embodiments, calculation of the ISF analyte level may include, for example and without limitation, some or all of the features described in <CIT>.

The process <NUM> includes a step <NUM> in which the transceiver <NUM> calculates ISF_ROC. The transceiver <NUM> calculates the ISF_ROC using at least the calculated ISF analyte level and one or more previously calculated ISF analyte levels (e.g., one or more ISF analyte levels calculated using previously received sensor data). The process <NUM> includes a step <NUM> in which the transceiver <NUM> calculates a blood analyte level. In some embodiments, the transceiver <NUM> may calculate the blood analyte level by performing a lag compensation. The transceiver <NUM> calculates the blood analyte level using at least the ISF analyte level and the ISF_ ROC calculated in steps <NUM> and <NUM>, respectively.

The process <NUM> includes a step <NUM> of displaying the calculated blood analyte level. In some embodiments, the step <NUM> may include displaying the calculated blood analyte level on a display (e.g., display <NUM>) of the transceiver <NUM>. The step <NUM> includes the transceiver <NUM> conveying the calculated blood analyte level to a display device (e.g., display device <NUM>) for display. In some non-limiting embodiments, the transceiver <NUM> may convey the calculated blood analyte level to the display device <NUM> via wired or wireless communication using the connector IC <NUM> or wireless communication IC <NUM>. The display device <NUM> is configured to receive and display the conveyed blood analyte level. In some non-limiting embodiments, the display device <NUM> may display the received blood analyte level as a current blood analyte level (e.g., until a subsequent blood analyte level is received) and then as a historical/previous blood analyte level.

In some non-limiting embodiments, the process <NUM> may include a step <NUM> in which the transceiver <NUM> determines whether to perform a lag correction for one or more previously calculated blood analyte levels (i.e., one or more lag-compensated but uncorrected blood analyte levels). In some non-limiting embodiments, the transceiver <NUM> may determine to lag-correct an uncorrected, lag-compensated blood analyte value if a threshold amount of time has passed since the blood analyte value was calculated. In some non-limiting embodiments, the threshold amount of time may be, for example and without limitation, <NUM> minute, <NUM> minutes, or any amount of time in between (e.g., <NUM> minutes). In some non-limiting alternative embodiments, the transceiver <NUM> may determine to lag-correct an uncorrected, lag-compensated blood analyte value if a threshold amount of ISF analyte levels have been calculated since the blood analyte level was calculated. In some non-limiting embodiments, the threshold of amount of ISF analyte levels calculated since the blood analyte level was calculated may be an integer in the range from <NUM> to <NUM>. In some embodiments, if the transceiver <NUM> determines to perform a lag correction, the process <NUM> may proceed to an ISF_ROC updating step <NUM>. In some embodiments, if the transceiver <NUM> determines not to perform a lag correction, the process <NUM> may proceed back to step <NUM>.

However, the step <NUM> of determining whether to perform a lag correction is not required. For example, in some alternative embodiments, the transceiver <NUM> may perform a lag correction for one or more uncorrected, lag-compensated blood analyte levels automatically each time a new ISF analyte level is calculated.

The process <NUM> includes the ISF_ROC updating step <NUM>. In some embodiments, the ISF_ROC updating step <NUM> may include the transceiver <NUM> calculating an updated ISF_ROC for lag correcting a lag-compensated blood analyte level. The lag-compensated blood analyte level may have been calculated using a first ISF analyte level and an original ISF_ROC. The transceiver <NUM> calculates an updated ISF_ROC using (i) one or more past ISF analyte values (e.g., one or more ISF analyte values having time stamps prior to the time stamp of the first ISF analyte level), (ii) the first ISF analyte level, and (iii) one or more subsequent ISF analyte values (e.g., one or more ISF analyte values having time stamps later than the time stamp of the first ISF analyte level).

The process <NUM> includes a step <NUM> in which the transceiver <NUM> calculates a corrected blood analyte level. The transceiver <NUM> calculates the corrected blood analyte value using the updated ISF_ROC instead of the original ISF_ROC. The transceiver <NUM> calculates the corrected blood analyte value using at least the updated ISF_ROC and the first ISF analyte level.

The process <NUM> includes a step <NUM> of displaying the corrected blood analyte level. In some embodiments, the step <NUM> may include displaying the calculated blood analyte level on a display (e.g., display <NUM>) of the transceiver <NUM>. The step <NUM> includes the transceiver <NUM> conveying the corrected blood analyte level to a display device (e.g., display device <NUM>) for display. In some non-limiting embodiments, the transceiver <NUM> may convey the corrected blood analyte level to the display device <NUM> via wired or wireless communication using the connector IC <NUM> or wireless communication IC <NUM>. The display device <NUM> is configured to receive and display the corrected blood analyte level. In some non-limiting embodiments, the display device <NUM> may be configured to (i) display the uncorrected, lag-compensated blood analyte level until the display device <NUM> receives the corrected blood analyte level and (ii) after receiving the corrected blood analyte level, display the corrected blood analyte level instead of the uncorrected blood analyte level. In some embodiments, the process <NUM> may proceed from step <NUM> back to step <NUM>.

In some embodiments, the steps of process <NUM> illustrated in <FIG> may be carried out in the order illustrated in <FIG>. However, this is not required. For example, in some alternative embodiments, steps <NUM>-<NUM> may be performed any time after step <NUM> (e.g., in between steps <NUM> and <NUM>, in between steps <NUM> and <NUM>, in between steps <NUM> and <NUM>, and/or simultaneously or interspersed with steps <NUM>-<NUM>) and need not be performed after step <NUM>.

<FIG> is a flow chart illustrating a process <NUM> for calculating and correcting blood analyte levels. In some embodiments, the process <NUM> may be a non-limiting example of steps performed by the iterative process <NUM> illustrated in <FIG>. In some embodiments, one or more steps of the process <NUM> may be performed by an analyte monitoring system, such as, for example, the analyte monitoring system <NUM>. Steps of the process <NUM> are performed by a transceiver, such as, for example, the transceiver <NUM>. In some non-limiting embodiments, one or more steps of the process <NUM> may be performed by a processor, such as, for example, the PIC microcontroller <NUM> of the transceiver <NUM>.

In some embodiments, the process <NUM> may include a step <NUM> in which the transceiver <NUM> determines whether the transceiver <NUM> has received first sensor data from the sensor <NUM>. The first sensor data include a set of one or more sensor measurements, such as, for example and without limitation, one or more light measurements and/or one or more temperature measurements.

In some embodiments, the first sensor data may be associated with a first time stamp. In some non-limiting embodiments, the transceiver <NUM> may receive the first time stamp from the sensor <NUM>. In some non-limiting embodiments, the received first sensor data may include the first time stamp. In some embodiments, the first time stamp may reflect the time at which one or more sensor measurements included in the first sensor data were taken. However, it is not required that the transceiver <NUM> receive the first time stamp from the sensor <NUM>. For example, in some alternative embodiments, the transceiver <NUM> may assign the first time stamp to the first sensor data after receiving the first sensor data. In these embodiments, the first time stamp may reflect when the transceiver <NUM> received the first sensor data.

In some non-limiting embodiments, if the sensor <NUM> has received first sensor data, the process <NUM> may proceed from step <NUM> to a first ISF analyte level calculation step <NUM>. In some non-limiting embodiments, if the transceiver <NUM> has not received first sensor data, the process <NUM> may return to step <NUM>.

The process <NUM> includes the step <NUM> in which the transceiver <NUM> calculates a first ISF analyte level using the received first sensor data. In some embodiments, the first ISF analyte level may be a measurement of the amount or concentration of the analyte in the interstitial fluid in proximity to the analyte indicator element <NUM>. The process <NUM> includes a step <NUM> in which the transceiver <NUM> calculates a first ISF_ROC. The transceiver <NUM> calculates the first ISF_ROC using at least the calculated first ISF analyte level and one or more previously calculated ISF analyte levels (e.g., one or more ISF analyte levels calculated using previously received sensor data). The process <NUM> includes a step <NUM> in which the transceiver <NUM> calculates a first blood analyte level. In some embodiments, the transceiver <NUM> may calculate the first blood analyte level by performing a lag compensation. The transceiver <NUM> calculates the first blood analyte level using at least the first ISF analyte level and the first ISF_ROC calculated in steps <NUM> and <NUM>, respectively.

The process <NUM> includes a step <NUM> of displaying the calculated first blood analyte level. In some embodiments, the step <NUM> may include displaying the calculated first blood analyte level on a display (e.g., display <NUM>) of the transceiver <NUM>. The step <NUM> includes the transceiver <NUM> conveying the calculated first blood analyte level to a display device (e.g., display device <NUM>) for display. In some non-limiting embodiments, the transceiver <NUM> may convey the calculated first blood analyte level to the display device <NUM> via wired or wireless communication using the connector IC <NUM> or wireless communication IC <NUM>. The display device <NUM> is configured to receive and display the conveyed first blood analyte level. In some non-limiting embodiments, the display device <NUM> may display the first blood analyte level as a current blood analyte level (e.g., until a subsequent blood analyte level is received) and then as a historical/previous blood analyte level.

In some embodiments, the process <NUM> may include a step <NUM> in which the transceiver <NUM> determines whether the transceiver <NUM> has received second sensor data from the sensor <NUM>. The second sensor data include a second set of one or more sensor measurements, such as, for example and without limitation, one or more light measurements and/or one or more temperature measurements.

In some embodiments, the second sensor data may be associated with a second time stamp. In some embodiments, the time recorded by the second time stamp may be later than the time recorded by the first time stamp. In some non-limiting embodiments, the transceiver <NUM> may receive the second time stamp from the sensor <NUM>. In some non-limiting embodiments, the received second sensor data may include the second time stamp. In some embodiments, the second time stamp may reflect the time at which one or more sensor measurements included in the second sensor data were taken. However, it is not required that the transceiver <NUM> receive the second time stamp from the sensor <NUM>. For example, in some alternative embodiments, the transceiver <NUM> may assign the second time stamp to the second sensor data after receiving the second sensor data. In these embodiments, the second time stamp may reflect when the transceiver <NUM> received the second sensor data.

In some non-limiting embodiments, if the sensor <NUM> has received second sensor data, the process <NUM> may proceed from step <NUM> to a second ISF analyte level calculation step <NUM>. In some non-limiting embodiments, if the transceiver <NUM> has not received second sensor data, the process <NUM> may return to step <NUM>.

In some non-limiting embodiments, the process <NUM> may include the step <NUM> in which the transceiver <NUM> calculates a second ISF analyte level using the received second sensor data. In some embodiments, the second ISF analyte level may be a measurement of the amount or concentration of the analyte in the interstitial fluid in proximity to the analyte indicator element <NUM>.

In some non-limiting embodiments, the process <NUM> may include a step <NUM> in which the transceiver <NUM> calculates a second ISF_ROC. In some embodiments, the transceiver <NUM> may calculate the second ISF_ROC using at least the calculated second ISF analyte level and one or more previously calculated ISF analyte levels (e.g., one or more ISF analyte levels calculated using previously received sensor data, such as, for example and without limitation, the first ISF analyte level calculated in step <NUM>). In some non-limiting embodiments, the process <NUM> may include a step <NUM> in which the transceiver <NUM> calculates a second blood analyte level. In some embodiments, the transceiver <NUM> may calculate the second blood analyte level by performing a lag compensation. In some embodiments, the transceiver <NUM> may calculate the second blood analyte level using at least the second ISF analyte level and the second ISF_ROC calculated in steps <NUM> and <NUM>, respectively.

he process <NUM> may include a step <NUM> in which the transceiver <NUM> calculates an updated first ISF_ROC for lag correcting the lag-compensated, first blood analyte level. The first blood analyte level may have been calculated using the first ISF analyte level and the original first ISF_ROC. The transceiver <NUM> calculates the updated first ISF_ROC using (i) one or more past ISF analyte values (e.g., one or more ISF analyte values having time stamps prior to the first time stamp of the first ISF analyte level), (ii) the first ISF analyte level, and (iii) one or more subsequent ISF analyte values (e.g., one or more ISF analyte values having a time stamp later than the time stamp of the first ISF analyte level, such as, for example and without limitation, the second ISF analyte level).

The process <NUM> includes a step <NUM> in which the transceiver <NUM> calculates a corrected first blood analyte level. The transceiver <NUM> calculates the corrected first blood analyte value using the updated first ISF_ROC instead of the original first ISF_ROC. The transceiver <NUM> calculates the corrected first blood analyte value using at least the updated first ISF_ROC and the first ISF analyte level.

In some non-limiting embodiments, the process <NUM> may include a step <NUM> of displaying the second blood analyte level as well as the corrected first blood analyte level. In some embodiments, the step <NUM> may include displaying one or more of the calculated second blood analyte level and the corrected first blood analyte level on a display (e.g., display <NUM>) of the transceiver <NUM>. The step <NUM> may include the transceiver <NUM> conveying the second blood analyte level as well as the corrected first blood analyte level, to a display device (e.g., display device <NUM>) for display. In some non-limiting embodiments, the transceiver <NUM> may convey one or more of the second blood analyte level and the corrected first blood analyte level to the display device <NUM> via wired or wireless communication using the connector IC <NUM> or wireless communication IC <NUM>. In some embodiments, the display device <NUM> may be configured to receive and display one or more of the second blood analyte level and the corrected first blood analyte level. In some non-limiting embodiments, the display device <NUM> may be configured to (i) display the uncorrected, lag-compensated first blood analyte level until the display device <NUM> receives the corrected first blood analyte level and (ii) after receiving the corrected first blood analyte level, display the corrected first blood analyte level instead of the uncorrected first blood analyte level. In some non-limiting embodiments, the display device <NUM> may display the second blood analyte level as a current blood analyte level and may display the corrected first blood analyte level instead of the uncorrected first blood analyte level as a historical/previous blood analyte level.

In some embodiments, the steps of process <NUM> illustrated in <FIG> may be carried out in the order illustrated in <FIG>. However, this is not required. For example, in some alternative embodiments, steps <NUM> and <NUM> may be performed before steps <NUM> and <NUM>, simultaneously with steps <NUM> and <NUM>, or interspersed with steps <NUM> and <NUM> (e.g., performed in the order of steps <NUM>, <NUM>, <NUM>, <NUM>; steps <NUM>, <NUM>, <NUM>, <NUM>; steps <NUM>, <NUM>, <NUM>, <NUM>; steps <NUM>, <NUM>, <NUM>, <NUM>). In some alternative embodiments, step <NUM> may be broken into separate steps of displaying the second blood analyte level and displaying the corrected first blood analyte level, which may be performed after steps <NUM> and <NUM>, respectively.

In some embodiments, steps <NUM> and <NUM> may be performed only after the transceiver <NUM> determines that a lag correction should be performed for the lag-compensated but uncorrected first blood analyte level calculated in step <NUM>. For example and without limitation, in some non-limiting embodiments, the transceiver <NUM> may determine to lag-correct the uncorrected, lag-compensated first blood analyte value if a threshold amount of time (e.g., T minutes, where <NUM> ≤ T ≤ <NUM>) has passed since the first blood analyte value was calculated and/or if a threshold amount of ISF analyte levels have been calculated since the first blood analyte level was calculated. However, a step of determining whether to perform a lag correction for the uncorrected, lag-compensated first blood analyte value is not required. For example, in some alternative embodiments, the transceiver <NUM> may perform a lag correction for the uncorrected, lag-compensated first blood analyte levels automatically following calculation of the second ISF analyte level in step <NUM>.

In some embodiments, the process <NUM> may include one or more of steps <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and <NUM>, which may be the same as the corresponding steps of process <NUM>. In some embodiments, the process <NUM> may include a step <NUM> of displaying one or more of the first and second blood analyte levels calculated in steps <NUM> and <NUM>, respectively. In some embodiments, the step <NUM> may include displaying one or more of the calculated first and second blood analyte levels on a display (e.g., display <NUM>) of the transceiver <NUM>. In some embodiments, the step <NUM> may additionally or alternatively include the transceiver <NUM> conveying one or more of the first and second blood analyte levels to a display device (e.g., display device <NUM>) for display. In some non-limiting embodiments, the transceiver <NUM> may convey one or more of the first and second blood analyte levels to the display device <NUM> via wired or wireless communication using the connector IC <NUM> or wireless communication IC <NUM>. In some embodiments, the display device <NUM> may be configured to receive and display one or more of the first and second blood analyte levels. In some non-limiting embodiments, the display device <NUM> may display the second blood analyte level as a current blood analyte level and may display the corrected first blood analyte level instead of the uncorrected first blood analyte level as a historical/previous blood analyte level.

In some embodiments, the process <NUM> may include a step <NUM> in which the transceiver <NUM> determines whether the transceiver <NUM> has received third sensor data from the sensor <NUM>. In some embodiments, the third sensor data may include a third set of one or more sensor measurements, such as, for example and without limitation, one or more light measurements and/or one or more temperature measurements.

In some embodiments, the third sensor data may be associated with a third time stamp. In some embodiments, the time recorded by the third time stamp may be later than the time recorded by the second time stamp. In some non-limiting embodiments, the transceiver <NUM> may receive the third time stamp from the sensor <NUM>. In some non-limiting embodiments, the received third sensor data may include the third time stamp. In some embodiments, the third time stamp may reflect the time at which one or more sensor measurements included in the third sensor data were taken. However, it is not required that the transceiver <NUM> receive the third time stamp from the sensor <NUM>. For example, in some alternative embodiments, the transceiver <NUM> may assign the third time stamp to the third sensor data after receiving the third sensor data. In these embodiments, the third time stamp may reflect when the transceiver <NUM> received the third sensor data.

In some non-limiting embodiments, if the sensor <NUM> has received third sensor data, the process <NUM> may proceed from step <NUM> to a third ISF analyte level calculation step <NUM>. In some non-limiting embodiments, if the transceiver <NUM> has not received third sensor data, the process <NUM> may return to step <NUM>.

In some non-limiting embodiments, the process <NUM> may include the step <NUM> in which the transceiver <NUM> calculates a third ISF analyte level using the received third sensor data. In some embodiments, the third ISF analyte level may be a measurement of the amount or concentration of the analyte in the interstitial fluid in proximity to the analyte indicator element <NUM>.

In some non-limiting embodiments, the process <NUM> may include a step <NUM> in which the transceiver <NUM> calculates a third ISF_ROC. In some embodiments, the transceiver <NUM> may calculate the third ISF_ROC using at least the calculated third ISF analyte level and one or more previously calculated ISF analyte levels (e.g., one or more ISF analyte levels calculated using previously received sensor data, such as, for example and without limitation, one or more of the first and second ISF analyte levels calculated in steps <NUM> and <NUM>, respectively). In some non-limiting embodiments, the process <NUM> may include a step <NUM> in which the transceiver <NUM> calculates a third blood analyte level. In some embodiments, the transceiver <NUM> may calculate the third blood analyte level by performing a lag compensation. In some embodiments, the transceiver <NUM> may calculate the third blood analyte level using at least the third ISF analyte level and the third ISF_ROC calculated in steps <NUM> and <NUM>, respectively.

The process <NUM> includes a step <NUM> in which the transceiver <NUM> calculates an updated first ISF_ROC for lag correcting the lag-compensated, first blood analyte level. The first blood analyte level may have been calculated using the first ISF analyte level and the original first ISF_ROC. The transceiver <NUM> calculates the updated first ISF_ROC using (i) one or more past ISF analyte values (e.g., one or more ISF analyte values having time stamps prior to the first time stamp of the first ISF analyte level), (ii) the first ISF analyte level, and (iii) one or more subsequent ISF analyte values (e.g., one or more ISF analyte values having a time stamp later than the time stamp of the first ISF analyte level, such as, for example and without limitation, one or more of the second and third ISF analyte levels).

The process <NUM> includes a step <NUM> in which the transceiver <NUM> calculates a corrected first blood analyte level. The transceiver <NUM> calculates the corrected first blood analyte value using the updated first ISF_ROC instead of the original first ISF_ROC. The transceiver <NUM> calculates the corrected first blood analyte value using at least the updated first ISF_ROC and the first ISF analyte level calculated in steps <NUM> and <NUM>, respectively.

In some non-limiting embodiments, the process <NUM> may include a step <NUM> of displaying one or both of the second blood analyte level and the third blood analyte levels, as well as the corrected first blood analyte level. In some embodiments, the step <NUM> may include displaying one or more of the second blood analyte level, the third blood analyte levels, and the corrected first blood analyte level on a display (e.g., display <NUM>) of the transceiver <NUM>. The step <NUM> may include the transceiver <NUM> conveying one or both of the second blood analyte level and the third blood analyte levels, as well as the corrected first blood analyte level, to a display device (e.g., display device <NUM>) for display. In some non-limiting embodiments, the transceiver <NUM> may convey one or more of the second blood analyte level, the third blood analyte levels, and the corrected first blood analyte level to the display device <NUM> via wired or wireless communication using the connector IC <NUM> or wireless communication IC <NUM>. The display device <NUM> may be configured to receive and display one or both of the second blood analyte level and the third blood analyte levels, as well as the corrected first blood analyte level. In some non-limiting embodiments, the display device <NUM> may be configured to (i) display the uncorrected, lag-compensated first blood analyte level until the display device <NUM> receives the corrected first blood analyte level and (ii) after receiving the corrected first blood analyte level, display the corrected first blood analyte level instead of the uncorrected first blood analyte level. In some non-limiting embodiments, the display device <NUM> may display the third blood analyte level as a current blood analyte level, may display the second blood analyte level as a historical/previous blood analyte level, and may display the corrected first blood analyte level instead of the uncorrected first blood analyte level as a historical/previous blood analyte level. That is, the corrected first blood analyte level may replace the uncorrected first blood analyte level in a display of historical/previous blood analyte levels.

In some embodiments, the steps of process <NUM> illustrated in <FIG> may be carried out in the order illustrated in <FIG>. However, this is not required. For example, in some alternative embodiments, steps <NUM> and <NUM> may be performed before steps <NUM> and <NUM>, simultaneously with steps <NUM> and <NUM>, or interspersed with steps <NUM> and <NUM> (e.g., performed in the order of steps <NUM>, <NUM>, <NUM>, <NUM>; steps <NUM>, <NUM>, <NUM>, <NUM>; steps <NUM>, <NUM>, <NUM>, <NUM>; steps <NUM>, <NUM>, <NUM>, <NUM>). In some alternative embodiments, step <NUM> may be broken into separate steps of displaying the third blood analyte level and displaying the corrected first blood analyte level, which may be performed after steps <NUM> and <NUM>, respectively.

In some embodiments, steps <NUM> and <NUM> may be performed only after the transceiver <NUM> determines that a lag correction should be performed for the lag-compensated but uncorrected first blood analyte level calculated in step <NUM>. For example and without limitation, in some non-limiting embodiments, the transceiver <NUM> may determine to lag-correct the uncorrected, lag-compensated first blood analyte value if a threshold amount of time (e.g., T minutes, where <NUM> ≤ T ≤ <NUM>) has passed since the first blood analyte value was calculated and/or if a threshold amount of ISF analyte levels have been calculated since the first blood analyte level was calculated. However, a step of determining whether to perform a lag correction for the uncorrected, lag-compensated first blood analyte value is not required. For example, in some alternative embodiments, the transceiver <NUM> may perform a lag correction for the uncorrected, lag-compensated first blood analyte levels automatically following calculation of the third ISF analyte level in step <NUM>.

Embodiments of the present invention have been fully described above with reference to the drawing figures. For example, although <FIG> shows the process <NUM> calculating an updated first ISF_ROC and a corrected first blood analyte level in steps <NUM> and <NUM>, respectively, after calculating two subsequent ISF analyte levels (i.e., are second and third ISF analyte levels), this is not required, and, in some alternative embodiments, the transceiver <NUM> may calculate more than two subsequent ISF analyte levels (e.g., N subsequent ISF analyte levels, where N is an integer in the range from <NUM> to <NUM>).

Claim 1:
A method of calculating and correcting analyte levels in a first medium using measurements from a second medium, the method comprising:
using a transceiver (<NUM>) to calculate an initial second medium analyte level based on at least initial measurement data;
using the transceiver to calculate an initial second medium analyte level rate of change based on at least the initial second medium analyte level and one or more past second medium analyte levels;
using the transceiver to calculate a first medium analyte level based on at least the initial second medium analyte level and the initial second medium analyte level rate of change;
using the transceiver to convey the first medium analyte level to a display device (<NUM>);
using the display device to receive and display the first medium analyte level;
using the transceiver to calculate a subsequent second medium analyte level based on at least subsequent measurement data;
using the transceiver to calculate an updated second medium analyte level rate of change based on at least the initial second medium analyte level, the subsequent second medium analyte level, and the one or more past second medium analyte levels;
using the transceiver to calculate a corrected first medium analyte level based on at least the initial second medium analyte level and the updated second medium analyte level rate of change;
using the transceiver to convey the corrected first medium analyte level to the display device; and
using the display device to receive the corrected first medium analyte level and, after receiving the corrected first medium analyte level, display the corrected first medium analyte level instead of the first medium analyte level;
wherein the display device displays the first medium analyte level until display device receives the corrected first medium analyte level.