Abstract: In response to insertion of a continuous glucose monitoring (CGM) sensor into the skin of user, a CGM system compares an identifier of the sensor to any previously-stored identifiers of previously-inserted sensors. If the identifier does not match a previously-stored identifier, indicating a newly-inserted sensor, the identifier and a time stamp are stored and CGM may begin. Upon removal of the sensor, a removal time stamp is stored. If the identifier of an inserted sensor matches a previously-stored identifier, indicating a reinserted sensor, a reinsertion time is obtained and an elapsed removal time is checked to determine whether it exceeds a maximum removal time limit. If it does, CGM is halted. If it does not, CGM may continue with the reinserted sensor. Methods of tracking insertion and removal times of a CGM sensor are also provided, as are other aspects.

Abstract: A base unit of a wearable device for continuous analyte monitoring includes a cup configured to receive a power source. A first power source contact is at least partially located in the cup and configured to electrically contact a first terminal of the power source in response to the power source being received in the cup. At least one base contact is electrically coupled to the first power source contact, the at least one base contact configured to electrically contact at least one transmitter contact of a transmitter unit in response to the transmitter unit and the base unit being coupled together. Numerous other embodiments are provided.

Abstract: An apparatus for inserting a continuous analyte monitoring transmitter that includes an outer member, an inner member configured to telescope relative to the outer member, a transmitter, a bias member, an insertion device, and a pivot member. Force is applied to press the outer member toward an insertion site over the duration of a stroke. During a first portion of the stroke, the pivot member cannot pivot and the motion of the outer member translates to the insertion device until the biosensor is inserted at the insertion site. Over a second portion of the stroke, the continued motion causes a first pivot window in the outer member to overlap with a second pivot window in the inner member, allowing the pivot member to pivot and retract the insertion device from the insertion site, leaving the implanted biosensor.

Abstract: A method of filtering a signal in a continuous analyte monitoring system (CAM) includes applying adaptive filtering to the signal using an adaptive filter to generate a filtered continuous analyte monitoring signal during an analyte monitoring period, and increasing the adaptive filtering applied to the signal as a function of increasing noise on the signal. Other methods, apparatus, continuous analyte monitoring devices, and continuous glucose monitoring devices are also disclosed.

Abstract: An electrochemical test sensor is adapted to receive a fluid sample including an analyte. The electrochemical test sensor includes a base. The base includes an enzyme adapted to react with the analyte. The electrochemical test sensor further includes a plurality of electrodes, a near field communication (NFC) tag chip, an analog front end (AFE) and a microcontroller.

Abstract: A continuous analyte monitor wearable device. The wearable device includes a primary portion comprising at least a sensor assembly comprising a biosensor, and a secondary portion comprising a pocket configured to receive a transmitter unit and a sealable opening to the pocket, the sealable opening containing an adhesive on edges thereof; and a backing member provided over the adhesive wherein removing the backing member exposes the adhesive to seal the sealable opening and encapsulate the transmitter unit. Biosensor inserters and method of using the biosensor inserter are also provided.

Abstract: Embodiments provide systems, methods, and apparatus for reducing the impact of user-entered data errors in a data management system (DMS) such as for diabetes. Embodiments include storing user-entered data received from a user into a primary DMS database; storing secondary data received from a source other than the user into a secondary tracking database; associating the secondary data with one or more events described by the user-entered data; cross-checking the user-entered data against the associated secondary data; evaluating user-entered data based on the cross-checking results; presenting for review evaluated user-entered data; treating user-entered data in the primary DMS database based on review results; and determining a diabetes management plan based on the treated user-entered data. Numerous other aspects are provided.

Abstract: A biosensor system determines analyte concentration from an output signal generated from a light-identifiable species or a redox reaction of the analyte. The biosensor system compensates at least 50% of the total error in the output signal with a primary function and compensates a portion of the remaining error with a residual function. The amount of error compensation provided by the primary and residual functions may be adjusted with a weighing coefficient. The compensation method including a primary function and a residual function may be used to determine analyte concentrations having improved accuracy from output signals including components attributable to error.

Abstract: 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.

Abstract: A method of determining glucose values during continuous glucose monitoring (CGM) measurements includes providing a CGM device including a sensor, a memory, and a processor; applying a constant voltage potential to the sensor; measuring a primary current signal resulting from the constant voltage potential and storing the measured primary current signal in the memory; applying a probing potential modulation sequence to the sensor; measuring probing potential modulation current signals resulting from the probing potential modulation sequence and storing measured probing potential modulation current signals in the memory; determining an initial glucose concentration based on a conversion function and a measured probing potential modulation current signal; determining a connection function value based on the primary current signal and a plurality of the probing potential modulation current signals; and determining a final glucose concentration based on the initial glucose concentration and the connection functio

Abstract: Some embodiments of the present invention include pairing two wireless devices by placing at least one of two devices in a pairing mode; performing at least one pairing motion event with at least one of the wireless devices to satisfy at least one pairing condition; detecting satisfaction of the at least one pairing condition; and pairing the two wireless devices in response to detecting satisfaction of the at least one pairing condition. Numerous other aspects are provided.

Abstract: During analyte analysis, errors may be introduced into an analysis by both the biosensor system used to perform the analysis and by errors in the output signal measured by the measurement device of the biosensor. For a reference sample, system error may be determined through the determination of relative error. However, during an analysis of a test sample with the measurement device of the biosensor system, true relative error cannot be known. A pseudo-reference concentration determined during the analysis may be used as a substitute for true relative error. The present invention introduces the determination of a pseudo-reference concentration determined during the analysis as a substitute for the true relative error and uses an anchor parameter to compensate for the system error in the analysis-determined pseudo-reference concentration.

Abstract: A biosensor inserter includes a push member with a push element, a contact member including a latch, a transmitter carrier supporting a transmitter and sensor assembly, and a pivot member having a latch end, the pivot member supporting an insertion device during biosensor insertion. In operation, the push member is telescoped axially by the user relative to the contact member, which is provided in contact with a user's skin. This pushes the push element against the pivot member and translates the transmitter carrier during insertion of the biosensor. During a first portion of a stroke of the insertion device, insertion of the biosensor is accomplished, and the pivot member is prevented from pivoting. In a second portion of the stroke, after latch end moves past the latch, the pivot member is allowed to pivot and the insertion device is retracted. Other system and method embodiments are provided.

Abstract: A flexible printed circuit board (PCB) may have one or more coin cell batteries mounted thereto such that the flexibility of the flexible PCB is maintained. The flexible PCB has one or more battery contact pads fabricated thereon. Each battery contact pad includes a pattern of metalized vias each extending from a top surface to a bottom surface of the flexible PCB. A coin cell battery may be positioned over or under the battery contact pad. Conductive light curable epoxy is applied to and in each metalized via to contact and adhere to the coin cell battery to form a conductive path from the battery through the battery contact pad to printed conductors on the flexible PCB. Methods of mounting one or more coin cell batteries to a flexible PCB are also provided, as are other aspects.

Abstract: A method of determining glucose values during continuous glucose monitoring (CGM) measurements includes providing a CGM device including a sensor, a memory, and a processor; applying a constant voltage potential to the sensor; measuring a primary current signal resulting from the constant voltage potential and storing the measured primary current signal in the memory; applying a probing potential modulation sequence to the sensor; measuring probing potential modulation current signals resulting from the probing potential modulation sequence and storing measured probing potential modulation current signals in the memory; determining an initial glucose concentration based on a conversion function value and the primary current signal; determining a connection function based on the primary current signal and a plurality of the probing potential modulation current signals; and determining a final glucose concentration based on the initial glucose concentration and the connection function value.

Abstract: A method of filtering a signal in a continuous analyte monitoring (CAM) system includes applying time-varying filtering to the signal using a time-varying filter to generate a filtered continuous analyte monitoring signal during an analyte monitoring period. Other methods, apparatus, continuous analyte monitoring devices, and continuous glucose monitoring devices are also disclosed.

Abstract: A biosensor inserter is configured to insert a biosensor. The biosensor inserter includes a push member including a receiver, a contact member translatable relative to the push member, and a trocar holder having a sheath configured to receive a trocar assembly including a trocar therein. The trocar holder is configured to be insertable into, and removable from, the receiver. Thus, an amount of medical waste can be minimized by discarding only the removable trocar holder and trocar assembly after use. System and method embodiments are provided.

Abstract: A portable data-management system based on an analyte testing device which communicates wirelessly with a mobile device. The mobile device runs an application to manage and analyze data obtained by the analyte testing device. The mobile device may assist the user in displaying testing data, identifying patterns to assist healthy behavior or issue warnings based on the collected data. The mobile device may be connected to a network to store user health data for use by other parties.

Abstract: In some embodiments, a sensor assembly for a continuous glucose monitoring system is provided that includes (1) a sensor carrier having a sensor unit receiving area and an electronics receiving area, the electronics receiving area including a substrate; (2) a sensor unit having a sterilized region, the sterilized region including at least a portion of a sensor and an introducer; and (3) electronics for the continuous glucose monitoring system. The sensor unit is positioned within the sensor unit receiving area of the sensor carrier and the electronics are positioned on the substrate within the electronics receiving area of the sensor carrier so as to form a sensor assembly having the sensor electrically connected to the substrate of the electronics receiving area while maintaining sterilization of the sterilized region of the sensor unit. Numerous other aspects are provided.

Abstract: Sensor clip assemblies, sensor clips, analyte testing systems, and methods for making and using the same are disclosed. A sensor clip assembly is disclosed for storing and dispensing analyte testing sensors. The sensor clip assembly includes numerous test sensors arranged in a stack. Each test sensor is configured to assist in testing an analyte in a fluid sample. The sensor clip assembly also includes a skeletal frame with a top, a bottom, and numerous sides. The top, bottom and sides are interconnected to define an internal chamber within which is stored the stack of test sensors. At least one of the sides includes one or more elongated rails with structural gaps on opposing sides thereof. For some configurations, multiple sides of the skeletal frame comprise at least one or multiple elongated rails, each of which has structural gaps on opposing sides thereof and may be columnar in nature.