Analyte sensor related notes and event log information

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 technology]

[0001] Detection of various analytes in an individual may be essential for monitoring their health. Deviations from normal analyte levels may indicate multiple physiological conditions. For example, in a diabetic individual, detection of abnormal glucose levels may be essential for maintaining health. By monitoring glucose levels with sufficient regularity, the diabetic individual may be able to take corrective action (e.g., by injecting insulin to lower glucose levels or by eating to raise glucose levels) before serious physiological harm occurs. Other analytes that are subject to physiological dysregulation may also be desirable to monitor in a similar manner in order to maintain good health.

[0002] Analyte monitoring in an individual may occur periodically or continuously over a period of time. Periodic analyte monitoring may occur by taking samples of bodily fluids, such as blood, at set time intervals and analyzing ex vivo. Continuous analyte monitoring may be performed using one or more sensors that remain implanted within the individual's tissues, such as cutaneously, subcutaneously, or intravenously, while the analysis may occur in vivo. The implanted sensors may collect analyte data continuously or sporadically, depending on the individual's particular health needs.

[0003] An individual's analyte levels may be affected by a variety of external stimuli related to that individual's particular lifestyle. For example, if an individual has diabetes, that individual's food intake, exercise, or insulin injections will affect glucose levels. Such lifestyle behaviors may further affect other analyte levels. Additionally, other individual-specific lifestyle events may affect analyte levels and / or be worth monitoring for an individual to determine what lifestyle events affect the analyte levels.

[0004] Traditionally, analyte sensors provide feedback to a user based on information (e.g., data) collected by the sensor via a receiver, which can limit the user's ability to input lifestyle data and affect the output of the analyte sensor, among other things. Additionally, errors or events encountered during operation of the receiver and / or sensor may not be accessible or difficult to access by the user and / or by a troubleshooter (e.g., a customer service representative). As such, erratic analyte measurements with no known source or contributing factor may result. [Brief description of the drawings]

[0005] The following figures are included to illustrate certain aspects of the present disclosure and should not be considered as exclusive embodiments. The disclosed subject matter is capable of considerable modification, permutations, combinations, and equivalents in form and function without departing from the scope of the present disclosure. [Figure 1A] FIG. 1 illustrates a display screen of a computing device presenting a specimen monitoring scan display window consistent with one or more embodiments of the present disclosure. [Figure 1B] FIG. 1 illustrates a display screen of a computing device presenting a specimen monitoring scan display window consistent with one or more embodiments of the present disclosure. [Figure 2A] FIG. 2 illustrates a display screen of a computing device presenting an input display window consistent with one or more embodiments of the present disclosure. [Figure 2B] FIG. 2 illustrates a display screen of a computing device presenting an input display window consistent with one or more embodiments of the present disclosure. [Figure 2C] FIG. 2 illustrates a display screen of a computing device presenting an input display window consistent with one or more embodiments of the present disclosure. [Figure 3A]1A-1C illustrate a series of input display window views illustrating user interactions consistent with one or more embodiments of the present disclosure. [Figure 3B] 1A-1C illustrate a series of input display window views illustrating user interactions consistent with one or more embodiments of the present disclosure. [Figure 3C] 1A-1C illustrate a series of input display window views illustrating user interactions consistent with one or more embodiments of the present disclosure. [Figure 3D] 1A-1C illustrate a series of input display window views illustrating user interactions consistent with one or more embodiments of the present disclosure. [Figure 3E] 1A-1C illustrate a series of input display window views illustrating user interactions consistent with one or more embodiments of the present disclosure. [Figure 3F] 1A-1C illustrate a series of input display window views illustrating user interactions consistent with one or more embodiments of the present disclosure. [Figure 3G] 1A-1C illustrate a series of input display window views illustrating user interactions consistent with one or more embodiments of the present disclosure. [Figure 3H] 1A-1C illustrate a series of input display window views illustrating user interactions consistent with one or more embodiments of the present disclosure. [Figure 3I] 1A-1C illustrate a series of input display window views illustrating user interactions consistent with one or more embodiments of the present disclosure. [Figure 3J] 1A-1C illustrate a series of input display window views illustrating user interactions consistent with one or more embodiments of the present disclosure. [Figure 4A] 1A-1C illustrate a series of input display window views illustrating user interactions consistent with one or more embodiments of the present disclosure. [Figure 4B] 1A-1C illustrate a series of input display window views illustrating user interactions consistent with one or more embodiments of the present disclosure. [Figure 4C] 1A-1C illustrate a series of input display window views illustrating user interactions consistent with one or more embodiments of the present disclosure. [Figure 4D] 1A-1C illustrate a series of input display window views illustrating user interactions consistent with one or more embodiments of the present disclosure. [Figure 4E] 1A-1C illustrate a series of input display window views illustrating user interactions consistent with one or more embodiments of the present disclosure. [Figure 4F] 1A-1C illustrate a series of input display window views illustrating user interactions consistent with one or more embodiments of the present disclosure. [Figure 4G] 1A-1C illustrate a series of input display window views illustrating user interactions consistent with one or more embodiments of the present disclosure. [Figure 4H] 1A-1C illustrate a series of input display window views illustrating user interactions consistent with one or more embodiments of the present disclosure. [Figure 4I] 1A-1C illustrate a series of input display window views illustrating user interactions consistent with one or more embodiments of the present disclosure. [Figure 4J] 1A-1C illustrate a series of input display window views illustrating user interactions consistent with one or more embodiments of the present disclosure. [Figure 5A] A diagram showing a display screen of a computing device presenting a specimen monitoring scan display window after user input consistent with one or more embodiments of the present disclosure. [Figure 5B] A diagram showing a display screen of a computing device presenting a specimen monitoring scan display window after user input consistent with one or more embodiments of the present disclosure. [Figure 6A] FIG. 1 illustrates a display screen of a computing device presenting a specimen monitoring daily display window consistent with one or more embodiments of the present disclosure. [Figure 6B]FIG. 1 illustrates a display screen of a computing device presenting a specimen monitoring daily display window consistent with one or more embodiments of the present disclosure. [Figure 6C] FIG. 1 illustrates a display screen of a computing device presenting a specimen monitoring daily display window consistent with one or more embodiments of the present disclosure. [Figure 6D] FIG. 1 illustrates a display screen of a computing device presenting a specimen monitoring daily display window consistent with one or more embodiments of the present disclosure. [Figure 7A] 1 illustrates a display screen of a computing device presenting a pop-up display window consistent with one or more embodiments of the present disclosure. [Figure 7B] 1 illustrates a display screen of a computing device presenting a pop-up display window consistent with one or more embodiments of the present disclosure. [Figure 7C] 1 illustrates a display screen of a computing device presenting a pop-up display window consistent with one or more embodiments of the present disclosure. [Figure 8A] FIG. 1 illustrates a display screen of a computing device presenting various user selections for generating a report consistent with one or more embodiments of the present disclosure. [Figure 8B] FIG. 1 illustrates a display screen of a computing device presenting various user selections for generating a report consistent with one or more embodiments of the present disclosure. [Figure 9A] FIG. 1 illustrates a display screen of a computing device presenting a limited number of user selections including an event log button consistent with one or more embodiments of the present disclosure. [Figure 9B] FIG. 1 illustrates a display screen of a computing device presenting a limited number of user selections including an event log button consistent with one or more embodiments of the present disclosure. [Figure 10A]FIG. 2 illustrates a display screen of a computing device presenting an event log display window consistent with one or more embodiments of the present disclosure. [Figure 10B] FIG. 2 illustrates a display screen of a computing device presenting an event log display window consistent with one or more embodiments of the present disclosure. [Figure 11] FIG. 1 is a block diagram illustrating an example of an in-vivo analyte monitoring system consistent with one or more embodiments of the present disclosure. [Figure 12] FIG. 2 is a block diagram illustrating an example of a data processing unit consistent with one or more embodiments of the present disclosure. [Figure 13] FIG. 1 is a block diagram illustrating an example of a display device consistent with one or more embodiments of the present disclosure. [Figure 14] FIG. 1 is a schematic diagram illustrating an example of an analyte sensor consistent with one or more embodiments of the present disclosure. [Figure 15A] FIG. 1 is a perspective view illustrating an exemplary embodiment of a skin-penetrating analyte sensor consistent with one or more embodiments of the present disclosure. [Figure 15B] FIG. 15B depicts a cross-sectional view of a portion of the analyte sensor of FIG. 15A consistent with one or more embodiments of the present disclosure. [Figure 15C] FIG. 1 is a plan view of a transcutaneous sensor consistent with one or more embodiments of the present disclosure. [Figure 15D] FIG. 1 is a plan view of a transcutaneous sensor consistent with one or more embodiments of the present disclosure. [Figure 16] 1A-1D are cross-sectional views illustrating examples of analyte sensors consistent with one or more embodiments of the present disclosure. [Figure 17] 1A-1D are cross-sectional views illustrating examples of analyte sensors consistent with one or more embodiments of the present disclosure. [Figure 18] 1A-1D are cross-sectional views illustrating examples of analyte sensors consistent with one or more embodiments of the present disclosure. [Figure 19] 1A-1D are cross-sectional views illustrating examples of analyte sensors consistent with one or more embodiments of the present disclosure. [Figure 20A]1A-1D are cross-sectional views illustrating examples of analyte sensors consistent with one or more embodiments of the present disclosure. [Figure 20B] FIG. 20B is a cross-sectional view illustrating an example analyte sensor taken along line AA of FIG. 20A in accordance with one or more embodiments of the present disclosure. [Figure 20C] FIG. 20B is a cross-sectional view illustrating an example analyte sensor taken along line AA of FIG. 20A in accordance with one or more embodiments of the present disclosure. [Figure 21] FIG. 1 is a conceptual diagram illustrating an example of an analyte monitoring system consistent with one or more embodiments of the present disclosure. [Figure 22] FIG. 1 is a block diagram illustrating an example of an on-body electronic device consistent with one or more embodiments of the present disclosure. [Diagram 23] FIG. 1 is a block diagram illustrating an example of a display device consistent with one or more embodiments of the present disclosure. [Figure 24] FIG. 1 is a flow diagram depicting an example of information exchange within an analyte monitoring system consistent with one or more embodiments of the present disclosure. [Figure 25A] FIG. 2 illustrates a display screen of a computing device presenting a start-up display window consistent with one or more embodiments of the present disclosure. [Figure 25B] FIG. 2 illustrates a display screen of a computing device presenting a start-up display window consistent with one or more embodiments of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0006] The present disclosure generally relates to computing devices that allow a user to input data regarding the lifestyle habits of a sensor user and that allow the user to access an event log associated with an analyte monitoring sensor.

[0007] The computing devices described herein may improve user interaction by allowing the user to customize inputs related to the lifestyle habits of the sensor user and easily and quickly access such information, particularly as it relates to specific analyte levels occurring in the sensor user's body. As used herein, with respect to the use of the computer devices and display windows of the present disclosure, the term "user" and grammatical variations thereof include any individual who operates the computing device and interacts with its display screen, including, but not limited to, the sensor user, the sensor user's physician, the sensor user's family member, and the like. As used herein, the term "sensor user" and grammatical variations thereof refer to an individual whose analyte level is being measured or monitored. The computing devices described herein may further improve user interaction with the computing device by allowing the user to access event information related to the functionality of an analyte monitoring system communicatively coupled to the computing device, such that the user may self-troubleshoot and / or transmit such information to a customer service representative for assistance.

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

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

[0010] Often, computing devices associated with analyte monitoring sensors, or other devices that transmit information to computing devices, are limited in ease of use and require multiple steps to access data or activate certain functions. As used herein, the terms "analyte monitoring sensor," "analyte sensor," or simply "sensor," and grammatical variations thereof, refer to ex vivo or in vivo sensing devices that can determine analyte levels in the body and transmit data related to those analyte levels. In preferred embodiments, the analyte monitoring sensor is an in vivo sensor, such as a continuous analyte monitoring sensor. Sensors and sensing systems are described in more detail herein below.

[0011] That is, conventional computing devices typically require data and functionality to be split into multiple layers and views, requiring the user to scroll through many windows or to switch views periodically, often wasting the user's time. When such computing devices are coupled with analyte monitoring sensors designed for disease management or health monitoring purposes, the inconvenience of these multiple layers and views can negatively impact the user experience, including discouraging use.

[0012] Typically, conventional computing devices associated with analyte monitoring sensors do not allow a user to input specific information about the sensor user's lifestyle that can be easily entered and then easily accessible without the user having to navigate through many views. For example, conventional computing devices may layer various potential lifestyle inputs without allowing for customization or specific input of information, resulting in data that is limited (e.g., meals without associated carbohydrate amounts, exercise without intensity or duration, etc.) and further cannot be viewed in a single display window. However, linking a sensor user's lifestyle events to specific dates and times of analyte level measurements (e.g., concentrations) may be important to control certain diseases (e.g., diabetes) or to the health of the sensor user. The multiple steps characteristic of conventional computing devices may discourage users from linking the sensor user's lifestyle events to their analyte levels, which may result in poor disease management and adverse health effects.

[0013] Additionally, embodiments of the present disclosure allow a user quick access to events related to the functioning of a paired analyte monitoring sensor, thereby enabling the user to determine how to troubleshoot the operation of that sensor. Conventional computing devices do not provide this capability, which can result in inaccurate analyte level measurements being obtained, potentially resulting in poor disease management or adverse health effects.

[0014] Thus, the embodiments described herein enable a user to access snapshot views of important sensor user lifestyle data and events related to the functioning of an analyte monitoring sensor. These snapshot views consolidate otherwise disparate data, if any, contained in a conventional computing device. Consolidating such data expedites the entry of lifestyle information and allows easy access (e.g., by the sensor user, by a treating physician, by family members such as parents or siblings) to previously summarized data related to the sensor user's lifestyle. Thus, embodiments of the present disclosure improve the performance of display screens and interactive interfaces related to analyte sensor measurements, thereby improving the assessment and treatment of various analyte-monitored diseases.

[0015] Access to such lifestyle snapshots of information related to particular analyte measurements (e.g., concentrations at particular times and dates) allows for rapid and accurate adjustments to a user's health status and / or positive or negative lifestyle choices. For example, a user can determine whether exercise at a particular intensity is beneficial or detrimental to analyte levels and modify their exercise plan accordingly. A user can identify particular food groups that are beneficial or detrimental to analyte levels and adjust dietary decisions accordingly.

[0016] The present disclosure's access to an event log snapshot of information about a particular analyte measurement (e.g., concentration at a particular date and time) allows a user to troubleshoot a potentially erroneous analyte measurement that may lead to unnecessary or potentially harmful therapeutic actions (e.g., if the sensor is too cold to provide an accurate measurement, the user knows not to immediately inject insulin or ingest certain foods to alter glucose levels). Additionally, the combination of the sensor user's lifestyle information with the present disclosure's event log allows the user to more accurately understand the analyte measurement and make appropriate therapeutic decisions.

[0017] Although FIGS. 1A-10B describe the computing device of the present disclosure with respect to a glucose analyte monitoring sensor, 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 sensor user's lifestyle 1A and 1B, there are shown two exemplary embodiments of a display screen of a computing device that displays 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 grammatical variations thereof, refers 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. A scan display window is distinguishable from a computing device's analyte monitoring daily display window, which is discussed in detail herein below.

[0019] As shown in FIGS. 1A and 1B, the scan display window may include an icon in the upper right corner of the display window that, when selected, allows a user to scan an analyte monitoring sensor communicatively coupled to a computing device having a display screen displaying the scan display window. For example, in one embodiment, activating or selecting the "scan" icon (or other selectable symbol or button prompting a scan, such as "ready to scan" or "please scan") automatically collects data from a computing device as described herein. In some embodiments, when a computing device is placed in proximity to an analyte monitoring sensor, a connection is established (e.g., a near field communication (NFC) connection) and data from the sensor may be transmitted to the computing device. In certain embodiments, the scan display window or other display window may be automatically activated to display the sensor user's analyte level (e.g., displaying a graphical display, actual analyte level or concentration, other derived analyte level (e.g., A1c)) to the user. That is, one or more of the display screens of the computing device may automatically alert the user (e.g., as a notification) of the scan data (e.g., the display window of FIG. 1A or FIG. 1B may automatically appear on the computing device). The display may display any or all of the following: specimen level trend arrows, trend specimen level messages, current specimen measurement values, etc., as described below.

[0020] In some embodiments, if the computing device is idle (e.g., a cell phone in sleep mode), a notification banner may be displayed, launch a scan display window, and / or alert a user (e.g., a sensor user) to scan an analyte monitoring sensor. That is, the computing device may be configured, and may be pre-configured or configured by a user, including the sensor user, to prompt the user to scan the sensor user's analyte level at a particular time. For example, if the computing device is a cell phone, the scan display window may be displayed and / or another form of prompt may be displayed without departing from the scope of the present disclosure, even if it is locked or otherwise in a "sleep" mode (and any variations thereof). That is, if 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 sensor user's analyte level, thereby allowing the user to easily obtain an analyte level (e.g., glucose) without actually activating the computing device or transitioning it out of sleep mode. In some embodiments, the computing device may automatically scan for analyte measurements when the computing device described herein (e.g., a cell phone, tablet, PDA, fitness monitor or pedometer, etc.) is placed near the analyte monitoring system. That is, embodiments of the present disclosure may or may not require a physical scan.

[0021] Thus, the scan display window displays a particular past scan (e.g., the scan that occurred just before or shortly before the scan display window was displayed, shown as 137 mg / dL in FIG. 1A), but may also be used by the user to initiate a new scan (e.g., a successive scan from the previous scan, or a scan after a period of time has passed). For example, a user may want to perform a successive scan just after or shortly after the previous scan to test the accuracy of the combined sensor.

[0022] The scan display window may further include one or more clocks (digital or analog, applicable throughout all display windows herein), a current analyte level concentration based on the last scan of the analyte monitoring sensor, a graphical representation of the analyte level over time, and a coded target range for 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 representation of the analyte level over time is depicted with time on the x-axis and analyte level in milligrams per deciliter (mg / dL) 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 may be used to define the graphical display without departing from the scope of the present disclosure, provided that the level of the analyte is associated with a specific date and time.

[0023] 1A and 1B, the scan display window may inform the sensor user whether their 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 may be defined by the computing device or a user (e.g., the sensor user) and thus, in some embodiments, may be adjustable for individualization.

[0024] The trend arrows may include a diagonal upward right arrow to indicate that the analyte level is rising, a vertical upward arrow to indicate that the analyte level is rising rapidly, a horizontal right or left (preferably right) arrow to indicate that the analyte level is stable or changing slowly, a diagonal downward arrow to indicate that the analyte level is falling, and a vertical downward arrow to indicate that the analyte level is falling rapidly. The trend analyte level message may include language stating that the analyte level is above a high threshold, between a target range and a high threshold, within a target range, below a low threshold, or between a target range and a low threshold. Alternatively, or in addition to the trend arrows and / or trend messages, color coding may be used, such as orange, yellow, green, yellow, and red, to indicate that the analyte level is above a high threshold, between a target range and a high threshold, within a target range, below a low threshold, or between a target range and a low threshold, respectively. In an embodiment of the present disclosure, the trend arrows, trend messages, and color coding may be displayed simultaneously or alternatively in the scan display window. Thus, one or more means of communicating the sensor user's analyte level trend may be employed to suit a particular individual (e.g., a color-blind user may not find color coding helpful and may therefore rely on one or both of the trend arrows and / or messages). As shown in Figures 1A and 1B, the glucose analyte level is within the target range, showing a horizontal right trend arrow, a trend message with the message "Glucose is in range," and green color coding, respectively.

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

[0026] The scan display window of the present disclosure may include a feature for quick access to a limited number of user input buttons related to the sensor user's lifestyle at a particular date and time. As shown in FIG. 1A and FIG. 1B, access to the user input buttons may be in the form of a button having an icon in the shape of a pen or pencil. In some embodiments, the pen or pencil icon may be depicted pointing generally downward and to the left, although other configurations are within the scope of the present disclosure. The icon may be alone or may be accompanied by accompanying text, such as "Add Note" as shown in FIG. 1A. As used herein, the term "Add Note Button" and grammatical variations thereof refer to a button as part of a display window (e.g., a scan display window) of a computing device having multiple display windows that allows user input about the sensor user's lifestyle, and is not limited to a particular term or icon. For example, add diary, enter note, notepad icon, etc., other text or symbols may be used alone or in combination without departing from the scope of the present disclosure.

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

[0028] Thus, upon selection of the add note button (see FIGS. 1A and 1B), a computing device having a display screen of the present disclosure may transition to an input display window. Referring now to FIGS. 2A and 2B, two exemplary embodiments of a display screen of a computing device are shown that display an input display window, or more specifically, in these embodiments, an "add note" display window. As used herein, "input display window" and grammatical variations thereof refer to a display window of a computing device having a display screen configured to allow a user to input information regarding the sensor user's lifestyle, whether freeform or with specific prompts.

[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 the sensor user at a particular 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 a computing device. As shown in Figures 2A-2C, such a limited number of user input buttons may include, but are not limited to, food, fast acting insulin, long acting insulin, exercise, comments, and any combination thereof. The various user input buttons may be associated with various icons, as shown in Figures 2A and 2B. It should be understood that there is no requirement that such icons exist, and the particular style of the icons present is not limited to those shown in Figures 2A and 2B, provided that they represent particular user input buttons.

[0030] In some embodiments, the user input may 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 may be configured such that the display screen is predictive. For example, if the sensor user's analyte level is high, the computing device may automatically display or provide a user input button to prompt the user (e.g., the sensor user) to input data related to the sensor user's lifestyle, such as a recent meal or insulin injection. That is, the computing device may be configured to detect certain spikes in the analyte level and prompt the user to input data related to the sensor user's lifestyle. For example, if the sensor user's glucose spikes, perhaps because they have just eaten, the food user input button may be displayed, or if the glucose level suddenly drops, perhaps because the sensor user has just been administered an insulin bolus, the fast-acting or long-acting user input button may be automatically displayed. Thus, the user may be prompted to input based on the dynamic measurements of the analyte monitoring sensor.

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

[0032] The input display window may further include a number of additional information for viewing or manipulation by a user of the computing device, including, but not limited to, a current analyte level concentration based on the last scan of the analyte monitoring sensor, trend arrows and / or messages, color coding, a specific date and time, a selectable cancel button, and / or a selectable acknowledge (or "Done") button. Other features of the input display window may include a selectable scan button or icon, a selectable main menu button or icon, a selectable settings button or icon, and / or a selectable back button or icon, as shown in FIG. 2B, without departing from the scope of this disclosure. It is understood that various components of the input display window, including, but not limited to, the terminology, color coding, arrow direction, scale, size, placement, and / or icons, may be modified without departing from the scope of this disclosure, provided that there is a limited number of user input buttons for user input regarding the lifestyle habits of the sensor user.

[0033] 3A-3J, a series of views of an input display window depicting user interactions 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 may interact with a limited number of user input buttons displayed therein. When selecting to use the limited number of user input buttons to input specific information regarding the sensor user's lifestyle, the associated icon may be highlighted or accentuated (e.g., by color, bolding, etc.) to explain to the user that the input is complete or in progress. Each user input regarding the sensor user's lifestyle is linked, as described below, via the electronics of the computing device to a specific date and time when the user entered the information and acknowledged the input (e.g., selected the "Done" button). In doing so, the user may track the sensor user's lifestyle selections in relation to the specific analyte levels being measured or monitored by the analyte monitoring sensor. Additionally, as described below, a computing device having a display screen according to embodiments described herein may directly associate the sensor user's lifestyle information with the analyte monitoring data on the scan display, and further enable direct access to the lifestyle information therefrom.

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

[0035] Once a single user input regarding the sensor user's lifestyle has been made, the user may acknowledge the input and input into the input display window (e.g., by selecting a done button) that the user has completed the input. Alternatively, the user may wish to continue inputting additional information regarding the sensor user's lifestyle. FIGS. 3D and 3E show a user who has already input a food input further selecting a selectable symbol for inputting fast acting insulin, whereupon the user is prompted to input the particular units of fast acting insulin that the user has taken at that particular date and time. Although not shown, the user may similarly select a selectable symbol for inputting a dose of long acting insulin (e.g., in units). As shown in FIG. 3E, as additional input regarding the sensor user's lifestyle is made, any previous input remains visible and editable by the user to ensure that a complete picture of the sensor user's lifestyle at that particular date and time is accurately captured. If the user makes multiple entries of information regarding the sensor user's lifestyle habits, 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 computing device's display screen (see Figures 4H-4J, which show scroll bars on the right side of the display window).

[0036] 3F and 3J show the user further selecting a selectable symbol for inputting an exercise, after which the user may be prompted to select a particular energy intensity level. For example, the "select intensity" prompt shown in FIG. 3F may provide a selectable menu (e.g., a drop-down menu, a scrollable menu, etc.) that allows the user to select a particular intensity, such as low, medium, or high intensity options, shown in FIG. 3G. Once the user selects a particular exercise intensity, the user may be prompted to input the duration of the exercise, as shown in FIG. 3H. As shown in FIG. 3H, the selectable menu for inputting the duration is selected by the user, and the display screen of the computing device may then transition to a duration display window (see FIG. 3I).

[0037] As used herein, a "duration display window" and grammatical variations thereof refer to a display window of a computing device having a display screen configured to allow a user to select or enter a particular duration. As shown in FIG. 3I, the duration display window may include a selectable menu for entering duration information in hours and minutes, depicted as a scrolling menu in FIG. 3I, but this may be any form of selectable menu, including allowing a user to enter duration information in hours and minutes (such as via typing, text, or voice-activated input). In some embodiments, the duration display window further allows for the entry of other time intervals, such as seconds, without departing from the scope of this disclosure. The duration display may further include other features and functions, such as a duration display window title (e.g., "Edit Time"), a selectable cancel button, and / or a selectable acknowledge (or "Done") button, without departing from the scope of this disclosure. Upon acknowledgement of the entered time, the display screen of the computing device transitions back to the input display window.

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

[0039] Although not shown, the user may further enter comments into the input display window via a keyboard or touch screen, via voice-activated text, or via a selectable menu with specific pre-coded narratives. These pre-coded narratives may be included as part of the computing device or may be configurable by the user. For example, such narratives may relate to stress, sleep patterns, or other general lifestyle events relevant to the sensor user's life. If included, these comments may be, but need not be, visible 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 this disclosure.

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

[0041] 3J and 4J depict a user's 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 "Done" button). It should be understood that any or all of the user input buttons, including comment input, may be selected to input information regarding the sensor user's lifestyle habits 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 computing device display screen transitions back to the scan display window and can associate the particular input data with the particular date and time the input was approved and can display the particular input as a selectable icon (see FIG. 5A). As shown in FIGS. 5A and 5B, the scan display window can be updated to display the time the input information was approved by the user and associate such time with a particular analyte level. Alternatively, if the data was entered within a finite time after the scan (e.g., less than 3 or 5 minutes), the user input information can be automatically associated with the particular date and time of the last scan, or the user can input a particular date and time for association without departing from the scope of this disclosure.

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

[0044] The analyte monitoring daily display window of the computing device may be accessed by transitioning out of the analyte monitoring scan display window, such as by pressing the back arrow icon shown in the upper left corner of FIGS. 5A and 5B, or by other methods of transitioning display windows. As used herein, the term "analyte monitoring daily display window" or simply "daily display window" and grammatical variations thereof 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, over a period of at least 24 hours. The daily display window may be the primary display window of the computing device described herein. Representative embodiments of daily display windows according to one or more embodiments of the present disclosure are illustrated in FIGS. 6A-6D.

[0045] As shown in Figures 6A-6D, the features of the Daily Display window include an icon banner showing a countdown of the sensor life of the associated analyte monitoring sensor (e.g., in days and hours represented graphically, such as a color-changing or shape-changing bar), a graphical display of the analyte level over a period of at least 24 hours, a coded target range for the analyte level (e.g., the shaded area of ​​100-140 mg / dL in Figures 6A and 6B), a selectable scan button or icon (e.g., the top right icon in Figure 6A or the bell icon in Figure 6B), a selectable main menu button or icon (e.g., the 6A and 6B ), a selectable settings button or icon (e.g., the vertical dot icon in the upper right corner of FIG. 6B ), an indication of the time period represented by the daily display window (e.g., "Last 24 Hours"), an indication of the time when a new sensor will be ready for use (e.g., an indication of the warm-up time remaining or the time when the sensor will be ready), including an icon ("i") indicating that such information is being displayed, and / or various data related to analyte levels during the measurement period (e.g., "Target Time", "Last Scan", "Average", etc.). In some embodiments, the selectable settings button or icon is integrated so that information regarding such settings, as well as the information described below, is located 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 the user's input data regarding the sensor user's lifestyle habits as described above. The selectable symbols may be positioned along the timeline of the graphical representation such that their location correlates to the date and time that a particular input was recorded. In this way, the input information regarding the sensor user's lifestyle habits can be correlated to a particular analyte level, thereby enabling the sensor user to make informed decisions regarding future lifestyle choices and their impact on a particular analyte level. As shown in FIGS. 6A and 6B, the dates may be displayed relative to the current date (e.g., Wed / Thur in FIG. 6A and Sat / Sun in FIG. 6B) and / or the actual date may be displayed. Other features may be displayed in the daily display window of a computing device described herein without departing from the scope of this disclosure. It is further understood that various components of the daily display window, including but not limited to the terminology, color coding, arrow direction, scale, size, placement, and / or icons, may be changed without departing from the scope of this disclosure.

[0047] The selectable symbols (or icons) in the daily display window may be any signal that indicates a summary of the information entered by the user. In some embodiments, the selectable symbols in the daily display window may be a single symbol (e.g., the running man symbol in FIG. 6A), two or more overlaid symbols (e.g., the apple and syringe symbol in FIG. 6B), or stacked symbols showing numbers representing the number of inputs for a particular date and time (e.g., the stacked symbols showing 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 are representative of user input information, and may or may not correlate with the symbols displayed in the input display window (if at all).

[0048] A user may select one of the selectable icons 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 in the embodiment of Figures 7A and 7B. As shown, the pop-up display window may include a 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 chooses to select to provide input (see, e.g., Figures 2A and 2B above). The pop-up display window may include an optional summary showing the information entered by the user, including, but not limited to, associated icons, descriptions of the user input buttons, and dates of input provided by the user, as shown in Figures 7A-7C. Additionally, the pop-up display window may include a selectable edit icon (e.g., a pencil or pen icon, or any other form of selectable edit button) located at a position within the pop-up display window that is selectable to allow the user to access the input display window again and modify the input, for example, if such modification is necessary to ensure accuracy of the input. Further, in some embodiments, a selectable accept button (e.g., "OK") may be included, where selection of the accept button causes the pop-up display window to close (e.g., become hidden or no longer be displayed) and the entire daily display window to reappear. Alternatively, or in addition, the user may select a portion of the pop-up display window (i.e., not a selectable edit icon button or the accept button) to hide the pop-up display window and display the entire daily display window again, or the user may select a portion of the daily display window (i.e., not an otherwise selectable button) to hide the pop-up display window and display the entire daily display window again.

[0049] Other features may be displayed in the computing device pop-up display window described herein without departing from the scope of this disclosure, provided that they include a summary of input information at a particular date and time related to the sensor user's lifestyle. It is further understood that various components of the daily display window, including but not limited to the terminology, color coding, arrow direction, scale, size, placement, and / or icons, may be altered without departing from the scope of this disclosure.

[0050] Event logs related to analyte monitoring sensors As discussed above, the computing device with multiple display screens of the present disclosure may include an event log associated with an analyte monitoring sensor at a particular date and time. Thus, the computing device tracks the functioning of the analyte monitoring sensor, allows a user to access the event log of the analyte monitoring sensor for monitoring or troubleshooting, and allows the user to transmit the event log data to a customer service representative who can assist the user in troubleshooting the sensor. Figures 8A-10B illustrate one or more embodiments of a computing device described herein that allows a user to access and transmit an event log of a communicatively coupled analyte monitoring sensor. It should be understood that various features of Figures 8A-10B may be altered without departing from the scope of the present disclosure, including, but not limited to, terminology, color coding, scale, size, arrangement, and / or icons.

[0051] 8A and 8B, there are shown display screens of a computing device of the present disclosure displaying various user selectable buttons accessible from a selectable main menu button or icon or a selectable settings button or icon, in accordance with one or more embodiments of the present disclosure. The user selectable buttons may be generalized buttons for navigating multiple 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 associated with the computing device and / or an analyte monitoring sensor communicatively coupled thereto. Any suitable user selectable buttons may be included in the embodiment shown in Figures 9A and 9B without departing from the scope of the present disclosure, including, but not limited to, a home display window, a logbook display window, a reminder display window, report display windows associated with various usage patterns (e.g., daily patterns, goal times, low or high analyte (e.g., glucose) events, average analyte (e.g., glucose) levels, daily graphs, estimated analyte or analyte-related levels (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 a user selectable button.

[0052] Upon selecting 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 directed to a new menu display window that displays a list of 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, which transitions to a menu display window having a limited number of user selectable buttons, including an event log button. In the non-limiting embodiment shown in FIGS. 9A and 9B, other user selectable buttons displayed in the menu display window include, but are not limited to, how to apply the sensor, how to scan the sensor, analyte (e.g., glucose) readings, user manual, terms of use, and / or privacy notice. Although the event log button is depicted as part of the help menu display window in FIGS. 9A and 9B, 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 this disclosure. The menu display window (shown as a help menu display window in FIGS. 9A and 9B) may further include a selectable scan button or icon, a main menu or settings menu icon, and / or a back button, among other potential features.

[0053] A user may select the event log button and be directed to an event log of a computing device of the present disclosure. That is, when a 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 grammatical variations thereof refer to a display window of a computing device having a display screen configured to show at least one event associated with an analyte monitoring sensor at a particular date and time. FIGS. 10A and 10B show an embodiment of an event log display window, according to one or more embodiments of the present disclosure. As shown, each event may, but is not necessarily 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 when the event occurred.

[0054] In some embodiments, the event log records events related to errors in scanning the analyte monitoring sensor, events related to the temperature of the sensor (e.g., the sensor may be too cold to provide an accurate analyte measurement), and / or the detection of a new sensor. Any suitable events related to the functioning of the sensor may be further 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 sensor user to take a particular action, such as initiating or monitoring an analyte measurement using a new sensor detected by the computing device. In other embodiments, the event log may further display a link or page number of a user manual that describes the event (e.g., which may be an error event) and associated remedial steps. The link may be to a user manual stored on the device or to a website that contains information about the error. If the computing device receives multiple event log entries, the event log display window may include a scroll bar (e.g., to the right or left of the window) to allow 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] While the event log may be useful to a user of the computing device and associated sensor, the event log display window may further enable a user to send the event log data to a customer service representative, such as the manufacturer of the sensor where the event is occurring. The event log data may be sent to the customer service representative 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 grammatical variations thereof refer to a user selectable button that can send event log information associated with the analyte monitoring sensor, regardless of the particular button terminology, size, shape, etc. Alternatively, or additionally, the troubleshooting data send button may send data to a customer service representative associated with the computing device, not just the manufacturer of the sensor. In other embodiments, upon receipt of the data event log, a 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 remedial action that the customer service representative may take, such as alerting the user that the sensor is faulty, advising the user to stop using the sensor, alerting the user that a new replacement sensor is being sent, or a combination thereof.

[0056] 25A and 25B, various display screens of a computing device are shown presenting a start-up display window consistent with one or more embodiments of the present disclosure. The start-up display window may include various elements, including, as shown, a brand name (e.g., FreeStyle™ LibreLink™), an analyte monitoring device (e.g., a glucose sensor) that may be communicatively coupled to the computing device, one or more brand icons (e.g., a butterfly), a button that allows access to multiple additional display screens, a selectable main menu button or icon, and / or a selectable settings button or icon.

[0057] Exemplary Embodiments of an In-Vivo Analyte Monitoring System 11, an analyte monitoring system 100 includes an analyte monitoring sensor 101, a data processing unit 102 connectable to the sensor 101, and a primary receiver unit or display device 104. In some examples, the primary display device 104 is configured to communicate with the data processing unit 102 via a communication link 103. In some embodiments, the primary display device 104 may be further configured to transmit data to a data processing terminal 105 for evaluation or otherwise processing or formatting the data received by the primary display device 104. The data processing terminal 105 may be configured to receive data directly from the data processing unit 102 via a communication link 107, which may optionally be configured for bidirectional communication. Additionally, the data processing unit 102 may include electronics and a transmitter or transceiver for transmitting and / or receiving data to and / or from the primary display device 104 and / or the data processing terminal 105 and / or optionally a secondary receiver unit or display device 106.

[0058] Also shown in FIG. 11 is an optional secondary display device 106 operatively coupled to the communication link 103 and configured to receive data transmitted from the data processing unit 102. The secondary display device 106 may be configured to communicate with the primary display device 104 as well as the data processing terminal 105. In some embodiments, the secondary display device 106 may be configured for two-way wireless communication with each of the primary display device 104 and the data processing terminal 105. As described in more detail below, in some examples, the secondary display device 106 may be a receiver with limited functionality compared to the primary display device 104, e.g., the secondary display device 106 may include a limited or minimal number of functions and features compared to the primary display device 104. Thus, the secondary display device 106 may include a smaller and more compact housing (in one or more (including all) dimensions) or be incorporated into a device such as, for example, a watch, an armband, a PDA, an MP3 player, a mobile phone, or the like. Alternatively, the secondary display device 106 may be configured with the same or substantially similar functions and features as the primary display device 104. The secondary display device 106 may include a docking portion configured to mate with a docking cradle unit for placement near the bedside for overnight monitoring, for example, and / or a two-way communication device. The docking cradle may be capable of recharging the power source.

[0059] A computing device with multiple display screens as described herein may be either or both of the primary display device 104 and / or the secondary display device 106, or the display device 1120, according to an embodiment of the present disclosure.

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

[0061] In a multi-component environment, each component may be configured to be uniquely identified by one or more of the other components in the system to easily resolve communication conflicts between the various components in the analyte monitoring system 100. For example, unique IDs, communication channels, etc. may be used.

[0062] In some embodiments, the sensor 101 is physically located in or on the body of a user whose analyte level is being monitored. The 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 the data processing unit 102. The data processing unit 102 is coupleable with the sensor 101 such that both devices are located in or on the user's body with at least a portion of the analyte sensor 101 positioned transcutaneously. The data processing unit 102 may include a fixation element, such as an adhesive, to secure it to the user's body. A mount (not shown) may be used that is attachable to the user and coupleable with the data processing unit 102. For example, the mount may include an adhesive surface. The data processing unit 102 performs data processing functions, which may include, but are not limited to, filtering and encoding data signals, each of which corresponds to the user's sampled analyte level, for transmission to the primary display device 104 via the communication link 103. In some embodiments, the sensor 101 or the data processing unit 102 or the combined sensor / data processing unit may be fully implantable below the user's skin surface.

[0063] In some embodiments, the primary display device 104 may include an analog interface section including an RF receiver and an antenna configured to communicate with the data processing unit 102 via a communication link 103, and a data processing section for processing data received from the 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, the primary display device 104 in some embodiments is configured to synchronize with the data processing unit 102 to uniquely identify the data processing unit 102, for example based on the identification information of the data processing unit 102, and then periodically receive a signal transmitted from the data processing unit 102 related to the analyte level monitored by the sensor 101.

[0065] With continued reference to FIG. 11 , the data processing terminal 105 may include a portable computer, including a personal computer, laptop or handheld device (e.g., a personal digital assistant (PDA), a telephone, including a mobile phone (e.g., a multimedia and Internet enabled mobile phone, including an iPhone®, Blackberry®, Android® phone, or similar phone), an mp3 player (e.g., an iPOD®, 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. Additionally, 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 user's detected analyte level.

[0066] The data processing terminal 105 may include a drug delivery device (e.g., an infusion device), such as an insulin infusion pump, configured to administer a drug (e.g., insulin) to the user and may be configured to communicate with the primary display device 104 to receive, among other things, the measured analyte levels. Alternatively, the primary display device 104 may be configured to integrate an infusion device therein, such that the primary display device 104 is configured to administer an appropriate drug (e.g., insulin) to the user, for example, to manage and modify a basal profile, as well as to determine, among other things, an appropriate bolus for administration based on the detected analyte levels received from the data processing unit 102. The infusion device may be an external device or an internal device, such as a device that is fully implantable 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 the analyte signals from the data processing unit 102, thus incorporating 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, but not limited to, an RF communication protocol, an infrared communication protocol, a Bluetooth-enabled communication protocol, an 802.11x wireless communication protocol, or an equivalent wireless communication protocol that enables secure wireless communication of multiple units (e.g., in accordance with Health Insurance Portability and Accountability Act (HIPPA) requirements) while avoiding potential data collisions and interference.

[0068] Figure 12 is a block diagram representing an embodiment of the data processing unit 102 of the analyte monitoring system shown in Figure 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 processing circuitry and non-transitory memory for storing software instructions for execution by the processing circuitry) may be used to implement one or more functions or routines associated with the operation of the data processing unit (and / or display device) using, for example, one or more state machines and buffers.

[0069] As seen in the embodiment of FIG. 12, the analyte sensor 101 (FIG. 11) includes four contacts, three of which are electrodes, namely, a working electrode (W) 210, a reference electrode (R) 212, and a counter electrode (C) 213, each operably coupled to the analog interface 201 of the data processing unit 102. This embodiment also shows an optional guard contact (G) 211. Fewer or more electrodes can be used without departing from the scope of the present disclosure. 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 more than one working electrode and / or reference electrode and / or counter electrode.

[0070] FIG. 13 is a block diagram of an embodiment of a receiver / monitoring unit, such as the primary display device 104 of the analyte 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 may include a processing circuit and non-transitory memory that stores software instructions for execution by the processing circuit). The primary display device 104 also includes a power source 306 operably coupled to a power conversion and monitoring section 308. In addition, the power conversion and monitoring section 308 is also coupled to the processing and storage section 307. Also shown are a receiver serial communication section 309 and an output 310, each of which is 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 a display screen as described above) or may not include a user input and / or interface component.

[0071] In some embodiments, the test strip interface 301 includes an analyte testing portion (e.g., a glucose level testing portion) that receives a blood (or other bodily fluid sample) analyte test or information related thereto. For example, the test strip interface 301 may include a test strip port for accepting a test strip (e.g., a glucose test strip). The device may determine the analyte level of the test strip and, optionally, display (or otherwise communicate) the analyte level on the output 310 of the primary display device 104. Any suitable test strip may be used, such as a test strip that requires only a very small amount of sample (e.g., 3 microliters or less, e.g., 1 microliter or less, e.g., 0.5 microliters or less, e.g., 0.1 microliters or less) applied to the strip to obtain accurate glucose information. The glucose information obtained by the in vitro glucose testing device may be used for various purposes, calculations, etc. For example, the information may be used to calibrate the sensor 101 (FIG. 11), to confirm and increase the reliability of the results of the sensor 101, etc. (e.g., if the information obtained by the sensor 101 is used to make 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 / infusion device 105 may be configured to receive the analyte value wirelessly over a communications link, for example from a blood glucose meter. In further embodiments, a user operating or using the analyte monitoring system 100 may manually input the analyte value using, for example, a user interface (e.g., a keyboard, keypad, touch screen, voice commands, etc.) incorporated into 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 / infusion device 105.

[0073] Figure 14 illustrates generally an embodiment of an analyte sensor 400 according to one or more embodiments of the present disclosure. As shown in Figure 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 technique, such as chemical vapor deposition (CVD), physical vapor deposition, sputtering, reactive sputtering, printing, coating, ablation (e.g., laser ablation), painting, dip coating, etching, etc. Materials include, but are not limited to, any one or more of 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.

[0074] The analyte sensor 400 may be fully implantable in a user, or may be configured such that only a portion is disposed within the user (internal) and another portion is disposed outside (external) of the user. For example, the sensor 400 may include a first portion that is positionable above the surface of the skin 410 and a second portion that is disposed below the surface of the skin. In such an embodiment, the external portion may include contacts (connected by wires to respective electrodes of the second portion) for connecting to another device, such as a sensor control device that is also external to the user. While the embodiment of FIG. 14 shows three electrodes side-by-side on the same surface of the base 404, other configurations are contemplated including, but not limited to, fewer or more electrodes, some or all electrodes present on different surfaces of the base or on different bases, some or all electrodes stacked, electrodes of different materials and dimensions, etc.

[0075] FIG. 15A shows a perspective view of an embodiment of an analyte sensor 500 having a first portion (which in this embodiment may be characterized as a major portion) that is positionable above the surface of the skin 510 and a second portion (which in this embodiment may be characterized as a minor portion) that is positionable below the surface of the skin (e.g., penetrating the skin into the subcutaneous space 520) and includes an insertion tip 530 that contacts the user's biological fluids, such as interstitial fluid. A working electrode contact portion 511, a reference electrode contact portion 512, and a counter electrode contact portion 513 are disposed on the first portion of the sensor 500 that is located above the skin surface 510. A working electrode 501, a reference electrode 502, and a counter electrode 503 are shown on the second portion of the sensor 500, specifically the insertion tip 530. As shown in FIG. 15A, wiring may be provided from the electrodes at the tip 530 to the contacts. It should be understood that more or less electrodes may be provided on the sensor without departing from the scope of the present disclosure. For example, the sensor may include two or more working electrodes, and / or the counter and reference electrodes may be a single counter / reference electrode, and so forth.

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

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

[0078] A second insulating layer 506, such as a second dielectric layer in some embodiments, may be disposed or laminated over at least a portion of the second conductive layer 509. Additionally, a third conductive layer 503 may be disposed over at least a portion of the second insulating layer 506 to provide a counter electrode 503. Finally, a third insulating layer 507 may be disposed or laminated over at least a portion of the third conductive layer 503. In this manner, 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., a dielectric layer). Although the embodiments of Figures 15A and 15B show layers having different lengths, 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, may be provided in a coplanar manner such that two or more electrodes are disposed on the same plane on the substrate 504 (e.g., side-by-side, parallel, or at an angle with respect to each other). For example, coplanar electrodes may include appropriate spacing between them and / or may include dielectric or insulating materials disposed between the conductive layers / electrodes. Furthermore, in some embodiments, one or more of the electrodes 501, 502, 503 may be disposed on opposite sides 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 a first side and their respective contacts may be on a second side, e.g., wiring connecting the electrodes and the contacts may cross the substrate.

[0080] 15C and 15D, another embodiment of an analyte 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 FIG. 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 membrane 524 covering the substrate 521 and 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 may be disposed in any other suitable positions 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. Substrate 521 includes a distal end 525 configured to be inserted into the skin of a user and a proximal end 526 opposite distal end 525 configured to be connected to various electrical connections for transmitting an output signal of transcutaneous sensor 520. Distal end 525 can have a pointed or rounded tip or other tip shape that facilitates insertion of sensor 520 into the skin of a user.

[0081] 1B , the first working electrode 522 can include a first active sensing area 527 and the second working electrode 523 can include a second active sensing area 528. Although not shown, the first active sensing area 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 area 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 area 527 and the second active sensing area 528 correspond to a physiological condition of the user, such as, for example, the user's blood glucose level. Furthermore, in the illustrated embodiment, the first active sensing area 527 of the first working electrode 522 has a first area and the second active sensing area 528 of the second working electrode 523 has a second area, which may be the same or different.

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

[0083] Further, in the illustrated embodiment, the first area of ​​the first active sensing area 527 is larger than the second area of ​​the second active sensing area 528. In the illustrated embodiment, the first active sensing area 527 and the second active sensing area 528 each include a series of separate sensing spots 531, 532 (e.g., dots), respectively. In the illustrated embodiment, the size of each of the separate sensing spots 531 in the first active sensing area 527 is equal or substantially equal to the size of each of the separate sensing spots 532 in the second active sensing area 528. In a preferred embodiment, the number of separate spots 531 in the first active sensing area 527 is greater than the number of separate spots 532 in the second active sensing area 528, but in other embodiments the number of separate sensing spots 531, 532 may be equal or there may be fewer separate sensing spots 531 than separate sensing spots 532 without departing from the scope of the present disclosure. Although in the illustrated embodiment, there are six uniformly sized separate sensing spots 531 in the first active sensing area 527 and three uniformly sized separate sensing spots 532 in the second active sensing area 528, in one or more embodiments, the first active sensing area 527 and the second active sensing area 528 may include any other suitable number of separate sensing spots without departing from the scope of the present disclosure. Further, in one or more embodiments, the first active sensing area 527 and / or the second active sensing area 528 may include a continuous strip (e.g., an elongated oval) rather than a series of separate sensing spots. Further, in one or more embodiments, the first area of ​​the first active sensing area 527 may be equal or substantially equal to the second area of ​​the second active sensing area 528.

[0084] Additionally, 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. Additionally, in the illustrated embodiment, the counter electrode 533 is separated from the first working electrode 522 by a first dielectric insulator layer 535, and the reference electrode 534 is separated from the second working electrode 523 by a second dielectric insulator layer 536.

[0085] An embodiment of a double-sided stacked sensor configuration that may be utilized in connection with the present disclosure is described with reference to Figures 16-18. Figure 16 illustrates 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, e.g., at least a generally planar dielectric base substrate, having a first conductive layer 602 that substantially covers the entire first surface area, e.g., top surface area, of the insulating substrate 601, e.g., the conductive layer extends substantially the entire length of the substrate to the distal end and the entire width of the substrate from side edge to side edge. A second conductive layer 603 covers substantially the entire second surface, e.g., bottom surface, of the insulating base substrate 601. However, one or both of the conductive layers may terminate proximal to the distal end and / or have a width that is less than the width of the insulating substrate 601 that terminates at a selected distance from the side edges of the substrate, which may be equidistant or different from each of the side edges.

[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 a reference electrode and / or a counter electrode. If the conductive layer 603 functions as either the reference electrode or the counter electrode but not both, a third electrode may optionally be provided either on a surface region of the proximal portion of the sensor (not shown), on a separate substrate, or on an additional conductive layer disposed either above or below the conductive layers 602 or 603 and separated therefrom by an insulating layer(s). For example, in some embodiments in which the analyte sensor 600 is configured to be partially implanted, the conductive layer 603 may be configured to include a reference electrode and a third electrode (not shown) present only in the non-implanted proximal portion of the sensor may be configured to include the counter electrode of the sensor.

[0087] A first insulating layer 604 covers at least a portion of the conductive layer 602, and a 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 ​​one or more conductive layers.

[0088] 17 shows a cross-sectional view of a distal portion of a double-sided analyte sensor 700 including at least a generally planar insulating base substrate 701, e.g., at least a generally planar dielectric base substrate, having a first conductive layer 702 covering substantially the entire first surface area, e.g., top surface area, of the insulating substrate 701, e.g., the conductive layer extends substantially the entire length of the substrate to the distal end and the entire width of the substrate from side edge to side edge. A second conductive layer 703 covers substantially the entire second surface, e.g., 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 have a width less than the width of the insulating substrate 701 terminating at a selected distance from the side edges of the substrate, which may be equidistant or different from each of the side edges.

[0089] 17, the conductive layer 702 is configured to include a working electrode, as discussed in more detail below, that includes a sensing area 702A disposed on at least a portion of the first conductive layer 702. It should be noted that although a single sensing area 702A is shown, in other embodiments, multiple spatially separated sensing elements may be utilized without departing from the scope of the present disclosure.

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

[0091] A first insulating layer 704 covers a portion of the conductive layer 702, and a 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 area of ​​the conductive layer where the sensing region 702A is located. The insulating layer 705 on the bottom / reference electrode side of the sensor may extend any suitable length of the distal section of the sensor, for example, the entire length of both the primary and secondary conductive layers or portions thereof. For example, as shown in FIG. 17, the bottom insulating layer 705 extends across 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 ends of the secondary conductive material 703A that extend along the side edges of the substrate 701 are not covered by the insulating layer 705 and are therefore exposed to the environment during operational use.

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

[0093] It should be noted that although Figures 16-18 are depicted or discussed herein as being capable of providing the working and reference electrodes in a particular layered configuration, the relative arrangement of these layers may be altered. For example, a counter electrode layer may be provided on one side of an insulating base substrate, while a working electrode layer and a reference electrode layer are provided in a stacked configuration on the other side of the insulating base substrate. Additionally, by adjusting the number of conductive and insulating layers, a different number of electrodes than those shown in Figures 16-18 may be provided. For example, a three or four electrode sensor may be provided.

[0094] One or more membranes, which may function as one or more of the analyte flux modulating layers and / or interferent removing layers and / or biocompatible layers, discussed in more detail below, may be included with, on, or around the sensor (e.g., as one or more of the outermost layers). The membranes of the present disclosure may take many forms. For example, the membrane may include only one component or multiple components. The membrane may also have a spherical shape, such as surrounding the terminal region (e.g., the sides and terminal tip) of the sensor. The membrane may also have a generally planar structure and be characterized as a layer. A planar membrane may be smooth or have slight (topological) variations in the surface. The membrane may be configured as other non-planar structures. For example, the membrane may 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, a first membrane layer 706 may be provided only on the sensing area 702A on the working electrode 702 to regulate the rate of diffusion or flux of the analyte to the sensing area. For embodiments in which the membrane layer is provided on a single component / material, it may be appropriate to do so in the same stripe configuration and manner used for the other material / component. Here, the membrane material 706 preferably has a width greater than the width of the sensing component 702A. It is important to control the thickness of the membrane 706, as this serves to limit the flux of the analyte to the active area of ​​the sensor, thus contributing to the sensitivity of the sensor. Providing the membrane 706 in the form of stripes / bands facilitates control of its thickness. A second membrane layer 707, coating the remaining surface area of ​​the sensor tail, may be provided to also serve as a biocompatible conformal coating and provide smooth edges across the entire sensor.

[0096] In other sensor embodiments, as shown in Figure 18, a single homogenous membrane 806 may be coated over the entire sensor surface area, or at least over both sides of the distal tail. Note that to coat the distal and side ends of the sensor, membrane material may need to be applied following singulation of the sensor precursors. In some embodiments, the analyte sensor is dip coated to apply one or more membranes after singulation. Alternatively, the analyte sensor may be slot die coated, with each side of the analyte sensor being coated separately.

[0097] 19 illustrates a cross-sectional view of a distal portion of an exemplary double-sided analyte sensor 900 according to one embodiment of the present disclosure, the double-sided analyte sensor including an at least generally planar insulating base substrate 901, e.g., an at least generally planar dielectric base substrate, having a first conductive layer 902. A second conductive layer 903 is disposed on a first side, e.g., a bottom side, 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 proximate the distal end and / or have a width less than the width of the insulating substrate 901 terminating at a selected distance from a side edge of the substrate, which distance may be equidistant 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 traces having a width less than the width of the insulating base substrate.

[0098] 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 sensing region is discussed in more detail below. As shown herein, it should be noted that multiple spatially separated sensing components or layers may be utilized in forming the working electrode, e.g., one or more separate sensing spots or "dots" or regions may be provided on the conductive layer 903, or a single sensing component may be used (not shown).

[0099] 19 embodiment, conductive layer 906 is configured to include a reference electrode including a secondary layer of conductive material 906A, e.g., Ag / AgCl, disposed on a distal portion of conductive layer 906. Similar to conductive layers 902 and 903, conductive layer 906 may terminate proximal to the distal end and / or may have a width less than the width of insulating substrate 901 terminating at a selected distance from the side edges of the substrate, which may be equidistant or different from each of the side edges, as discussed in more detail below with reference to FIGS.

[0100] In the embodiment shown in FIG. 19, the conductive layer 902 is configured to include a counter electrode. A first insulating layer 904 covers a portion of the conductive layer 902, and a 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 area 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 area of ​​the conductive layer 903 where the sensing area 908 is located. As mentioned above, in some embodiments, multiple spatially separated sensing components or layers may be provided (as shown), while in other embodiments, a single sensing area may be provided without departing from the scope of the present disclosure. The insulating layer 907 on the first side, e.g., the bottom surface of the sensor (in the view provided by FIG. 19), may extend any suitable length of the distal section of the sensor, e.g., it may extend the entire length or a portion of both the conductive layers 906 and 906A. 19, the bottom insulating layer 907 extends across the entire bottom surface area of ​​the secondary conductive material 906A and terminates distally of 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 therefore exposed to the environment during operational use.

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

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

[0103] One way to address this potential problem is to provide one of the conductive layers, e.g., the electrode layers, at least in part as a relatively narrow electrode, e.g., including a relatively narrow conductive trace, so that during the separation process, the sensor is cut on either side of the narrow electrode such that one electrode is cut without severing the narrow electrode.

[0104] For example, referring to Figures 20A-20C, a sensor 1000 is shown that includes insulating layers 1003 and 1005. The insulating layers 1003 and 1005 may be thin compared to the generally planar insulating base substrate layer 1001, or vice versa. For example, the insulating layers 1003 and 1005 may have a thickness in the range of 15-30 μm, and the substrate layer 1001 has a thickness in the range of 0.1-0.15 mm. Such sensors can be manufactured in sheets, with a single sheet containing multiple sensors. However, such a process generally requires separation of the sensors before use. If such separation requires cutting two or more conductive layers separated by an insulating layer, a short circuit between the two conductive layers may occur, especially if the insulating layer is thin. To avoid such short circuits, fewer 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, at least in part, as an electrode, e.g., an electrode having a narrow width relative to one or more other conductive layers, including a conductive trace, such that during the separation process, a first conductive layer separated from the second conductive layer only by a thin insulating layer, e.g., an insulating layer having a thickness in the range of 15-30 μm, is cut while the second conductive layer is not cut.

[0105] 20A and 20C, the sensor 1000 includes an at least generally planar insulating base substrate 1001. Disposed on the at least 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 15-30 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 15-30 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 relative to the conductive layer 1004, as shown in the cross-sectional view taken at line AA in FIG. 20B. Alternatively, the second conductive layer 1004 may be an electrode having a narrow width relative to the conductive layer 1002, as shown in the cross-sectional view taken at line AA in FIG. 20C. A separation cut line 1006 is shown in FIG. 20B and FIG. 20C. The sensor may be separated, for example, by cutting both sides of the relatively narrow conductive electrode, for example, in region 1007, as shown in FIG. 20B and FIG. 20C. With reference to FIG. 20B, separation by cutting along the separation cut line 1006 cuts the conductive layer 1004 but not the conductive layer 1002. With reference to FIG. 20C, separation by cutting along the separation cut line 1006 cuts the conductive layer 1002 but not the conductive layer 1004.

[0107] An embodiment of a sensing region may be described as the area shown generally as 508 in Figure 115B and 908 in Figure 9. As noted above, the sensing region may be provided as a single sensing component as shown in Figure 15B as 508, in Figure 17 as 702A, and in Figure 18 as 802A, or as multiple sensing components as shown in Figure 19 as 908. Multiple sensing components or sensing "spots" are described in U.S. Patent Application Publication No. 2012 / 0150005, which is incorporated herein by reference in its entirety.

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

[0109] Sensing zone formulations that can include a glucose converting agent can include, for example, a redox mediator, such as, for example, hydrogen peroxide or a transition metal complex, such as a ruthenium-containing complex or an osmium-containing complex, among other components, and an analyte-responsive enzyme, such as, for example, 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 zone includes glucose oxidase. The sensing zone can also include other optional components, such as, for example, a polymer, and, for example, a bifunctional short-chain epoxide crosslinker, such as polyethylene glycol (PEG).

[0110] In some embodiments, the sensing region formulation includes a protein switch component that allows for the detection of any desired analyte. The use of a 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 be coupled 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), providing a qualitative or quantitative detection platform for any desired analyte. The selected enzyme is coupled (e.g., covalently bound) to a selective analyte-binding ligand (e.g., peptide, antibody, antibody fragment, other immunoglobulin, apatamer, etc.) such that binding of the analyte-binding ligand by the analyte present in the sample being analyzed alters (e.g., inhibits or enhances) the activity of the selected enzyme. The presence of the analyte in the analyzed sample thereby increases or decreases (e.g., changes the redox state of the reaction solution) the detectable product of the enzyme activity, as desired. Although specific examples of selected enzymatic components of the protein switch are described herein, it should be understood that any enzyme or enzymatic functional portion thereof that catalyzes the production of a detectable (e.g., electrochemically detectable) product may be used. Any of a wide variety of analytes may be detected using such systems, 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, and the like. The analyte-binding portion of the protein switch may be derived from a protein that binds the analyte. Such proteins that bind the analyte may include, for example, antibodies, receptors (including full-length, fragments, and single-chain receptors), and artificial binding proteins created 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 may be derived from a ligand.

[0111] The protein switch can be derived from a protein that has a binding affinity for an analyte, allowing the protein switch to detect the analyte at physiological levels. The protein switch can be made from an analyte-binding protein that has desirable kinetics for binding physiological levels 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 March 8, 2017), and U.S. Provisional Patent Application No. 62 / 544,364 (filed August 11, 2017), both of which are incorporated herein by reference in their entirety for all purposes.

[0112] In some embodiments, two or more different protein switch systems responsive 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 generates a detectable result. In other embodiments, the different analytes generate different or distinguishable signals, so that each analyte can be detected and analyzed separately (e.g., generating different signals or generating the same signal in different regions (e.g., different layers of a multi-layer sensor)).

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

[0114] As discussed above, the analyte sensor may include an analyte-responsive enzyme to provide a sensing component or sensing area. Some analytes, such as oxygen, may be directly electrooxidized or electroreduced 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 electrooxidation or electroreduction of the analyte. A catalyst may be used for analytes, such as oxygen, that can be directly electrooxidized or electroreduced on the working electrode. For these analytes, each working electrode includes a sensing area (see, e.g., sensing area 508 in FIG. 15B) adjacent to or on the surface of the working electrode. In many embodiments, the sensing area 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 a reaction of the analyte to generate 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] A variety of different sensing area configurations can be used in embodiments of the present disclosure. The sensing area is often placed in contact with or in close proximity to an electrode, such as a working electrode. In some embodiments, the sensing area is deposited on the conductive material of the working electrode. The sensing area may extend beyond the conductive material of the working electrode. In some cases, the sensing area may extend over other electrodes, for example, over a counter electrode and / or a reference electrode (or if a counter / reference is provided).

[0117] The sensing region in direct contact with the working electrode may include an electron transfer agent to directly or indirectly transfer electrons between the analyte and the working electrode, and / or a catalyst to facilitate a reaction of the analyte. For example, a glucose, lactate, or oxygen electrode may be formed having a sensing region that includes a catalyst that includes glucose oxidase, glucose dehydrogenase, lactate oxidase, or laccase, respectively, and an electron transfer agent that facilitates the electro-oxidation of glucose, lactate, or oxygen, respectively. As noted above, a protein switch may be used to provide an indirect mechanism for detecting an analyte of interest by converting the binding of the analyte to a binding partner into a change in the activity of an enzyme.

[0118] In other embodiments, the sensing region is not deposited directly on the working electrode. Instead, for example, the sensing region 508 (FIG. 15) may be spaced apart from the working electrode, for example, separated from the working electrode 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 interferent removing layer and / or a biocompatible layer.

[0119] In some embodiments including two or more working electrodes, one or more of the working electrodes may not have a corresponding sensing area or may have an area that does not include one or more components (e.g., electron transfer agent and / or catalyst) required to electrolyze 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 areas, e.g., 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 with redox potentials several hundred millivolts higher or lower than the redox potential of a standard calomel electrode (SCE). Electron transfer agents can be organic, organometallic, or inorganic. Examples of organic redox species are quinones and species with quinoid structures in their oxidation state, such as Nile Blue and indophenol. Examples of organometallic redox species are metallocenes, including ferrocene. Examples of inorganic redox species are ferrocyanide, 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 the sample is being analyzed. For example, the electron transfer agent includes a redox species, for example, but not limited to, the redox species can be bound to a polymer, which in turn is placed on or near the working electrode. The bond between the redox species and the polymer can be a covalent bond, a coordinate 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, but in some embodiments, the redox species is a transition metal compound or complex, for example, a compound or complex of osmium, ruthenium, iron, and cobalt. It will be appreciated that many of the redox species described for use with a polymer component may be used without the polymer component.

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

[0123] Suitable electron transfer agents are osmium transition metal complexes having one or more ligands, each of which has a nitrogen-containing heterocycle, such as 2,2'-bipyridine, 1,10-phenanthroline, 1-methyl, 2-pyridylbiimidazole, or a derivative thereof. The electron transfer agent may have one or more ligands covalently attached in a polymer, each of which has at least one nitrogen-containing heterocycle, such as pyridine, imidazole, or a derivative thereof. One example of an electron transfer agent includes (a) a polymer or copolymer having pyridine or imidazole functional groups, and (b) an osmium cation complexed with two ligands, each of which has 2,2'-bipyridine, 1,10-phenanthroline, or a derivative thereof, where the two ligands are not necessarily the same. Some derivatives of 2,2'-bipyridine for complexing with osmium cations include, but are not limited to, mono-, di-, and polyalkoxy-2,2'-bipyridines, including 4,4'-dimethyl-2,2'-bipyridine and 4,4'-dimethoxy-2,2'-bipyridine. Derivatives of 1,10-phenanthroline for complexing with osmium cations include, but are not limited to, mono-, di-, and polyalkoxy-1,10-phenanthrolines, such as 4,7-dimethyl-1,10-phenanthroline and 4,7-dimethyl-1,10-phenanthroline. Polymers for complexing with osmium cations 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 of poly(1-vinylimidazole) include acrylonitrile, acrylamide, substituted or quaternized N-vinylimidazole, such as electron transfer agents having osmium complexed to a polymer or copolymer of poly(1-vinylimidazole).

[0124] Embodiments may use electron transfer agents having redox potentials in the range of about -200 mV to about +200 mV versus a standard calomel electrode (SCE). The sensing region may include a catalyst capable of catalyzing a reaction of the analyte. The catalyst may act as an electron transfer agent in some embodiments. One example of a suitable catalyst is an enzyme that catalyzes a reaction of the analyte. For example, if 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) may be used. If the analyte of interest is lactate, lactate oxidase or lactate dehydrogenase may be used. If the analyte of interest is oxygen, or if oxygen is produced or consumed in response to a reaction of the analyte, laccase may be used.

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

[0126] In some embodiments, the sensor operates at a low oxidation potential, e.g., about +40 mV vs. Ag / AgCl. The 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 that includes (1) an osmium-based mediator molecule that includes 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), e.g., an analyte flux modulating layer, may be included in the sensor to act as a diffusion limiting barrier that reduces the rate of mass transport of the analyte, e.g., glucose or lactate, into the region around the working electrode. Mass transport limiting layers are useful to limit the flux of analytes to the working electrode in electrochemical sensors so that the sensor responds linearly over a wide range of analyte concentrations and is easily calibrated. The mass transport limiting layer may comprise a polymer and may be biocompatible. The mass transport limiting layer may provide many functions, such as biocompatibility and / or interferent removal functions.

[0128] In some embodiments, the mass transport limiting layer is a film made of a crosslinked polymer containing heterocyclic nitrogen groups, such as polymers of polyvinylpyridine and polyvinylimidazole. Embodiments also include films made of polyurethane, or polyetherurethane, or chemically related materials, or films made of silicone, and the like.

[0129] The membrane may be formed by in situ crosslinking of a polymer modified with a zwitterionic moiety, a non-pyridine copolymer component, and optionally another moiety that is either hydrophilic or hydrophobic and / or has other desirable properties, in an alcohol buffer. The modified polymer may be made from a precursor polymer that includes a heterocyclic nitrogen group. For example, the precursor polymer may be polyvinylpyridine or polyvinylimidazole. Optionally, hydrophilic or hydrophobic modifiers 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 may be formed in situ by applying an alcohol buffer solution of the crosslinker and modified polymer to the enzyme-containing sensing area and allowing the solution to cure for about 1-2 days or other suitable time. The crosslinker-polymer solution may be applied to the sensing area by placing one or more droplets of the membrane solution on the sensor, by immersing the sensor in the membrane solution, by spraying the membrane solution on the sensor, etc. In general, the thickness of the membrane is controlled by the concentration of the membrane solution, the number of droplets of membrane solution applied, the number of times the sensor is immersed in the membrane solution, the volume of membrane solution sprayed on the sensor, or any combination of these factors. The membrane thus applied may have any combination of the following functions: (1) mass transport limitation, e.g., reducing the flux of analyte that can reach the sensing area, (2) improving biocompatibility, or (3) reducing interferents.

[0131] In some examples, the membrane may form one or more bonds with the sensing region. Bonds refer to any type of interaction between atoms or molecules that allows chemical compounds to form associations with each other, such as, 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 may form crosslinks between the polymer of the membrane and the polymer of the sensing region. In some embodiments, crosslinking of the membrane to the sensing region helps reduce the occurrence of membrane peeling from the sensing region.

[0132] In some embodiments, the sensing system detects hydrogen peroxide to estimate glucose levels. For example, a hydrogen peroxide detection sensor may be constructed in which the sensing area contains an enzyme, such as glucose oxidizer, glucose dehydrogenase, and is placed in close proximity to a working electrode. The sensing area may be covered by one or more layers, such as a membrane that is selectively permeable to glucose. As glucose passes through the membrane, it is oxidized by the enzyme, reduced glucose oxidase, by reacting with molecular oxygen to produce hydrogen peroxide.

[0133] A particular embodiment includes a hydrogen peroxide detection sensor constructed from a sensing region prepared by combining, for example, (1) a redox mediator having a transition metal complex, including an Os polypyridyl complex having an oxidation potential of about +200 mV vs. SCE, and (2) periodate-oxidized horseradish peroxidase (HRP). Such a sensor functions in a reduction mode, where the working electrode is controlled at a negative potential relative to the potential of the Os complex, resulting in mediated reduction of hydrogen peroxide through the HRP catalyst.

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

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

[0136] In some embodiments, the substrate is flexible. For example, if the sensor is configured for implantation into a user, the sensor can be flexible (although rigid sensors can also be used for implantable sensors) to reduce pain to the user and damage to tissue due to sensor implantation and / or wear. In many cases, a flexible substrate increases the comfort of the user and allows a wider range of activities. Suitable materials for flexible substrates include, for example, non-conductive plastic or polymeric materials, and other non-conductive, flexible, deformable materials. Examples of useful plastic or polymeric materials include polycarbonate, polyester (e.g., Mylar™ and polyethylene terephthalate (PET)), polyvinyl chloride (PVC), polyurethane, polyether, polyamide, polyimide, or copolymers of these thermoplastics, such as the thermoplastic 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 substrates include low conductive ceramics, such as aluminum oxide and silicon dioxide. Implantable sensors with rigid substrates can have sharp tips and / or sharp edges to aid in the implantation of the sensor without an additional insertion device.

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

[0139] In addition to flexibility considerations, it is often desirable for implantable sensors to have a physiologically harmless substrate, eg, a substrate approved for in vivo use by a regulatory agency or civilian agency.

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

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

[0142] The anticoagulant may be applied to at least a portion of that portion of the sensor that is to be implanted. The anticoagulant may be applied, for example, by bath, spray, brushing, immersion, or the like. The anticoagulant may be allowed to dry on the sensor. The anticoagulant may be immobilized on the surface of the sensor or may be allowed to diffuse away from the sensor surface. The amount of anticoagulant placed on the sensor may be less than that typically used to treat medical conditions involving blood clots, and thus has only a limited localized effect.

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

[0144] With continued reference to FIG. 21, the analyte monitoring system 1100 includes a display device 1120 (e.g., such as a computing device described herein) that 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 inputting data or commands into the display device 1120 or otherwise controlling the operation of the display device 1120. It should be noted that some embodiments may include devices without a display or without user interface components. These devices may be functionalized to store data as data loggers and / or provide a route for transferring data from the on-body electronics and / or display-less devices to another device and / or location. The embodiments are described herein as display devices for illustrative purposes that 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 electronics 1110 may be configured to store in memory some or all of the monitored analyte-related data received from the analyte sensor 1101 during the monitoring period and maintain it in memory until the end of the usage period. In such embodiments, the stored data is retrieved from the on-body electronics 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 electronics 1110 from the skin surface on which the on-body electronics 1110 was placed during the monitoring period. In such a data logging configuration, the real-time monitored analyte levels are not communicated to the display device 1120 or otherwise transmitted from the on-body electronics 1110 during the monitoring period, but rather are retrieved from the on-body electronics 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 may 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 a speaker, a microphone, and software routines for generating, processing, and storing voice drive signals, may be provided in the on-body electronics 1110.

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

[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 port configured to connect to a compatible data cable. The display device 1120 may also include an integrated in-vitro glucose meter, including an in-vitro test strip port 1124 for receiving in-vitro glucose test strips for performing in-vitro blood glucose measurements.

[0149] 21 , the display 1122 in some embodiments is configured to display a variety of information, some or all of which may be displayed simultaneously or at different times on the display 1122. In some embodiments, the displayed information is user selectable, such that a user may customize the information shown on a given display screen. The display 1122 may include, but is not limited to, a graphical display 1138 for providing a graphical output of glucose values ​​over a monitored period of time (which may show key markers such as diet, exercise, sleep, heart rate, blood pressure, etc.), a numeric display 1132 for providing monitored glucose values ​​(obtained or received in response to a request for information), and a trend or directional arrow display 1131 for indicating the rate of change of the analyte and / or the rate of change of the analyte.

[0150] 21, the display 1122 may also include, for example, a date display 1135 to provide date information to a user, a time information display 1139 to provide time information to a user, a battery level indicator display 1133 to graphically indicate the status of the battery (rechargeable or disposable) of the display device 1120, a sensor calibration status icon display 1134 to notify the user that analyte sensor calibration is required, for example, in a monitoring system that requires periodic, daily, or a predetermined number of user calibration events, an audio / vibration settings icon display 1136 to indicate the status of an audio / vibration output or an alarm condition, and a wireless connection status icon display 1137 to indicate a wireless communication connection with other devices, such as the on-body electronics, the data processing module 1160, the remote terminal 1170, etc. As further shown in FIG. 21, the display 1122 may further include simulated touch screen buttons 1140, 1141 for accessing menus, changing the display graph output configuration, or otherwise controlling the operation of the display device 1120.

[0151] 21 , in some embodiments, the display 1122 of the display device 1120 may be configured to output alarm and / or alert notifications, glucose values, and the like, in addition to or in lieu of a visual display, which may be audible, tactile, or any combination thereof. In one aspect, the display device 1120 may include other output components, such as a speaker, a vibration output component, and the like, to provide audible and / or vibration output indications to a user in addition to the visual output indications provided on the display 1122.

[0152] After placing the on-body electronics 1110 on the skin surface and the analyte sensor 1101 in vivo to establish fluid contact with interstitial fluid (or other suitable bodily fluid), the on-body electronics 1110 of some embodiments is configured to wirelessly communicate analyte-related data (e.g., data corresponding to the monitored analyte level and / or monitored temperature data, and / or stored historical analyte-related data) when the on-body electronics 1110 receives a command or request signal from the display device 1120. In some embodiments, the on-body electronics 1110 may be configured to at least periodically broadcast real-time data related to the monitored analyte level received by the display device 1120 when the display device 1120 is within communication range of the data broadcast from the on-body electronics 1110, e.g., when a command or request from the display device is not 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 electronics 1110 to initiate a data transfer, and in response, the on-body electronics 1110 may be configured to wirelessly transmit stored analyte-related data collected during the monitoring period to the display device 1120. The display device 1120 can then be connected to a remote terminal 1170, such as a personal computer, and serves as a data conduit for transferring the stored analyte level information from the on-body electronics 1110 to the remote terminal 1170. In some embodiments, data received from the on-body electronics 1110 may be stored (permanently or temporarily) in one or more memories of the display device 1120. In certain other embodiments, the display device 1120 is configured as a data conduit for passing data received from the on-body electronics 1110 to the remote terminal 1170 connected to the display device 1120.

[0154] 21 , the analyte monitoring system 1100 also includes 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 analyte 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 doctor's office or a hospital. For example, the remote terminal 1170 may be located at a location other than the location of the display device 1120. 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 at least about 1 mile apart, e.g., at least about 10 miles apart, e.g., at least about 1100 miles apart. 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 a 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 incorporated by reference in its entirety for all purposes. The data processing module 1160 further includes a communication port, driver, or connector for establishing wired communication with one or more of the display device 1120, the on-body electronics 1110, or the remote terminal 1170, including, 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 a polling or query signal to the on-body electronics 1110 at predetermined time intervals (e.g., once every minute, once every five minutes, etc.) and, in response, receive monitored analyte level information from the on-body electronics 1110. The data processing module 1160 stores the received analyte level information in its memory and / or relays or retransmits 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 retransmits or passes through the received analyte level data from the on-body electronics 1110 to the display device 1120 or a remote terminal or both (e.g., over a data network such as a cellular or WiFi data network).

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

[0159] Referring again to FIG. 21 , in some embodiments, the data processing module 1160 is programmed to send a command or signal to the on-body electronics 1110 at predetermined time intervals, such as once every minute, or once every 5 minutes, or once every 30 minutes, or any other suitable or desired programmable time interval, to request analyte-related data from the on-body electronics 1110. Upon receiving the requested analyte-related data, the data processing module 1160 stores the received data. In this manner, the analyte monitoring system 1100 can be configured to receive continuously monitored analyte-related information at programmed or programmable time intervals, which is stored and / or displayed to a user. The data stored in the data processing module 1160 may then be provided or transmitted to a display device 1120, a remote terminal 1170, or the like, for subsequent data analysis, such as, for example, identifying the frequency of periods of blood glucose level excursions over a monitored period, or the frequency of occurrence of alarm events during a monitored period, to improve treatment-related decisions. Using this information, a doctor, health care provider, or user may adjust or recommend changes to diet, daily habits, exercise routines, etc.

[0160] In another embodiment, the data processing module 1160 transmits a command or signal to the on-body electronics 1110 to receive the analyte-related data in response to user actuation of a switch provided on the data processing module 1160 or a user-initiated command received from the display device 1120. In a further embodiment, the data processing module 1160 is configured to transmit a command or signal to the on-body electronics 1110 in response to receiving a user-initiated command only after a predetermined time interval has elapsed. 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 electronics 1110 if the user does not initiate communication within a programmed period of time, such as, for example, about 5 hours since the last communication (or 10 hours since the last communication, or 24 hours since 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 electronics 1110. In this manner, a user or healthcare provider can program or configure the data processing module 1160 to provide constant compliance with the analyte monitoring regimen such that frequent determinations of analyte levels are maintained or performed by the user.

[0161] In some embodiments, when a programmed or programmable alarm condition is detected (e.g., a detected glucose level monitored by the analyte sensor 1101 that is outside a predetermined tolerance range indicating a physiological condition requiring attention or intervention for medical treatment or analysis (e.g., a hypoglycemic condition, a hyperglycemic condition, an impending hyperglycemic condition or an impending hypoglycemic condition)), one or more output indications may be generated by the control logic or processor of the on-body electronics 1110 and output on a user interface of the on-body electronics 1110 to a user so that corrective action can be taken in a timely manner. Additionally or alternatively, if the display device 1120 is within communication range, the output indication or alarm data may 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 electronics 1110 may execute a software program stored in memory to determine future or predicted analyte levels based on information obtained from the analyte sensor 1101, such as the current analyte level, the rate of change of the analyte level, the acceleration of change in the analyte level, and / or analyte trend information determined based on stored monitored analyte data providing a historical trend or direction of analyte level fluctuations as a function of time during a monitored period. Predictive alarm parameters may be programmed or programmable in the display device 1120, or the on-body electronics 1110, or both, and may be output to the user in advance predicting that the user's analyte level will reach a future level, allowing the user to take corrective action in a timely manner.

[0163] For example, information such as the fluctuation or oscillation of the monitored analyte level as a function of time over a monitored period of time providing analyte trend information may be determined by one or more control logic or processors of the display device 1120, the data processing module 1160, and / or the remote terminal 1170, and / or the on-body electronics 1110. Such information may 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, for example, trend or directional arrow display 1131) or other icon, for example, whose position on the screen relative 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 may be utilized by the user to determine corrective actions required to ensure that the analyte level remains within an acceptable and / or clinically safe range. Other visual indicators including color, flashing, fading, etc., as well as audio indicators including changes in pitch, volume, or tone of the 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 glucose rate of change, programmed clinically significant glucose threshold levels (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 will take to reach a clinically significant level, and output a notification of increasing intensity, etc., prior to reaching the clinically significant level, e.g., 30 minutes, and / or 20 minutes, and / or 10 minutes, and / or 5 minutes, and / or 3 minutes, and / or 1 minute, etc., before the clinically significant level is expected.

[0164] 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, micro SD card, Compact Flash card, XD card, Memory Stick card, Memory Stick Duo card, or USB memory stick / device, that includes executable programs stored on such devices for execution upon connection to one or more of the on-body electronics 1110, remote terminal 1170, or display device 1120, respectively. In further aspects, the software algorithms for execution by the data processing module 1160 may be provided as a downloadable application for downloading to a communication device, such as a WiFi or Internet enabled smartphone or mobile phone, including a personal digital assistant (PDA), for execution by the communication device.

[0165] Examples of smartphones include Windows, Android, iPhone, Palm WebOS, Blackberry, or Symbian operating systems based mobile phones with data network connectivity for data communication over an Internet connection and / or a local area network (LAN). A PDA, as described above, includes a portable electronic device including, for example, one or more processors and data communication capabilities 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 over the Internet). In such an embodiment, the remote terminal 1170 may be configured to provide executable application software to one or more of the above communication devices when communication between the remote terminal 1170 and the device is established.

[0166] In yet other embodiments, the executable software application may be provided over the air (OTA) as an OTA download such 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 either automatically or based on a user's confirmation or approval on the communication device to perform 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 display device 1120.

[0167] 21 , in some embodiments, new software and / or software updates, such as software patches or fixes, firmware updates or software driver upgrades, among others, for the display device 1120 and / or the on-body electronics 1110 and / or the data processing module 1160 may be provided by the remote terminal 1170 when communication between the remote terminal 1170 and the display device 1120 and / or the data processing module 1160 is established. For example, software upgrades, executable programming changes or modifications of the on-body electronics 1110 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 electronics 1110 to update its software or programmable functionality. For example, in some embodiments, the software received and installed on the on-body electronics 1110 may include software bug fixes, changes to previously disabled software parameters (e.g., changing the time interval for storing sample-related data, resetting or adjusting the time base or information of the on-body electronics 1110, changing the type of data transmitted, the data transmission sequence, or the duration of data storage, among other things).

[0168] On-Body Electronics In some embodiments, the on-body electronics (or sensor control device) 1110 (FIG. 21) includes at least some of the electronic components that operate the sensors and display devices. The electronic components of the on-body electronics typically include a power source for operating the on-body electronics and sensors, a sensor circuit for obtaining signals from the sensors and operating the sensors, 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 optional on-body electronics. In some embodiments, the processing circuit partially or fully evaluates the signals from the sensors and communicates the resulting data to optional on-body electronics 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 electronics may optionally include electronics for transmitting the sensor signals or processed data from the processing circuitry to a receiver / display unit, a data storage unit for temporarily or permanently storing data from the processing circuitry, a temperature probe circuitry for receiving signals from and operating the temperature probe, a reference voltage generator for providing a reference voltage for comparison with the sensor-generated signal, and / or a watchdog circuit for monitoring operation of electronic components of the on-body electronics.

[0170] Additionally, the on-body electronics may include digital and / or analog components utilizing semiconductor devices including transistors. To operate these semiconductor devices, the on-body electronics may include other components including, for example, bias control generators for properly biasing the analog and digital semiconductor devices, oscillators for providing clock signals, digital logic and timing components for providing timing signals and logical operations for the digital components of the circuit.

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

[0172] Referring to FIG. 21, in some embodiments, the adhesive patch 1140 has a footprint on the body that is less than about 3.0 inches in diameter, e.g., less than about 2.0 inches in diameter, less than about 1.0 inch in diameter, and in some embodiments, the adhesive patch can have a diameter of 1.0 inch to about 1.5 inches or less.

[0173] In some embodiments, the on-body electronics 1110 is configured such that it has 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 inches excluding the adhesive patch 1140, for example, less than about 0.8 square inches excluding the adhesive patch 1140, for example, less than about 0.75 square inches excluding the adhesive patch 1140, for example, less than about 0.7 square inches excluding the adhesive patch 1140, and in some embodiments the surface area of ​​the on-body electronics unit may be from about 0.75 square inches to about 0.79 square inches excluding the adhesive patch 1140.

[0174] In some embodiments, the on-body electronics 1110 including the adhesive patch 1140 has a surface area of ​​about 3.0 square inches or less including the adhesive patch, such as about 2.0 square inches or less including the adhesive patch, such as about 1.9 square inches or less including the adhesive patch, such as about 1.8 square inches or less including the adhesive patch, such as about 1.75 square inches or less including the adhesive patch, such as about 1.6 square inches or less including the adhesive patch, and in some embodiments the surface area of ​​the on-body electronics unit may be about 1.75 square inches to about 1.77 square inches or less.

[0175] FIG. 22 is a block diagram of the on-body electronics 1110 (FIG. 21) in some embodiments. With reference to FIG. 22, in some embodiments, the on-body electronics 1110 includes a control unit 1210 (e.g., but not limited to, one or more processors (or processing circuits) and / or ASICs with processing circuits) operably coupled to an analog front-end circuit 1270 to process signals, such as raw current signals received from the analyte sensor 1101. Also shown in FIG. 22 is a memory 1220 operably coupled to the control unit 1210 for storing data and / or software routines for execution by the 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, the control unit 1210 accesses data or software routines stored in the memory 1220 to retrieve one or more stored software routines for execution, as well as to update, store, or replace data or information stored in the memory 1220. Also shown in FIG. 22 is a power source 1260 that, in some embodiments, provides power to some or all of the components of the on-body electronics 1110. For example, in some embodiments, the power source 1260 is configured to provide power to the components of the on-body electronics 1110, except for the communication module 1240. In such embodiments, the on-body electronics 1110 is configured to operate the analyte sensor 1101 to detect and monitor an analyte level at predetermined or programmed (or programmable) time intervals, e.g., to generate and store a signal or data corresponding to the detected analyte level.

[0177] In some embodiments, the power source 1260 within the on-body electronics 1110 may be switched between its internal power source (e.g., a battery) and the RF power received from the display device 1120. For example, in some embodiments, the on-body electronics 1110 may include a diode or switch in the internal power connection path of the on-body electronics 1110 such that when a predetermined level of RF power is detected by the on-body electronics 1110, the diode or switch is triggered to disable the internal power connection (e.g., creating an open circuit in the power connection path) and the components of the on-body electronics are powered with the received RF power. The open circuit in the power connection path prevents depletion or dissipation of the internal power source, as would be the case if the internal power source were used to power the on-body electronics 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, powering the on-body electronics 1110 with the internal power source. In this manner, in some embodiments, switching between the internal power source and RF power from the display device 1120 may be configured to extend or extend 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 communications module 1240 is remotely powered, for example, with RF power from a display device 1120 located within a predetermined distance from the on-body electronics 1110. In such an embodiment, the analyte level is sampled and stored in the memory 1220 based on predetermined or programmed time intervals as described above. When analyte level information is requested based on a request or send command received from another device, such as the display device 1120 (FIG. 21), for example, using RF power from the display device, the communications 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 on the on-body electronics 1110. In some embodiments, the output unit 1250 may include an LED indicator, for example, to alert the user of one or more predefined conditions related to the operation of the on-body electronics 1110 and / or the determined analyte level. As a non-limiting example, the on-body electronics 1110 may be programmed to assert a notification using an LED indicator or other indicator on the on-body electronics 1110 if the signal received from the analyte sensor 1101 (based on one sampled sensor data point or multiple sensor data points) indicates that the signal is outside of a programmed tolerance range, potentially indicating a health risk condition such as hyperglycemia or hypoglycemia, or the onset or likelihood of such a condition. With such a prompt or instruction, the user is timely informed of such potential condition and can use the display device 1120 to obtain glucose level information from the on-body electronics 1110 to confirm the presence of such a condition so that corrective action can be taken in a timely manner.

[0181] Referring again to FIG. 22, the antenna 1230 and communication module 1240 operatively coupled to the control unit 1210 may be configured to detect and process RF power when the on-body electronics 1110 is located within a predetermined proximity range of the display device 1120 (FIG. 21) that is providing or radiating RF power. Additionally, the on-body electronics 1110 may provide the display device 1120 with analyte level information and, optionally, analyte trend or historical 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 electronics 1110 and provided to the display device 1120 along with the real-time analyte level information. For example, the trend information may include a series of spaced analyte level data for a period of time since the last transmission of analyte level information to the display device 1120. Alternatively, the trend information may include the past 30 minutes or 1 hour of analyte level data 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 electronics 1110 is configured to store the analyte level data in a first and second FIFO buffer that are part of the memory 1220. The first FIFO buffer stores 16 (or 10 or 20) of the most recent 1-minute intervals of analyte level data. The second FIFO buffer stores the most recent 8 hours (or 10 hours or 3 hours) of analyte level data in 10-minute (or 15-minute or 20-minute) intervals. The stored analyte level data is transmitted from the on-body electronics 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 the glucose rate of change and uses the analyte level data from the second FIFO buffer to determine historical plots or trend information.

[0183] In some embodiments, for configurations of the on-body electronics that include a power source, the on-body electronics may be configured to detect RF control commands (ping signals) from the display device 1120. More specifically, an on / off key (OOK) detector is provided in the on-body electronics and is turned on and powered by the on-body electronics power source to detect RF control commands or ping signals 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 certain aspects, once an RF control command is detected, the on-body electronics determines which response packet is required and generates a response packet to send back to the display device 1120. In this embodiment, the analyte sensor 1101 continuously receives power from the on-body electronics power source or battery 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 electronics receives RF power (from the display device 1120) and begins transmitting data to the display device 1120. In one embodiment, the power source for the on-body electronics may include a rechargeable battery that charges when the on-body electronics receives RF power (e.g., from the display device 1120).

[0184] Returning to FIG. 21 , in some embodiments, the on-body electronics 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 electronics 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 electronics 1110 provides an RF response signal including data related to, for example, a sampled analyte level from the sensor 1101. Additional information regarding the operation of RFID communications can be found in U.S. Pat. No. 7,545,272, U.S. Application Nos. 12 / 698,624, 12 / 699,653, 12 / 761,387, and U.S. Patent Application Publication No. 2009 / 0108992, the entireties of which are incorporated herein by reference 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 electronics 1110 is within the transmitted RF field of the RFID reader, an antenna of the on-body electronics 1110 is adjusted, which 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, when the display device 1120 is placed within a predetermined range of the on-body electronics 1110 and receives a response signal from the on-body electronics 1110, the display device 1120 is configured to output an indication (audible, visual or otherwise) to confirm acquisition of an analyte level measurement. That is, during the 5-10 days that the on-body electronics 1110 is worn, the user may place the display device 1120 within a predetermined distance (e.g., about 1-5 inches, or about 1-10 inches, or about 1-12 inches) of the on-body electronics 1110 at any time, and after waiting a sample acquisition period of several seconds, an audible indication will be output confirming receipt of real-time analyte level information. The received analyte information may be output on the display 1122 (FIG. 21) of the display device 1120 for presentation to the user.

[0187] In some embodiments, the on-body electronics 1110 includes an ASIC that includes a RISC (reduced instruction set computing) processor on a chip, an EEPROM, and registers (A / D converters operably coupled to the analyte sensors). The EEPROM in some embodiments includes a portion programmed therein with one or more properties or details related to memory management routines. Examples of properties 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 memory, whether the memory location is a loop buffer (e.g., overwrite older stored values ​​with new values ​​when the end of the buffer is reached).

[0188] In some embodiments, a preset number of specific events may be broken down 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 ready event (e.g., A / D conversion of a signal from an analyte sensor is complete and the digitized data is ready to be stored), or (3) a log data (10 minutes analyte data) ready event (e.g., when 10 minutes of analyte data is available for storage). For example, in some embodiments, 10 minutes of analyte data is available when the last A / D conversion of 10 minutes of analyte data is complete. In some embodiments, other events or conditions may be defined.

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

[0190] In some embodiments, the characteristics stored in the EEPROM associated with a particular event may be modified. For example, the source and destination addresses may be changed or modified to point to a different memory device or storage unit of the on-body electronics 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 the on-body electronics 1110 to store an amount of data (e.g., about 30, about 45, about 60 or more days of 1-minute sampled analyte data (or 5-minute sampled data, or 10-minute sampled data)) that is much larger than an on-demand application where a limited amount of data is stored (e.g., 15 samples of 1-minute sampled analyte data and 6 hours of past 10-minute sampled analyte data). In some embodiments, the amount of data to store in the data logger application may exceed the capacity of the on-chip EEPROM. In such cases, a larger capacity off-chip EEPROM may be provided in the on-body electronics 1110 to store data from the data logger application. In some embodiments, to configure the on-body electronics 1110 to store sampled analyte data in a larger capacity off-chip EEPROM, characteristics stored in the EEPROM associated with the event are reprogrammed or updated (e.g., by updating the source or destination addresses associated with the event) so that data logging or storage is directed to the larger off-chip EEPROM.

[0191] In this manner, by updating or reprogramming the portion of the on-chip EEPROM that stores the event characteristics, the data storage locations in the on-body electronics 1110 may be updated or modified depending on the desired application or use of the on-body electronics 1110. Additionally, other stored characteristics associated with one or more particular events may be updated or reprogrammed in the EEPROM as needed to modify the use or application of the on-body electronics 1110 in the analyte monitoring system 1100. This is further advantageously accomplished without reprogramming or modifying the stored routines for executing particular events by the RISC processor.

[0192] Display Devices / Computing Devices Figure 23 is a block diagram of the display device 1120 shown in Figure 21 in some embodiments. Although the term display device is used, the device can be configured to read data without displaying it 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 protocol (e.g., NFC-to-Bluetooth or Bluetooth Low Energy). With reference to Figure 23, the display device 1120 (Figure 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., a user interface) 1121. The display device 1120 may also include 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 a data processing module 1160 (FIG. 21), a remote terminal 1170 (FIG. 21), or other devices such as a personal computer, a server, a mobile computing device, a mobile phone, a pager, or other handheld data processing device, including a mobile phone, such as an Internet-enabled smartphone, with data communication and processing capabilities, 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 coupled to a control unit 1310, which further 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 of sample (e.g., 1 microliter or less, e.g., about 0.5 microliters or less, e.g., about 0.1 microliters or less) 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 instrument can accept and process a variety of 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 that operate using amperometric technology, those that operate using coulometric technology, etc.). Detailed descriptions of such test strips and devices for performing in vitro analyte monitoring are 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 by reference herein in their entireties and for all purposes.

[0195] The glucose information obtained by the in vitro glucose testing device may be used for a variety of purposes. For example, the information may be used to calibrate the analyte sensor 1101 (FIG. 21) if the sensor requires in vivo calibration, to confirm the results of the analyte sensor 1101 to increase the reliability of the results from the sensor 1101 indicating the monitored analyte level (e.g., information obtained by the sensor 1101 is employed in treatment-related decisions), and the like. In some embodiments, the analyte sensor does not require calibration by human intervention during its lifespan. However, in some embodiments, the system may be programmed to self-detect a problem and take action, such as, for example, shutting down and / or notifying the user. For example, the analyte monitoring system may be configured to detect a system malfunction or a potential degradation of the sensor stability or a potential adverse condition associated with the operation of the analyte sensor, and the system may notify the user, for example, using the display device 1120 (FIG. 21), to perform a 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 results of an in vitro blood glucose measurement).

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

[0197] 23, a power source 1320, such as one or more batteries, rechargeable or disposable, is also provided and operably coupled to the control unit 1310 and configured to provide the display device 1120 (FIG. 21) with the power necessary for operation. Additionally, the display device 1120 may include an antenna 1351, such as a 433 MHz (or other equivalent) loop antenna, a 13.56 MHz antenna, or a 2.45 GHz antenna, 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 electronics 1110 (FIG. 21). Additionally, an inductive loop antenna 1341 is provided and coupled to a square wave driver 1340 operably coupled to the control unit 1310.

[0198] In some embodiments, the data packet received from the on-body electronics and in response to the request from the display device includes, for example, one or more of the current glucose level from the analyte sensor, the current estimated rate of blood glucose change, and glucose trend history based on automated measurements taken and stored in the memory of the skin electronics. 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 blood glucose change may be output as a directional arrow 1131 (FIG. 21) on the display 1122, and the glucose trend history based on stored monitored values ​​may be output as a graphical trace 1138 (FIG. 21) on the display 1122. In some embodiments, the processor (or processing circuitry) 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 or programmable by the user.

[0199] In some embodiments, the display device 1120 is programmed to maintain a time period between each successive request for analyte data from the on-body electronics 1110. For example, in some embodiments, the display device 1120 is configured to, after an initial analyte data request is transmitted to the on-body electronics 1110 and monitored analyte level information is received from the on-body electronics 1110, not allow a subsequent request for analyte data to be transmitted to the on-body electronics 1110 until a predetermined time period measured from the transmission of the initial analyte data request has elapsed. For example, when the display device 1120 is operated to transmit a request for analyte-related data to the on-body electronics 1110, an internal clock or timer of the display device 1120 begins or starts an internal clock or timer programmed with a predetermined time period that counts down. The display device 1120 in some embodiments includes programming that disables or prevents transmission of a second subsequent request for analyte data from the on-body electronics 1110 until after the predetermined time period has elapsed.

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

[0201] In some embodiments, the display device 1120 may be programmed or programmable to discard or identify data received from the on-body electronics 1110 that is corrupted or otherwise contains errors. For example, in some embodiments, no minimum period between subsequent analyte data requests is enforced or programmed in the display device 1120. However, the display device 1120 includes software routines that identify corrupted or otherwise data based on an inspection of the data packet. For example, each data packet received from the on-body electronics 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 in a data packet from the on-body electronics 1110, in some embodiments, a value of 1 indicates that the data is not corrupted. In such embodiments, the on-body electronics 1110 is configured to reset this bit in the data packet to 0 at the end of each sampling period (e.g., after every minute) and change the value to 1 if the A / D conversion routine is completed during the sampling period without errors.

[0202] Data Communication and Processing Routines Referring now to FIG. 24, which illustrates data and / or command exchanges between the on-body electronics 1110 and the display device 1120 during an initialization and pairing routine, the display device 1120 provides an initial signal 1421 to the on-body electronics 1110. If the received initial signal 1421 includes RF energy above a predetermined threshold level 1403, an envelope detector of the on-body electronics 1110 is triggered 1404, one or more oscillators of the on-body electronics 1110 are turned on, and the control logic or processor of the on-body electronics 1110 is latched on momentarily to retrieve 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 sent to the display device 1120. The response signal 1422 from the on-body electronics 1110 includes an identification code, such as a serial number of the on-body electronics 1110. The on-body electronics 1110 then return to the inactive 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 electronics 1110 does not send a response signal to the display device 1120, and the serial number of the on-body electronics 1110 is not provided to the display device 1120. The on-body electronics 1110 then returns 1403 to shelf mode and remains in a powered down state until it detects a subsequent initial signal 1421 from the display device 1120.

[0204] When the display device 1120 receives a data packet containing identification information or a serial number from the on-body electronics 1110, it extracts 1412 that information from the data packet. With the serial number of the on-body electronics 1110 extracted, the display device 1120 determines whether the on-body electronics 1110 associated with the received serial number has been configured. If the body electronics 1110 associated with the received serial number has already been configured, for example by 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 configured. In this manner, in some embodiments, the display device 1120 is configured to pair with an on-body electronic device that has not yet been paired with or configured by another display device.

[0205] Returning to FIG. 24, if the on-body electronics 1110 associated with the extracted serial number has not been configured 1413, the display device 1120 is configured to send a wake-up signal to the on-body electronics 1110 that includes a configuration command. In some embodiments, the wake-up command from the display device 1120 includes the serial number of the on-body electronics 1110, such that only on-body electronics with the same serial number included in the wake-up command will detect and exit the inactive shelf mode and enter the active mode. More specifically, when a wake-up command including a serial number is received by the on-body electronics 1110, the control logic or one or more processors (or processing circuits) of the on-body electronics 1110 execute routines 1403, 1404, and 1405 to temporarily exit shelf mode if 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 (because that determination was made previously and that serial number was the one sent to the display device 1120). The on-body electronics 1110 then determines 1406 whether the received serial number (received in the wake-up command) matches its own stored serial number. If the two serial numbers do not match, the routine returns to the beginning, with the on-body electronics 1110 again in inactive shelf mode 1402. On the other hand, if the on-body electronics 1110 determines 1406 that the received serial number matches its stored serial number, then the control logic or one or more processors of the on-body electronics 1110 are latched permanently on 1407 and the oscillator is turned on to activate the on-body electronics 1110. Further, referring back to FIG. 24, if the on-body electronics 1110 determines 1406 that the received serial number matches its own serial number, then the display device 1120 and the on-body electronics 1110 are successfully paired 1416.

[0206] In this manner, using a wireless signal to turn on and initialize the on-body electronics 1110 may extend the shelf life of the on-body electronics 1110 since much less current is drawn or consumed from the on-body electronics 1110 power source during the time the on-body electronics 1110 is in an inactive, shelf mode prior to operation. In some embodiments, while in the inactive shelf mode, the on-body electronics 1110 has minimal operation, if any, requiring extremely low current. The RF envelope detector of the on-body electronics 1110 may operate in two modes: a desensitized mode that responds to signals received less than about 1 inch, and a normal operation mode that has normal signal sensitivity to respond to signals received at a distance of about 3-12 inches.

[0207] During initial pairing between the display device 1120 and the on-body electronics 1110, in some embodiments, the display device 1120 transmits its identification information, such as, for example, a 4-byte display device ID that may include its serial number. The on-body electronics 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 manner, the display device 1120 can distinguish detected data packets from the on-body electronics 1110 to determine that a received or detected data packet originated from a paired or correct on-body electronics 1110. The display device ID based pairing routine in some embodiments avoids potential collisions between multiple devices, especially when the on-body electronics 1110 does not selectively provide analyte-related data to a particular display device, but rather provides it to any display device that is within range, and / or broadcasts data packets to any display device within communication range.

[0208] In some embodiments, the payload size from the display device 1120 to the on-body electronics 1110 is 12 bytes, which includes 4 bytes of display device ID, 4 bytes of 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 electronics 1110 for real-time monitored analyte information and / or recorded or stored analyte data, in some embodiments, the response data packet sent to the display device 1120 includes a total of 418 bytes, including 34 bytes of status information, time information, and calibration data, 96 bytes of the most recent 16 1-minute glucose data points, and 288 bytes of the most recent 15-minute interval glucose data over 12 hours. Depending on the size or capacity of the memory or storage unit of the on-body electronics 1110, the data stored and subsequently provided to the display device 1120 may have different time resolutions and / or span longer or shorter periods of time. 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 level indicative of a historical trend in the monitored analyte level may be processed and / or determined by the on-body electronics 1110, or alternatively or additionally, the stored data may be provided to the display device 1120, which may then determine trend information for the monitored analyte level based on the received data packets.

[0210] The size of the data packets provided from the on-body electronics 1110 to the display device 1120 may vary depending on the communications protocol and / or the underlying data transmission frequency, whether 433 MHz, 13.56 MHz, or 2.45 GHz, used, in addition to other parameters such as the presence of a data processing device, such as a processor or processing circuit (e.g., a central processing unit CPU) in the on-body electronics 1110, as well as the size of ASIC state machines, data buffers and / or memory.

[0211] In some embodiments, upon successful activation of the on-body electronics 1110 and pairing with the display device 1120, a control unit of the display device 1120 may be programmed to generate and output one or more visual, audible and / or tactile notifications for output to a user on the display 1122 or on a user interface of the display device 1120. In some embodiments, only one display device may be paired with one on-body electronic device at a time. 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, under control of the processor of the display device 1120, outputs the remaining operational life of the user's analyte sensor 1101. Additionally, as the end of the sensor's life approaches, the display device may be configured to output a notification to alert the user that the sensor's end of life is approaching. The schedule for such notifications may be programmed or programmable by the user and executed by the processor of the display device.

[0213] 21 , in some embodiments, the analyte monitoring system 1100 may store historical analyte data along with date and / or time stamps and / or contemporaneous temperature measurements in a memory, such as a memory configured as a data logger as described above. In some embodiments, the analyte data is stored at a frequency such as about once per minute, or about once per 10 minutes, or about once per hour. Data logger embodiments may store historical analyte data for a predetermined period of time, e.g., a duration specified by a physician, e.g., from about one day to about one month or more, e.g., about three days or more, e.g., about five days or more, e.g., about seven days or more, e.g., about two weeks or more, e.g., about one month or more.

[0214] Other durations may be appropriate depending on the clinical significance of the data being observed. The analyte monitoring system 1100 may display the analyte measurements to the subject during the monitoring period. In some embodiments, the data is not displayed to the subject. Optionally, the data logger may transmit the historical analyte data to a receiving device located adjacent, for example, in close proximity to the data logger. For example, the receiving device may be configured to communicate with the data logger using a transmission protocol that operates at low power over distances from a fraction of an inch to several feet. For example, but not limited to, such proximity protocols include Certified Wireless USB™, TransferJet™, Bluetooth™ (IEEE 802.15.1), WiFi™ (IEEE 802.11), ZigBee™ (IEEE 802.15.4-2006), Wibree™, and the like.

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

[0216] The analyte data parameters may be calculated by a processor or processing circuit executing a program stored in memory. In some embodiments, the processor executing the program stored in memory is located in the data processing module 1160 (FIG. 21). In some embodiments, the processor executing the program stored in memory is located in the display device 1120. An exemplary technique for analyzing the data is an applied ambulatory glucose profile (AGP) analysis technique. Additional detailed description is provided in U.S. Pat. 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 Ser. Nos. 10 / 745,878 and 11 / 060,365, the entire disclosures of which are incorporated herein by reference in their entirety for all purposes.

[0217] As mentioned above, in certain aspects of the present disclosure, individual glucose measurement data can be obtained on demand or upon request from a display device, and the glucose measurements are obtained from an in vivo glucose sensor that is transdermally placed beneath a user's skin layer and further has a portion of the sensor maintained in fluid contact with bodily fluids beneath the skin layer. Thus, in aspects of the present disclosure, a user of an analyte monitoring system can conveniently determine real-time glucose information at any time using the RFID communication protocols described above.

[0218] In one aspect, the integrated assembly including the on-body electronics and the insertion device can be sterilized, packaged as a single device, and provided to the user. Furthermore, during manufacturing, the insertion device assembly may be terminal packaged to provide cost savings, for example, avoiding the use of costly thermoformed trays or foil seals. In addition, the insertion device can include end caps rotatably coupled to the insertion device body, which provide a safe and sterile environment for the sensor provided in the insertion device along with the integrated assembly (and avoid the use of desiccants for the sensor). Also, the end cap sealed insertion device can be configured to retain the sensor in the housing from significant movement during shipping, such that the position of the sensor relative 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 sample monitoring scan display window including an Add Note button; actuation of the Add Note button transitions on the computing device to an input display window listing a limited number of user inputs related to lifestyle events of a sensor user for a particular date and time; selecting one or more of the limited number of user inputs; the input display window configured for entering information related to one or more selected user inputs; receiving input of information related to the one or more selected user inputs into the input display window; displaying in a sample monitoring daily display window on the computing device a selectable symbol that correlates to a summary of information entry for the particular date and time; selecting the selectable symbol causes a pop-up display window to be displayed on the computing device displaying the summary of information entry overlaid on the sample 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 sample monitoring scan display window including an add note button, an input display window listing a limited number of user inputs related to lifestyle events of a sensor user for a particular date and time and configured for entry of information related to one or more selected user inputs, a sample monitoring daily display window configured to display a selectable symbol that correlates to a summary of the information entry for the particular date and time, the pop-up display window displaying the summary of the information entry upon selection of the selectable symbol, the pop-up display window being overlaid on top of the sample monitoring daily display window, the system further comprising a sample 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, the plurality of display windows including a sample monitoring scan display window including an add note button, an input display window listing a limited number of user inputs related to a sensor user's lifestyle habits for a particular date and time and configured for input of information related to one or more selected user inputs, a sample monitoring daily display window configured to display a selectable symbol that correlates to a summary of the information input for the particular date and time, and a pop-up display window that displays the summary of the information input upon selection of the selectable symbol, the pop-up display window being overlaid on top of the sample monitoring daily display window.

[0222] Embodiment D: A method comprising: displaying a menu display window of a computing device listing a limited number of user-selectable buttons including an event log button; selecting the event log button transitioning to an event log display window of the computing device, the event log display window displaying one or more events associated with a sample monitoring sensor at a particular date and time.

[0223] Embodiment E: 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 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 associated with a sample monitoring sensor at a particular date and time, the system further comprising a sample monitoring sensor communicatively coupled to the sample monitoring sensor.

[0224] Embodiment F: 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 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 associated with a sample monitoring sensor at a particular 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: A computing device is communicatively coupled to an analyte monitoring sensor.

[0226] Element 2: A computing device communicatively coupled to a glucose monitoring sensor. Element 3: A summary of information entries is linked to the specimen measurements at the specified 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, ultra fast acting insulin, fast acting insulin, exercise, comments, and any combination thereof.

[0228] Element 6: The analyte monitoring scan display window displays a graphical representation of the analyte concentration. Element 7: The Sample Monitoring Scan Display window displays a graphical representation of the glucose concentration.

[0229] Element 8: The Analyte Monitoring Daily Display window displays a graphical representation of the analyte concentration. Element 9: The Analyte 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: A computing device is communicatively coupled to an analyte monitoring sensor, and the limited number of user inputs related to lifestyle events of a sensor user are dynamic based on analyte measurements from the analyte monitoring sensor.

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

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

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

[0234] Element 14: Further including accessing the menu display window from the main menu display window. Element 15: Further including accessing the menu display window from a main menu display window when a user selects a help button.

[0235] Element 16: The one or more events associated with the analyte monitoring sensor are selected from the group consisting of a scan error event, a sensor overcooling event, a new sensor found event, and any combination thereof.

[0236] Element 17: The event log display window further includes a Send Troubleshooting Data button. Element 18: The event log display window further includes a send troubleshooting data button, the method further including, upon selection of the send troubleshooting data button, sending information related to the event to a customer service representative.

[0237] Element 19: An event log display window displays the one or more events associated with the analyte monitoring sensor along with an accompanying description of the one or more events.

[0238] Element 20: An event log display window displays the one or more events associated with the analyte monitoring sensor along with an accompanying icon or symbol. Element 21: Further including referencing, on the event log display window, a user manual related to the one or more events and a link to the related page thereof.

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

[0240] Unless otherwise indicated, all numbers expressing quantities and the like in the specification and the associated claims should be understood as being modified in all instances by the term "about." Accordingly, unless indicated to the contrary, the numerical parameters set forth in the following specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained by embodiments of the invention. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should, at the very least, be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.

[0241] One or more exemplary embodiments incorporating various features are presented herein. For clarity, not all features of a physical implementation are described or shown in this application. It is understood that in developing a physical embodiment incorporating an embodiment of the invention, numerous implementation-specific decisions must be made to achieve the developer's goals, which may vary from implementation to implementation and from time to time, such as compliance with system-related, business-related, government-related, and other constraints. While the developer's efforts may be time consuming, such efforts are nevertheless routine undertakings for those of ordinary skill in the art having the benefit of this disclosure.

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

[0243] As used herein, the phrase "at least one" preceding a list of items, together with the term "and" or "or" separating any of the items, modifies the entire list, not each member (i.e., each item) of the list. The phrase "at least one" allows for the meaning to include 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 phrase "at least one of A, B, and C" or "at least one of A, B, or C" refers, respectively, to A only, B only, or C only, or any combination of A, B, and C, and / or at least one of each of A, B, and C.

[0244] Thus, the disclosed systems, tools, and methods are well adapted to achieve the objects and advantages mentioned, as well as those inherent therein. The specific embodiments disclosed above are illustrative only, as the teachings of the disclosure may be modified and implemented in different but equivalent manners, as will be apparent to those skilled in the art having the benefit of the teachings herein. Moreover, no limitations are intended to the details of construction or design shown herein, except as set forth in the appended claims. Thus, it is apparent that the specific exemplary embodiments disclosed above may be altered, combined, or modified, and all such variations are considered to be within the scope of the present disclosure. The systems, tools, and methods illustratively disclosed herein may be suitably practiced in the absence of elements not specifically disclosed herein and / or any elements disclosed herein. Although the systems, tools, and methods are described in terms of "comprising," "containing," or "including" various components or steps, the systems, tools, and methods may also "consist essentially of" or "consist of" various components and steps. All of the numerical values ​​and ranges disclosed above may vary to some extent. Whenever a numerical range with a lower limit and an upper limit is disclosed, any number and any included range within the range is specifically disclosed. In particular, any range of values ​​disclosed herein (in the form of "about a to about b," or equivalently, "approximately a to approximately b," or equivalently, "approximately a to b") should be understood to define any number and range encompassed within the broader range of values. Moreover, the terms in the claims have their plain and ordinary meaning unless expressly and unambiguously defined otherwise by the patent owner. Moreover, the indefinite article "a" or "an" used in the claims is defined herein to mean one or more of the element it introduces. 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 glucose level of a user using a glucose monitoring sensor in communication with a computing device, comprising: monitoring a glucose level via 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 interstitial fluid of the user; displaying on the computing device a window containing a graphical representation of glucose data over time received from the glucose monitoring sensor; displaying on the computing device a menu including an event log button; transitioning to an event log display window on the computing device upon selection of the event log button; the event log display window displays one or more events associated with operation of the glucose monitoring sensor at a particular date and time configured to assist in troubleshooting operation of the glucose monitoring sensor, each of the one or more events including an event title and an event description; The method, wherein the event log display window includes a selectable button configured to cause the glucose monitoring sensor to transmit information from an event log and information about the glucose monitoring sensor when the selectable button is selected.

2. The method of claim 1 , wherein an event of the one or more events further comprises an event association number.

3. The method of claim 1 , wherein the glucose data is received from the glucose monitoring sensor by a near-field wireless communication method when the computing device is placed in proximity to the glucose monitoring sensor.

4. The method of claim 1 , wherein an event of the one or more events comprises an error in scanning the glucose monitoring sensor with the computing device to receive the glucose data.

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

6. The method of claim 1 , wherein an event of the one or more events is associated with a new glucose monitoring sensor.

7. The method of claim 1 , further comprising providing corrective instructions associated with one of the one or more events on the event log display window.

8. The method of claim 1 , wherein an event of the one or more events includes a corresponding icon.

9. The method of claim 1 , wherein the event log button is displayed on a menu display window that includes a limited number of user-selectable buttons.

10. 1. A system for monitoring a glucose level of a user, comprising: a glucose monitoring sensor configured to monitor a glucose level of a user, 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 interstitial fluid of the user; 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 display windows comprising: a window containing a graphical representation of glucose data over time received from the glucose monitoring sensor; a menu display window including an event log button; an event log display window displayed when the event log button is selected, the event log display window displaying one or more events associated with operation of the glucose monitoring sensor at a particular date and time configured to assist in troubleshooting operation of the glucose monitoring sensor, each of the one or more events including an event title and an event description; The system, wherein the event log display window includes a selectable button configured to cause the glucose monitoring sensor to transmit information from an event log and information about the glucose monitoring sensor when the selectable button is selected.

11. The system of claim 10 , wherein the computing device comprises a phone and the display screen of the computing device is a touch screen display.

12. The system of claim 10 , wherein an event of the one or more events further includes an event association number.

13. The system of claim 10 , wherein the glucose data is received from the glucose monitoring sensor by a near-field wireless communication method when the computing device is placed in proximity to the glucose monitoring sensor.

14. The system of claim 10 , wherein an event of the one or more events includes an error in scanning the glucose monitoring sensor with the computing device to receive the glucose data.

15. The system of claim 10 , wherein an event of the one or more events includes an event related to a temperature of the glucose monitoring sensor.

16. The system of claim 10 , wherein an event of the one or more events is associated with a new glucose monitoring sensor.

17. The system of claim 10 , further comprising providing on the event log display window corrective instructions associated with one of the one or more events.

18. The system of claim 10 , wherein the event log button is displayed on a menu display window that includes a limited number of user-selectable buttons.

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