Abstract: Medical devices, systems, and methods related thereto a glucose monitoring system having a first display unit in data communication with a skin-mounted assembly, the skin-mounted assembly including an in vivo sensor and a transmitter. The first display unit and a second display unit are in data communication with a data management system. The first display unit comprises memory that grants a first user first access level rights and the second display unit comprises memory that grants a second individual second access level rights.

Abstract: Methods and devices to monitor an analyte in body fluid are provided. Embodiments include continuous or discrete acquisition of analyte related data from a transcutaneously positioned in vivo analyte sensor automatically or upon request from a user. The in vivo analyte sensor is coupled to an electronics unit holding a memory with instruction to cause processing circuitry to initiate a predetermined time period that is longer than a predetermined life of the sensor, during the predetermined time period, convert signals from the sensor related to glucose to respective corresponding glucose levels, without relying on any post-manufacture independent analyte measurements from a reference device, and at the expiration of the predetermined time period, disable, deactivate, or cease use of one or more feature.

Abstract: Improved digital interfaces, graphical user interfaces, and alarms for analyte monitoring systems are provided. For example, disclosed herein are various embodiments of methods, systems, and interfaces for signal loss condition determination, Time-in-Ranges interfaces, GMI metrics, urgent low glucose alarms, alarm suppression features, alarm setup interfaces, and alarm unavailability detection features. In addition, various embodiments of interfaces for alarm logging and compatibility checking of an analyte monitoring software application are described. Also, various embodiments of interface enhancements are described, including an enhanced visibility mode, a voice accessibility mode, additional interfaces relating to user privacy, as well as caregiver alarms, among other embodiments.

Abstract: Embodiments described herein include methods and/or systems for updating a medical device. Embodiments include medical devices which are configured for updates in response to various events including connection of a peripheral device to the medical device, a user initiated event, or based on received recommendations.

Abstract: Methods and devices and systems include generating analyte data based on signals from an analyte sensor transcutaneously positioned in contact with interstitial fluid under a skin layer of a user and to generate signals corresponding to an analyte level of a target analyte. The analyte data corresponds to the analyte level of the target analyte over a wear period. Methods include storing the analyte data over the wear period. Methods include determining one or more indications based on the analyte data. Methods include determining a reimbursement insurance code based at least in part on stored sensor information associated with the analyte sensor. Methods include communicating at least a portion of the analyte data and the reimbursement insurance code to an electronic record associated with the user and stored by a remote electronic medical record system. Methods include providing the one or more indications on a user interface unit.

Abstract: Embodiments of the present disclosure include detecting a concurrent occurrence of a decrease in monitored analyte level and a corresponding decrease in monitored on-skin temperature, confirming a presence of an impending hypoglycemic condition, and asserting a notification corresponding to the confirmed impending hypoglycemic condition. Devices, methods, systems and kits incorporating the same are also provided.

Abstract: Methods and devices and systems including a communication module operatively coupled to a data collection module for communicating the stored analyte related data after the analyte related data is stored in the data collection module over a predetermined time period, and a user interface unit configured to communicate with the communication module to receive from the communication module the stored analyte related data in the data collection module over the predetermined time period, and to output information associated with the monitored analyte level, where the user interface unit is configured to operate in a prospective analysis mode including substantially real time output of information associated with the monitored analyte level, or a retrospective analysis mode including limited output of information during the predetermined time period wherein no information related to the monitored analyte level is output during the predetermined time period, are provided.

Abstract: Methods and devices and systems including a communication module operatively coupled to a data collection module for communicating the stored analyte related data after the analyte related data is stored in the data collection module over a predetermined time period, and a user interface unit configured to communicate with the communication module to receive from the communication module the stored analyte related data in the data collection module over the predetermined time period, and to output information associated with the monitored analyte level, where the user interface unit is configured to operate in a prospective analysis mode including substantially real time output of information associated with the monitored analyte level, or a retrospective analysis mode including limited output of information during the predetermined time period wherein no information related to the monitored analyte level is output during the predetermined time period, are provided.

Abstract: Medical devices, systems, and methods related thereto a glucose monitoring system having a first display unit in data communication with a skin-mounted assembly, the skin-mounted assembly including an in vivo sensor and a transmitter. The first display unit and a second display unit are in data communication with a data management system. The first display unit comprises memory that grants a first user first access level rights and the second display unit comprises memory that grants a second individual second access level rights.

Abstract: Embodiments of the present disclosure include detecting a concurrent occurrence of a decrease in monitored analyte level and a corresponding decrease in monitored on-skin temperature, confirming a presence of an impending hypoglycemic condition, and asserting a notification corresponding to the confirmed impending hypoglycemic condition. Devices, methods, systems and kits incorporating the same are also provided.

Abstract: Medical devices, systems, and methods related thereto a glucose monitoring system having a first display unit in data communication with a skin-mounted assembly, the skin-mounted assembly including an in vivo sensor and a transmitter. The first display unit and a second display unit are in data communication with a data management system. The first display unit comprises memory that grants a first user first access level rights and the second display unit comprises memory that grants a second individual second access level rights.

Abstract: Embodiments described herein include methods and/or systems for updating a medical device. Embodiments include medical devices which are configured for updates in response to various events including connection of a peripheral device to the medical device, a user initiated event, or based on received recommendations.

Abstract: Medical devices, systems, and methods related thereto having hierarchical restrictive access schemes are provided. Such medical devices, systems, and methods may include an in vitro analyte monitoring device, an in vivo analyte monitoring device, and/or a drug infusion device having, among other features, hierarchical permission schemes allowing individual access levels thereto.

Abstract: Methods and devices and systems including a communication module operatively coupled to a data collection module for communicating the stored analyte related data after the analyte related data is stored in the data collection module over a predetermined time period, and a user interface unit configured to communicate with the communication module to receive from the communication module the stored analyte related data in the data collection module over the predetermined time period, and to output information associated with the monitored analyte level, where the user interface unit is configured to operate in a prospective analysis mode including substantially real time output of information associated with the monitored analyte level, or a retrospective analysis mode including limited output of information during the predetermined time period wherein no information related to the monitored analyte level is output during the predetermined time period, are provided.

Abstract: Methods and analyte sensors including at least a first working electrode having a first active area thereon, and performing a dip coating operation to deposit a bilayer membrane upon the first working electrode and the first active area. The bilayer may include an inner layer having a first membrane polymer and an outer layer having a second membrane polymer, the first membrane polymer and the second membrane polymer differing from one another. The dip coating operation may comprise one or more first dips in a first membrane formulation to form the inner layer of the bilayer membrane and one or more second dips in a second membrane formulation to form the outer layer of the bilayer membrane upon the inner layer.

Abstract: Systems, devices and methods are provided for the monitoring and management of an individual's wellness and nutrition using analyte data from an in vivo analyte sensor. Generally, a sensor control device is provided for wear on the body. The sensor control device can include an in vivo analyte sensor for measuring an analyte level in a bodily fluid, an accelerometer for measuring the physical activity level of the subject, as well as communications circuitry for wirelessly transmitting data to a reader device. Furthermore, disclosed herein are embodiments of various graphical user interfaces for displaying analyte metrics on a reader device, comparing the analyte response of various foods and/or meals, modifying daily nutrient recommendations based on analyte metrics and physical activity level measurements, and other features described herein. Additionally, the embodiments disclosed herein can be used to monitor various types of analytes.

Abstract: Systems, devices and methods are provided for the monitoring and management of an individual's wellness and nutrition using analyte data from an in vivo analyte sensor. Generally, a sensor control device is provided for wear on the body. The sensor control device can include an in vivo analyte sensor for measuring an analyte level in a bodily fluid, an accelerometer for measuring the physical activity level of the subject, as well as communications circuitry for wirelessly transmitting data to a reader device. Furthermore, disclosed herein are embodiments of various graphical user interfaces for displaying analyte metrics on a reader device, comparing the analyte response of various foods and/or meals, modifying daily nutrient recommendations based on analyte metrics and physical activity level measurements, and other features described herein. Additionally, the embodiments disclosed herein can be used to monitor various types of analytes.

Abstract: Systems, devices and methods are provided for the monitoring and management of an individual's wellness and nutrition using analyte data from an in vivo analyte sensor. Generally, a sensor control device is provided for wear on the body. The sensor control device can include an in vivo analyte sensor for measuring an analyte level in a bodily fluid, an accelerometer for measuring the physical activity level of the subject, as well as communications circuitry for wirelessly transmitting data to a reader device. Furthermore, disclosed herein are embodiments of various graphical user interfaces for displaying analyte metrics on a reader device, comparing the analyte response of various foods and/or meals, modifying daily nutrient recommendations based on analyte metrics and physical activity level measurements, and other features described herein. Additionally, the embodiments disclosed herein can be used to monitor various types of analytes.

Abstract: Methods and devices and systems including a communication module operatively coupled to a data collection module for communicating the stored analyte related data after the analyte related data is stored in the data collection module over a predetermined time period, and a user interface unit configured to communicate with the communication module to receive from the communication module the stored analyte related data in the data collection module over the predetermined time period, and to output information associated with the monitored analyte level, where the user interface unit is configured to operate in a prospective analysis mode including substantially real time output of information associated with the monitored analyte level, or a retrospective analysis mode including limited output of information during the predetermined time period wherein no information related to the monitored analyte level is output during the predetermined time period, are provided.