Notes and event log information associated with analyte sensors

Abstract

To provide improved methods and computing devices that allow a user to input data about a sensor user's lifestyle and allow the user to access an event log associated with an analyte monitoring sensor.SOLUTION: A method includes: receiving into an input display window an input of information associated with one or more selected user inputs; and displaying a selectable symbol correlating with a summary of the input of information at a specific date and time on an analyte monitoring daily display window on a computing device. Selecting the selectable symbol displays, on the computing device, a pop-up display window displaying the summary of the input of information overlaid upon the analyte monitoring daily display window.SELECTED DRAWING: Figure 1A

Description

Background Art

[0001] The detection of various specimens within an individual may be essential for monitoring their health status. Deviations from normal specimen levels can indicate multiple physiological conditions. For example, in individuals with diabetes, the detection of abnormal glucose levels can be essential for maintaining health. By monitoring glucose levels with sufficient regularity, individuals with diabetes may be able to take corrective measures (e.g., by injecting insulin to lower glucose levels or by eating to raise glucose levels) before significant physiological harm occurs. Other specimens that are subject to physiological dysregulation may also desirably be monitored similarly to maintain good health.

[0002] Specimen monitoring in an individual can be performed periodically or continuously over a period of time. Periodic specimen monitoring can be performed by collecting samples of body fluids such as blood at set time intervals and analyzing them ex vivo. Continuous specimen monitoring can be performed using one or more sensors implanted within an individual's tissue, such as in the skin, subcutaneous, or intravenous, and the analysis may be performed in vivo. The implanted sensors can collect specimen data continuously or sporadically according to the specific health needs of the individual.

[0003] An individual's specimen level can be affected by various external stimuli related to that individual's specific lifestyle habits. For example, if an individual has diabetes, their food intake, exercise, or insulin injection will affect their glucose level. Such lifestyle actions may further affect other specimen levels. Additionally, other individual-specific lifestyle events may affect specimen levels and / or it may be valuable for an individual to monitor to determine which lifestyle events affect that specimen level.

[0004] Conventionally, a specimen sensor provides feedback to a user based on information (e.g., data) collected by the sensor via a receiver, which limits the ability of the user to input lifestyle data and can particularly affect the output of the specimen sensor. Further, errors or events encountered during the operation of the receiver and / or sensor may not be accessible, or may be difficult to access, by the user and / or by a troubleshooting person (e.g., a customer service person). As a result, unstable specimen measurements without a known source or cause may be obtained.

Brief Description of the Drawings

[0005] The following figures are included to illustrate certain aspects of the present disclosure and should not be regarded as exclusive embodiments. The disclosed subject matter is capable of considerable modification, alteration, combination, and equivalents in form and function without departing from the scope of the present disclosure.

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Embodiments for Carrying Out the Invention

[0006] The present disclosure generally relates to a computing device that enables a user to input data regarding the user's lifestyle habits as a sensor user and enables the user to access an event log related to a specimen monitoring sensor.

[0007] The computing device described in the present disclosure can improve the interaction with the user by enabling the user to customize inputs related to the lifestyle of the sensor user and access such information easily and quickly, especially since it is related to specific analyte levels occurring in the body of the sensor user. As used herein, with respect to the use of the computing device and display window of the present disclosure, the terms "user" and its grammatical variations include any individual who operates the computing device and interacts with its display screen, which includes, but is not limited to, the sensor user, the sensor user's physician, the sensor user's family, etc. As used herein, the term "sensor user" and its grammatical variations refer to the individual whose analyte levels are being measured or monitored. The computing device described herein enables the user to access event information related to the function of a specimen monitoring system communicatively coupled to the computing device so that the user can self-troubleshoot and / or transmit such information to a customer service representative for assistance, thereby further improving the user interaction with the computing device.

[0008] As used herein, the terms "computing device" and its grammatical variations refer to any type of device capable of processing and displaying information, including, but not limited to, mobile phones, tablets, receivers or data readers, PDAs, etc., regardless of whether the display is grayscale or color, and is further defined below with reference to display devices 104, 106 (see FIG. 11) and 1120 (see FIG. 21). As used herein, the terms "communicatively coupled" and its grammatical variations refer to any electronic communication between two components by any means, whether wired or wireless, including components that can be coupled and do not actively communicate.

[0009] In some embodiments, the computing device of the present application is preferably a handheld device such as a touchscreen mobile phone. As used herein, the term "lifestyle" and its grammatical variations refer to the behavioral patterns of the sensor user, including but not limited to food intake, activities, exercise, sleep patterns, stress, etc.

[0010] Often, the computing device associated with the analyte monitoring sensor, or another device that transmits information to the computing device, has limited usability and requires multiple steps to access data or activate certain functions. As used herein, the terms "analyte monitoring sensor", "analyte sensor", or simply "sensor", and their grammatical variations refer to ex vivo or in vivo detection devices that can determine the analyte level of the body and transmit data related to those analyte levels. In a preferred embodiment, the analyte monitoring sensor is an in vivo sensor such as a continuous analyte monitoring sensor. The sensors and detection systems are described in more detail below in this specification.

[0011] That is, in conventional computing devices, it is usually necessary to divide data and functions into multiple layers and views, and the user needs to scroll through many windows or switch views periodically, often wasting the user's time. When such a computing device is combined with an analyte monitoring sensor designed for the purpose of disease management or health monitoring, the inconvenience of these multiple layers and views can have an adverse impact on the user experience, which includes losing the desire to use.

[0012] Typically, conventional computing devices associated with specimen monitoring sensors do not allow users to input specific information regarding the lifestyle habits of the sensor user that is easily inputtable and then easily accessible without the user having to navigate through many views. For example, conventional computing devices may stratify various potential lifestyle inputs without allowing customization of the information or specific inputs, and as a result, the data is limited (e.g., a meal without the associated amount of carbohydrates, exercise without intensity or duration), and furthermore, cannot be viewed in a single display window. However, linking the lifestyle habits of the sensor user to the specimen-level measurements (e.g., concentration) at a specific date and time may be important for controlling a specific disease (e.g., diabetes) or for the health of the sensor user. The multiple steps characteristic of conventional computing devices may discourage the user from linking their lifestyle events to the specimen level, which can result in poor disease management and adverse health effects.

[0013] Furthermore, embodiments of the present disclosure enable rapid user access to events related to the function of paired specimen monitoring sensors, thereby enabling the user to determine how to troubleshoot the operation of the sensors. Since conventional computing devices do not provide this function, accurate specimen-level measurements cannot be obtained, which can result in inadequate disease management or adverse health effects.

[0014] Accordingly, with the embodiments described herein, a user can access a snapshot view of important sensor user lifestyle data and an important snapshot view of events related to the functions of the analyte monitoring sensors. These snapshot views collate data, if any, contained in conventional computing devices, or otherwise heterogeneous data. Collating such data facilitates the input of lifestyle information and enables easy access to already summarized data related to the lifestyle of the sensor user (e.g., access by the sensor user, by a treating physician, by family members such as parents or siblings). Thus, embodiments of the present disclosure improve the performance of the display screen and interactive interface related to analyte sensor measurements, thereby improving the evaluation and treatment of various diseases monitored by the analyte.

[0015] By accessing such a lifestyle snapshot of information related to a particular analyte measurement (e.g., the concentration at a particular date and time), it becomes possible to quickly and accurately adjust the user's health status and / or positive or negative lifestyle choices. For example, the user can determine whether exercise at a particular intensity is beneficial or harmful to the analyte level and accordingly change the exercise plan. The user can identify specific food groups that are beneficial or harmful to the analyte level and accordingly adjust the dietary decision.

[0016] Access to the event log snapshot of information regarding a particular analyte measurement (e.g., the concentration at a particular date and time) of the present disclosure enables the user to troubleshoot potentially incorrect analyte measurements that could lead to unnecessary or potentially harmful treatment actions (e.g., when the sensor is too cold to make an accurate measurement, the user knows not to immediately inject insulin or consume a certain food to change the glucose level). Further, the combination of the sensor user's lifestyle information and the event log of the present disclosure enables the user to more accurately understand the analyte measurements and make appropriate treatment decisions.

[0017] Figures 1A to 10B illustrate the computing device of the present disclosure with respect to a glucose analyte monitoring sensor. However, it should be understood that the computing device of the present disclosure is suitable for use with any other type of analyte monitoring sensor (e.g., a lactate monitoring sensor) without departing from the scope of the present disclosure.

[0018] Input of information and notes corresponding to the lifestyle of the sensor user Referring now to FIGS. 1A and 1B, two exemplary embodiments of the display screen of a computing device are shown that display an analyte monitoring scan display window, or more specifically, in these embodiments, a "my glucose" display window. As used herein, an "analyte monitoring scan display window" or simply a "scan display window", and its grammatical variations, refer to a display window of a computing device having a display screen configured to show at least one characteristic (e.g., date and time) of a measured analyte associated with a particular analyte scan event, which may include additional analyte measurements. The scan display window is distinguishable from the analyte monitoring daily display window of the computing device, which is discussed in detail below herein.

[0019] As shown in FIGS. 1A and 1B, when selected, the scan display window enables scanning of a specimen monitoring sensor communicatively coupled to a computing device having a display screen on which the user displays the scan display window, and may include an icon in the upper right corner of the display window. For example, in one embodiment, when the "Scan" icon (or other selectable symbol or button that prompts scanning, such as "Ready to Scan" or "Please Scan") is activated or selected, data is automatically collected from the computing device described herein. In some embodiments, when a computing device is placed near the specimen monitoring sensor, a connection is established (e.g., a Near Field Communication (NFC) connection) and data from the sensor can be transmitted to the computing device. In certain embodiments, the scan display window or other display window can be automatically activated to display to the user the specimen level of the sensor user (e.g., a graphical display, the actual specimen level or concentration, other derived specimen levels (e.g., A1c), etc.). That is, one or more of the display screens of the computing device can automatically alert the user (e.g., as a notification) about the scan data (e.g., the display window of FIG. 1A or 1B can automatically appear on the computing device). The display can display any or all of a specimen level trend arrow, a trend specimen level message, the current specimen measurement value, etc., as described below.

[0020] In some embodiments, when the computing device is in an idle state (e.g., a mobile phone in sleep mode), a notification banner can be displayed to alert the user (e.g., the sensor user) to launch the scan display window and / or scan the analyte monitoring sensor. That is, the computing device can be configured to prompt the user to scan the analyte level of the sensor user at a specific time, which can be preconfigured or configured by a user including the sensor user. For example, if the computing device is a mobile phone, whether it is locked or in the "sleep" mode (and any variations thereof), the scan display window is displayed and / or another form of prompt is displayed without departing from the scope of the present disclosure. That is, when the computing device has a sleep mode, the embodiments described herein enable the computing device to communicate to the user the need to scan the analyte level of the sensor user, thereby enabling the user to easily obtain the analyte level (e.g., glucose) without actually activating the computing device or transitioning from the sleep mode. In some embodiments, the computing device can automatically scan the analyte measurements when the computing device (e.g., a mobile phone, tablet, PDA, fitness monitor, or pedometer, etc.) described herein is placed near the analyte monitoring system. That is, in the embodiments of the present disclosure, there may be cases where a physical scan is required and cases where it is not required.

[0021] Accordingly, the scan display window displays a particular past scan (e.g., a scan that occurred immediately before or a little before the scan display window is displayed, shown as 137 mg / dL in FIG. 1A), but can be used by the user to initiate a new scan (e.g., a consecutive scan from the previous scan, or a scan after a certain period of time). For example, the user may want to perform a consecutive scan immediately after or a little after the previous scan to test the accuracy of the coupled sensor.

[0022] The scan display window may further include one or more clocks (digital or analog, applicable to all display windows throughout this specification), the current analyte level concentration based on the last scan of the analyte monitoring sensor, a graphical display of the analyte level over time, and a coded target range of the analyte level (e.g., the shaded region of 100 - 140 mg / dL in FIGS. 1A and 1B). As shown in FIGS. 1A and 1B, the graphical display of the analyte level over time is drawn with time on the x-axis and the analyte level in milligrams per deciliter (mg / dL) per deciliter on the y-axis. Other units (e.g., use of a 24-hour clock, use of millimoles per liter (mmol / L) for the analyte level, etc.) or unit intervals can define the graphical display without departing from the scope of the present disclosure, provided that the level of the analyte is associated with a particular date and time.

[0023] In some embodiments, as shown in FIGS. 1A and 1B, the scan display window can notify the sensor user whether the analyte level is within a particular target range by displaying an analyte level trend arrow and / or a trend analyte level message. The target range can be defined by a computing device or the user (e.g., the sensor user), and thus, in some embodiments, can be adjustable for customization.

[0024] Trend arrows can include an upward - right diagonal arrow indicating that the analyte level is rising, a vertical upward arrow indicating that the analyte level is rising rapidly, a horizontal right or left (preferably right) arrow indicating that the analyte level is stable or changing slowly, a downward - right diagonal arrow indicating that the analyte level is decreasing, and a vertical downward arrow indicating that the analyte level is decreasing rapidly. The trend analyte - level message can include words stating that the analyte level is above a high threshold, between the target range and the high threshold, within the target range, below a low threshold, or between the target range and the low threshold. Alternatively, or in addition to the trend arrows and / or the trend message, color - coding can be used, such as in orange, yellow, green, yellow, and red, to indicate respectively that the analyte level is above a high threshold, between the target range and the high threshold, within the target range, below a low threshold, or between the target range and the low threshold. In embodiments of the present disclosure, the trend arrows, the trend message, and the color - coding can be displayed simultaneously or alternatively in a scan - display window. Thus, one or more means for communicating the trend of the analyte level to the sensor user can be employed to accommodate a particular individual (e.g., for a user with color blindness, color - coding may not be useful, and thus one or both of the trend arrows and / or the message may be relied upon). As shown in FIGS. 1A and 1B, the glucose analyte level is within the target range, indicated by each of a horizontal right trend arrow, a trend message of the message “Glucose is in range”, and a green color - coding.

[0025] Thus, when scanning the analyte level of the sensor user corresponding to the measurement value provided by the analyte monitoring sensor, the scan display window of the computing device described herein having a display screen can be accessed. The scan display window may further be a display window for accessing other functions, including accessing a user input button associated with the lifestyle of the sensor user at a certain date and time. As used herein, the term "button" and its grammatical variations, when actuated (e.g., pressed or contacted), without limitation as to size, style, texture, tactile, shape, etc., refer to an element of a computing device having multiple display screens that causes some change to a particular display window (e.g., embodied in a computer screen, hyperlink, keyboard, slide bar, scroll bar, etc.). It should be understood that various components of the scan display window, including but not limited to terms, color-coding, arrow direction, scale, size, arrangement, and / or icons, can be changed without departing from the scope of the present disclosure.

[0026] The scan display window of the present disclosure may include a function for quickly accessing a limited number of user input buttons related to the lifestyle of the sensor user at a specific date and time. As shown in FIGS. 1A and 1B, access to the user input button may be in the form of a button having an icon in the shape of a pen or a pencil. In some embodiments, the pen or pencil icon may be drawn generally pointing downward and to the left, although other configurations are also within the scope of the present disclosure. The icon may be alone or may be accompanied by accompanying text such as "Add Note" shown in FIG. 1A. As used herein, the terms "note addition button" and its grammatical variations refer to a button as part of a display window of a computing device (e.g., a scan display window) having a plurality of display windows that enable user input regarding the lifestyle of the sensor user, and are not limited to specific terms or icons. For example, other texts or symbols, alone or in combination, may be used without departing from the scope of the present disclosure, such as adding a diary, entering a note, a notepad icon, etc.

[0027] The note addition button can include an icon and any accompanying text that the user can select (e.g., via a touch screen in this embodiment) and transition to an input display window having a limited number of user input buttons associated with the lifestyle of the sensor user at a specific date and time. It should be understood that any other icon and / or text design or term that prompts the user to understand that selecting the relevant button results in access to the input display window can be used in accordance with the present disclosure without departing from the scope of this specification.

[0028] Accordingly, when the note addition button (see FIGS. 1A and 1B) is selected, a computer device having a display screen of the present disclosure may transition to an input display window. Here, referring to FIGS. 2A and 2B, two exemplary embodiments of a display screen of a computing device that displays an input display window, or more specifically, a "note addition" display window in these embodiments, are shown. As used herein, "input display window" and its grammatical variations refer to a display window of a computing device having a display screen configured to enable a user to input information regarding the lifestyle habits of a sensor user, whether free-form or a specific prompt.

[0029] The input display window of the present disclosure may include a list of a limited number of user input buttons related to the lifestyle habits of a sensor user at a specific date and time. These user input buttons may be designed to track certain known influencers of an analyte being measured by an analyte monitoring sensor communicatively coupled to the computing device. As shown in FIGS. 2A through 2C, such a limited number of user input buttons may include, but are not limited to, food, rapid-acting insulin, long-acting insulin, exercise, comment, and any combination thereof. The various user input buttons may be associated with various icons, as shown in FIGS. 2A and 2B. It should be understood that there is no need for such icons to exist, and the specific style of the icons that do exist is not limited to those shown in FIGS. 2A and 2B, provided that they represent specific user input buttons.

[0030] In some embodiments, the user input can be dynamic based on information previously collected from previous input information. For example, in some embodiments, the user input buttons that appear are associated with the most frequently used functions such as taking a meal or an insulin bolus. In other embodiments, the computing device can be configured such that the display screen is predictive. For example, when the analyte level of the sensor user is high, the computing device can automatically display or provide user input buttons to prompt the user (e.g., the sensor user) to input data related to the sensor user's lifestyle habits such as a recent meal or insulin injection. That is, the computing device can be configured to detect certain spikes in the analyte level and prompt the user to input data related to the sensor user's lifestyle habits. For example, if the glucose has risen sharply because the sensor user has probably just eaten, the food user input button is displayed, or if the glucose level has suddenly dropped, perhaps because the sensor user has just been administered an insulin bolus, the rapid-acting or long-acting user input buttons can be automatically displayed. Thus, the user can be prompted to input based on the dynamic measurements of the analyte monitoring sensor.

[0031] The user input buttons in the input display window can be selected by selecting the associated icon, the description of the user input button, and / or a selectable symbol (e.g., a checkbox). For example, as shown in FIGS. 2A and 2B, the user input buttons for food, rapid-acting insulin, long-acting insulin, and exercise are selectable using selectable symbols in the form of checkboxes, while the comment input button becomes selectable when the word "comment" or the comment icon is selected (see FIG. 2A). Any variation in selectability is encompassed within the teachings of the present disclosure described herein without departing from its scope.

[0032] The input display window can further include a plurality of additional information for viewing or operation by a user of the computing device, which includes, but is not limited to, the current analyte level concentration based on the last scan of the analyte monitoring sensor, trend arrows, and / or messages, color-coding, specific date and time, selectable cancel button, and / or selectable approval (or "complete") button. Other functions of the input display window may include, without departing from the scope of the present disclosure, selectable scan buttons or icons, selectable main menu buttons or icons, selectable settings buttons or icons, and / or selectable back buttons or icons as shown in FIG. 2B. It should be understood that various components of the input display window, including, but not limited to, terms, color-coding, arrow direction, scale, size, arrangement, and / or icons, can be changed without departing from the scope of the present disclosure, provided that there are a limited number of user input buttons for user input regarding the sensor user's lifestyle habits.

[0033] Referring now to FIGS. 3A - 3J, a series of views of an input display window representing user interaction according to one or more embodiments of the present disclosure are shown. Within the input display window (e.g., FIGS. 2A and 2B), a user can interact with a limited number of user input buttons displayed therein. When choosing to input specific information regarding the lifestyle of the sensor user using the limited number of user input buttons, the associated icon can be highlighted or emphasized (e.g., by color, bold text, etc.) to explain to the user whether the input is complete or in progress. Each user input regarding the lifestyle of the sensor user is linked via the electronic device of the computing device at a specific date and time when the user has input the information and approved the input (e.g., selected the "done" button), as will be explained below. By doing so, the user can track the lifestyle choices of the sensor user in relation to the specific analyte levels being measured or monitored by the analyte monitoring sensor. Further, as will be explained below, a computing device having a display screen according to the embodiments described herein directly associates the lifestyle information of the sensor user with the analyte monitoring data on the scan display and further enables direct access to the lifestyle information therefrom.

[0034] As shown in FIGS. 3A - 3C, a user can select a food user input button by selecting a selectable symbol (e.g., a checkbox), and then additional information is prompted to the user within an input display window. In this embodiment, the user is prompted to select a meal appropriate for the input, which may be in the form of a drop - down menu, a scroll menu, or other selectable menu type. The selection of meals can include, but is not limited to, breakfast, lunch, dinner, and snacks, without being restricted to any particular order. As shown in FIG. 3C, upon selecting an appropriate meal (e.g., lunch), the user can input specific information regarding the meal that may be related to a particular analyte level being measured or monitored by the analyte monitoring sensor. As shown in FIG. 3C, the user can input a specific gram of carbohydrates related to the sensor user's meal, which can be input via, for example, a keyboard or touch screen, voice - activated text, and / or another input - able or selectable menu. Other specific information may also be prompted for user input, provided it is related to the analyte level of interest, such as a specific type of sugar for glucose monitoring, without departing from the scope of the present disclosure.

[0035] When a single user input regarding the lifestyle of the sensor user is made, the user can approve the input and indicate (e.g., by selecting a completion button) in the input display window that the user has completed the input. Alternatively, the user may wish to continue entering additional information regarding the lifestyle of the sensor user. FIGS. 3D and 3E show a user who has already entered food input further selecting selectable symbols for the input of rapid-acting insulin, whereupon the user is then prompted to enter the specific units of rapid-acting insulin ingested at that particular date and time. Although not shown, the user may similarly select selectable symbols for entering the dosage of long-acting insulin (e.g., in units). As shown in FIG. 3E, in the event of additional input regarding the lifestyle of the sensor user, any previous input remains visible and editable by the user to ensure that the overall picture of the sensor user's lifestyle at that particular date and time is accurately captured. When the user makes multiple inputs of information regarding the lifestyle of the sensor user, the input display window may include a scroll bar (e.g., on the right or left side of the display window) to allow the user to access information that exceeds the size of the display screen of the computing device (see FIGS. 4H-4J showing a scroll bar on the right side of the display window).

[0036] Figures 3F and 3J show that the user further selects selectable symbols for the input of exercise, and then the user can be prompted to select a specific energy intensity level. For example, the "Select Intensity" prompt shown in Figure 3F enables the user to select a selectable menu (e.g., a drop-down menu, a scrollable menu, etc.) that allows the user to select a specific intensity such as the low-intensity, medium-intensity, and high-intensity options shown in Figure 3G. When the user selects a specific exercise intensity, as shown in Figure 3H, the user can be prompted to enter the duration of the exercise. As shown in Figure 3H, a selectable menu for entering the duration is selected by the user, and then the display screen of the computing device can transition to a duration display window (see Figure 3I).

[0037] As used herein, "duration display window" and its grammatical variations refer to the display window of a computing device having a display screen configured to allow the user to select or enter a specific duration. As shown in Figure 3I, the duration display window may include a selectable menu for entering duration information in hours and minutes, depicted as a scroll menu in Figure 3I, but this may be any form of selectable menu that includes enabling the user to enter duration information in hours and minutes (e.g., via typing, text, or voice-activated input). In some embodiments, the duration display window may further enable the input of other time intervals such as seconds without departing from the scope of the present disclosure. The duration display may further include other features and functions such as a title for the duration display window (e.g., "Edit Time"), a selectable cancel button, and / or a selectable approval (or "Done") button without departing from the scope of the present disclosure. When the entered time is approved, the display screen of the computing device transitions back to the input display window.

[0038] In other embodiments, rather than the user selecting a selectable symbol for input of an exercise and then transitioning to the duration display window, if the user selects a particular energy intensity level, a selectable menu for inputting duration information in hours and minutes can be directly displayed in the input display window (see FIGS. 4H and 4I). In such embodiments, the information is directly input into the input display window and is viewable along with additional input information entered by the user in relation to the sensor user's lifestyle habits.

[0039] Although not shown, the user can further enter comments into the input display window via a keyboard or touch screen, via voice-activated text, or via a selectable menu having specific pre-coded narratives. These pre-coded descriptions may be included as part of the computing device or may be configurable by the user. For example, such descriptions may relate to stress, sleep patterns, or other common lifestyle events related to the sensor user's life. When included, these comments are viewable, but not necessarily, along with other input information within the input display screen (as well as within the pop-up display windows of FIGS. 7A and 7B) without departing from the scope of the present disclosure.

[0040] FIGS. 4A-4J show a series of views of an input display window according to one or more embodiments described herein that represent user interactions according to one or more embodiments of the present disclosure. FIGS. 4A-4J represent embodiments that are substantially similar to the embodiments described above with reference to FIGS. 3A-3J, although the aesthetics and specific features are different, and thus will not be described in detail again here.

[0041] Figs. 3J and 4J represent a user-completed input display screen according to one or more embodiments of the present disclosure, which allows the user to view all input information in a single location and approve the input information (e.g., by selecting a "complete" button). It should be understood that any or all of the user input buttons, including comment input, may be selected, and information regarding the sensor user's lifestyle habits may be input without departing from the scope of the present disclosure.

[0042] Upon approval of the input information related to the sensor user's lifestyle habits, the display screen of the computing device transitions back to the scan display window, where specific input data can be associated with the specific date and time when the input was approved, and specific inputs can be displayed as selectable icons (see Fig. 5A). As shown in Figs. 5A and 5B, the scan display window displays the time when the input information was approved by the user and can be updated to associate such time with a specific analyte level. Alternatively, if the data is input within a finite time after the scan (e.g., less than 3 or 5 minutes), the user input information is automatically associated with the specific date and time of the last scan, or, without departing from the scope of the present disclosure, the user may input a specific date and time for association.

[0043] Visually, time can be displayed as a clock or as the amount of time elapsed since the last scan and / or user input. The scan display window can display the last scan as a hatched line in a graphical representation of analyte levels over a relatively short time period (e.g., 8 - 12 hours), can include selectable icons or other selectable symbols to indicate that user information is associated with a particular scan or analyte level at a particular time, and / or can include selectable edit buttons to enable the user to enter additional notes and / or edit notes that have already been entered (e.g., "Edit Note" in FIG. 5A or the pencil or pen icon in FIG. 5B). As shown, icons or other symbols are used to indicate that user information has been entered at a particular date and time and are editable by selecting the selectable edit button or directly selecting the icon or symbol without departing from the scope of the present disclosure.

[0044] The analyte monitoring daily display window of a computing device can be accessed by transitioning from the analyte monitoring scan display window, for example, by pressing the back arrow icon shown in the upper left corner of FIGS. 5A and 5B, or by other means of transitioning the display window. As used herein, the term "analyte monitoring daily display window" or simply "daily display window" and its grammatical variations refer to a display window of a computing device having a display screen configured to show a plurality of measured analyte levels (e.g., concentrations) each associated with a particular date and time and covering a period of at least 24 hours. The daily display window can be the primary display window of the computing device described herein. Representative embodiments of the daily display window according to one or more embodiments of the present disclosure are shown in FIGS. 6A - 6D.

[0045] As shown in FIGS. 6A-6D, the functions of the daily display window include an icon bar (e.g., in days and times represented by a graphic such as a bar whose color or shape changes) indicating the countdown of the sensor life of the associated analyte monitoring sensor, a graphic display of the analyte level over a period of at least 24 hours, a coded target range of the analyte level (e.g., the shaded area of 100-140 mg / dL in FIGS. 6A and 6B), a selectable scan button or icon (e.g., the upper right icon in FIG. 6A or the bell icon in FIG. 6B), a selectable main menu button or icon (e.g., the hamburger icon in the upper left corner of FIGS. 6A and 6B), a selectable settings button or icon (e.g., the vertical dot icon in the upper right corner of FIG. 6B), a display of the period represented by the daily display window (e.g., "Past 24 Hours"), an icon ("i") indicating that such information is being displayed, a display of the time when a new sensor is ready for use (e.g., display of remaining warm-up time or sensor ready time), and / or various data related to the analyte level during the measurement period (e.g., "Target Time", "Last Scan", "Average", etc.), but is not limited thereto. In some embodiments, the selectable settings button or icon is integrated such that information regarding such settings and the information described below are placed within the selectable main menu (i.e., rather than having two separate menus).

[0046] In addition to these features, as shown in FIGS. 6A and 6B, the daily display window may display one or more selectable symbols that correlate to user input data regarding the sensor user's lifestyle habits. The selectable symbols may be arranged along a graphical timeline such that their locations correlate to the date and time at which a particular input was recorded. By doing so, input information regarding the sensor user's lifestyle habits can be correlated to a particular analyte level, thereby enabling the sensor user to make an informed decision regarding future lifestyle choices and their impact on a particular analyte level. As shown in FIGS. 6A and 6B, the dates may be a relative display based on the current date (e.g., Tue / Thu in FIG. 6A, and Sat / Sun in FIG. 6B), and / or the actual dates may be displayed. Other features may be displayed in the daily display window of the computing device described herein without departing from the scope of the present disclosure. It should be further understood that various components of the daily display window, including but not limited to terms, color-coding, arrow directions, scales, sizes, arrangements, and / or icons, may be changed without departing from the scope of the present disclosure.

[0047] The selectable symbols (or icons) of the daily display window can be any signal that indicates a summary of the information input by the user. In some embodiments, the selectable symbols of the daily display window can be a single symbol (e.g., the running person symbol in FIG. 6A), two or more overlaid symbols (e.g., the apple and syringe symbols in FIG. 6B), or stacked symbols that indicate a number representing the number of inputs at a particular date and time (e.g., the stacked symbols indicating the number '3' in FIG. 6A and the number '4' in FIG. 6B). Any other symbols may be suitable without departing from the scope of the present disclosure, provided that they represent user input information, and may or may not be correlated with the symbols (if any) displayed in the input display window.

[0048] As shown in the embodiments of FIGS. 7A and 7B, the user can select one of the icons selectable from the daily display window to display a pop-up display window of a summary of the input information overlaid on the daily display window. As shown, the pop-up display window may include the time of input and a summary of the input information entered by the user, which may vary depending on which limited user input button the user selected to provide the input (see, for example, FIGS. 2A and 2B above). The pop-up display window may include any summary showing information entered by the user, including but not limited to the relevant icon, an explanation of the user input button, and the date of the input provided by the user, as shown in FIGS. 7A-7C. Further, the pop-up display window may include a selectable edit icon (e.g., a pencil or pen icon, or any other form of a selectable edit button) located at a position within the pop-up display window, and this edit icon is selectable to enable the user to access the input display window again and change the input if such a change is necessary, for example, to ensure the accuracy of the input. Further, in some embodiments, a selectable approval button (e.g., "OK") may be included, and selecting the approval button closes the pop-up display window (e.g., becomes invisible or is no longer displayed), and the entire daily display window appears again. Alternatively, or additionally, the user can select a part of the pop-up display window (i.e., not the selectable edit icon button or approval button) to make the pop-up display window invisible and display the entire daily display window again, or the user can select a part of the daily display window (i.e., not a button selectable in other ways) to make the pop-up display window invisible and display the entire daily display window again.

[0049] Without departing from the scope of the present disclosure, other features may be displayed in the pop-up display window of the computing device described herein, provided that they include a summary of the input information at a specific date and time related to the sensor user's lifestyle. It should be further understood that various components of the daily display window, including but not limited to terms, color-coding, arrow directions, scales, sizes, arrangements, and / or icons, may be changed without departing from the scope of the present disclosure.

[0050] Event log related to the specimen monitoring sensor As described above, a computing device having a plurality of display screens according to the present disclosure may include an event log related to the specimen monitoring sensor at a specific date and time. Thus, the computing device enables tracking of the functions of the specimen monitoring sensor, allows the user to access the event log of the specimen monitoring sensor for monitoring or troubleshooting, and enables the user to send the event log data to a customer service representative who can assist the user in troubleshooting the sensor. FIGS. 8A-10B illustrate one or more embodiments of the computing device described herein that enable a user to access and send an event log of a communicatively coupled specimen monitoring sensor. It should be understood that various features of FIGS. 8A-10B, including but not limited to terms, color-coding, scales, sizes, arrangements, and / or icons, may be changed without departing from the scope of the present disclosure.

[0051] Referring now to FIGS. 8A and 8B, there is shown a display screen of a computing device of the present disclosure that displays various user-selectable buttons accessible from a selectable main menu button or icon or a selectable settings button or icon according to one or more embodiments of the present disclosure. The user-selectable buttons may be generalized buttons for navigating a plurality of display screens of the computing device and, in some embodiments, may be accessed via an icon or menu symbol (e.g., a hamburger icon or a vertical dot icon). Thus, the generalized user-selectable buttons enable user selection to access various display screens related to the computing device and / or a sample monitoring sensor communicatively coupled thereto. Any suitable user-selectable buttons are included in the embodiments shown in FIGS. 9A and 9B without departing from the scope of the present disclosure, which include a home display window, a logbook display window, a reminder display window, report display windows associated with various usage patterns (e.g., daily pattern, target time, low or high sample (e.g., glucose) events, average sample (e.g., glucose) level, daily graph, estimated sample or sample-related level (e.g., A1c), and / or sensor usage), a settings display window, a share display window, an about display window, an account display window, and / or a help display window. One or more icons may or may not be associated with the user-selectable buttons and is not limited thereto.

[0052] When a user selects one of the generalized user-selectable buttons from the main menu or the settings menu (collectively referred to herein as the "main menu"), the user is led to a new menu display window that presents a limited number of additional user-selectable buttons, including an event log button. As shown in FIGS. 9A and 9B, the generalized button may be a "Help" button and transitions to a menu display window having a limited number of user-selectable buttons, including the event log button. In the non-limiting embodiments shown in FIGS. 9A and 9B, other user-selectable buttons displayed in the menu display window include, but are not limited to, methods of applying the sensor, methods of scanning the sensor, analyte (e.g., glucose) measurements, user manuals, terms of use, and / or privacy notifications. Although the event log button is depicted in FIGS. 9A and 9B as part of the help menu display window, it should be understood that the location of the event log button may be accessible via any of the generalized user-selectable buttons described above without departing from the scope of the present disclosure. The menu display window (shown as the help menu display window in FIGS. 9A and 9B) may further include, among other potential features, a selectable scan button or icon, a main menu or settings menu icon, and / or a back button.

[0053] The user may select the event log button and be led to the event log of the computing device of the present disclosure. That is, when the user selects the event log button, the computing device transitions to an event log display window. As used herein, the term "event log display window" and its grammatical variations refer to a display window of a computing device having a display screen configured to show at least one event related to a specimen monitoring sensor at a particular date and time. FIGS. 10A and 10B show embodiments of an event log display window according to one or more embodiments of the present disclosure. As shown, each event can be accompanied by, but does not necessarily have to be accompanied by, among other potential features, an event association number (e.g., "375" in FIG. 10A and "335" and "336" in FIG. 10B), an event title, an event description, an icon or symbol of the event, and / or the date and time at which the event occurred.

[0054] In some embodiments, the event log records events related to errors in scans of the specimen monitoring sensor, events related to the temperature of the sensor (e.g., the sensor may be too cold to provide accurate specimen measurements), and / or the detection of a new sensor. Any suitable event related to the functionality of the sensor may further be included in the event log without departing from the scope of the present disclosure. In some embodiments, the event log prompts the user and / or the sensor user to take a specific action, such as starting or monitoring a specimen measurement, using the new sensor detected by the computing device. In other embodiments, the event log may further display a link or page number to a user manual that explains the event (e.g., which may be an error event) and related improvement steps. The link may be to a user manual stored on the device or to a website containing information about the error. If the computing device receives multiple event log entries, the event log display window includes a scroll bar (e.g., on the right or left of the window) to enable the user to access information that exceeds the size of the display screen of the computing device, as shown in FIGS. 10A and 10B.

[0055] Event logs can be useful to users of computing devices and associated sensors, and an event log display window can further enable the user to send event log data to customer service personnel, such as those involved in the manufacture of the sensors where the events occurred. The event log data can be sent to customer service personnel using a user-selectable button, such as a "troubleshooting data send button," as shown in FIG. 10B. As used herein, the term "troubleshooting data send button" and its grammatical variations refer to a user-selectable button that can send event log information related to a specimen monitoring sensor, regardless of the terminology, size, shape, etc. of a particular button. Alternatively, or in addition, the troubleshooting data send button can send data to customer service personnel associated with not only the manufacturer of the sensor but also the computing device. In other embodiments, upon receiving a data event log, confirmation of the received message may be sent back to the user in the form of a banner, icon, or other symbol. The message may include further information regarding improvement measures that a customer service representative may take, such as warning the user that the sensor is malfunctioning, advising the user to stop using the sensor, warning the user that a new replacement sensor has been sent, or combinations thereof.

[0056] Referring now to FIGS. 25A and 25B, various display screens of a computing device presenting a startup display window conforming to one or more embodiments of the present disclosure are shown. The startup display window can include various elements, as shown, including a brand name (e.g., FreeStyle™ LibreLink™), a specimen monitoring device (e.g., a glucose sensor) that can be communicatively coupled to the computing device, one or more brand icons (e.g., a butterfly), buttons that enable access to multiple additional display screens, a selectable main menu button or icon, and / or a selectable settings button or icon.

[0057] Exemplary Embodiment of an In Vivo Specimen Monitoring System Referring now to FIG. 11, specimen monitoring system 100 includes a specimen monitoring sensor 101, a data processing unit 102 connectable to sensor 101, and a primary receiver unit or display device 104. In some examples, primary display device 104 is configured to communicate with data processing unit 102 via communication link 103. In some embodiments, primary display device 104 may be further configured to transmit data to data processing terminal 105 for evaluating or otherwise processing or formatting data received by primary display device 104. Data processing terminal 105 may be configured to receive data directly from data processing unit 102 via communication link 107, and communication link 107 may optionally be configured for two-way communication. Further, data processing unit 102 may include electronics and a transmitter or transceiver for transmitting and / or receiving data between primary display device 104 and / or data processing terminal 105 and / or optionally a secondary receiver unit or display device 106.

[0058] FIG. 11 also shows an optional secondary display device 106 operably coupled to communication link 103 and configured to receive data transmitted from data processing unit 102. Secondary display device 106 may be configured to communicate with primary display device 104 as well as data processing terminal 105. In some embodiments, secondary display device 106 may be configured for bi-directional wireless communication with each of primary display device 104 and data processing terminal 105. As will be described in more detail below, in some examples, secondary display device 106 may be a receiver with limited functionality as compared to primary display device 104; for example, secondary display device 106 may include a limited or minimal number of functions and features as compared to primary display device 104. Accordingly, secondary display device 106 may include a smaller and more compact housing (in one or more (including all) dimensions), or may be incorporated into a device such as a wristwatch, armband, PDA, MP3 player, cellular phone, etc. Alternatively, secondary display device 106 may be configured with the same or substantially similar functions and features as primary display device 104. Secondary display device 106 may include, for example, a docking portion configured to mate with a docking cradle unit for placement near a bedside for night-time monitoring, and / or a bi-directional communication device. The docking cradle can recharge the power supply.

[0059] A computing device having a plurality of display screens described herein may be either or both of primary display device 104 and / or secondary display device 106, or display device 1120, according to embodiments of the present disclosure.

[0060] In the embodiment of the specimen monitoring system 100 shown in FIG. 11, only one specimen sensor 101, a data processing unit 102, and a data processing terminal 105 are shown. However, it will be understood by those skilled in the art that the specimen monitoring system 100 may include two or more sensors 101 and / or two or more data processing units 102, and / or two or more data processing terminals 105. Multiple sensors may be arranged for the user to monitor specimens either simultaneously or at different times. In some embodiments, the specimen information obtained by a first sensor arranged for the user may be used as a comparison with the specimen information obtained by a second sensor. This helps to confirm or verify the information of the specimen obtained from one or both sensors. Such redundancy can be useful when the specimen information is considered in important decisions related to treatment. In some embodiments, the first sensor can be used to calibrate the second sensor.

[0061] In a multi-component environment, each component is configured to be uniquely identified by one or more of the other components within the system, so that communication conflicts between the various components within the specimen monitoring system 100 can be easily resolved. For example, a unique ID, a communication channel, etc. can be used.

[0062] In some embodiments, sensor 101 is physically disposed within or on the body of a user whose analyte level is being monitored. Sensor 101 may be configured to at least periodically sample the user's analyte level and convert the sampled analyte level into a corresponding signal for transmission by data processing unit 102. Data processing unit 102 is couplable to sensor 101 such that at least a portion of the analyte sensor 101 is disposed transcutaneously and both devices are disposed within or on the body of the user. Data processing unit 102 may include a securing element such as an adhesive to secure it to the user's body. A mount (not shown) that is attachable to the user and couplable to data processing unit 102 may be used. For example, the mount may include an adhesive surface. Data processing unit 102 performs data processing functions, such functions may include, but are not limited to, filtering and encoding of data signals, and each of the data signals corresponds to the user's sampled analyte level for transmission to primary display device 104 via communication link 103. In some embodiments, sensor 101 or data processing unit 102 or the combined sensor / data processing unit may be fully implantable beneath the user's skin surface.

[0063] In some embodiments, primary display device 104 includes an analog interface section that includes an RF receiver and an antenna configured to communicate with data processing unit 102 via communication link 103, and a data processing section for processing data received from data processing unit 102, including data decoding, error detection and correction, data clock generation, data bit recovery, etc., or any combination thereof.

[0064] During operation, in some embodiments, the primary display device 104 is configured to synchronize with the data processing unit 102 and uniquely identify the data processing unit 102, for example, based on the identification information of the data processing unit 102, and then periodically receive signals transmitted from the data processing unit 102 related to the analyte level being monitored by the sensor 101.

[0065] Continuing to refer to FIG. 11, the data processing terminal 105 may include a portable computer, such as a personal computer, laptop, or handheld device (e.g., a personal digital assistant (PDA), a mobile phone (e.g., an iPhone (registered trademark), Blackberry (registered trademark), an Android (registered trademark) phone, or a similar multimedia and Internet-enabled mobile phone), a phone, an mp3 player (e.g., an iPod (registered trademark), etc.), a pager, etc.), and / or a drug delivery device (e.g., an infusion device), each of which may be configured for data communication with a display device via a wired or wireless connection. Further, the data processing terminal 105 may be further connected to a data network (not shown) for storing, retrieving, updating, and / or analyzing data corresponding to the detected analyte level of the user.

[0066] The data processing terminal 105 includes a drug delivery device such as an insulin infusion pump (e.g., an infusion device), which is configured to administer a drug (e.g., insulin) to a user and, in particular, may be configured to communicate with the primary display device 104 to receive the measured analyte level. Alternatively, the primary display device 104 may be configured to integrate the infusion device therein such that, for example, it manages and modifies a basal profile and, in particular, determines an appropriate bolus for administration based on the detected analyte level received from the data processing unit 102 to administer an appropriate drug (e.g., insulin) to the user. The infusion device may be an external device or an internal device such as a device that can be fully embedded in the user.

[0067] In some embodiments, the data processing terminal 105, which may include an infusion device such as an insulin pump, is configured to receive an analyte signal from the data processing unit 102 and thus incorporates the functionality of the primary display device 104, including data processing for managing the user's insulin therapy and analyte monitoring. In some embodiments, the communication link 103 shown in FIG. 11, as well as one or more of the other communication interfaces, may use one or more wireless communication protocols such as an RF communication protocol, an infrared communication protocol, a Bluetooth-compatible communication protocol, an 802.11x wireless communication protocol, or an equivalent wireless communication protocol that enables secure wireless communication of multiple units while avoiding potential data collisions and interference (e.g., in accordance with the requirements of the Health Insurance Portability and Accountability Act (HIPPA)), but is not limited thereto.

[0068] FIG. 12 is a block diagram representing an embodiment of the data processing unit 102 of the sample monitoring system shown in FIG. 11. User input and / or interface components may be included, or the data processing unit may not include user input and / or interface components. In some embodiments, one or more application specific integrated circuits (ASICs) (e.g., having a processing circuit and a non-transitory memory for storing software instructions for execution by the processing circuit) are used to implement, for example, one or more functions or routines related to the operation of the data processing unit (and / or display device) using one or more state machines and buffers.

[0069] As seen in the embodiment of FIG. 12, the sample sensor 101 (FIG. 11) includes four contacts, three of which are electrodes, namely, the working electrode (W) 210, the reference electrode (R) 212, and the counter electrode (C) 213, each of which is operatively coupled to the analog interface 201 of the data processing unit 102. This embodiment also shows an optional guard contact (G) 211. Without departing from the scope of the present disclosure, fewer or more electrodes may be used. For example, the functions of the counter electrode and the reference electrode may be provided by a single counter / reference electrode. In some embodiments, there may be two or more working electrodes and / or reference electrodes and / or counter electrodes.

[0070] FIG. 13 is a block diagram of an embodiment of a receiver / monitoring unit such as the primary display device 104 of the specimen monitoring system shown in FIG. 11. The primary display device 104 includes one or more of a test strip interface 301, an RF receiver 302, a user input 303, an optional temperature detection section 304, and a clock 305, each of which is operably coupled to a processing and storage section 307 (which can include a processing circuit and a non-transitory memory storing software instructions for execution by the processing circuit). The primary display device 104 also includes a power supply 306 operably coupled to a power conversion and monitoring section 308. Further, the power conversion and monitoring section 308 is also coupled to the processing and storage section 307. Further shown are a receiver serial communication section 309 and an output 310, each operably coupled to the processing and storage section 307. The primary display device 104 may include a user input and / or interface component (e.g., a computing device having the display screen described above), or may not include a user input and / or interface component.

[0071] In some embodiments, the test strip interface 301 includes a sample test portion (e.g., a glucose level test portion) that receives a blood (or other body fluid sample) specimen test or information related thereto. For example, the test strip interface 301 may include a test strip port for receiving a test strip (e.g., a glucose test strip). The device can determine the specimen level of the test strip and optionally display (or otherwise notify) the specimen level at output 310 of the primary display device 104. To obtain accurate glucose information, any suitable test strip may be used, such as a test strip that requires only a very small amount (e.g., 3 microliters or less, e.g., 1 microliter or less, e.g., 0.5 microliter or less, e.g., 0.1 microliter or less) of sample applied to the strip. The glucose information obtained by the in vitro glucose test device can be used for various purposes, calculations, etc. For example, the information can be used to calibrate the sensor 101 (FIG. 11), confirm the results of the sensor 101 to enhance its reliability (e.g., when the information obtained by the sensor 101 is used for treatment-related decisions).

[0072] In further embodiments, the data processing unit 102 and / or the primary display device 104 and / or the secondary display device 106, and / or the data processing terminal / injection device 105 may be configured to wirelessly receive specimen values via a communication link, for example, from a blood glucose meter. In further embodiments, a user operating or using the specimen monitoring system 100 may manually input the specimen values using a user interface (e.g., a keyboard, keypad, touch screen, voice command, etc.) incorporated in one or more of the data processing unit 102, the primary display device 104, the secondary display device 106, and / or the data processing terminal / injection device 105.

[0073] FIG. 14 schematically shows an embodiment of a specimen sensor 400 according to one or more embodiments of the present disclosure. As shown in FIG. 14, the sensor may include electrodes 401, 402, and 403 on a base 404. The electrodes (and / or other features) may be applied or processed using any suitable techniques such as chemical vapor deposition (CVD), physical vapor deposition, sputtering, reactive sputtering, printing, coating, ablation (e.g., laser ablation), painting, dip coating, etching, etc. The materials may include, but are not limited to, aluminum, carbon (including graphite), cobalt, copper, gallium, gold, indium, iridium, iron, lead, magnesium, mercury (as an amalgam), nickel, niobium, osmium, palladium, platinum, rhenium, rhodium, selenium, silicon (e.g., doped polycrystalline silicon), silver, tantalum, tin, titanium, tungsten, uranium, vanadium, zinc, zirconium, mixtures thereof, and alloys, oxides, or metal compounds of these elements, any one or more of which may be included.

[0074] The specimen sensor 400 may be configured to be fully implantable in a user, or only a part thereof may be disposed within the user (internally) and another part may be disposed outside the user (externally). For example, the sensor 400 may include a first part that can be disposed on the surface of the skin 410 and a second part disposed under the surface of the skin. In such an embodiment, the external part may include contacts (connected to respective electrodes of the second part by wiring) for connecting to another device such as a sensor control device that is also external to the user. The embodiment of FIG. 14 shows three electrodes arranged on the same surface of the base 404, while other configurations are contemplated including fewer or more electrodes, some or all of the electrodes present on different surfaces of the base or different bases, stacked electrodes, electrodes of different materials and dimensions, etc., but are not limited thereto.

[0075] FIG. 15A shows a perspective view of an embodiment of a specimen sensor 500 having a first portion (which may be characterized as a main portion in this embodiment) that can be disposed on the surface of the skin 510 and a second portion (which may be characterized as a small portion in this embodiment) that can be disposed under the surface of the skin (e.g., penetrate the skin and enter the subcutaneous space 520) and includes an insertion tip 530 that contacts the user's biological fluid such as interstitial fluid. The contact portion 511 of the working electrode, the contact portion 512 of the reference electrode, and the contact portion 513 of the counter electrode are disposed on the first portion of the sensor 500 located on the skin surface 510. The working electrode 501, the reference electrode 502, and the counter electrode 503 are shown in the second portion of the sensor 500, particularly the insertion tip 530. As shown in FIG. 15A, wiring can be provided from the electrodes at the tip 530 to the contacts. It should be understood that more or fewer electrodes may be provided on the sensor without departing from the scope of the present disclosure. For example, the sensor may include more than one working electrode, and / or the counter electrode and the reference electrode may be a single pair / reference electrode, etc.

[0076] FIG. 15B shows a partial cross-sectional view of the sensor 500 of FIG. 15A. The electrodes 501, 509 / 502 and 503 of the sensor 500, as well as the substrate and dielectric layer, are provided in a layered configuration or structure. For example, as shown in FIG. 15B, in one embodiment, the sensor 500 (such as the specimen sensor 101 of FIG. 11) includes a substrate layer 504 and a first conductive layer 501, such as carbon or gold, disposed on at least a portion of the substrate layer 504 that can provide a working electrode. A sensing region 508 disposed on at least a portion of the first conductive layer 501 is also shown.

[0077] In some embodiments, the first insulating layer 505, such as the first dielectric layer, is disposed or laminated on at least a portion of the first conductive layer 501. Further, the second conductive layer 509 may be disposed or laminated on at least a portion of the first insulating layer (or dielectric layer) 505. As shown in FIG. 15B, the second conductive layer 509 may provide a reference electrode together with a second conductive material 502, such as a layer of silver / silver chloride (Ag / AgCl) (e.g., 509 and 502 may together form a reference electrode).

[0078] In some embodiments, the second insulating layer 506, such as the second dielectric layer, may be disposed or laminated on at least a portion of the second conductive layer 509. Further, the third conductive layer 503 may be disposed on at least a portion of the second insulating layer 506 to provide a counter electrode 503. Finally, the third insulating layer 507 may be disposed or laminated on at least a portion of the third conductive layer 503. In this way, the sensor 500 may be laminated such that at least a portion of each of the conductive layers is separated by a respective insulating layer (e.g., dielectric layer). The embodiments of FIGS. 15A and 15B show layers having different lengths, but some or all of the layers may have the same or different lengths and / or widths without departing from the scope of the present disclosure.

[0079] In some embodiments, some or all of the electrodes 501, 502, 503 may be provided on the same side of the substrate 504 in a layered structure as described above, or alternatively, two or more electrodes may be provided in a coplanar manner such that they are arranged on the same plane on the substrate 504 (e.g., side by side, parallel, or inclined with respect to each other). For example, electrodes on the same plane may include an appropriate spacing therebetween and / or may include a dielectric material or an insulating material disposed between the conductive layers / electrodes. Further, in some embodiments, one or more of the electrodes 501, 502, 503 may be disposed on the opposite side of the substrate 504. In such embodiments, the contact pads may be on the same side or different sides of the substrate. For example, the electrodes may be on the first side and their respective contacts may be on the second side, e.g., the wiring connecting the electrodes and the contacts may cross the substrate.

[0080] Referring now to FIGS. 15C and 15D, another embodiment of a specimen monitoring sensor according to one or more embodiments of the present disclosure is shown, which represents a variation of the sensor 500 of FIG. 15A. As shown in FIGS. 15C and 15D, a transcutaneous sensor 520 according to one or more embodiments of the present disclosure includes a substrate 521, a first working electrode 522 on the substrate 521, a second working electrode 523 on the substrate 521, and a sensor film 524 covering the substrate 421 as well as the first working electrode 522 and the second working electrode 523. In the illustrated embodiment, the first working electrode 522 and the second working electrode 523 are disposed on opposite sides of the substrate 511, but in one or more embodiments, the first working electrode 522 and the second working electrode 523 can be disposed at any other suitable location on the substrate 521. For example, in one or more embodiments, the first working electrode 522 and the second working electrode 523 may be on the same side of the substrate 521. The substrate 521 includes a distal end 525 configured to be inserted into the user's skin and a proximal end 526 opposite the distal end 525 configured to be connected to various electrical connections for transmitting the output signal of the transcutaneous sensor 520. The distal end 525 can have a pointed or rounded tip, or other shaped tips that facilitate insertion of the sensor 520 into the user's skin.

[0081] Continuing to refer to the embodiment shown in FIG. 1B, the first working electrode 522 can include a first active sensing region 527, and the second working electrode 523 can include a second active sensing region 528. Although not shown, the first active sensing region 527 of the first working electrode 522 is configured to convert the analyte signal into a first output signal (e.g., a current output signal), and the second active sensing region 528 of the second working electrode 523 is configured to convert the analyte signal into a second output signal (e.g., a current output signal). The output signals of the first active sensing region 527 and the second active sensing region 528 correspond to the user's physiological state, such as the user's blood glucose level. Further, in the illustrated embodiment, the first active sensing region 527 of the first working electrode 522 has a first region, and the second active sensing region 528 of the second working electrode 523 has a second region that may be the same or different.

[0082] The first active sensing region 527 of the first working electrode 522 is longitudinally offset along the substrate 521 from the second active sensing region 528 of the second working electrode 523. In the illustrated embodiment, the most distal end of the first active sensing region 527 is spaced from the distal end 525 of the substrate 521 by a first distance d1, and the most distal end of the second active sensing region 528 is spaced from the distal end 525 of the substrate 521 by a second distance d2 that is greater than the first distance d1 (i.e., the most distal end of the second active sensing region 528 is spaced from the distal end 525 of the substrate 521 by a distance greater than the most distal end of the first active sensing region 527). Further, in the illustrated embodiment, the most proximal end of the first active sensing region 527 is spaced from the distal end 525 of the substrate by a third distance d3, and the most proximal end of the second active sensing region 528 is spaced from the distal end 525 of the substrate 521 by a fourth distance d4 that is equal to or substantially equal to the third distance d3 (i.e., the most proximal ends of the first active sensing region 527 and the second active sensing region 528 are spaced from the distal end 525 of the substrate 521 by the same or substantially the same distance). Thus, in the illustrated embodiment, the longitudinal central portion 529 of the first active sensing region 527 is offset from the longitudinal central portion 530 of the second active sensing region 528. In one or more embodiments, the most proximal end of the first active sensing region 527 may not be aligned with the most proximal end of the second active sensing region 528.

[0083] Furthermore, in the illustrated embodiment, the first region of the first active sensing region 527 is larger than the second region of the second active sensing region 528. In the illustrated embodiment, the first active sensing region 527 and the second active sensing region 528 each include a series of discrete sensing spots 531, 532 (e.g., dots). In the illustrated embodiment, the size of each of the discrete sensing spots 531 within the first active sensing region 527 is equal to or substantially equal to the size of each of the discrete sensing spots 532 within the second active sensing region 528. In a preferred embodiment, the number of discrete spots 531 within the first active sensing region 527 is greater than the number of discrete spots 532 within the second active sensing region 528, but in other embodiments, without departing from the scope of the present disclosure, the number of discrete sensing spots 531, 532 may be equal, or the number of discrete sensing spots 531 may be less than the number of discrete sensing spots 532. In the illustrated embodiment, there are six discrete sensing spots 531 of uniform size in the first active sensing region 527 and three discrete sensing spots 532 of uniform size in the second active sensing region 528, but in one or more embodiments, the first active sensing region 527 and the second active sensing region 528 may include any other suitable number of discrete sensing spots without departing from the scope of the present disclosure. Furthermore, in one or more embodiments, the first active sensing region 527 and / or the second active sensing region 528 may include a continuous strip (e.g., an elongated ellipse) instead of a series of discrete sensing spots. Furthermore, in one or more embodiments, the first region of the first active sensing region 527 may be equal to or substantially equal to the second region of the second active sensing region 528.

[0084] Furthermore, in one or more embodiments, the transcutaneous sensor 520 can include a reference electrode, a counter electrode, or a counter-reference electrode. In the illustrated embodiment, the transcutaneous sensor 520 includes a counter electrode 533 and a reference electrode 534. In the illustrated embodiment, the reference electrode 534 and the counter electrode 533 are on opposite sides of the substrate 521, but may be on the same side of the substrate 521 without departing from the scope of the present disclosure. Further, in the illustrated embodiment, the counter electrode 533 is separated from the first working electrode 522 by a first dielectric insulating layer 535, and the reference electrode 534 is separated from the second working electrode 523 by a second dielectric insulating layer 536.

[0085] Embodiments of a double-sided stacked sensor configuration that can be utilized in connection with the present disclosure are described with reference to FIGS. 16-18. FIG. 16 shows a cross-sectional view of a distal portion of a double-sided analyte sensor 600. The analyte sensor 600 includes at least a generally planar insulating base substrate 601, such as at least a generally planar dielectric base substrate, which has a first conductive layer 602 that substantially covers the first surface region of the insulating substrate 601, such as the entire upper surface region. For example, the conductive layer substantially extends over the entire length of the substrate to the distal end and across the entire width of the substrate from side end to side end. A second conductive layer 603 substantially covers the second surface of the insulating base substrate 601, such as the entire bottom surface. However, one or both of the conductive layers may terminate proximal to the distal end and / or may have a width that is less than the width of the insulating substrate 601 that terminates at a selected distance from the side ends of the substrate, which distance may be equidistant from each of the side ends or different.

[0086] One of the first or second conductive layers, for example, the first conductive layer 602, may be configured to include the working electrode of the sensor. The opposing conductive layer, here the second conductive layer 603, may be configured to include the reference electrode and / or the counter electrode. If the conductive layer 603 functions as either the reference electrode or the counter electrode but not both, the third electrode may optionally be disposed on the surface area (not shown) of the proximal portion of the sensor, on a separate substrate, or on or under either of the conductive layers 602 or 603, and provided on top of an additional conductive layer separated from those layers by an insulating layer(s). For example, in some embodiments where the analyte sensor 600 is configured to be partially embedded, the conductive layer 603 is configured to include the reference electrode, and a third electrode (not shown) that is present only in the non-embedded proximal portion of the sensor may be configured to include the counter electrode of the sensor.

[0087] The first insulating layer 604 covers at least a portion of the conductive layer 602, and the second insulating layer 605 covers at least a portion of the conductive layer 603. In one embodiment, at least one of the first insulating layer 604 and the second insulating layer 605 does not extend to the distal end of the analyte sensor 600, leaving an exposed area of the one or more conductive layers.

[0088] FIG. 17 shows a cross-sectional view of the distal portion of a dual-sided analyte sensor 700 including at least a generally planar insulating base substrate 701, such as a generally planar dielectric base substrate, having a first conductive layer 702 that substantially covers the first surface area, such as the entire top surface area, of the insulating substrate 701. For example, the conductive layer extends substantially over the entire length of the substrate to the distal end and across the entire width of the substrate from side edge to side edge. The second conductive layer 703 substantially covers the second surface, such as the entire bottom surface, of the insulating base substrate 701. However, one or both of the conductive layers may terminate proximal to the distal end and / or may have a width smaller than the width of the insulating substrate 701 that terminates at a selected distance from the side edges of the substrate, and this distance may be equal or different from each of the side edges.

[0089] In the embodiment of FIG. 17, the conductive layer 702 is configured to include a working electrode including a sensing region 702A disposed on at least a portion of the first conductive layer 702, as discussed in more detail below. Although a single sensing region 702A is shown, it should be noted that in other embodiments, a plurality of spatially separated sensing elements may be utilized without departing from the scope of the present disclosure.

[0090] In the embodiment of FIG. 17, the conductive layer 703 is configured to include a reference electrode including a secondary layer of conductive material 703A, such as Ag / AgCl, disposed on the distal portion of the conductive layer 703.

[0091] The first insulating layer 704 covers a portion of the conductive layer 702, and the second insulating layer 705 covers a portion of the conductive layer 703. The first insulating layer 704 does not extend to the distal end of the analyte sensor 700, leaving an exposed region of the conductive layer where the sensing region 702A is disposed. The insulating layer 705 on the bottom / reference electrode side of the sensor may extend for any suitable length of the distal section of the sensor, for example, over the entire length of both the primary and secondary conductive layers or a portion thereof. For example, as shown in FIG. 17, the bottom insulating layer 705 extends over the entire bottom surface area of the secondary conductive material 703A but terminates proximal to the distal end of the length of the conductive layer 703. It should be noted that at least the end of the secondary conductive material 703A extending along the side edge of the substrate 701 is not covered by the insulating layer 705 and is thus exposed to the environment during operational use.

[0092] In another embodiment, as shown in FIG. 18, the sample sensor 800 has an insulating layer 804 on the working electrode side of the insulating base substrate 801, which may be provided prior to the sensing region 802A. The insulating layer 804 has at least two portions spaced apart from each other by the sensing region 802A on the conductive layer 802. Next, the sensing region 802A is provided in the interval between the two portions. For example, if multiple sensing components or layers are desired, more than two spaced-apart portions may be provided. The bottom insulating layer 805 has a length that terminates proximal to the secondary conductive layer 803A on the bottom primary conductive layer 803. As described above, additional conductive layers and dielectric layers may be provided on one or both sides of the sensor.

[0093] FIGS. 16-18 are depicted or discussed herein as capable of providing working and reference electrodes in a particular layered configuration, but it should be noted that the relative arrangement of these layers can be changed. For example, the counter electrode layer may be provided on one side of the insulating base substrate, while the working electrode layer and the reference electrode layer are provided in a stacked configuration on the opposite side of the insulating base substrate. Further, by adjusting the number of conductive and insulating layers, a different number of electrodes than those shown in FIGS. 16-18 can be provided. For example, a sensor with three or four electrodes may be provided.

[0094] One or more membranes that can function as one or more of the analyte flux adjustment layer and / or the interference substance removal layer and / or the biocompatible layer, which will be discussed in more detail below, can be included with, on, or around the sensor (e.g., as one or more of the outermost layers). The membranes of the present disclosure can take many forms. For example, a membrane can include just one component or multiple components. The membrane can also have a spherical shape that surrounds the terminal regions (e.g., the sides and the tip) of the sensor. The membrane can generally have a planar structure and can be characterized as a layer. The planar membrane can be smooth or can have slight (topological) variations on the surface. The membrane can be configured as other non-planar structures. For example, the membrane can have a cylindrical or partially cylindrical shape, a hemispherical or other partially spherical shape, an irregular shape, or other rounded or curved shapes.

[0095] In some embodiments, as shown in FIG. 17, the first membrane layer 706 is provided only on the sensing region 702A on the working electrode 702 and can adjust the rate of diffusion or flux of the analyte into the sensing region. In embodiments where the membrane layer is provided on a single component / material, it may be appropriate to do so in the same stripe configuration and method as used for other materials / components. Here, the membrane material 706 preferably has a width greater than the width of the sensing component 702A. This functions to limit the flux of the analyte into the active region of the sensor, and thus it is important to control the thickness of the membrane 706 to contribute to the sensitivity of the sensor. Providing the membrane 706 in the form of stripes / bands facilitates the control of its thickness. A second membrane layer 707 that coats the remaining surface region of the sensor tail can also function as a biocompatible conformal coating and may be provided to provide a smooth edge across the entire sensor.

[0096] In other sensor embodiments, as shown in FIG. 18, a single homogeneous membrane 806 may be coated across the entire sensor surface area or at least on both sides of the distal tail. It should be noted that in order to coat the distal and side ends of the sensor, the membrane material may need to be applied following singulation of the sensor precursor. In some embodiments, the analyte sensor is dip-coated to apply one or more membranes after separation. Alternatively, the analyte sensor may be slot-die coated, and each side of the analyte sensor is coated separately.

[0097] FIG. 19 shows a cross-sectional view of a distal portion of an exemplary dual-sided analyte sensor 900 according to an embodiment of the present disclosure. The dual-sided analyte sensor includes at least a generally planar insulating base substrate 901 having a first conductive layer 902, for example, at least a generally planar dielectric base substrate. A second conductive layer 903 is disposed on a first side, e.g., the bottom surface, of the insulating base substrate 901. Although depicted as extending to the distal end of the sensor, one or both of the conductive layers may terminate proximal to the distal end and / or may have a width smaller than the width of the insulating substrate 901 that terminates at a selected distance from the side edges of the substrate. This distance may be equal or different from each of the side edges. For example, the first and second conductive layers may be provided to define electrodes, including, for example, electrode wiring having a width smaller than the width of the insulating base substrate.

[0098] In the embodiment of FIG. 19, the conductive layer 903 is configured to include a working electrode including a sensing region 908 disposed on at least a portion of the conductive layer 903, which will be discussed in more detail below. As shown herein, a plurality of spatially separated sensing components or layers are utilized in forming the working electrode. For example, one or more separate sensing spots or “dots” or regions are provided on the conductive layer 903, or a single sensing component may be used (not shown). It should be noted.

[0099] In the embodiment of FIG. 19, the conductive layer 906 is configured to include a reference electrode including a secondary layer of conductive material 906A, such as Ag / AgCl, disposed on the distal portion of the conductive layer 906. Similar to the conductive layers 902 and 903, the conductive layer 906 may terminate proximal to the distal end and / or may have a width smaller than the width of the insulating substrate 901 that terminates at a selected distance from the side edge of the substrate, which distance may be equal or different from each of the side edges, as will be discussed in more detail below with reference to FIGS. 20A - 20C.

[0100] In the embodiment shown in FIG. 19, the conductive layer 902 is configured to include a counter electrode. The first insulating layer 904 covers a portion of the conductive layer 902, and the second insulating layer 905 covers a portion of the conductive layer 903. The first insulating layer 904 does not extend to the distal end of the analyte sensor 900, leaving an exposed region of the conductive layer 902 that functions as a counter electrode. The insulating layer 905 covers a portion of the conductive layer 903, leaving an exposed region of the conductive layer 903 where the sensing region 908 is disposed. As described above, in some embodiments, a plurality of spatially separated sensing components or layers may be provided (as shown), while in other embodiments, a single sensing region may be provided without departing from the scope of the present disclosure. The first side, e.g., the insulating layer 907 on the bottom surface of the sensor (in the figure provided by FIG. 19), can extend for any suitable length of the distal section of the sensor, e.g., it can extend for the entire length or a portion of both the conductive layers 906 and 906A. For example, as shown in FIG. 19, the bottom insulating layer 907 extends across the entire bottom surface area of the secondary conductive material 906A and terminates distal to the distal end of the length of the conductive layer 906. Note that at least the ends of the secondary conductive material 906A that extend along the side edges of the substrate 901 are not covered by the insulating layer 907 and are thus exposed to the environment during operational use.

[0101] As shown in FIG. 19, the homogeneous film 909 may be coated across the entire sensor surface area or at least across both sides of the distal tail. Note that in order to coat the distal and side ends of the sensor, the film material may need to be applied following separation of the sensor precursor. In some embodiments, the analyte sensor is dip-coated to apply one or more films (or one film in various stages) after separation. Alternatively, the analyte sensor may be slot-die coated, with each side of the analyte sensor being coated separately. Although the film 909 is shown in FIG. 19 as having a square shape that conforms to the underlying surface change, it can also have a more spherical or amorphous shape.

[0102] When manufacturing a layered sensor, it may be desirable to utilize relatively thin insulating layers to reduce the overall width of the sensor. For example, referring to FIG. 19, the insulating layers 904, 905, and 907 may be relatively thin compared to the insulating substrate layer 901. For example, the insulating layers 904, 905, and 907 can have a thickness in the range of 20 - 25 micrometers (μm), while the substrate layer 901 can have a thickness in the range of 0.1 - 0.15 millimeters (mm). However, during separation of such a sensor where separation is achieved by cutting two or more conductive layers separated by such thin insulating layers, a short circuit can occur between the two conductive layers.

[0103] One way to address this potential problem is to provide one of the conductive layers, such as an electrode layer, at least partially as a relatively narrow electrode that includes a relatively narrow conductive wiring, such that during the separation process, the sensor is cut on both sides of the narrow electrode such that one electrode is cut off without cutting the narrow electrode.

[0104] For example, referring to FIGS. 20A to 20C, a sensor 1000 including insulating layers 1003 and 1005 is shown. The insulating layers 1003 and 1005 may generally be thinner compared to the generally planar insulating base substrate layer 1001, and vice versa. For example, the insulating layers 1003 and 1005 can have a thickness in the range of 15 to 30 μm, and the substrate layer 1001 can have a thickness in the range of 0.1 to 0.15 mm. Such sensors can be manufactured in sheets, and a single sheet can include multiple sensors. However, such a process generally requires separation of the sensors before use. When such separation requires cutting two or more conductive layers separated by an insulating layer, especially when the insulating layer is thin, there is a possibility of a short circuit occurring between the two conductive layers. To avoid such a short circuit, a smaller number of conductive layers than all of the conductive layers may be cut during the separation process. For example, at least one of the conductive layers may be provided as an electrode having a narrow width with respect to one or more other conductive layers including electrodes, for example, conductive wirings, such that during the separation process, only the first conductive layer separated from the second conductive layer by a thin insulating layer, for example, an insulating layer having a thickness in the range of 15 to 30 μm, is cut while the second conductive layer is not cut.

[0105] Continuing to refer to FIGS. 20A and 20C, the sensor 1000 includes at least a generally planar insulating base substrate 1001. Disposed on at least the generally planar insulating base substrate 1001 is a first conductive layer 1002. A first relatively thin insulating layer 1003, for example, an insulating layer having a thickness in the range of 15 to 30 μm, is disposed on the first conductive layer 1002, and a second conductive layer 1004 is disposed on the relatively thin insulating layer 1003. Finally, a second relatively thin insulating layer 1005, for example, an insulating layer having a thickness in the range of 15 to 30 μm, is disposed on the second conductive layer 1004.

[0106] As shown in FIG. 20B, the first conductive layer 1002 may be an electrode having a narrow width with respect to the conductive layer 1004, as shown in the cross-sectional view taken along line A-A of FIG. 20B. Alternatively, the second conductive layer 1004 may be a conductive electrode having a narrow width with respect to the conductive layer 1002, as shown in the cross-sectional view taken along line A-A of FIG. 20C. The separation cut line 1006 is shown in FIGS. 20B and 20C. The sensor can be separated, for example, in the region 1007, as shown in FIGS. 20B and 20C, by cutting both sides of the relatively narrow conductive electrode. Referring to FIG. 20B, the separation by cutting along the separation cut line 1006 cuts the conductive layer 1004 but does not cut the conductive layer 1002. Referring to FIG. 20C, the separation by cutting along the separation cut line 1006 cuts the conductive layer 1002 but does not cut the conductive layer 1004.

[0107] Embodiments of the sensing area can be described as an area schematically shown as 508 in FIG. 115B and as 908 in FIG. 9. As described above, the sensing area may be provided as a single sensing component as shown as 508 in FIG. 15B, as 702A in FIG. 17, and as 802A in FIG. 18, or may be provided as a plurality of sensing components as shown as 908 in FIG. 19. The plurality of sensing components or sensing “spots” are described in U.S. Patent Application Publication No. 2012 / 0150005, which is hereby incorporated by reference in its entirety.

[0108] As used herein, the term "sensing region" and its grammatical variations are broad terms and can be described as the active chemical region of an analyte monitoring sensor or biosensor. The sensing region can take many forms. The sensing region can include just one component or multiple components (such as sensing region 908 in FIG. 19, for example). In the embodiment of FIG. 15B, for example, the sensing region is generally a planar structure and can be characterized as a layer. The planar sensing region can be smooth or have small (topological) variations on the surface. The sensing region can also be a non-planar structure. For example, the sensing region can have a cylindrical or partially cylindrical shape, a hemispherical or other partially spherical shape, an irregular shape, or other rounded or curved shapes.

[0109] A sensing region formulation that can include a glucose converting agent can include, among other components, for example, a redox mediator such as hydrogen peroxide, or a transition metal complex such as a ruthenium-containing complex or an osmium-containing complex, and an analyte-responsive enzyme such as a glucose-responsive enzyme (e.g., glucose oxidase, glucose dehydrogenase, etc.) or a lactate-responsive enzyme (e.g., lactate oxidase). In some embodiments, the sensing region includes glucose oxidase. The sensing region can also include, for example, a polymer and any other optional components such as a bifunctional short-chain epoxide crosslinking agent such as polyethylene glycol (PEG).

[0110] In some embodiments, the sensing region formulation includes a protein switch component that enables the detection of any desired analyte. The use of the protein switch allows a selected redox mediator, such as hydrogen peroxide, or a transition metal complex such as a ruthenium-containing complex or an osmium-containing complex, to bind to a selected enzyme, such as a glucose-responsive enzyme (e.g., glucose oxidase, glucose dehydrogenase, etc.) or a lactate-responsive enzyme (e.g., lactate oxidase), enabling a qualitative or quantitative detection platform for any desired analyte. The selected enzyme is covalently bound to a selective analyte-binding ligand (e.g., a peptide, antibody, antibody fragment, other immunoglobulin, aptamer, etc.) such that binding of an analyte-binding ligand by an analyte present in the sample being analyzed changes (e.g., inhibits or enhances) the activity of the selected enzyme. The presence of an analyte in the analyzed sample thereby increases or decreases, as desired, a detectable product of the enzyme activity (e.g., changes the redox state of the reaction solution). Specific examples of selected enzyme components of the protein switch are described herein, but it should be understood that any enzyme or functional portion thereof that catalyzes the production of a detectable (e.g., electrochemically detectable) product may be used. Any of a variety of analytes, including but not limited to proteins and peptides, lipids, carbohydrates, metabolites, hormones, synthetic molecules (e.g., drugs) or their metabolites, antibodies, pathogen components, nucleic acids, toxins, minerals, etc., can be detected using such a system. The analyte-binding portion of the protein switch can be derived from a protein that binds the analyte. Such proteins that bind the analyte can include, for example, antibodies, receptors (including full-length, fragments, and single-chain receptors), and artificial binding proteins made using scaffold or display technologies. Alternatively, if the analyte to be detected is a receptor or is derived from a receptor, the analyte-binding portion can be derived from a ligand.

[0111] The protein switch can be derived from a protein having binding affinity for an analyte, thereby enabling the protein switch to detect the analyte at the physiological level. The protein switch can be made from an analyte-binding protein having desirable kinetics for binding at the physiological level of the analyte. Specific examples of protein switch components for a wide variety of analytes, and methods for designing, creating, enhancing, and optimizing protein switch components (e.g., using libraries of fusion proteins and high-throughput screening techniques) are described in U.S. Provisional Patent Application No. 62 / 468,878, filed Mar. 8, 2017, and U.S. Provisional Patent Application No. 62 / 544,364, filed Aug. 11, 2017, both of which are hereby incorporated by reference in their entirety for all purposes.

[0112] In some embodiments, two or more different protein switch systems that respond to two or more different analytes are used in a single sensor. In some such embodiments, the different analytes generate the same reporter signal in the same region such that the presence of any analyte produces a detectable result. In other embodiments, each analyte can be detected and analyzed separately (e.g., by generating different signals or the same signal in different regions (e.g., different layers of a multilayer sensor)) because different analytes generate different or distinguishable signals.

[0113] In certain examples, the analyte-responsive enzyme is distributed throughout the sensing region. For example, the analyte-responsive enzyme can be uniformly distributed throughout the sensing region, such that the concentration of the analyte-responsive enzyme is substantially the same throughout the sensing region. In some cases, the sensing region can have a uniform distribution of the analyte-responsive enzyme. In some embodiments, the redox mediator is distributed throughout the sensing region. For example, the redox mediator can be uniformly distributed throughout the sensing region, such that the concentration of the redox mediator is substantially the same throughout the sensing region. In some cases, the sensing region can have a uniform distribution of the redox mediator. In some embodiments, as described above, both the analyte-responsive enzyme and the redox mediator are uniformly distributed throughout the sensing region.

[0114] As described above, the analyte sensor can include an analyte-responsive enzyme to provide a sensing component or sensing region. Some analytes, such as oxygen, can be directly electrochemically oxidized or reduced on the sensor, more specifically at least on the working electrode of the sensor. Other analytes, such as glucose and lactate, require the presence of at least one electron transfer agent and / or at least one catalyst to facilitate the electrochemical oxidation or reduction of the analyte. The catalyst can be used for analytes such as oxygen that can be directly electrochemically oxidized or reduced on the working electrode. In the case of these analytes, each working electrode includes a sensing region (see, e.g., sensing region 508 of FIG. 15B) proximate to or on the surface of the working electrode. In many embodiments, the sensing region is formed only near or on at least a small portion of the working electrode.

[0115] The sensing region can include one or more components constructed to facilitate the electrochemical oxidation or reduction of the analyte. The sensing region can include, for example, a catalyst that catalyzes the reaction of the analyte to produce a response at the working electrode, an electron transfer agent that transfers electrons between the analyte and the working electrode (or other component), or both.

[0116] In embodiments of the present disclosure, various different sensing region configurations can be used. The sensing region is often disposed in contact with or in proximity to an electrode such as a working electrode. In some embodiments, the sensing region is deposited on the conductive material of the working electrode. The sensing region may extend beyond the conductive material of the working electrode. In some cases, the sensing region may extend over other electrodes, e.g., over a counter electrode and / or a reference electrode (or where a counter / reference is provided).

[0117] The sensing region in direct contact with the working electrode may include an electron transfer agent for directly or indirectly moving electrons between the analyte and the working electrode, and / or a catalyst for promoting the reaction of the analyte. For example, a glucose, lactate, or oxygen electrode can be formed to have a sensing region that includes a catalyst such as glucose oxidase, glucose dehydrogenase, lactate oxidase, or laccase, respectively, and an electron transfer agent that promotes the electrooxidation of glucose, lactate, or oxygen, respectively. As described above, a protein switch can be used to provide an indirect mechanism for detecting a target analyte by converting the binding of the analyte to its binding partner into a change in enzyme activity.

[0118] In other embodiments, the sensing region is not directly deposited on the working electrode. Instead, for example, the sensing region 508 (FIG. 15) may be spaced apart from the working electrode and separated from the working electrode, e.g., by a separation layer. The separation layer may include one or more membranes or films or a physical distance. In addition to separating the working electrode from the sensing region, the separation layer may also function as a mass transport limiting layer and / or an interference removal layer and / or a biocompatible layer.

[0119] In some embodiments that include two or more working electrodes, one or more of the working electrodes may not have a corresponding sensing region, or may have a region that does not contain one or more components (e.g., an electron transfer agent and / or a catalyst) required for electrolyzing the analyte. Thus, the signal at this working electrode may correspond to a background signal that can be removed from the analyte signal obtained from one or more other working electrodes associated with fully functional sensing regions, for example, by subtracting that signal.

[0120] In some embodiments, the sensing region includes one or more electron transfer agents. Electron transfer agents that can be used are electroreducible and electrooxidizable ions or molecules having a redox potential that is several hundred millivolts higher or lower than the redox potential of a standard calomel electrode (SCE). The electron transfer agent can be an organic, organometallic, or inorganic substance. Examples of organic redox species are quinones and species having a quinoid structure in their oxidized state, such as Nile blue and indophenol. Examples of organometallic redox species are metallocenes including ferrocene. Examples of inorganic redox species are hexacyanoferrate(III) salts, ruthenium hexamine, and the like. Further examples include those described in U.S. Patent Nos. 6,736,957, 7,501,053, and 7,754,093, the disclosures of each of which are incorporated herein by reference in their entirety.

[0121] In some embodiments, the electron transfer agent has a structure or charge that prevents or substantially reduces the diffusion loss of the electron transfer agent during the period in which the sample is being analyzed. For example, the electron transfer agent includes a redox species. For example, the redox species can be bound to a polymer, and this polymer can then be disposed on or near the working electrode, but is not limited thereto. The bond between the redox species and the polymer can be a covalent bond, a coordination bond, or an ionic bond. Any organic, organometallic, or inorganic redox species can be bound to a polymer and used as an electron transfer agent. In some embodiments, the redox species is a transition metal compound or complex, such as a compound or complex of osmium, ruthenium, iron, and cobalt. It will be recognized that many of the redox species described for use with a polymer component may be used without the polymer component.

[0122] Embodiments of the polymeric electron transfer agent can include a redox species covalently bonded in a polymer composition. An example of this type of mediator is poly(vinylferrocene). Another type of electron transfer agent includes an ionically bonded redox species. This type of mediator can include a charged polymer bonded to an oppositely charged redox species. An example of this type of mediator includes a negatively charged polymer bonded to a positively charged redox species such as an osmium or ruthenium polypyridyl cation. Another example of an ionically bonded mediator is a positively charged polymer including a quaternized poly(4-vinylpyridine) or poly(1-vinylimidazole) bonded to a negatively charged redox species such as ferricyanide or ferrocyanide. In other embodiments, the electron transfer agent includes a redox species coordinately bonded to a polymer. For example, the mediator can be formed by coordinating an osmium or cobalt 2,2'-bipyridyl complex to poly(1-vinylimidazole) or poly(4-vinylpyridine).

[0123] A suitable electron transfer agent is an osmium transition metal complex having one or more ligands, each ligand having a nitrogen-containing heterocycle such as 2,2'-bipyridine, 1,10-phenanthroline, 1-methyl, 2-pyridylbiimidazole, or derivatives thereof. The electron transfer agent may have one or more ligands covalently bonded in the polymer, each ligand having at least one nitrogen-containing heterocycle such as pyridine, imidazole, or derivatives thereof. An example of an electron transfer agent includes (a) a polymer or copolymer having a pyridine or imidazole functional group, and (b) an osmium cation complexed with two ligands, each ligand including 2,2'-bipyridine, 1,10-phenanthroline, or a derivative thereof, and the two ligands are not necessarily the same. Some derivatives of 2,2'-bipyridine for complex formation with the osmium cation include, but are not limited to, 4,4'-dimethyl-2,2'-bipyridine, and mono-, di-, and polyalkoxy-2,2'-bipyridine including 4,4'-dimethoxy-2,2'-bipyridine. Derivatives of 1,10-phenanthroline for complex formation with the osmium cation include, but are not limited to, 4,7-dimethyl-1,10-phenanthroline, and mono-, di-, and polyalkoxy-1,10-phenanthroline such as 4,7-dimethyl-1,10-phenanthroline. Polymers for complex formation with the osmium cation include, but are not limited to, polymers and copolymers of poly(1-vinylimidazole) (referred to as "PVI") and poly(4-vinylpyridine) (referred to as "PVP"). Suitable copolymer substituents for poly(1-vinylimidazole) include acrylonitrile, acrylamide, substituted or quaternized N-vinylimidazole, for example, an electron transfer agent in which osmium is complexed with a polymer or copolymer of poly(1-vinylimidazole).

[0124] Embodiments can use an electron transfer agent having a redox potential in the range of about -200 mV to about +200 mV relative to a standard calomel electrode (SCE). The sensing region may include a catalyst that can catalyze the reaction of the analyte. The catalyst may, in some embodiments, act as an electron transfer agent. An example of a suitable catalyst is an enzyme that catalyzes the reaction of the analyte. For example, when the analyte of interest is glucose, a catalyst including glucose oxidase, glucose dehydrogenase (e.g., pyrroloquinoline quinone (PQQ)-dependent glucose dehydrogenase, flavin adenine dinucleotide (FAD)-dependent glucose dehydrogenase, or nicotinamide adenine dinucleotide (NAD)-dependent glucose dehydrogenase) can be used. When the analyte of interest is lactate, lactate oxidase or lactate dehydrogenase can be used. When the analyte of interest is oxygen, or when oxygen is produced or consumed in response to the reaction of the analyte, laccase can be used.

[0125] In some embodiments, the catalyst can be attached to a polymer to crosslink the catalyst with another electron transfer agent that can be a polymer as described above. In some embodiments, a second catalyst may be used. This second catalyst can be used to catalyze the reaction of the product compound resulting from the catalytic reaction of the analyte. The second catalyst can act together with the electron transfer agent to electrolyze the product compound to generate a signal at the working electrode. Alternatively, the second catalyst may be provided in an interferent removal layer to catalyze a reaction for removing interferents.

[0126] In some embodiments, the sensor operates at a low oxidation potential, e.g., a potential of about +40 mV relative to Ag / AgCl. This sensing region uses, for example, an osmium (Os)-based mediator constructed for low-potential operation. Thus, in some embodiments, the sensing element is a redox-active component including (1) an osmium-based mediator molecule containing a (bidentate) ligand, and (2) a glucose oxidase enzyme molecule. These two components are combined in the sensing region of the sensor.

[0127] A mass transport limiting layer (not shown), such as an analyte flux regulating layer, can be included in the sensor to function as a diffusion limiting barrier that reduces the rate of mass transport of an analyte, such as glucose or lactate, to the region around the working electrode. The mass transport limiting layer is useful for restricting the flux of analyte to the working electrode in an electrochemical sensor so that the sensor responds linearly over a wide range of analyte concentrations and can be easily calibrated. The mass transport limiting layer may include a polymer and may be biocompatible. The mass transport limiting layer can provide many functions, such as biocompatibility and / or interference removal functions.

[0128] In some embodiments, the mass transport limiting layer is a membrane composed of a crosslinked polymer containing a heterocyclic nitrogen group, such as a polymer of polyvinylpyridine and polyvinylimidazole. Embodiments also include membranes made from polyurethane, or polyetherurethane, or chemically related materials, or membranes made from silicone.

[0129] The membrane can be formed by crosslinking in situ a polymer modified in an alcohol buffer with zwitterionic moieties, a non-pyridine copolymer component, and optionally either a hydrophilic or hydrophobic moiety and / or another moiety having other desirable properties. The modified polymer may be made from a precursor polymer containing a heterocyclic nitrogen group. For example, the precursor polymer may be polyvinylpyridine or polyvinylimidazole. Optionally, a hydrophilic or hydrophobic modifier can be used to “fine-tune” the permeability of the resulting membrane to the analyte of interest. Any hydrophilic modifier, such as poly(ethylene glycol), hydroxyl, or polyhydroxyl modifiers, can be used to enhance the biocompatibility of the polymer or the resulting membrane.

[0130] The membrane can be formed in situ by applying a cross-linking agent and an alcohol buffer solution of a modified polymer to the enzyme-containing sensing region and allowing the solution to cure for about 1 to 2 days or other appropriate time. The cross-linking agent-polymer solution can be applied to the sensing region by placing one or more droplets of the membrane solution on the sensor, immersing the sensor in the membrane solution, spraying the membrane solution onto the sensor, etc. Generally, the thickness of the membrane is controlled by the concentration of the membrane solution, the number of droplets of the applied membrane solution, the number of times the sensor is immersed in the membrane solution, the volume of the membrane solution sprayed onto the sensor, or any combination of these factors. The membrane thus applied can have any combination of the following functions: (1) mass transport limitation, e.g., reduction of the flux of the analyte reaching the sensing region, (2) improvement of biocompatibility, or (3) reduction of interferents.

[0131] In some examples, the membrane can form one or more bonds with the sensing region. Bond means any type of interaction between atoms or molecules that enables chemical compounds to form associations with each other, including but not limited to covalent bonds, ionic bonds, dipole-dipole interactions, hydrogen bonds, London dispersion forces, etc. For example, in situ polymerization of the membrane can form cross-links between the polymer of the membrane and the polymer of the sensing region. In some embodiments, cross-linking of the membrane to the sensing region promotes reduction of the occurrence of peeling of the membrane from the sensing region.

[0132] In some embodiments, the sensing system detects hydrogen peroxide and estimates glucose levels. For example, a hydrogen peroxide detection sensor can be constructed in which the sensing region contains an enzyme such as glucose oxidase, glucose dehydrogenase, etc. and is disposed in proximity to the working electrode. The sensing region can be covered by one or more layers, e.g., a membrane that is selectively permeable to glucose. When glucose passes through the membrane, it is oxidized by the enzyme, and the reduced glucose oxidase is oxidized by reacting with molecular oxygen to produce hydrogen peroxide.

[0133] Certain embodiments include a hydrogen peroxide detection sensor constructed from a sensing region prepared by, for example, combining (1) a redox mediator having a transition metal complex containing an Os polypyridyl complex having an oxidation potential of about +200 mV relative to SCE, and (2) horseradish peroxidase (HRP) iodate oxidation. Such a sensor functions in a reduction mode, and the working electrode is controlled to a potential negative relative to the potential of the Os complex, such that mediated reduction of hydrogen peroxide occurs through the HRP catalyst.

[0134] In another example, a potentiometric sensor can be constructed as follows. The glucose sensing region is constructed by combining (1) a redox mediator having a transition metal complex containing an Os polypyridyl complex having an oxidation potential of about -200 mV to +200 mV relative to SCE, and (2) glucose oxidase. Then, under zero current conditions, the sensor can be used in a potentiometric measurement mode by exposing the sensor to a glucose-containing solution and allowing the ratio of reduced / oxidized Os to reach an equilibrium value. The reduced / oxidized Os ratio varies in a reproducible manner with glucose concentration, and the potential of the electrode varies in a similar manner.

[0135] The substrate can be formed using a variety of non-conductive materials, including, for example, polymer or plastic materials and ceramic materials. The materials suitable for a particular sensor can be determined, at least in part, based on the desired use of the sensor and the properties of the materials.

[0136] In some embodiments, the substrate is flexible. For example, if the sensor is configured for implantation into a user, making the sensor flexible (although a rigid sensor can also be used for an implantable sensor) can reduce user discomfort and damage to tissue due to implantation and / or wear of the sensor. In many cases, a flexible substrate enhances user comfort and enables a wide range of activities. Materials suitable for flexible substrates include, for example, non-conductive plastics or polymer materials, and other non-conductive, flexible, deformable materials. Examples of useful plastic or polymer materials include polycarbonate, polyester (e.g., Mylar (trademark) and polyethylene terephthalate (PET)), polyvinyl chloride (PVC), polyurethane, polyether, polyamide, polyimide, or copolymers of these thermoplastic plastics such as thermoplastic resin PETG (glycol-modified polyethylene terephthalate).

[0137] In other embodiments, the sensor is fabricated using a relatively rigid substrate, for example, to provide structural support against bending or breaking. Examples of rigid materials that can be used as the substrate include low-conductive ceramics such as aluminum oxide and silicon dioxide. An implantable sensor with a rigid substrate can have a sharp tip and / or sharp edges to assist in implanting the sensor without an additional insertion device.

[0138] It will be understood that for many sensors and sensor applications, both rigid and flexible sensors can operate properly. The flexibility of the sensor can also be controlled and varied along a continuum, for example, by changing the composition and / or thickness of the substrate.

[0139] In addition to considerations regarding flexibility, implantable sensors often desirably have a physiologically harmless substrate, for example, a substrate approved for in vivo use by a regulatory authority or private institution.

[0140] The sensor can include optional features that facilitate insertion of the implantable sensor. For example, the sensor may be pointed at its tip to facilitate insertion (see FIGS. 5C and 5E). Additionally, the sensor can include barbs that assist in securing the sensor within the user's tissue during operation of the sensor. However, the barbs are generally small enough that they cause little damage to the subcutaneous tissue when the sensor is removed for replacement.

[0141] The implantable sensor can optionally also have an anticoagulant disposed on a portion of the substrate that is implanted into the user. This anticoagulant can reduce or eliminate clotting of blood or other body fluids around the sensor, particularly after insertion of the sensor. Blood clots can foul the sensor or reduce the amount of analyte diffusing into the sensor in a non-reproducible manner. Examples of useful anticoagulants include heparin and tissue plasminogen activator (TPA), as well as other known anticoagulants.

[0142] The anticoagulant can be applied to at least a portion of that part of the sensor being implanted. The anticoagulant can be applied, for example, by bathing, spraying, brushing, or dipping. The anticoagulant can be dried on the sensor. The anticoagulant may be immobilized on the surface of the sensor or allowed to diffuse away from the sensor surface. The amount of anticoagulant disposed on the sensor may be less than the amount typically used in the treatment of medical conditions involving blood clots and thus have only a limited local effect.

[0143] FIG. 21 shows an exemplary in vivo-based analyte monitoring system 1100 according to a particular embodiment of the present disclosure. As shown, the analyte monitoring system 1100 includes on body electronics 1110 electrically coupled to an in vivo analyte sensor 1101 (the proximal portion of which is shown in FIG. 21) and attached to an adhesive layer 1140 for attachment to the skin surface of a user's body. The on body electronics 1110 includes an on body housing 1119 that defines an internal compartment. Also shown in FIG. 21 is an insertion device 1150 that, when operated, transcutaneously disposes a portion of the analyte sensor 1101 in fluid contact with a body fluid through the skin surface and disposes the on body electronics 1110 and the adhesive layer 1140 on the skin surface. In some embodiments, the on body electronics 1110, the analyte sensor 1101, and the adhesive layer 1140 are sealed within the housing of the insertion device 1150 prior to use, and in some embodiments, the adhesive layer 1140 is sealed within the housing or provides a terminal seal for the insertion device 1150 itself.

[0144] Continuing to refer to FIG. 21, the analyte monitoring system 1100 includes a display 1122 for outputting information to a user, and input components 1121, such as buttons, actuators, touch-sensitive switches, capacitive switches, pressure-sensitive switches, jog wheels, etc., for entering data or commands into the display device 1120 or otherwise controlling the operation of the display device 1120 (e.g., a computing device as described herein). It should be noted that some embodiments may include devices without a display or devices without user interface components. These devices can be configured to store data as a data logger and / or provide a route for transferring data from an on-body electronic device and / or a displayless device to another device and / or location. Embodiments are described herein as a display device for illustrative purposes only and are in no way intended to limit the embodiments of the present disclosure. It will be apparent that in some embodiments, devices without a display may also be used.

[0145] In some embodiments, the on-body electronic device 1110 can be configured to store some or all of the monitored analyte-related data received from the analyte sensor 1101 during the monitoring period in memory and maintain it in memory until the end of the usage period. In such embodiments, the stored data is obtained from the on-body electronic device 1110 at the end of the monitoring period, for example, after the analyte sensor 1101 is removed from the user by detaching the on-body electronic device 1110 from the skin surface where the on-body electronic device 1110 was placed during the monitoring period. In such a data logging configuration, the analyte levels monitored in real time are not transmitted to the display device 1120 during the monitoring period or otherwise transmitted from the on-body electronic device 1110, but rather are obtained from the on-body electronic device 1110 after the monitoring period.

[0146] In some embodiments, the input component 1121 of the display device 1120 may include a microphone, and the display device 1120 may include software configured to analyze audio input received from the microphone, such that the functions and operations of the display device 1120 can be controlled by voice commands. In some embodiments, the output component of the display device 1120 includes a speaker for outputting information as an audible signal. Similar voice response components such as speakers, microphones, and software routines for generating, processing, and storing voice drive signals may be provided in the on-body electronic device 1110.

[0147] In some embodiments, the display 1122 and the input component 1121 may be integrated into a single component, for example, a display capable of detecting the presence and position of physical contact touches on the display, such as a touch screen user interface. In such embodiments, the user can control the operation of the display device 1120 by utilizing a set of pre-programmed motion commands including, but not limited to, single-tapping or double-tapping the display, dragging a finger or instrument on the display, moving multiple fingers or instruments towards each other, moving multiple fingers or instruments away from each other. In some embodiments, the display includes a touch screen having a region of pixels with single or dual-function capacitive elements that function as an LCD element and a touch sensor.

[0148] The display device 1120 also includes a data communication port 1123 for wired data communication with an external device such as, for example, a remote terminal (personal computer) 1170. Exemplary embodiments of the data communication port 1123 include a USB port, a mini USB port, an RS-232 port, an Ethernet® port, a FireWire port, or other similar data communication ports configured to connect to a compatible data cable. The display device 1120 may also include an integrated in vitro glucose meter that includes an in vitro test strip port 1124 for receiving an in vitro glucose test strip for performing an in vitro blood glucose measurement.

[0149] Continuing to refer to FIG. 21, in some embodiments, the display 1122 is configured to display various information, some or all of which may be displayed on the display 1122 simultaneously or at different times. In some embodiments, the displayed information is user-selectable such that the user can customize the information presented on a given display screen. The display 1122 may include, but is not limited to, a graphic display 1138 for providing a graphical output of glucose values over a monitored period (which may indicate important markers such as meals, exercise, sleep, heart rate, blood pressure, etc.), a numerical display 1132 for providing a monitored glucose value (e.g., obtained or received in response to a request for information), and a trend or direction arrow display 1131 indicating the rate of change and / or the rate of change rate of the analyte.

[0150] As further shown in FIG. 21, the display 1122 may include, for example, a date display 1135 that provides date information to the user, a time information display 1139 that provides time information to the user, a battery level indicator display 1133 that graphically shows the state of the battery (rechargeable or disposable) of the display device 1120, a sensor calibration status icon display 1134 that notifies the user that sample sensor calibration is required in a monitoring system that requires, for example, periodic, daily, or a predetermined number of user calibration events, an audio / vibration setting icon display 1136 that displays the status of the audio / vibration output or alarm state, and a wireless connection status icon display 1137 that indicates a wireless communication connection with other devices such as on-body electronic devices, data processing modules 1160, remote terminals 1170, etc. As further shown in FIG. 21, the display 1122 may further include pseudo touch screen buttons 1140, 1141 for accessing a menu, changing the display graph output configuration, or controlling the operation of the display device 1120 in another way.

[0151] Referring again to FIG. 21, in some embodiments, the display 1122 of the display device 1120 may be additionally or instead of a visual display configured to output alarm and / or alert notifications, alarm notifications such as glucose values, which may be audible, tactile, or any combination thereof. In one aspect, the display device 1120 may include other output components such as speakers, vibration output components, etc. to provide audible and / or vibration output displays to the user in addition to the visual output display provided on the display 1122.

[0152] After placing the on-body electronic device 1110 on the skin surface and the specimen sensor 1101 in vivo to establish fluid contact with interstitial fluid (or other suitable body fluids), in some embodiments, the on-body electronic device 1110 is configured to wirelessly communicate specimen-related data (e.g., data corresponding to the monitored specimen level and / or the monitored temperature data, and / or stored past specimen-related data) when the on-body electronic device 1110 receives a command or request signal from the display device 1120. In some embodiments, the on-body electronic device 1110 may be configured to at least periodically broadcast real-time data related to the monitored specimen level received by the display device 1120 when the display device 1120 is within the communication range of the data broadcast from the on-body electronic device 1110, e.g., when no command or request from the display device is required to transmit the information.

[0153] For example, the display device 1120 may be configured to send one or more commands to the on-body electronic device 1110 to initiate data transfer, and in response, the on-body electronic device 1110 may be configured to wirelessly transmit the stored specimen-related data collected during the monitoring period to the display device 1120. Next, the display device 1120 can be connected to a remote terminal 1170 such as a personal computer and function as a data route for transferring the stored specimen level information from the on-body electronic device 1110 to the remote terminal 1170. In some embodiments, the data received from the on-body electronic device 1110 may be (permanently or temporarily) stored in one or more memories of the display device 1120. In certain other embodiments, the display device 1120 is configured as a data route for passing the data received from the on-body electronic device 1110 to the remote terminal 1170 connected to the display device 1120.

[0154] Continuing to refer to FIG. 21, the specimen monitoring system 1100 also shows a data processing module 1160 and a remote terminal 1170. The remote terminal 1170 may include a personal computer, a server terminal, a laptop computer, or other suitable data processing device including software for data management and analysis and communication with components within the specimen monitoring system 1100. For example, the remote terminal 1170 may be connected to a local area network (LAN), a wide area network (WAN), or other data network for unidirectional or bidirectional data communication between the remote terminal 1170 and the display device 1120 and / or the data processing module 1160.

[0155] The remote terminal 1170 in some embodiments may include one or more computer terminals located in a physician's office or a hospital. For example, the remote terminal 1170 may be located at a location other than where the display device 1120 is located. The remote terminal 1170 and the display device 1120 may be in different rooms or different buildings. The remote terminal 1170 and the display device 1120 may be separated by at least about 1 mile, for example, at least about 10 miles, for example, at least about 1100 miles. For example, the remote terminal 1170 may be in the same city as the display device 1120, the remote terminal 1170 may be in a different city than the display device 1120, the remote terminal 1170 may be in the same state as the display device 1120, the remote terminal 1170 may be in a different state than the display device 1120, the remote terminal 1170 may be in the same country as the display device 1120, or the remote terminal 1170 may be in a different country than the display device 1120.

[0156] In some embodiments, a separate optional data communication / processing device, such as data processing module 1160, may be provided in the analyte monitoring system 1100. The data processing module 1160 may include components for communicating using one or more wireless communication protocols such as, for example, but not limited to, infrared (IR) protocol, Bluetooth® protocol, Zigbee® protocol, and 802.11 wireless LAN protocol. Additional descriptions of communication protocols including those based on the Bluetooth protocol and / or Zigbee protocol can be found in U.S. Patent Application Publication No. 2006 / 0193375, which is hereby incorporated by reference in its entirety for all purposes. The data processing module 1160 may further include a communication port, driver, or connector for establishing wired communication with one or more of the display device 1120, the on-body electronic device 1110, or the remote terminal 1170, which may include, for example, but not limited to, a USB connector and / or port, an Ethernet connector and / or port, a FireWire® connector and / or port, or an RS-232 port and / or connector.

[0157] In some embodiments, the data processing module 1160 is programmed to send polling or query signals to the on-body electronic device 1110 at a predetermined time interval (e.g., once per minute, once every five minutes, etc.) and, in response, receive monitored analyte level information from the on-body electronic device 1110. The data processing module 1160 stores the received analyte level information in its memory and / or relays or re-transmits the received information to another device such as the display device 1120. More specifically, in some embodiments, the data processing module 1160 may be configured as a data relay device that re-transmits or passes received analyte level data from the on-body electronic device 1110 to the display device 1120 or the remote terminal or both (e.g., via a data network such as a cellular or WiFi data network).

[0158] In some embodiments, the on-body electronic device 1110 and the data processing module 1160 can be placed on the user's skin surface within a predetermined distance (e.g., about 1 to 12 inches, or about 1 to 10 inches, or about 1 to 7 inches, or about 1 to 5 inches) of each other so that periodic communication between the on-body electronic device 1110 and the data processing module 1160 is maintained. Alternatively, the data processing module 1160 may be worn on the user's belt or clothing item so that a desired distance for communication between the on-body electronic device 1110 and the data processing module 1160 is maintained for data communication. In a further aspect, the housing of the data processing module 1160 can be configured to couple or engage with the on-body electronic device 1110 such that the two devices are combined or integrated as a single assembly and placed on the skin surface. In a further embodiment, the data processing module 1160 is removably engaged or connected to the on-body electronic device 1110 to provide additional modularity such that the data processing module 1160 can be optionally removed or reattached as needed.

[0159] Referring again to FIG. 21, in some embodiments, data processing module 1160 is programmed to send commands or signals to the on-body electronic device 1110 at a predetermined time interval, such as once per minute, or once every 5 minutes, or once every 30 minutes, or any other suitable or desired programmable time interval, to request sample-related data from the on-body electronic device 1110. When the data processing module 1160 receives the requested sample-related data, it stores the received data. In this way, the sample monitoring system 1100 can be configured to continuously receive sample-related information monitored at programmed or programmable time intervals, which can be stored and / or displayed to the user. The data stored in the data processing module 1160 can then be provided or transmitted to, for example, the display device 1120, the remote terminal 1170, etc. for subsequent data analysis, such as to identify the frequency of excursions of blood glucose levels over the monitored period, or the frequency of occurrence of alarm events during the monitored period, to improve treatment-related decisions. Using this information, a physician, healthcare provider, or user can adjust or recommend changes to routines such as diet, daily habits, exercise, etc.

[0160] In another embodiment, the data processing module 1160 transmits a command or signal to the on-body electronic device 1110 to receive analyte-related data in response to a user-initiated command received from a user-actuated switch or display device 1120 provided on the data processing module 1160. In a further embodiment, the data processing module 1160 is configured to transmit a command or signal to the on-body electronic device 1110 only after a predetermined time interval has elapsed in response to the receipt of a user-initiated command. For example, in some embodiments, the data processing module 1160 may be programmed to automatically transmit a request command or signal to the on-body electronic device 1110 if the user does not initiate a communication within a programmed period, such as about 5 hours (or 10 hours or 24 hours) from the last communication. Alternatively, the data processing module 1160 may be programmed to activate an alarm to notify the user that a predetermined time has elapsed since the last communication between the data processing module 1160 and the on-body electronic device 1110. In this way, the data processing module 1160 can be programmed or configured to provide a certain level of compliance to the analyte monitoring regimen so that frequent determinations at the analyte level are maintained or performed by the user or a healthcare provider.

[0161] In some embodiments, when a programmed or programmable alarm state is detected (e.g., a detected glucose level monitored by a specimen sensor 1101 outside a predetermined tolerance indicating a physiological state (e.g., hypoglycemic state, hyperglycemic state, impending hyperglycemic state or impending hypoglycemic state) requiring attention or intervention for medical treatment or analysis), one or more output displays are generated by the control logic or processor of the on-body electronic device 1110 and can be output to the user on the user interface of the on-body electronic device 1110 so that corrective measures can be taken in a timely manner. In addition, or alternatively, if a display device 1120 is within the communication range, the output display or alarm data can be communicated to a display device 1120 having a processor that controls the display 1122 to output one or more notifications upon detecting receipt of the alarm data.

[0162] In some embodiments, the control logic or processor of the on-body electronic device 1110 executes a software program stored in a memory and, based on the monitored specimen data stored, which provides information obtained from the specimen sensor 1101, such as the current specimen level, the rate of change of the specimen level, the acceleration of change of the specimen level, and / or the historical trend or direction of specimen level variation as a function of time during the monitored period, determines a specimen trend information based on which a future or predicted specimen level can be determined. The predictive alarm parameters may be programmed or programmable in the display device 1120, or the on-body electronic device 1110, or both, and can output to the user in advance the prediction that the user's specimen level will reach a future level. Thereby, the user can take corrective measures at an appropriate timing.

[0163] For example, information such as fluctuations or oscillations in the monitored analyte level as a function of time over a monitored period that provides analyte trend information can be determined by one or more control logics or processors of the display device 1120, the data processing module 1160, and / or the remote terminal 1170, and / or the on-body electronic device 1110. Such information can be displayed, for example, as a graph (such as a line graph), to show the user the current and / or historical and / or predicted future analyte levels measured and predicted by the analyte monitoring system 1100. Such information may be displayed as a directional arrow (see, e.g., the display 1131 of a trend or directional arrow), or other icon, and, for example, its relative position on the screen with respect to a reference point indicates whether the analyte level is increasing or decreasing, as well as the acceleration or deceleration of the increase or decrease in the analyte level. This information can be utilized by the user to determine corrective measures necessary to ensure that the analyte level remains within an acceptable range and / or a clinically safe range. Other visual indicators, including color, blinking, fading, etc., as well as audio indicators including changes in pitch, volume, or tone of an audio output, and / or vibration or other tactile indicators may be incorporated into the display of trend data as a means of notifying the user of the current level and / or direction and / or rate of change of the monitored analyte level. For example, based on the determined rate of glucose change, a programmed clinically significant glucose threshold level (e.g., hyperglycemic and / or hypoglycemic levels), and the current analyte level derived by the in vivo analyte sensor, the system 1100 may include an algorithm stored in a computer-readable medium for determining the time it takes to reach a clinically important level, and prior to reaching the clinically important level, output a notification, for example, 30 minutes before, and / or 20 minutes before, and / or 10 minutes before, and / or 5 minutes before, and / or 3 minutes before, and / or 1 minute before, etc., when the clinically important level is expected, with the intensity, etc. increasing.

[0164] Returning again to FIG. 21, in some embodiments, the software algorithms for execution by the data processing module 1160 may be stored on an external memory device such as an SD card, a micro SD card, a CompactFlash® card, an XD card, a Memory Stick card, a Memory Stick Duo card, or a USB memory stick / device, including an executable program stored on such a device for execution upon connection to one or more of the on-body electronic device 1110, the remote terminal 1170, or the display device 1120. In a further aspect, the software algorithms for execution by the data processing module 1160 may be provided as a downloadable application for execution by a communication device, such as a cellular phone including a Wi-Fi or Internet-enabled smartphone or personal digital assistant (PDA), to be downloaded to the communication device.

[0165] Examples of smartphones include cellular phones with a data network connection function for data communication via an Internet connection and / or a local area network (LAN), based on the Windows®, Android®, iPhone® operating system, Palm® WebOS™, Blackberry® operating system, or Symbian® operating system. PDAs as described above include portable electronic devices including, for example, one or more processors and a data communication function having a user interface (e.g., a display / output unit and / or an input unit, configured to perform data processing, e.g., data upload / download via the Internet). In such embodiments, the remote terminal 1170 may be configured to provide executable application software to one or more of the above communication devices when communication is established between the remote terminal 1170 and the device.

[0166] In yet other embodiments, the executable software application may be provided wirelessly (OTA) as an OTA download so that a wired connection to the remote terminal 1170 is not required. For example, the executable application may be automatically downloaded to the communication device as a software download and installed on the device for use automatically or based on user confirmation or approval on the communication device to execute the installation of the application, depending on the configuration of the communication device. The OTA download and installation of software may include software applications and / or routines that are updates or upgrades to existing functions or features of the data processing module 1160 and / or the display device 1120.

[0167] Referring again to the remote terminal 1170 of FIG. 21, in some embodiments, new software and / or software updates, such as software patches or fixes, firmware updates, or software driver upgrades, for the display device 1120 and / or the on-body electronic device 1110 and / or the data processing module 1160, may be provided by the remote terminal 1170 when communication is established between the remote terminal 1170 and the display device 1120 and / or the data processing module 1160. For example, an upgrade of the software of the on-body electronic device 1110, a change or modification of executable programming may be received from the remote terminal 1170 by one or more of the display device 1120 or the data processing module 1160 and then provided to the on-body electronic device 1110 to update the software or programmable function. For example, in some embodiments, the software received and installed on the on-body electronic device 1110 may include software bug fixes, changes to previously stopped software parameters (especially changes to the storage time interval of sample-related data, reset or adjustment of the time-based or information of the on-body electronic device 1110, transmitted data type, data transmission sequence, or change in data storage period).

[0168] On-body electronic device In some embodiments, an on-body electronic device (or sensor control device) 1110 (FIG. 21) includes at least a portion of the electronic components that operate a sensor and a display device. The electronic components of the on-body electronic device typically include a power source for operating the on-body electronic device and the sensor, a sensor circuit for obtaining signals from the sensor and operating the sensor, a measurement circuit for converting the sensor signals into a desired format, and a processing circuit for obtaining signals from at least the sensor circuit and / or the measurement circuit and providing the signals to an optional on-body electronic device. In some embodiments, the processing circuit partially or fully evaluates the signals from the sensor, communicates the resulting data to an optional on-body electronic device, and / or activates an optional alarm system if the analyte level exceeds a threshold. The processing circuit often includes digital logic circuitry.

[0169] The on-body electronic device may optionally include an electronic device for transmitting sensor signals or processed data from the processing circuit to a receiver / display unit, a data storage unit for temporarily or permanently storing data from the processing circuit, a temperature probe circuit for receiving signals from a temperature probe and operating the temperature probe, a reference voltage generator for providing a reference voltage for comparison with the sensor-generated signals, and / or a watchdog circuit for monitoring the operation of the electronic components of the on-body electronic device.

[0170] Further, the on-body electronic device may include digital and / or analog components that utilize semiconductor devices including transistors. To operate these semiconductor devices, the on-body electronic device may include other components including, for example, a bias control generator for properly biasing analog and digital semiconductor devices, an oscillator for providing a clock signal, and digital logic and timing components for providing timing signals and logic operations for the digital components of the circuit.

[0171] As an example of the operation of these components, a sensor circuit and an optional temperature probe circuit provide a raw signal from the sensor to a measurement circuit. The measurement circuit converts the raw signal into a desired format, for example, using a current / voltage converter, a current / frequency converter, and / or a binary counter or other indicator that generates a signal proportional to the absolute value of the raw signal. This can be used, for example, to convert the raw signal into a format that can be used by digital logic circuitry. Next, the processing circuit can optionally evaluate the data and provide commands for operating the electronic device.

[0172] Referring to FIG. 21, in some embodiments, the adhesive patch 1140 has a footprint on the body with a diameter of less than about 3.0 inches, for example, less than about 2.0 inches, less than about 1.0 inch. In some embodiments, the adhesive patch can have a diameter of from 1.0 inch to about 1.5 inches or less.

[0173] In some embodiments, the on-body electronic device 1110 is configured to have a small surface area, for example, less than about 2 square inches excluding the adhesive patch 1140, for example, less than about 1.5 square inches excluding the adhesive patch 1140, for example, less than about 1 square inch excluding the adhesive patch 1140, for example, less than about 0.9 square inch excluding the adhesive patch 1140, for example, less than about 0.8 square inch excluding the adhesive patch 1140, for example, less than about 0.75 square inch excluding the adhesive patch 1140, for example, less than about 0.7 square inch excluding the adhesive patch 1140. In some embodiments, the surface area of the on-body electronic device unit can be from about 0.75 square inch to about 0.79 square inch excluding the adhesive patch 1140.

[0174] In some embodiments, the on-body electronic device 1110 including the adhesive patch 1140 has a surface area of about 3.0 square inches or less, including the adhesive patch, for example, about 2.0 square inches or less, including the adhesive patch, for example, about 1.9 square inches or less, including the adhesive patch, for example, about 1.8 square inches or less, including the adhesive patch, for example, about 1.75 square inches or less, including the adhesive patch, for example, about 1.6 square inches or less. In some embodiments, the surface area of the on-body electronic device unit may be from about 1.75 square inches to about 1.77 square inches or less.

[0175] FIG. 22 is a block diagram of an on-body electronic device 1110 (FIG. 21) in some embodiments. Referring to FIG. 22, in some embodiments, the on-body electronic device 1110 includes a control unit 1210 (e.g., one or more processors (or processing circuits) and / or an ASIC including a processing circuit, but not limited thereto) operably coupled to an analog front-end circuit 1270, and processes signals such as a bioelectric current signal received from the analyte sensor 1101. FIG. 22 also shows a memory 1220 operably coupled to the control unit 1210 for storing software routines for execution by the data and / or control unit 1210. The memory 1220 in some embodiments may include an electrically erasable programmable read-only memory (EEPROM), an erasable programmable read-only memory (EPROM), a random access memory (RAM), a read-only memory (ROM), a flash memory, or one or more combinations thereof.

[0176] In some embodiments, in addition to accessing data or software routines stored in memory 1220 to search for one or more stored software routines for execution, control unit 1210 updates, stores, or replaces data or information stored in memory 1220. FIG. 22 also shows a power supply 1260 that, in some embodiments, powers some or all of the components of the on-body electronic device 1110. For example, in some embodiments, power supply 1260 is configured to provide power to the components of on-body electronic device 1110, excluding communication module 1240. In such embodiments, on-body electronic device 1110 is configured to operate sample sensor 1101 to detect and monitor sample levels at predetermined or programmed (or programmable) time intervals and, for example, generate and store signals or data corresponding to the detected sample levels.

[0177] In some embodiments, the power supply 1260 within the on-body electronic device 1110 can be switched between its internal power source (e.g., a battery) and RF power received from the display device 1120. For example, in some embodiments, when a predetermined level of RF power is detected by the on-body electronic device 1110, a diode or switch is triggered to disable the internal power connection (e.g., form an open circuit in the power connection path), and the on-body electronic device 1110 can include a diode or switch provided in the internal power connection path of the on-body electronic device such that the components of the on-body electronic device are powered by the received RF power. The open circuit in the power connection path prevents the consumption or dissipation of the internal power source as would occur if the internal power source were used to power the on-body electronic device 1110.

[0178] When the RF power from the display device 1120 falls below a predetermined level, a diode or switch is triggered to establish a connection between the internal power source and other components of the on-body electronics 1110 and supply power to the on-body electronics 1110 with the internal power source. In this way, in some embodiments, the switching between the internal power source and the RF power from the display device 1120 can be configured to extend or prolong the useful life of the internal power source.

[0179] However, the stored analyte-related data is not transmitted or otherwise communicated to another device, such as the display device 1120 (FIG. 21), until the communication module 1240 of the on-body electronics 1110 is powered remotely by RF power from a display device 1120 disposed within a predetermined distance, for example, from the on-body electronics 1110. In such embodiments, the analyte level is sampled based on a predetermined or programmed time interval as described above and stored in the memory 1220. When analyte level information is requested based on a request or transmit command received from another device, such as the display device 1120 (FIG. 21), using RF power from the display device, the communication module 1240 of the on-body electronics 1110 initiates data transfer to the display device 1120.

[0180] Returning to FIG. 22, an optional output unit 1250 is provided in the on-body electronic device 1110. In some embodiments, the output unit 1250 may include an LED indicator, for example, to alert the user of one or more predetermined conditions related to the operation of the on-body electronic device 1110 and / or the determined analyte level. By way of non-limiting example, the on-body electronic device 1110 may indicate that a signal received from the analyte sensor 1101 (based on one sampled sensor data point or a plurality of sensor data points) exceeds a programmed tolerance, indicating a health risk condition such as hyperglycemia or hypoglycemia, or potentially indicating the onset or likelihood of such a condition, and may be programmed to assert a notification using the LED indicator or other indicator on the on-body electronic device 1110. With such a prompt or indication, the user can be timely notified of such potential conditions, confirm the existence of such conditions, obtain glucose level information from the on-body electronic device 1110 using the display device 1120, and take corrective action in a timely manner.

[0181] Referring again to FIG. 22, the antenna 1230 and the communication module 1240 operably coupled to the control unit 1210 may be configured to detect and process RF power when the on-body electronic device 1110 is disposed within a predetermined proximity of the display device 1120 (FIG. 21) that is providing or radiating RF power. Further, the on-body electronic device 1110 may provide the display device 1120 with analyte level information and, optionally, analyte trend or history information based on stored analyte level data. In certain embodiments, the trend information may include a plurality of analyte level information over a predetermined period of time that is stored in the memory 1220 of the on-body electronic device 1110 and provided to the display device 1120 along with real-time analyte level information. For example, the trend information may include analyte level data taken at a series of time intervals after the last transmission of analyte level information to the display device 1120. Alternatively, the trend information may include analyte level data for the past 30 minutes or 1 hour that is stored in the memory 1220 and retrieved under the control of the control unit 1210 for transmission to the display device 1120.

[0182] In some embodiments, the on-body electronic device 1110 is configured to store analyte level data in first and second FIFO buffers that are part of the memory 1220. The first FIFO buffer stores 16 (or 10 or 20) of the most recent analyte level data at 1-minute intervals. The second FIFO buffer stores the most recent 8 hours (or 10 hours or 3 hours) of analyte level data at 10-minute (or 15-minute or 20-minute) intervals. The stored analyte level data is transmitted from the on-body electronic device 1110 to the display unit 1120 in response to a request received from the display unit 1120. The display unit 1120 uses the analyte level data from the first FIFO buffer to estimate a glucose rate of change and uses the analyte level data from the second FIFO buffer to determine a history plot or trend information.

[0183] In some embodiments, with respect to the configuration of an on-body electronic device including a power source, the on-body electronic device may be configured to detect an RF control command (ping signal) from the display device 1120. More specifically, an on / off key (OOK) detector is provided in the on-body electronic device, turned on by the power source of the on-body electronic device, powered, and configured to detect an RF control command or ping signal from the display device 1120. Further details of the OOK detector are provided in U.S. Patent Application Publication No. 2008 / 0278333, the disclosure of which is incorporated by reference in its entirety for all purposes. In a particular aspect, when an RF control command is detected, the on-body electronic device determines which response packets are required and generates response packets to send back to the display device 1120. In this embodiment, the analyte sensor 1101 continuously receives power from the power source or battery of the on-body electronic device and operates to continuously monitor the analyte level during use. However, the sampled signal from the analyte sensor 1101 may not be provided to the display device 1120 until the on-body electronic device receives RF power (from the display device 1120) and starts transmitting data to the display device 1120. In one embodiment, the power source of the on-body electronic device may include a rechargeable battery that is charged when the on-body electronic device receives RF power (e.g., from the display device 1120).

[0184] Returning to FIG. 21, in some embodiments, the on-body electronic device 1110 and the display device 1120 may be configured to communicate using an RFID (Radio Frequency Identification) protocol. More specifically, in some embodiments, the display device 1120 is configured to interrogate the on-body electronic device 1110 (associated with an RFID tag) via an RF communication link, and in response to an RF interrogation signal from the display device 1120, the on-body electronic device 1110 provides an RF response signal that includes, for example, data related to a sampled analyte level from the sensor 1101. Additional information regarding the operation of RFID communication can be found in U.S. Patent No. 7,545,272, U.S. Applications Nos. 12 / 698,624, 12 / 699,653, 12 / 761,387, and U.S. Patent Application Publication No. 2009 / 0108992, which are hereby incorporated by reference in their entirety for all purposes.

[0185] For example, in one embodiment, the display device 1120 may include a backscatter RFID reader configured to provide an RF field, such that when the on-body electronic device 1110 is within the transmitted RF field of the RFID reader, the antenna of the on-body electronic device 1110 is tuned and then provides a reflected or response signal (e.g., a backscatter signal) to the display device 1120. The reflected or response signal may include sampled analyte level data from the analyte sensor 1101.

[0186] In some embodiments, the display device 1120 is disposed within a predetermined range of the on-body electronic device 1110, and upon receiving a response signal from the on-body electronic device 1110, the display device 1120 is configured to output a (audible, visual, or other) indication for verifying the acquisition of the analyte level measurement value. That is, during the 5 to 10 days of wearing the on-body electronic device 1110, the user can place the display device 1120 within a predetermined distance (e.g., about 1 to 5 inches, or about 1 to 10 inches, or about 1 to 12 inches) from the on-body electronic device 1110 at any time. After waiting for a sample acquisition period of several seconds, an audible indication for verifying the reception of real-time analyte level information is output. The received analyte information can be output to the display 1122 (FIG. 21) of the display device 1120 for presentation to the user.

[0187] In some embodiments, the on-body electronic device 1110 includes an ASIC that includes a RISC (Reduced Instruction Set Computing) processor, an EEPROM, and registers (A / D converters operably coupled to the analyte sensors) on the chip. The EEPROM in some embodiments includes a portion programmed therein with one or more characteristics or details related to memory management routines. Examples of characteristics or details include, for example, the source address (e.g., whether it is an array or a single memory location), the destination address, the size / number of bytes to copy to the memory, and whether the memory location is a loop buffer (e.g., overwriting older stored values with new values when the end of the buffer is reached).

[0188] In some embodiments, a pre-set number of specific events may be subdivided and stored. For example, such events may include, but are not limited to, (1) an RF power-on event, (2) an RF data read command, (3) an RF data log command, (4) a 1-minute data preparation event (e.g., A / D conversion of signals from a sample sensor is completed and the digitized data is ready to be stored), or (3) a log data (10-minute sample data) preparation event (e.g., when 10-minute sample data is available for storage). For example, in some embodiments, 10-minute sample data is available when the last A / D conversion of the 10-minute sample data is completed. In some embodiments, other events or states may be defined.

[0189] In some embodiments, when a RISC processor detects one of the specific events, the RISC processor executes a programmed memory management routine. During the execution of the memory management routine, the characteristics stored in the EEPROM are acquired. Based on the acquired characteristics, the memory management routine stores the data related to the detected event. For example, in some embodiments, when an RF data log command event is detected, the data related to this event is recorded in another section of the EEPROM on the ASIC chip according to the acquired characteristics (e.g., the source and destination addresses of the data related to this event).

[0190] In some embodiments, the characteristics stored in the EEPROM in relation to a particular event may be modified. For example, the source and destination addresses may be changed or modified to point to different memory devices or storage units of the on-body electronic device 1110 (e.g., a separate EEPROM or memory that is not part of the ASIC chip). For example, the data logger application of the monitoring system 1100 requires storing a much larger amount of data (e.g., data of sampled specimen data sampled at 1-minute intervals for about 30 days, about 45 days, about 60 days or more (or data sampled at 5-minute intervals, or data sampled at 10-minute intervals)) in the on-body electronic device 1110 than an on-demand application that stores a limited amount of data (e.g., 15 samples of specimen data sampled at 1-minute intervals and 6 hours of specimen data sampled at past 10-minute intervals). In some embodiments, the amount of data to be stored for the data logger application may exceed the capacity of the on-chip EEPROM. In such cases, an off-chip EEPROM with a larger capacity may be provided to the on-body electronic device 1110 to store the data from the data logger application. In some embodiments, the characteristics stored in the EEPROM related to the event are reprogrammed or updated (e.g., by updating the source or destination address related to the event) to configure the on-body electronic device 1110 to store the sampled specimen data in the off-chip EEPROM with a larger capacity, so that the data logging or storage is directed to the larger off-chip EEPROM.

[0191] In this way, by updating or reprogramming a part of the on-chip EEPROM that stores event characteristics, the location of data storage in the on-body electronic device 1110 can be updated or modified according to the desired application or use of the on-body electronic device 1110. Further, other stored characteristics related to one or more specific events can be updated or reprogrammed in the EEPROM as needed to modify the use or application of the on-body electronic device 1110 in the specimen monitoring system 1100. This is more advantageously achieved without reprogramming or changing the stored routines for executing specific events by the RISC processor.

[0192] Display device / Computing device FIG. 23 is a block diagram of the display device 1120 shown in FIG. 21 in some embodiments. Although the term display device is used, the device can be configured to read without displaying data and can be provided without a display, such as in the case of a relay device or other device that relays signals received according to the same or different transmission protocols (e.g., NFC-to-Bluetooth or Bluetooth Low Energy). Referring to FIG. 23, the display device 1120 (FIG. 21) includes a control unit 1310, such as one or more processors (or processing circuits) operably coupled to a display 1122, and an input component (e.g., user interface) 1121. The display device 1120 also includes one or more data communication ports, such as a USB port (or connector) 1123 or an RS-232 port 1330 (or any other wired communication port) for data communication with the data processing module 1160 (FIG. 21), a remote terminal 1170 (FIG. 21), or other devices, including other handheld data processing devices, such as a mobile phone, including a personal computer, a server, a mobile computing device, a cellular phone, a pager, or an Internet-connectable smartphone with data communication and processing functions including data storage and output.

[0193] Returning to FIG. 23, the display device 1120 may include a strip port 1124 configured to receive an in vitro test strip, the strip port 1124 being coupled to the control unit 1310, and further, the control unit 1310 includes programming to process a sample on the in vitro test strip received at the strip port 1124. Any suitable in vitro test strip may be employed, for example, a test strip that requires only a very small amount (e.g., less than 1 microliter, e.g., less than about 0.5 microliter, e.g., less than about 0.1 microliter) of sample applied to the strip to obtain accurate glucose information. A display device with an integrated in vitro monitor and test strip port may be configured to perform in vitro analyte monitoring without user calibration of the in vitro test strip (e.g., without calibration by human intervention).

[0194] In some embodiments, the integrated in vitro meter can accept and process various different types of test strips (e.g., those that require user calibration and those that do not), some of which may use different technologies (e.g., those operating using current measurement technology, those operating using charge measurement technology, etc.). A detailed description of such test strips and devices for performing in vitro analyte monitoring is provided in U.S. Pat. Nos. 6,377,894, 6,616,819, 7,749,740, 7,418,285, U.S. Patent Application Publication Nos. 2004 / 0118704, 2006 / 0096006, 2008 / 0066305, 2008 / 0267823, 2010 / 0094610, 2010 / 0094111, and 2010 / 0094112, and U.S. Application No. 12 / 695,947, the disclosures of all of which are incorporated herein by reference in their entirety and for all purposes.

[0195] The glucose information obtained by the in vitro glucose test device can be used for various purposes. For example, the information can be used to calibrate the analyte sensor 1101 (FIG. 21) when the sensor requires in vivo calibration, and to confirm the results of the analyte sensor 1101 to enhance the reliability of the results from the sensor 1101 indicating the monitored analyte level (e.g., the information obtained by the sensor 1101 is adopted for treatment-related decisions). In some embodiments, the analyte sensor does not require calibration by human intervention during its period of use. However, in some embodiments, the system may be programmed to self-detect problems and take actions such as shutting down and / or notifying the user. For example, the analyte monitoring system may be configured to detect malfunctions of the system, or potential degradation or potential adverse conditions of the stability of the sensor related to the operation of the analyte sensor, and the system may use, for example, a display device 1120 (FIG. 21) to notify the user to perform calibration of the analyte sensor or to compare the results received from the analyte sensor corresponding to the monitored analyte level with a reference value (such as the result of an in vitro blood glucose measurement).

[0196] In some embodiments, when a potential adverse condition related to the operation of the sensor and / or a potential sensor stability degradation state is detected, the system may be configured to shut down (automatically without notifying the user or after notifying the user), or to disable the output or display of the monitored analyte level information received by the on-body electronic device assembly. In some embodiments, the analyte monitoring system can be temporarily shut down or disabled to provide the user with an opportunity to correct the detected adverse condition or sensor instability. In other specific embodiments, when an abnormal sensor operating state or sensor instability is detected, the analyte monitoring system may be permanently disabled.

[0197] Continuing to refer to FIG. 23, a power source 1320 such as one or more rechargeable or disposable batteries is also provided and is operably coupled to the control unit 1310 and configured to provide the power necessary for operation to the display device 1120 (FIG. 21). Further, the display device 1120 includes an antenna 1351 such as a 433 MHz (or other equivalent) loop antenna, a 13.56 MHz antenna, or a 2.45 GHz antenna, which is coupled to a receiver processor 1350 (which may include, for example, a 433 MHz, 13.56 MHz, or 2.45 GHz transceiver chip) for wireless communication with the on-body electronic device 1110 (FIG. 21). Further, an inductive loop antenna 1341 is provided and is coupled to a square wave driver 1340 that is operably coupled to the control unit 1310.

[0198] In some embodiments, the data packets received from the on-body electronic device and received in response to a request from the display device include, for example, one or more of the current glucose level from a sample sensor, the current estimated rate of change of blood glucose, and the glucose trend history based on automatically measured values acquired and stored in the memory of the skin electronic device. For example, the current glucose level may be output as a numerical value on the display 1122 of the display device 1120, the current estimated rate of change of blood glucose may be output as a direction arrow 1131 (FIG. 21) on the display 1122, and the glucose trend history based on the stored monitored values may be output as a graphic trace 1138 (FIG. 21) on the display 1122. In some embodiments, the processor (or processing circuit) of the display device 1120 may be programmed to output more or less information for display on the display 1122, and further, the type and amount of information output to the display 1122 may be programmed by or be programmable by the user.

[0199] In some embodiments, the display device 1120 is programmed to maintain a period between each successive sample data request from the on-body electronic device 1110. For example, in some embodiments, the display device 1120 is configured not to permit a subsequent sample data request to be sent to the on-body electronic device 1110 until a predetermined period measured from the transmission of the first sample data request has elapsed, after the first sample data request has been sent to the on-body electronic device 1110 and monitored sample level information has been received from the on-body electronic device 1110. For example, when the display device 1120 is operated to send a request for sample-related data to the on-body electronic device 1110, an internal clock or timer of the display device 1120 starts or activates an internal clock or timer programmed with a predetermined period that counts down. The display device 1120 in some embodiments includes programming that invalidates or prevents the transmission of a second subsequent request for sample data from the on-body electronic device 1110 until a predetermined period has elapsed.

[0200] In some embodiments, the predetermined period includes about 120 seconds, about 90 seconds, about 60 seconds, or about 30 seconds or less. The predetermined period in some embodiments is the period for the on-body electronic device 1110 to perform analog-to-digital conversion to convert a signal sampled from the monitoring of the sample level into a corresponding digital signal for transmission, and / or is determined by the sampling period of the sample sensor 1101 that monitors the sample level every minute, or every 5 minutes, or every 10 minutes, or other suitable time intervals. The time intervals in some embodiments may be pre-programmed as software logic of the on-body electronic device 1110 or, alternatively, may be programmable and modifiable during the use of the in-vivo sensor.

[0201] In some embodiments, display device 1120 may be programmed or be programmable to discard or identify received data from on-body electronic device 1110 that is damaged or otherwise contains an error. For example, in some embodiments, a minimum period between subsequent analyte data requests is not enforced or programmed in display device 1120. However, display device 1120 includes software routines that identify damaged or non-damaged data based on inspection of data packets. For example, each data packet received from on-body electronic device 1110 includes a single bit or byte or other suitable portion of the data packet that provides an indication of the data status. In the case of a single bit as a data status identifier within a data packet from on-body electronic device 1110, in some embodiments, a value of 1 indicates that the data is not damaged. In such embodiments, on-body electronic device 1110 is configured to reset this bit within the data packet to 0 at the end of each sampling period (e.g., after each minute) and change the value to 1 if the A / D conversion routine completed without error during the sampling period.

[0202] Data Communication and Processing Routines Next, referring to FIG. 24 showing data and / or command exchange between the on-body electronic device 1110 and the display device 1120 during the initialization and pairing routine, the display device 1120 provides an initial signal 1421 to the on-body electronic device 1110. If the received initial signal 1421 contains RF energy exceeding a predetermined threshold level 1403, the envelope detector of the on-body electronic device 1110 is triggered 1404, one or more oscillators of the on-body electronic device 1110 are turned on, and the control logic or processor of the on-body electronic device 1110 is temporarily latched on to obtain and execute one or more software routines for extracting a data stream from the envelope detector 1404. If the data stream from the envelope detector returns a valid query 1405, a response signal 1422 is transmitted to the display device 1120. The response signal 1422 from the on-body electronic device 1110 includes an identification code such as the serial number of the on-body electronic device 1110. Thereafter, the on-body electronic device 1110 returns to the non-active shelf mode.

[0203] On the other hand, if the data stream from the envelope detector does not return a valid query from the display device 1120, the on-body electronic device 1110 does not transmit a response signal to the display device 1120, and the serial number of the on-body electronic device 1110 is not provided to the display device 1120 either. Thereafter, the on-body electronic device 1110 returns to the shelf mode 1403 and remains in the power-down state until a subsequent initial signal 1421 from the display device 1120 is detected.

[0204] When the display device 1120 receives a data packet including identification information or a serial number from the on-body electronic device 1110, it extracts that information from the data packet 1412. With the serial number of the on-body electronic device 1110 extracted, the display device 1120 determines whether the on-body electronic device 1110 associated with the received serial number is set. If the body electronic device 1110 associated with the received serial number has already been set by, for example, another display device, the display device 1120 returns to the beginning of the routine and transmits another initialization signal 1411 in an attempt to initialize another on-body electronic device that has not yet been set. In this way, in some embodiments, the display device 1120 is configured to pair with an on-body electronic device that is not yet paired with another display device or is not set by another display device.

[0205] Returning to FIG. 24, if the on-body electronic device 1110 associated with the extracted serial number is not set in case 1413, the display device 1120 is configured to send a wake-up signal including a set command to the on-body electronic device 1110. In some embodiments, the wake-up command from the display device 1120 includes the serial number of the on-body electronic device 1110, such that only the on-body electronic device having the same serial number included in the wake-up command detects and exits the inactive shelf mode and enters the active mode. More specifically, when a wake-up command including a serial number is received by the on-body electronic device 1110, the control logic or one or more processors (or processing circuits) of the on-body electronic device 1110 execute routines 1403, 1404, and 1405 to temporarily exit the shelf mode when the RF energy received with the wake-up signal (including the configuration command) exceeds a threshold level and determine that it is not a valid query (since that determination was made previously and the serial number was sent to the display device 1120). Thereafter, the on-body electronic device 1110 determines 1406 whether the received serial number (received in the wake-up command) matches the serial number stored therein. If the two serial numbers do not match, the routine returns to the beginning and the on-body electronic device 1110 is again placed in the inactive shelf mode 1402. On the other hand, if the on-body electronic device 1110 determines 1406 that the received serial number matches its stored serial number, the control logic or one or more processors of the on-body electronic device 1110 are permanently latched on 1407 and the oscillator is turned on to activate the on-body electronic device 1110. Further, referring back to FIG. 24, when the on-body electronic device 1110 determines that the received serial number matches its own serial number 1406, the display device 1120 and the on-body electronic device 1110 are successfully paired 1416.

[0206] In this way, when the on-body electronic device 1110 is turned on and initialized using a wireless signal, the current drawn or consumed from the power supply of the on-body electronic device 1110 is very low during the time when the on-body electronic device 1110 is in the non-active, shelf mode before operation, so the storage life of the on-body electronic device 1110 may be extended. In some embodiments, during the non-active shelf mode, the on-body electronic device 1110 has minimal operations that, if any, require extremely low current. The RF envelope detector of the on-body electronic device 1110 can operate in two modes: a desensitized mode that responds to received signals of less than about 1 inch and a normal operating mode that has normal signal sensitivity to respond to signals received at a distance of about 3 - 12 inches.

[0207] During the first pairing between the display device 1120 and the on-body electronic device 1110, in some embodiments, the display device 1120 transmits its identification information, such as a 4-byte display device ID that may include, for example, its serial number. The on-body electronic device 1110 stores the received display device ID in one or more storage units or memory components and then includes the stored display device ID data in a response packet or data provided to the display device 1120. In this way, the display device 1120 can distinguish the detected data packet from the on-body electronic device 1110 and determine that the received or detected data packet was transmitted from the paired or correct on-body electronic device 1110. The pairing routine based on the display device ID in some embodiments avoids potential collisions between multiple devices, especially when the on-body electronic device 1110 does not selectively provide specimen-related data to a specific display device but rather provides it to any display device within range and / or broadcasts the data packet to any display device within the communication range.

[0208] In some embodiments, the payload size from the display device 1120 to the on-body electronic device 1110 is 12 bytes, which includes a 4-byte display device ID, a 4-byte on-body device ID, 1 byte of command data, 1 byte of spare data space, and 2 bytes for CRC (Cyclic Redundancy Check) for error detection.

[0209] After pairing is complete, when the display device 1120 queries the on-body electronic device 1110 for real-time monitored analyte information and / or recorded or stored analyte data, in some embodiments, the response data packet transmitted to the display device 1120 includes 34 bytes of status information, time information, and calibration data, 96 bytes of the latest 16 one-minute glucose data points, and 288 bytes of the most recent 15-minute interval glucose data over 12 hours, for a total of 418 bytes. Depending on the size or capacity of the memory or storage unit of the on-body electronic device 1110, the data stored and subsequently provided to the display device 1120 may have different time resolutions and / or may cover longer or shorter periods. For example, with a larger data buffer, the glucose-related data provided to the display device 1120 may include glucose data over a 24-hour period at 15-minute sampling intervals, 10-minute sampling intervals, 5-minute sampling intervals, or 1-minute sampling intervals. Further, the determined variations in the monitored analyte levels indicating the historical trends of the monitored analyte levels may be processed and / or determined by the on-body electronic device 1110, or alternatively or additionally, the stored data may be provided to the display device 1120, and then the display device 1120 may determine the trend information of the monitored analyte levels based on the received data packet.

[0210] The size of the data packet provided from the on-body electronic device 1110 to the display device 1120 can vary depending on, for example, communication protocols and / or the data transmission frequency on which 433 MHz, 13.56 MHz, or 2.45 GHz is based, in addition to parameters such as the size of an ASIC state machine, data buffer, and / or memory, and the presence of a data processing device such as a processor or processing circuit (e.g., a central processing unit CPU) of the on-body electronic device 1110.

[0211] In some embodiments, upon successful activation of the on-body electronic device 1110 and pairing with the display device 1120, the control unit of the display device 1120 can be programmed to generate and output one or more visual, auditory, and / or tactile notifications for output to the user on the display 1122 or on the user interface of the display device 1120. In some embodiments, only one display device at a time can be paired with one on-body electronic device. Alternatively, in some embodiments, one display device may be configured to pair with multiple on-body electronic devices simultaneously.

[0212] Once paired, for example, the display 1122 of the display device 1120 outputs the remaining operating life of the user's analyte sensor 1101 under the control of the processor of the display device 1120. Further, as the end of the sensor's life approaches, the display device can be configured to output a notification warning the user that the end of the sensor's life is approaching. Such a notification schedule can be programmed by the user or be programmable and executed by the processor of the display device.

[0213] Referring again to FIG. 21, in some embodiments, the specimen monitoring system 1100 can store historical specimen data in a memory, such as a memory configured as the data logger described above, along with a date and / or timestamp and / or contemporaneous temperature measurements. In some embodiments, the specimen data is stored at a frequency such as once every about one minute, or once every about ten minutes, or once every about one hour. Embodiments of the data logger can store historical specimen data for a predetermined period, such as a duration specified by a physician, for example, from about one day to about one month or more, for example, about three days or more, for example, about five days or more, for example, about seven days or more, for example, about two weeks or more, for example, about one month or more.

[0214] Depending on the clinical significance of the data being observed, other durations may be appropriate. The specimen monitoring system 1100 can display the specimen measurements to the subject during the monitoring period. In some embodiments, the data is not displayed to the subject. Optionally, the data logger can transmit the historical specimen data to a receiving device disposed adjacent, for example, in proximity to the data logger. For example, the receiving device can be configured to communicate with the data logger using a low-power transmission protocol that operates over a distance ranging from a fraction of an inch to several feet. For example, without limitation, such proximity protocols include Certified Wireless USB (trademark), TransferJet (trademark), Bluetooth (registered trademark) (IEEE 802.15.1), WiFi (trademark) (IEEE 802.11), ZigBee (registered trademark) (IEEE 802.15.4-2006), Wibree (trademark), and the like.

[0215] Historical sample data sets can be analyzed using a variety of diagnostic approaches. For example, historical sample data obtained over several days may be correlated with the same date and / or time. Historical sample data may be correlated with meal times. For example, the data can take into account breakfast, lunch, and dinner. The data analysis for each meal can include pre-meal times (e.g., 1 or 2 hours) and post-meal times (e.g., 1 - 4 hours). Such an approach eliminates obvious glucose variations due to variations in the timing of meals alone. The parameters of the sample data can be determined based on the rate of change at one or more sample levels. In some embodiments, the sample data parameters can be determined with respect to whether a threshold related to the sample value is exceeded, e.g., hyperglycemic or hypoglycemic states, the percentage of time above the threshold, or the duration above the threshold.

[0216] The sample data parameters may be calculated by a processor or processing circuit that executes a program stored in a memory. In some embodiments, the processor that executes the program stored in the memory is provided in the data processing module 1160 (FIG. 21). In some embodiments, the processor that executes the program stored in the memory is provided in the display device 1120. An exemplary technique for analyzing the data is the applied ambulatory glucose profile (AGP) analysis technique. Additional detailed descriptions are provided in U.S. Patent Nos. 5,262,035, 5,264,104, 5,262,305, 5,320,715, 5,593,852, 6,175,752, 6,650,471, 6,746,582, 6,284,478, 7,299,082, and U.S. Patent Application Nos. 10 / 745,878, 11 / 060,365, the entire disclosures of which are hereby incorporated by reference in their entirety for all purposes.

[0217] As described above, in certain aspects of the present disclosure, individual glucose measurement data can be obtained from a display device on demand or upon request, and the glucose measurement value is obtained from an in vivo glucose sensor that is transdermally disposed under the user's skin layer and a portion of the sensor is maintained in fluid contact with the body fluid under the skin layer. Thus, in aspects of the present disclosure, a user of the specimen monitoring system can conveniently determine real-time glucose information at any time using the RFID communication protocol described above.

[0218] In one aspect, an integrated assembly including an on-body electronic device and an insertion device can be sterilized, packaged as a single device, and provided to a user. Further, during manufacturing, the insertion device assembly may be terminal-packaged to provide cost savings, for example, by avoiding the use of expensive thermoformed trays or foil seals. Additionally, the insertion device can include an end cap rotatably coupled to the insertion device body, which provides a safe and sterile environment for a sensor provided within the insertion device with the integrated assembly (and avoids the use of desiccants for the sensor). Also, the insertion device sealed with the end cap is configured to hold the sensor within the housing from significant movement during shipping so that the position of the sensor with respect to the integrated assembly and the insertion device is maintained from manufacturing, assembly, and shipping until the device is ready for use by the user.

[0219] Embodiments disclosed herein include the following. Embodiment A: A method, comprising: displaying, on a computing device, a specimen monitoring scan display window including a note addition button; when the note addition button is activated, transitioning, on the computing device, to an input display window that lists a limited number of user inputs related to the lifestyle events of a sensor user at a specific date and time; selecting one or more of the limited number of user inputs, wherein the input display window is configured to input information related to the one or more selected user inputs; further receiving, in the input display window, input of information related to the one or more selected user inputs; displaying, on a specimen monitoring daily display window on the computing device, selectable symbols correlated with a summary of the input of information at the specific date and time; and when the selectable symbol is selected, displaying, on the computing device, a pop-up display window that displays a summary of the input of the information overlaid on the specimen monitoring daily display window.

[0220] Embodiment B: A system comprising a computing device having a display screen configured to display a plurality of display windows, the plurality of display windows including a specimen monitoring scan display window including a note addition button, an input display window configured to list a limited number of user inputs related to the lifestyle events of a sensor user at a specific date and time and to be configured for input of information related to one or more selected user inputs, a specimen monitoring daily display window configured to display selectable symbols correlated with a summary of the input of information at the specific date and time, and a pop-up display window that displays a summary of the input of the information when the selectable symbol is selected, wherein the pop-up display window is overlaid on the specimen monitoring daily display window, and the system further comprising a specimen monitoring sensor communicatively coupled to the computing device.

[0221] Embodiment C: A system comprising a computing device having a display screen configured to display a plurality of display windows, wherein the plurality of display windows include a specimen monitoring scan display window including a note addition button, a limited number of user inputs related to the living habits of a sensor user at a specific date and time are listed, and an input display window configured for input of information related to one or more selected user inputs, and a specimen monitoring daily display window configured to display selectable symbols correlated with a summary of the input of information at the specific date and time, and a pop-up display window that displays a summary of the input of the information when the selectable symbol is selected, and the pop-up display window is overlaid on the specimen monitoring daily display window, a computing device.

[0222] Embodiment D: A method comprising displaying a menu display window of a computing device that lists a limited number of user-selectable buttons including an event log button, and transitioning to an event log display window of the computing device when the event log button is selected, and the event log display window displays one or more events related to a specimen monitoring sensor at a specific date and time.

[0223] Embodiment E: A system comprising a computing device having a display screen configured to display a plurality of display windows, wherein the plurality of display windows include a menu display window that lists a limited number of user-selectable buttons including an event log button, and an event log display window that displays one or more events related to a specimen monitoring sensor at a specific date and time, and the system further comprises a specimen monitoring sensor communicatively coupled to the specimen monitoring sensor, a system.

[0224] Embodiment F: A system comprising a computing device having a display screen configured to display a plurality of display windows, wherein the plurality of display windows includes a menu display window listing a limited number of user-selectable buttons including an event log button, and an event log display window displaying one or more events related to a specimen monitoring sensor at a specific date and time.

[0225] Each of Embodiments A, B, and C can have one or more of the following additional elements in any combination. Element 1: The computing device is communicatively coupled to a specimen monitoring sensor.

[0226] Element 2: The computing device is communicatively coupled to a glucose monitoring sensor. Element 3: A summary of the input of information is linked to the specimen measurement at the specific date and time.

[0227] Element 4: The pop-up display window further includes a selectable edit button. Element 5: The limited number of user inputs are selected from the group consisting of food, rapid-acting insulin, short-acting insulin, exercise, comment, and any combination thereof.

[0228] Element 6: The specimen monitoring scan display window displays a graphical representation of the specimen concentration. Element 7: The specimen monitoring scan display window displays a graphical representation of the glucose concentration.

[0229] Element 8: The specimen monitoring daily display window displays a graphical representation of the specimen concentration. Element 9: The specimen monitoring daily display window displays a graphical representation of the glucose concentration.

[0230] Element 10: Further includes closing the pop-up display window. Element 11: The computing device is communicatively coupled to the specimen monitoring sensor, and the limited number of user inputs related to the sensor user's lifestyle events are dynamic based on the specimen measurement values from the specimen monitoring sensor.

[0231] As a non-limiting example, exemplary combinations applicable to A, B, and C include, but are not limited to, each of 1 to 11, 1 and 2, 1 and 3, 1 and 4, 1 and 5, 1 and 6, 1 and 7, 1 and 8, 1 and 9, 1 and 10, 1 and 11, 2 and 3, 2 and 4, 2 and 5, 2 and 6, 2 and 7, 2 and 8, 2 and 9, 2 and 10, 2 and 11, 3 and 4, 3 and 5, 3 and 6, 3 and 7, 3 and 8, 3 and 9, 3 and 10, 3 and 11, 4 and 5, 4 and 6, 4 and 7, 4 and 8, 4 and 9, 4 and 10, 4 and 11, 5 and 6, 5 and 7, 5 and 8, 5 and 9, 5 and 10, 5 and 11, 6 and 7, 6 and 8, 6 and 9, 6 and 10, 6 and 11, 7 and 8, 7 and 9, 7 and 10, 7 and 11, 8 and 9, 8 and 10, 8 and 11, 9 and 10, 9 and 11, 10 and 11, and any combination of any of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and 11, including any combination of 1 to 11, but not limited to these.

[0232] Each of Embodiments A, B, and C can have one or more of the following additional elements in any combination. Element 12: The specimen monitoring sensor is a glucose monitoring sensor.

[0233] Element 13: The limited number of user-selectable buttons including the event log button further includes buttons selected from the group consisting of the sensor application method button, the sensor scanning method button, the user manual button, the terms of use button, the privacy notice button, and any combination thereof.

[0234] Element 14: Further includes accessing the main menu display window from the menu display window. Element 15: When the user selects the help button, further includes accessing the main menu display window from the menu display window.

[0235] Element 16: One or more events related to the specimen monitoring sensor are selected from the group consisting of a scan error event, a sensor supercooling event, a new sensor discovery event, and any combination thereof.

[0236] Element 17: The event log display window further includes a troubleshooting data transmission button. Element 18: The event log display window further includes a troubleshooting data transmission button, and the method further includes transmitting information related to the event to a customer service representative when the troubleshooting data transmission button is selected.

[0237] Element 19: The event log display window displays the one or more events related to the specimen monitoring sensor together with the accompanying explanations of the one or more events.

[0238] Element 20: The event log display window displays the one or more events related to the specimen monitoring sensor together with accompanying icons or symbols. Element 21: Further includes referring to the user manual related to the one or more events and the link to its related page on the event log display window.

[0239] Element 22: Further includes providing a correction instruction related to the one or more events on the event log display window. As a non-limiting example, exemplary combinations applicable to D, E, and F include, but are not limited to, each of 12 to 22, 12 and 13, 12 and 14, 12 and 15, 12 and 16, 12 and 17, 12 and 18, 12 and 19, 12 and 20, 12 and 21, 12 and 22, 13 and 14, 13 and 15, 13 and 16, 13 and 17, 13 and 18, 13 and 19, 13 and 20, 13 and 21, 13 and 22, 14 and 4, 14 and 16, 14 and 17, 14 and 18, 14 and 19, 14 and 20, 14 and 21, 14 and 22, 15 and 16, 15 and 17, 15 and 18, 15 and 19, 15 and 20, 15 and 21, 15 and 22, 16 and 17, 16 and 18, 16 and 19, 16 and 20, 16 and 21, 16 and 22, 17 and 18, 17 and 19, 17 and 20, 17 and 21, 17 and 22, 18 and 19, 18 and 20, 18 and 21, 18 and 22, 19 and 20, 19 and 21, 19 and 22, 20 and 21, 20 and 22, 21 and 22, any combination of 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, and 22, including any combination of 12 to 22, but not limited thereto.

[0240] Unless otherwise specified, all numbers representing amounts, etc. in this specification and the related patent claims should be understood to be modified in all cases by the term "about." Accordingly, unless indicated to the contrary, the numerical parameters shown in the following specification and the appended patent claims are approximate values that may vary depending on the desired characteristics required to be obtained by embodiments of the present invention. At least, not as an attempt to limit the application to the scope of the patent claims of the doctrine of equivalents, each numerical parameter should be construed by applying ordinary rounding methods, at least in light of the reported significant digits.

[0241] This specification presents one or more exemplary embodiments incorporating various features. In this application, for the sake of clarity, not all functions of the physical implementation are described or shown. In the development of a physical implementation incorporating embodiments of the present invention, it is understood that numerous implementation-specific decisions must be made to achieve the developer's goals, depending on the implementation and also from time to time, such as compliance with system-related, business-related, government-related, and other constraints. Although the developer's efforts may be time-consuming, such efforts are routine undertakings for those skilled in the art and are benefited by this disclosure.

[0242] Various systems, tools, and methods are described herein in terms of "comprising" various components or steps, but the systems, tools, and methods can also "consist essentially of" or "consist of" various components and steps.

[0243] As used herein, the phrase "at least one" preceding a series of items modifies the entire list of items, rather than each member of the list (i.e., each item), together with the term "and" or "or" that separates any of the items. The phrase "at least one of" enables the meaning of including at least one of any one of the items, and / or at least one of any combination of the items, and / or at least one of each of the items. By way of example, the phrases "at least one of A, B, and C" or "at least one of A, B, or C" each refer to only A, only B, or only C, or any combination of A, B, and C, and / or at least one of each of A, B, and C.

[0244] Accordingly, the disclosed systems, tools, and methods are well adapted to attain the recited objects and advantages, as well as those inherent therein. The teachings of this disclosure can be modified and implemented in different yet equivalent manners, as will be apparent to those skilled in the art who benefit from the teachings herein. Thus, the specific embodiments disclosed above are merely exemplary. Further, no limitation is intended with respect to the details of the structure or design shown herein, other than as described in the appended claims. Accordingly, it is evident that the specific exemplary embodiments disclosed above may be changed, combined, or modified, and all such variations are considered to be within the scope of this disclosure. The systems, tools, and methods exemplified herein can be suitably implemented even in the absence of elements specifically disclosed herein and / or in the absence of any of the elements disclosed herein. The systems, tools, and methods are described in terms of comprising, containing, or including various components or steps, but the systems, tools, and methods can also consist essentially of or consist of various components and steps. All numerical values and ranges disclosed above can vary somewhat. When numerical ranges with lower and upper limits are disclosed, any numbers and included ranges within that range are specifically disclosed. In particular, any range of values disclosed herein (in the form of "from about a to about b", or equivalently "from approximately a to approximately b", or equivalently "approximately a - b") is to be understood to define any number and range included within the broader range of values. Also, the terms of the claims have their plain and ordinary meaning unless otherwise explicitly and clearly defined by the patentee. Further, the indefinite articles "a" or "an" used in the claims are defined herein to mean one or more of the elements introduced by them. In the event of a conflict between the usage of a word or term in this specification and one or more patents or other documents that may be incorporated herein by reference, the definition consistent with this specification should be adopted.

Claims

1. 1. A method for monitoring a user's glucose level using a glucose monitoring sensor in communication with a computing device, comprising: monitoring a glucose level via the glucose monitoring sensor, the glucose monitoring sensor having a first portion configured to be placed above a skin surface of a user and a second portion configured to be placed below the skin surface and in contact with the interstitial fluid of the user; displaying on the computing device a window containing a graphical representation of glucose data received from the glucose monitoring sensor over time; displaying on the computing device a menu display window including an event log button; selecting the event log button transitions to an event log display window on the computing device, the event log display window displaying one or more events related to operation of the glucose monitoring sensor at a particular date and time configured to assist in troubleshooting operation of the glucose monitoring sensor; and displaying remediation instructions associated with the one or more events in the event log display window.

2. The method of claim 1 , wherein the remediation instructions include a link to a page in a user manual related to the one or more events.

3. The method of claim 1 , further comprising the computing device transmitting information about the one or more events and information about the glucose monitoring sensor to a remote location.

4. The method of claim 3 , wherein the remote location includes a computing device of a customer service representative associated with the glucose monitoring sensor.

5. 4. The method of claim 3, wherein the remediation instructions displayed in the event log display window are received from the remote location in response to information about the one or more events and information about the glucose monitoring sensor being transmitted to the remote location.

6. The method of claim 3 , wherein the computing device receives a message that includes a confirmation of receipt of information about the one or more events.

7. The method of claim 1 , wherein the information about the glucose monitoring sensor includes information about a manufacturer of the glucose monitoring sensor.

8. The method of claim 1 , further comprising the step of the computing device transmitting information about the computing device to a remote location.

9. The method of claim 1 , wherein the one or more events include an event related to the temperature of the glucose monitoring sensor.

10. The method of claim 1 , wherein the one or more events include an event related to an error in receiving glucose data from the glucose monitoring sensor.

11. 1. A system for monitoring a user's glucose level, comprising: a glucose monitoring sensor configured to monitor a user's glucose level, the glucose monitoring sensor including a first portion configured to be placed above a skin surface of the user and a second portion configured to be placed below the skin surface and in contact with the user's interstitial fluid; a computing device in wireless communication with the glucose monitoring sensor, the computing device having a display screen configured to display a plurality of display windows, the plurality of display windows comprising: a window containing a graphical representation of glucose data over time received from the glucose monitoring sensor; a menu display window containing an event log button; an event log display window that is displayed when the event log button is selected, the event log display window displaying one or more events related to operation of the glucose monitoring sensor at a particular date and time configured to assist in troubleshooting operation of the glucose monitoring sensor, and the event log display window further displaying remediation instructions related to the one or more events.

12. The system of claim 11 , wherein the remediation instructions include a link to a page in a user manual related to the one or more events.

13. The system of claim 11 , wherein the computing device is configured to transmit information about the one or more events and information about the glucose monitoring sensor to a remote location.

14. The system of claim 13 , wherein the remote location includes a computing device of a customer service representative associated with the glucose monitoring sensor.

15. 14. The system of claim 13, wherein the remediation instructions displayed in the event log display window are received from the remote location in response to information about the one or more events and information about the glucose monitoring sensor being sent to the remote location.

16. The system of claim 13 , wherein the computing device is configured to receive a message including a confirmation of receipt of information about the one or more events.

17. The system of claim 11 , wherein the information about the glucose monitoring sensor includes information about a manufacturer of the glucose monitoring sensor.

18. The system of claim 11 , further comprising transmitting information about the computing device to a remote location.

19. The system of claim 11 , wherein the one or more events include an event related to the temperature of the glucose monitoring sensor.

20. The system of claim 11 , wherein the one or more events include an event related to an error in receiving glucose data from the glucose monitoring sensor.

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