Abstract: A skin-adorned physiological or biochemical sensing device is disclosed herein. The device preferably comprises a first substrate and a second substrate. The first substrate comprises an array of solid microneedles designed to penetrate a biological interface to access a physiological fluid or tissue. Each microneedle is capable of electrical interface with the physiological fluid or tissue. The second substrate comprises integrated circuitry designed to transduce at least one signal produced by an electrophysiological or electrochemical reaction. A sensing device is formed that is capable of interpreting the signal arising from the electrophysiological or electrochemical reaction to ascertain the level of some physiological or biochemical entity.

Abstract: Fault detection and diagnostics for a microneedle array based continuous analyte monitoring device are provided. The electrochemical sensors, including the electrodes of the analyte monitoring device configured for measuring one or more target analytes, may experience various faults during use of the analyte monitoring device. By modeling the sensors as an electrical network, measurements of the electrical network may be correlated with operational parameters of the sensor. The voltage at the counter electrode provides an indication of the resistance or impedance between the working electrode and the counter electrode and is used to identify the occurrence of faults occurring at the continuous analyte monitoring device.

Abstract: 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.

Abstract: Aspects of the current subject matter are directed to a sensor assembly of an analyte monitoring device including one or more microneedle arrays. Aspects are directed to components and architecture of a sensor assembly to implement power and processing aspects of a microneedle array-based continuous analyte monitoring device for the detection and measuring of an analyte. A source of a power-on event is determined, and the analyte monitoring device is transitioned to a mode that corresponds to the determined source. When a power-on event is determined to be a valid power-on event, the analyte monitoring device is transition to a mode that corresponds to a type of the valid power-on event.

Abstract: Fault detection and diagnostics for a microneedle array based continuous analyte monitoring device are provided. The electrochemical sensors, including the electrodes of the analyte monitoring device configured for measuring one or more target analytes, may experience various faults during use of the analyte monitoring device. By modeling the sensors as an electrical network, measurements of the electrical network may be correlated with operational parameters of the sensor. The voltage at the counter electrode provides an indication of the resistance or impedance between the working electrode and the counter electrode and is used to identify the occurrence of faults occurring at the continuous analyte monitoring device.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: A device and method for the insertion of an analyte-selective microneedle array sensor into a dermal stratum of a user is disclosed herein. The device comprises a body portion, a recessed actuation portion, a carrier, a gating feature, and a disengagement feature. A user-directed application of a specified force to the actuation area causes the carrier to overcome the gating feature, thereby to effect the acceleration of the microneedle array sensor device towards the skin surface of a user with a specified impact force and velocity.

Abstract: A skin-adorned physiological or biochemical sensing device is disclosed herein. The device preferably comprises a first substrate and a second substrate. The first substrate comprises an array of solid microneedles designed to penetrate a biological interface to access a physiological fluid or tissue. Each microneedle is capable of electrical interface with the physiological fluid or tissue. The second substrate comprises integrated circuitry designed to transduce at least one signal produced by an electrophysiological or electrochemical reaction. A sensing device is formed that is capable of interpreting the signal arising from the electrophysiological or electrochemical reaction to ascertain the level of some physiological or biochemical entity.

Abstract: Devices and methods for low-latency analyte quantification enabled by the implementation of a microneedle-based analyte-selective sensor operating in the dermis or viable epidermis are disclosed herein. The sensing element of the device is contained within the microneedle-based analyte-selective sensor and configured to penetrate the stratum corneum of the skin and become positioned in the viable epidermis or dermis of the wearer such that the sensing element is located a spatial distance no greater than 500 micrometers from the plexus of the dermis of the wearer.

Abstract: A device and method for the coupling of an analyte-selective sensor and an infusion system into a singular body-worn device is disclosed herein. Following the coupling, information and/or power is/are exchanged between the two modalities (analyte-selective sensor and an infusion system) by means of a wireless electromagnetic transmission or an electrical connector. The analyte-selective sensor is configured to penetrate the stratum corneum to access the viable epidermis or dermis and measure the presence of an analyte. The infusion system is configured to penetrate the stratum corneum and deliver a solution-phase therapeutic agent.

Abstract: A device and method for the manual delivery of a therapeutic intervention in response to a physiological state of a user is disclosed herein. The device comprises a sensor, an infusion system, and a singular body-worn component. The sensor is configured to penetrate the stratum corneum to access the viable epidermis or dermis and measure the presence of an analyte. The infusion system is configured to deliver a solution-phase therapeutic agent based on an action of the user or a control algorithm.

Abstract: Ketoacidosis is a medical emergency that requires swift intervention to avert life-threatening sequel. A body-worn sensor (50) configured to measure the levels of a ketone compound circulating in a physiological fluid of a wearer and capable of generating an alert to the wearer if the level of the circulating ketone compound exceeds a pre-defined level or rate of change is disclosed herein. The sensor (50) preferably includes at least one of an electrochemical sensor, an optical sensor, a galvanic sensor, a voltammetric sensor, an amperometric sensor, a potentiometric sensor, an impedimetric sensor, a resistive sensor, a capacitive sensor, an ultrasonic sensor, a radio-frequency sensor, or a microwave sensor.