Abstract: A system and method is provided for a continuous glucose monitoring (CGM) system and the processing of data collected thereby. An internet gateway chip (140, 240, 340, 440) is included in elements of a CGM system to facilitate direct data communication with cloud network storage (150, 250, 350, 450) to thereby communicate and store data of a CGM sensor (110, 210, 310, 410) of the CGM system. The internet gateway chip can be included in a receiver (130, 230, 330), such as an existing wireless receiver and display device of the CGM; in a smart phone or similar device, where the smart phone is also the wireless receiver and display device of the CGM; or in the sensor, such as an existing sensor and/or transmitter (410, 420) of the CGM to facilitate direct data communication between the CGM system and cloud network storage.

Abstract: A system and method is provided for a continuous glucose monitoring (CGM) system and the processing of data collected thereby. An internet gateway chip (140, 240, 340, 440) is included in elements of a CGM system to facilitate direct data communication with cloud network storage (150, 250, 350, 450) thereby communicate and store data of a CGM sensor (110, 210, 310, 410) of the CGM system. The internet gateway chip can be included in a receiver (130, 230, 330), such as an existing wireless receiver and display device of the CGM; in a smart phone or similar device, where the smart phone is also the wireless receiver and display device of the CGM; or in the sensor, such as an existing sensor and/or transmitter (410, 420) of the CGM to facilitate direct data communication between the CGM system and cloud network storage.

Abstract: An optical analyte sensor and diabetes management system is provided. The sensor preferably includes a hydrogel matrix for receiving a sample containing an analyte at unknown concentration, a light emitter for emitting light at a stimulation frequency, a light receiver for receiving a fluorescence signal at a first isosbestic frequency, and at a second frequency, for measuring an intensity of the fluorescence signal and the first and second frequencies. A processor determines a concentration of the analyte based on the respective intensities.

Abstract: A medical device such as a cannula, catheter, needle or biosensing probe includes an elongated body for penetrating, inserting and/or positioning in or through the skin of a patient. The elongated body has an outer surface that when positioned in the patient with a coefficient of friction sufficient to inhibit movement between the elongated body on the skin at the insertion site to inhibit irritation at the infusion site. A lubricious coating is provided on the elongated body to assist in penetration and/or insertion of the elongated body into the patient. The lubricious coating can be removed by a shearing action by the insertion of the elongated body into the patient and/or by absorption of the lubricious coating to expose the outer surface of the elongated member.

Abstract: A medical device such as a cannula, catheter, needle or biosensing probe includes an elongated body for penetrating, inserting and/or positioning in or through the skin of a patient. The elongated body has an outer surface that when positioned in the patient with a coefficient of friction sufficient to inhibit movement between the elongated body on the skin at the insertion site to inhibit irritation at the infusion site. A lubricious coating is provided on the elongated body to assist in penetration and/or insertion of the elongated body into the patient. The lubricious coating can be removed by a shearing action by the insertion of the elongated body into the patient and/or by absorption of the lubricious coating to expose the outer surface of the elongated member.

Abstract: An optical analyte sensor and diabetes management system is provided. The sensor preferably includes a hydrogel matrix for receiving a sample containing an analyte at unknown concentration, a light emitter for emitting light at a stimulation frequency, a light receiver for receiving a fluorescence signal at a first isosbestic frequency, and at a second frequency, for measuring an intensity of the fluorescence signal and the first and second frequencies. A processor determines a concentration of the analyte based on the respective intensities.

Abstract: Systems, devices and methods for managing a physiological condition are configured to store predetermined output segments of content, analyze physiological data and other user information, and generate user-friendly information that provides an interpretation of the data (e.g., identifies selected data points, or determines pattern of physiological data over selected period(s)). An output segment management system with rules engine and method combines selected output segments to generate a presentation or message (e.g., with text, graphical, multimedia, video and/or audio information). The resulting presentation or message provides user information such as an explanation of selected data with selected user information incorporated therein, and optional recommendations (e.g., suggested user actions based on a designated protocol such as a clinical protocol).

Abstract: An optical analyte sensor and diabetes management system is provided. The sensor preferably includes a hydrogel matrix for receiving a sample containing an analyte at unknown concentration, a light emitter for emitting light at a stimulation frequency, a light receiver for receiving a fluorescence signal at a first isosbestic frequency, and at a second frequency, for measuring an intensity of the fluorescence signal and the first and second frequencies. A processor determines a concentration of the analyte based on the respective intensities.

Abstract: Pairing is provided between first and second wireless devices in a physiological condition management system. The first and second wireless devices are placed in proximity to initiate generation of a secret key via a random process at one of the devices and to exchange the secret key with the other device using a wireless near field communication (NFC) link. The shared secret key is then used to encrypt data for communication between the first and second wireless devices via a different secure radio frequency (RF) wireless channel.

Abstract: Pairing is provided between first and second wireless devices in a physiological condition management system. The first and second wireless devices are placed in proximity to initiate generation of a secret key via a random process at one of the devices and to exchange the secret key with the other device using a wireless near field communication (NFC) link. The shared secret key is then used to encrypt data for communication between the first and second wireless devices via a different secure radio frequency (RF) wireless channel.

Abstract: A physiological condition monitoring system (e.g., a continuous glucose monitoring system) includes a physiological condition meter and a physiological condition sensor. The physiological condition meter and the physiological condition sensor are be placed in proximity to exchange a secret key using a near field wireless link, which is used to encrypt data to secure a radio frequency (RF) wireless channel.

Abstract: A system and method is provided for a continuous glucose monitoring (CGM) system and the processing of data collected thereby. An internet gateway chip (140, 240, 340, 440) is included in elements of a CGM system to facilitate direct data communication with cloud network storage (150, 250, 350, 450) thereby communicate and store data of a CGM sensor (110, 210, 310, 410) of the CGM system. The internet gateway chip can be included in a receiver (130, 230, 330), such as an existing wireless receiver and display device of the CGM; in a smart phone or similar device, where the smart phone is also the wireless receiver and display device of the CGM; or in the sensor, such as an existing sensor and/or transmitter (410, 420) of the CGM to facilitate direct data communication between the CGM system and cloud network storage.

Abstract: A medical device such as a cannula, catheter, needle or biosensing probe includes an elongated body for penetrating, inserting and/or positioning in or through the skin of a patient. The elongated body has an outer surface that when positioned in the patient with a coefficient of friction sufficient to inhibit movement between the elongated body on the skin at the insertion site to inhibit irritation at the infusion site. A lubricious coating is provided on the elongated body to assist in penetration and/or insertion of the elongated body into the patient. The lubricious coating can be removed by a shearing action by the insertion of the elongated body into the patient and/or by absorption of the lubricious coating to expose the outer surface of the elongated member.

Abstract: An optical analyte sensor and diabetes management system is provided. The sensor preferably includes a hydrogel matrix for receiving a sample containing an analyte at unknown concentration, a light emitter for emitting light at a stimulation frequency, a light receiver for receiving a fluorescence signal at a first isosbestic frequency, and at a second frequency, for measuring an intensity of the fluorescence signal and the first and second frequencies. A processor determines a concentration of the analyte based on the respective intensities.

Abstract: Systems, devices and methods for managing a physiological condition are configured to store predetermined output segments of content, analyze physiological data and other user information, and generate user-friendly information that provides an interpretation of the data (e.g., identifies selected data points, or determines pattern of physiological data over selected period(s)). An output segment management system with rules engine and method combines selected output segments to generate a presentation or message (e.g., with text, graphical, multimedia, video and/or audio information). The resulting presentation or message provides user information such as an explanation of selected data with selected user information incorporated therein, and optional recommendations (e.g., suggested user actions based on a designated protocol such as a clinical protocol).

Abstract: A physiological condition monitoring system (e.g., a continuous glucose monitoring system) includes a physiological condition meter and a physiological condition sensor. The physiological condition meter and the physiological condition sensor are be placed in proximity to exchange a secret key using a near field wireless link, which is used to encrypt data to secure a radio frequency (RF) wireless channel.

Abstract: Electrochemical sensors for measurement of an analyte comprising an analyte sensing membrane comprising at least one salt of acetate ion, carbonate ion, bicarbonate ion, or mixtures thereof. Sensor testing methods comprising contacting an electrochemical sensor with an aqueous solution comprising at least one salt of acetate ion, carbonate ion, bicarbonate ion, or mixtures thereof and contacting the electrochemical sensor with one or more concentrations of analyte, the one or more concentrations of analyte being in the clinical concentration range of the analyte.

Abstract: The present invention relates generally to systems and methods for increasing oxygen availability to implantable devices. The preferred embodiments provide a membrane system configured to provide protection of the device from the biological environment and/or a catalyst for enabling an enzymatic reaction, wherein the membrane system includes a polymer formed from a high oxygen soluble material. The high oxygen soluble polymer material is disposed adjacent to an oxygen-utilizing source on the implantable device so as to dynamically retain high oxygen availability to the oxygen-utilizing source during oxygen deficits. Membrane systems of the preferred embodiments are useful for implantable devices with oxygen-utilizing sources and/or that function in low oxygen environments, such as enzyme-based electrochemical sensors and cell transplantation devices.

Abstract: The present invention relates generally to systems and methods for increasing oxygen availability to implantable devices. The preferred embodiments provide a membrane system configured to provide protection of the device from the biological environment and/or a catalyst for enabling an enzymatic reaction, wherein the membrane system includes a polymer formed from a high oxygen soluble material. The high oxygen soluble polymer material is disposed adjacent to an oxygen-utilizing source on the implantable device so as to dynamically retain high oxygen availability to the oxygen-utilizing source during oxygen deficits. Membrane systems of the preferred embodiments are useful for implantable devices with oxygen-utilizing sources and/or that function in low oxygen environments, such as enzyme-based electrochemical sensors and cell transplantation devices.

Abstract: A system is provided for sensing a blood parameter, such as an analyte, in a patient's vasculature. The system includes a vascular access device, a parameter sensor, a pressure sensor and a flow control device. The vascular access device supports the parameter sensor within the vasculature of the patient and includes an internal passageway for drawing samples onto and calibrating the parameter sensor. The pressure sensor is within the internal passageway. The flow control device modulates sample draw, calibration and flushing fluid flows to prevent or remove clots based on communication with the pressure sensor. Advantageously, the dynamic, adaptive modulation of flow reduces flushing and other cycle times while at the same time improving clot flushing. As another advantage, this enables reduction or elimination of the use of heparin and other anticoagulant components in the solution supplied for flushing and/or calibration.