Abstract: Methods and apparatus are provided for securely obtaining access to patient data associated with a patient using a sensor system configured for monitoring analyte levels of a patient. In one aspect, a method includes receiving, at a display device, one or more communications from the sensor system, wherein the one or more communications include identifiable information associated with the sensor system and are transmitted by the sensor system via an advertisement channel; inserting, at the display device, the identifiable information in a web request; providing, at the display device, the web request including the identifiable information to a data management system to request access to the patient data; and obtaining access to the patient data through a web browser upon the data management system verifying that the identifiable information matches a second identifiable information stored in the patient data.

Abstract: Techniques and protocols for enhancing wireless communications between an analyte sensor system and one or more other devices are described. Such techniques may include, for example, dynamic adjustment of transmission power when transmitting invitations, transmitting invitations with alternate (or different) payloads during different invitation periods, a reduction of handshake messages (e.g., client characteristic configuration descriptor (CCCD) messaging), etc. The various enhancements described herein may relate to various aspects of wireless communication protocols, including, for example, authentication, connection protocols, invitation message structure and content, device pairing, data transmission, etc.

Abstract: Systems and methods described provide dynamic and intelligent ways to change the required level of user interaction during use of a monitoring device. The systems and methods generally relate to real time switching between a first or initial mode of user interaction and a second or new mode of user interaction. In some cases, the switching will be automatic and transparent to the user, and in other cases user notification may occur. The mode switching generally affects the user's interaction with the device, and not just internal processing. The mode switching may relate to calibration modes, data transmission modes, control modes, or the like.

Abstract: Applicators for applying an on-skin assembly to skin of a host and methods of their use and/or manufacture are provided. An applicator includes an insertion assembly configured to insert at least a portion of the on-skin assembly into the skin of the host, a housing configured to house the insertion assembly, the housing comprising an aperture through which the on-skin assembly can pass, an actuation member configured to, upon activation, cause the insertion assembly to insert at least the portion of the on-skin assembly into the skin of the host, and a sealing element configured to provide a sterile barrier and a vapor barrier between an internal environment of the housing and an external environment of the housing.

Abstract: Systems and methods are provided for reconciling untrusted data of a subject using trusted data pertaining to the subject. Systems and methods are directed to evaluating differences in predicted data with respect to corresponding received data. Systems and methods estimate metabolic states from a combination of trusted and untrusted metabolic inputs, along with optionally using a personalized mathematical model with parameter optimization. Systems and methods provide for reconciled untrusted inputs with their measured impact of the glycemic signals that is consistent with a metabolic model. Estimation of future metabolic states for decision support and automated insulin dosing is enabled. Replay of scenarios with estimated or reconciled data is also provided.

Abstract: Glucose level measurements of a user are obtained over time, such as from a wearable glucose monitoring device being worn by the user. These glucose level measurements can be produced substantially continuously, such that the device may be configured to produce the glucose level measurements at regular or irregular intervals of time, responsive to establishing a communicative coupling with a different device, and so forth. These glucose level measurements are analyzed to detect deviations from past glucose measurements, such as glucose measurements received earlier in the day or glucose measurements received at corresponding times of one or more preceding days. Indications of detected deviations are provided to the user or communicated elsewhere, such as to a healthcare professional.

Abstract: Devices, systems, and methods for providing more accurate and reliable sensor data and for detecting sensor failures. Two or more electrodes can be used to generate data, and the data can be subsequently compared by a processing module. Alternatively, one sensor can be used, and the data processed by two parallel algorithms to provide redundancy. Sensor performance, including sensor failures, can be identified. The user or system can then respond appropriately to the information related to sensor performance or failure.

Abstract: The present disclosure relates to systems and methods for activating a circuit of an implant device. Consistent with one implementation, an implant device is provided with a sensor including a working electrode (WE) and a counter electrode (CE). The sensor may be configured to generate a first current at the CE when the implant device is implanted in a body of a subject. A sensing circuit may also be provided that is electrically coupled to the WE of the sensor. The sensing circuit may be activated based on the first current and utilize the sensor to measure one or more parameters of an individual or other subject.

Abstract: Systems and methods are provided for identifying therapeutic zones where there is glycemic dysfunction of a specific type that can be addressed by making strategic changes to behavior and/or therapy parameters. Systems and methods described herein evaluate large historical data sets to: identify a therapeutic zone or zones with glycemic dysfunction that are most readily addressable; quantify the glycemic impact of a plurality of different therapeutic adjustments in terms of either adjustments to historical doses or the parameters of a prospective dosing strategy to determine the highest possible improvement; and/or identify patient dosing strategies to provide therapy recommendations adapted for the patient's preferred behavioral dosing strategy.

Abstract: Adaptive on board estimation of exogenous pharmacon responsive to transient (i.e., impermanent) physiological effects is provided. Dynamically estimating an equivalent amount of an exogenous pharmacon on board (XOB), such as insulin and/or carbohydrates, left in the subject, is based on predictions of glucose time-series data. These estimated values, such as insulin on board (IOB), are useful for diabetes management software, including decision support and/or artificial pancreas (AP) algorithms, for example.

Abstract: An example continuous glucose monitor includes a printed circuit board (“PCB”) having first and second outer layers and an inner layer; a semiconductor package having a plurality of pins coupled to the first outer layer of the PCB; an electrical contact formed on the second outer layer of the PCB; a trace having a first portion disposed on the first outer layer, a second portion disposed on the inner layer, and a third portion disposed on the second outer layer, the trace having a first end coupled to a first pin of the plurality of pins and a second end coupled to the electrical contact; and an encapsulant disposed around a perimeter of the semiconductor package, the encapsulant covering the plurality of pins, the first portion of the sensor trace, the third portion of the sensor trace, wherein an upper surface of the semiconductor package remains exposed.

Abstract: 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.

Abstract: A method of predicting future blood glucose concentrations of an individual patient includes: selecting an individualized nonlinear physiological model of glucose-insulin dynamics, the selected model having a plurality of model parameters whose values are to be determined; estimating values for each of the model parameters in the plurality of model parameters, a first subset of the model parameters having values estimated from a priori population data and a second subset of the model parameters having values personalized for the individual patient by applying a parameter estimation technique to a priori information and data for the individual patient to obtain a posteriori information; and; applying a nonlinear prediction technique to the selected model using the estimated values for each of the model parameters to obtain a predicted blood glucose concentration of the individual patient at a future time.

Abstract: Systems and methods for continuous measurement of an analyte in a host are provided. The system generally includes a continuous analyte sensor configured to continuously measure a concentration of analyte in a host and a sensor electronics module physically connected to the continuous analyte sensor during sensor use, wherein the sensor electronics module is further configured to directly wirelessly communicate sensor information to one or more display devices. Establishment of communication between devices can involve using a unique identifier associated with the sensor electronics module to authenticate communication. Times tracked at the sensor electronics module and the display module can be at different resolutions, and the different resolutions can be translated to facilitate communication. In addition, the frequency of establishing communication channels between the sensor electronics module and the display devices can vary depending upon whether reference calibration information is being updated.

Abstract: A continuous glucose monitor (CGM)-driven basal insulin titration system and method for patients with Type 2 Diabetes can be adapted to the needs and concerns of subjects just starting on basal insulin therapy. The method uses as inputs historical CGM data, basal insulin dose information, reports of hypoglycemia, and past recommendations and generates an adjusted insulin dose along with a report advising whether to continue the titration process, or to stop. The method can generate a new recommendation on a regular basis (e.g., each day) until it determines an adequate, consistent dose size.

Abstract: Disclosed are systems, methods, and articles for determining compatibility of a mobile application and operating system on a mobile device. In some aspects, a method includes receiving one or more data values from a mobile device having a mobile medical software application installed thereon, the data value(s) characterizing a version of the software application, a version of an operating system installed on the mobile device, and one or more attributes of the mobile device; determining whether the mobile medical software application is compatible with the operating system by at least comparing the received data value(s) to one or more test values in a configuration file; and sending a message to the mobile device based on the determining, the message causing the software application to operate in one or more of a normal mode, a safe mode, and a non-operational mode.