A simple sensing device includes a case with one or more indicators to indicate levels of an analyte such as glucose. The sensing device for self-monitoring an analyte includes a single, flexible case adapted to adhere to a skin of a patient. It also includes a printed circuit board assembly inside the case. It further includes a first sensor extending from the flexible case and electrically coupled to the printed circuit board, and one or more indicators in the flexible case, where the indicator(s) are adapted to indicate whether a level of an analyte is within a normal range.

Method and device for outputting one or more signals associated with a monitored analyte level of an individual, the one or more signals including a substantially real time monitored analyte level and a rate of change information associated with the monitored analyte level, outputting a carbohydrate intake event indication, determining one or more data associated with one or more therapy information related to the monitored analyte level and the meal event indication, and outputting the determined one or more data over the outputted one or more signals associated with the monitored analyte level and the carbohydrate intake event indication are provided.

Embodiments of the invention provide amperometric analyte sensors having optimized elements such as interference rejection membranes as well as methods for making and using such sensors. The amperometric analyte sensor apparatus comprises: a base layer; a conductive layer disposed on the base layer and comprising a working electrode; an interference rejection membrane disposed on an electroactive surface of the working electrode, wherein the interference rejection membrane comprises poly(vinyl alcohol) (PVA) polymers crosslinked by an acid crosslinker, wherein the crosslinker is a dicarboxylic acid type monomer or a polymer comprising a carboxylic acid group; and an analyte sensing layer. While embodiments of the innovation can be used in a variety of contexts, typical embodiments of the invention include glucose sensors used in the management of diabetes.

Disclosed embodiments include methods and systems including a receiver unit of a glucose monitoring system. The receiver unit is configured to receive a key associated with a transmitter unit that enables the receiver unit to identify the transmitter unit, initiate communication with the transmitter unit, access a communication key uniquely associated with the transmitter unit, and receive communication packets from the remote transmitter unit on a periodic basis including data indicative of a glucose level of a bodily fluid. The receiver unit is further configured to process the data determine the glucose level for display, output a numerical representation of the determined glucose level in a GUI, and transmit data indicative of the glucose level to a second receiver unit.

A continuous glucose monitoring system and method has an inserter assembly for inserting a sensor through the skin and into subcutaneous tissue where an inserter housing with the sensor remains on the skin after insertion, a sensor housing cover attachable to the sensor housing after insertion where the sensor housing cover has an electronic module and a battery, and an electronic device equipped with wireless communication for communicating with the electronic module of the sensor housing cover assembly, the electronic device configured for receiving input signals from the sensor, converting the input signals to analyte date, displaying the analyte data on a user interface of the electronic device, storing the data for recall, and creating and/or sending reports of the data.

An analyte measurement kit includes a sensor assembly having a transcutaneous sensor and a controller. The controller includes a battery that powers the sensor assembly and includes a magnetic sensor that generates an electrical activation signal in dependence of a magnetic field. The controller switches from a pre-operative state into an operative state upon generation of the activation signal. The sensor assembly releasably couples to an inserter. The inserter executes an insertion routine that advances the sensor assembly from a retracted position in which the transcutaneous sensor stands back behind a skin contact surface of the inserter into an advanced position in which the transcutaneous sensor projects beyond the skin contact surface, and subsequently decouples the inserter from the sensor assembly. The inserter includes an activation magnet. Executing the insertion routine changes the magnetic coupling between the activation magnet and the sensor assembly and thereby generates the activation signal.

Methods and apparatus are provided for communication among display devices and sensor electronics unit in an analyte monitoring system. The analyte monitoring system may include a sensor that is configured to perform measurements indicative of analyte levels. The sensor may be communicatively coupled to the sensor electronics unit. The sensor electronics unit may be configured to transmit data indicative of analyte levels to the display devices using one or more communication protocols. Furthermore, the sensor electronics unit may be configured to operate in multiple modes, and switch between the modes in response to commands received from the display devices. Related systems, methods, and articles of manufacture are also described.

Systems and methods are provided for detecting changes or fluctuations in an analyte concentration signal that are abnormal, e.g., exceed a predetermined threshold, current trend of analyte concentration measurements, etc. Signals indicative of an analyte concentration in a host may be received from an analyte sensor. The signals may be monitored, and a determination can be made as to whether there is a change in the signal. Upon detecting such a change, the change can be compensated for such that a representation of the signal indicates the analyte concentration. Optionally, the cause of the detected changes or fluctuations can also be determined and information regarding the detected changes or fluctuations can be recorded and analyzed for subsequent optimization of the systems and methods as well for transmitting alerts, notifications, etc. to a user to take corrective action.

The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host.

An insertion device for inserting a medical device into a living body includes: a needle portion internally defining an accommodation space configured to accommodate the medical device and configured to be inserted into a living body together with the medical device accommodated in the accommodation space; and a movable portion that is movable with respect to the needle portion in the accommodation space in a direction of insertion of the needle portion. The needle portion comprises a clamping portion configured to change a form in the accommodation space between a first form in which the clamping portion clamps the medical device accommodated in the accommodation space and a second form in which the clamping portion does not clamp the medical device accommodated in the accommodation space. The movable portion engages the clamping portion to change the form of the clamping portion from the first form to the second form.