An analyte sensor system including a substrate, a first electrode disposed on a first surface of the substrate, a second electrode disposed on a second surface of the substrate, a third electrode provided in electrical contact with at least one of the first or second electrodes, where at least a portion of the first electrode and the second electrode are subcutaneously positioned in a patient, and where the third electrode is substantially entirely positioned external to the patient, and corresponding methods are provided.

A fully or partially implantable analyte sensor for continuously monitoring analyte concentration in a body fluid has a substrate with a first surface configured to face towards the body fluid. The sensor has a working electrode and an interferent electrode. The interferent electrode and the working electrode are electrically separated layers located adjacently on the first surface. The sensor has a further electrode, the further electrode being a counter electrode, a reference electrode or a counter/reference electrode. The working electrode and the interferent electrode each have a layer of a conductive material. The working electrode has an enzyme whereas the interferent electrode is devoid of enzyme. A method for producing the fully or partially implantable analyte sensor for continuously monitoring analyte concentration in a body fluid is also disclosed.

Sensor devices including dissolvable tissue-piercing tips are provided. The sensor devices can be used in conjunction with dissolvable needles configured for inserting the sensor devices into a host. Hardening agents for strengthening membranes on sensor devices are also provided. Methods of using and fabricating sensor devices are also provided.

Described herein are variations of an analyte monitoring system, including an analyte monitoring device. For example, an analyte monitoring device may include an implantable microneedle array for use in measuring one or more analytes (e.g., glucose), such as in a continuous manner. The microneedle array may include, for example, at least one microneedle including a tapered distal portion having an insulated distal apex, and an electrode on a surface of the tapered distal portion located proximal to the insulated distal apex. At least some of the microneedles may be electrically isolated such that one or more electrodes is individually addressable.

Electrochemical Impedance Spectroscopy (EIS) is used in conjunction with continuous glucose monitors and continuous glucose monitoring (CGM) to enable in-vivo sensor calibration, gross (sensor) failure analysis, and intelligent sensor diagnostics and fault detection. An equivalent circuit model is defined, and circuit elements are used to characterize sensor behavior.

Various examples are directed to systems and methods that may utilize an analyte sensor system comprising a sensor enclosure; an analyte sensor extending from the sensor enclosure; and sensor electronics positioned within the sensor enclosure. The sensor electronics may be configured to detect that a wireless signal has changed from a first state to a second state, where the wireless signal may be provided through the sensor enclosure. After detecting that the wireless signal has changed from the first state to the second state, the sensor electronics may monitor whether the wireless signal remains in the second state for at least a stability threshold time period. The sensor electronics may execute a responsive action in the sensor system based at least in part on whether the wireless signal remains in the second state for at least the stability threshold time period.

Systems and methods for processing sensor data are provided. In some embodiments, systems and methods are provided for calibration of a continuous analyte sensor. In some embodiments, systems and methods are provided for classification of a level of noise on a sensor signal. In some embodiments, systems and methods are provided for determining a rate of change for analyte concentration based on a continuous sensor signal. In some embodiments, systems and methods for alerting or alarming a patient based on prediction of glucose concentration are provided.

A continuous glucose monitoring (CGM) device may include a wearable portion having a sensor configured to produce glucose signals from interstitial fluid, a processor, a memory and transmitter circuitry. The memory may include a pre-determined gain function based on a point-of-interest glucose signal and glucose signals measured prior to the point-of-interest glucose signal. The memory may also include computer program code stored therein that, when executed by the processor, causes the CGM device to (a) measure and store a plurality of glucose signals using the sensor and memory; (b) for a presently-measured glucose signal, employ the plurality of previously-measured glucose signals stored in the memory and the pre-determined gain function to compute a compensated glucose value; and (c) communicate the compensated glucose value to a user of the CGM device. Numerous other embodiments are provided.

The present invention relates to an electrode assembly (eg a nanoelectrode assembly), to an electrochemical glucose biosensor comprising the electrode assembly and to an apparatus for combating (eg management of) diabetes mellitus which comprises the electrochemical glucose biosensor.

Devices, systems, and methods are provided herein for delivering medication (e.g., insulin) via a wearable pump having a patch-style form factor for adhesion to a user's body. The reusable pump may be coupled to a disposable cap housing a microdosing system for delivering precise, repeatable doses of medication to a cannula configured to deliver medication to a target infusion area beneath the user's outer skin layer. The system further may include an applicator for inserting the cannula into the user's skin and/or applying an adhesive pad to the skin.