Abstract: A glucose monitoring system includes a sensor control device comprising an analyte sensor coupled with sensor electronics, the sensor control device configured to transmit data indicative of an analyte level, and a reader device comprising a wireless communication circuitry configured to receive the data indicative of the analyte level, and one or more processors coupled with a memory.

Abstract: Techniques include a medical device including processors, one or more sensors configured to generate signals corresponding to one or more physiological signals detected in a body of a user, a communication module configured to communicate wirelessly with a receiving device using a communication protocol capable of data transmission or reception at multiple data rates, and memories including instructions to cause the one or more processors to transmit information to the receiving device indicating that the communication module is configured to communicate using the multiple data rates; determine one of the data rates to be utilized for at least one of data transmission or reception during a communication session with the receiving device; initialize the communication session with the receiving device using the determined data rate; and transmit, via to the receiving device and using the determined data rate, communications based on the signals corresponding to the physiological signals.

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: Methods and apparatus for acquiring data associated with a monitored analyte level, determining a glucose level based at least in part on the acquired data associated with the monitored analyte level, manipulating a data set based on a processing mode following the glucose level determination, where the processing mode includes one of a data set transmission and output display, a data set storing and output display without transmission, or a data set transmission and data set storing without output display are provided.

Abstract: A system and method to provide guidance for diabetes therapy includes determining glycemic risks based on an analysis of glucose data. The analysis includes visualization of a glucose median, the variability of glucose in a patient, and the risk of hypoglycemia. An Advanced Daily Patterns report includes a visualization of an ambulatory glucose profile and a glucose control measure. The glucose control measure provides a highly visible and understandable display of the glucose condition of a patient visually expressed in the categories of low glucose, median glucose, and glucose variability.

Abstract: A method of treatment of a type 2 diabetic patient includes selecting a type 2 diabetic patient having a predetermined comorbidity for treatment, initiating a continuous glucose monitor regimen for the selected type 2 diabetic patient, wherein after six months of initiation of the continuous glucose monitor regimen, a rate of hospitalization for a predetermined diagnostic category of the selected patient having the predetermined comorbidity is reduced by at least 12% relative to an average rate of hospitalization for the predetermined diagnostic category of selected patients having the predetermined comorbidity without the continuous glucose monitor regimen.

Abstract: The present disclosure provides methods for depositing a therapeutic agent onto analyte sensors (e.g., to reduce signal inaccuracies or in vivo sensor failure, e.g., due to foreign body response (FBR)). In certain embodiments, the present disclosure relates to a process for coating (e.g., dip coating) analyte sensors with therapeutic agent-containing polymer compositions to obtain analyte sensors that include a therapeutic agent. The present disclosure further relates to sharps coated with a therapeutic agent.

Abstract: Methods and Devices to monitor the level of at least one analyte are provided.

Abstract: In one embodiment, a method for secured communication between a medical sensor and a computing device includes receiving, by the medical sensor, an authentication request from the computing device. The method includes generating, based on values provided in the authentication request, a challenge-response message for the computing device. The method includes receiving, from the computing device, a responsive challenge-response message. The method includes verifying that the responsive challenge-response message includes an expected value and corresponds to an expected format. The method includes, in response to verifying the responsive challenge-response message, sending a sensor secret value to the computing device.

Abstract: Methods, systems and devices for providing improved calibration accuracy of continuous and/or in vivo analyte monitoring systems based at least in part on insulin delivery information are provided. Many of the embodiments disclosed herein can determine appropriate conditions for performing a calibration of the analyte sensor in view of the scheduled delivery of insulin or administered insulin amount. One or more other parameters or conditions can also be incorporated to improve calibration accuracy including, for example, the physiological model associated with a patient, meal information, exercise information, activity information, disease information, historical physiological condition information, as well as other types of information. Furthermore, according to some embodiments, calibration of the analyte sensor can be delayed or not performed at all, if appropriate conditions are not met.

Abstract: Systems, methods and apparatus are provided for determining an estimate of an analyte level over time. The invention includes sampling sensor data using an analyte sensor positioned at least partially subcutaneously; storing a plurality of datasets of sensor data, each at a different rate; determining an estimated analyte level based on the datasets; and outputting the estimated analyte level to a display. Numerous additional aspects are disclosed.

Abstract: Low profile continuous analyte measurement systems and systems and methods for implantation within the skin of a patient are provided.

Abstract: Embodiments of the present disclosure relate to analyte determining methods and devices (e.g., electrochemical analyte monitoring systems) that have a sensing surface that includes two or more sensing elements disposed laterally to each other, where the sensing surface is on a working electrode of in vivo and/or in vitro analyte sensors, e.g., continuous and/or automatic in vivo monitoring using analyte sensors and/or test strips. Also provided are systems and methods of using the, for example electrochemical, analyte sensors in analyte monitoring.

Abstract: Methods and system to provide glycemic control and therapy management based on monitored glucose data, and current and/or target HbA1C levels are provided.

Abstract: Analyte sensors responsive at low working electrode potentials may comprise an active area upon a surface of a working electrode, wherein the active area comprises a polymer, a redox mediator covalently bonded to the polymer, and at least one analyte-responsive enzyme covalently bonded to the polymer. A specific redox mediator responsive at low potential may have a structure of wherein G is a linking group covalently bonding the redox mediator to the polymer. A mass transport limiting membrane permeable to the analyte may overcoat the active area. In some sensor configurations, the mass transport limiting membrane may comprise a membrane polymer crosslinked with a branched crosslinker comprising three or more crosslinkable groups, such as polyethylene glycol tetraglycidyl ether.

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: The present disclosure provides methods of processing data provided by a transcutaneous or subcutaneous glucose sensor utilizing different algorithms to strike a balance between signal responsiveness accompanied by signal noise and the introduction of error associated with that noise. The methods utilize the strengths of a lag correction algorithm and a smoothing algorithm to optimize the quality and value of the resulting data (glucose concentrations and the rates of change in glucose concentrations) to a continuous glucose monitoring system. Also provided are systems and kits.

Abstract: Methods, devices, and systems may use a kinetic model to determine physiological parameters related to the kinetics of red blood cell glycation, elimination, and generation. Such physiological parameters can be used, for example, to determine a more reliable calculated HbA1c. In another example, a method may comprise: receiving a plurality of glucose levels over a time period; receiving a glycated hemoglobin (HbA1c) level corresponding to an end of the time period; determining at least one physiological parameter selected from the group consisting of: a red blood cell glycation rate constant (kgly), a red blood cell generation rate constant (kgen), a red blood cell elimination constant (kage), and an apparent glycation constant (K), based on (1) the plurality of glucose levels and (2) the HbA1c level; and adjusting a glucose level target based on the at least one physiological parameter.

Abstract: A system, apparatus, or device that includes an analyte sensor for monitoring analyte levels. The system, apparatus, or device can include a printed circuit board. The system, apparatus, or device can also include a connector connected to the printed circuit board and configured to establish an electrical connection between the proximal portion of the analyte sensor and the printed circuit board. The system, apparatus, or device can also include a battery connected to the printed circuit board and configured to power the printed circuit board. The system, apparatus, or device can also include a processor connected to the printed circuit board and configured to process data associated with the monitored one or more analyte levels. The analyte sensor can have a proximal portion and a distal portion, wherein the distal portion is configured to extend beneath a user's skin to monitor one or more analyte levels in a bodily fluid.