Generally, methods of analyte monitoring management, and articles of manufacturing related thereto, are provided. The methods include receiving analyte measurement data and analyzing the analyte measurement data for health related parameters. Recommendations are determined for creating or modifying a treatment program based on the analysis, and provided within a user-interface that enables a user to create or modify the treatment program. Further, generally, methods of for managing analyte measurement data, and articles of manufacturing related thereto, are provided. The methods include receiving analyte measurement data that represent data collected over a time period, and analyzing the analyte measurement data for analyte episodes within that time period. Threshold based episodes and/or rate-of-change based episodes may be determined.
Methods and systems for providing therapy related data management are provided. The subject systems include one or more device components, and at least one memory storage unit and at least one data storage unit associated with such one or more device components. The device components may include one or more of an analyte monitoring system, a fluid delivery device and a remote terminal. The subject methods include use of the subject systems to optimize treatment of a patient.
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
G16H 20/17 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
6.
SYSTEMS, DEVICES, AND METHODS FOR DUAL ANALYTE SENSOR
Systems, devices, and methods for a dual analyte sensor using glucose history from a glucose sensor in combination with data from a ketone sensor to control operation of a user interface device or insulin pump are provided. In some embodiments, the systems, apparatus or methods may make use of combination of glucose history and a β-hydroxybutyrate physiological model to better predict diabetic ketoacidosis (DKA), in comparison to a prediction based on a simple high glucose threshold. In other embodiments, the systems, apparatus or method may include features for generating an estimate of the patient's medication state and/or knowledge of medication information, such as a patient with T1 diabetes mellitus (DM) using an SGLT-2 inhibitor.
Improved graphical user interfaces for analyte monitoring systems are provided. For example, disclosed herein are various embodiments of GUIs, each of which include a graph portion comprising a trend line indicative of a user's analyte levels over a predetermined time period, and a plurality of summary metrics comprising a plurality of minimum analyte levels and maximum analyte levels associated with a plurality of time increments within the predetermined time period. In many embodiments, the plurality of minimum analyte levels and maximum analyte levels are aligned with an x-axis of the graph portion.
Systems, devices and methods are provided for incorporating a medication delivery device into an integrated management system. The integrated management system may be an integrated diabetes management system and may include a glucose monitor, a connected insulin pen, and software. The integrated management system may produce a plurality of reports that may include data related to analyte levels (e.g., glucose levels) and medication delivered (e.g., insulin delivered). The integrated system may also include a mode in which certain types of data are no longer shared and/or stored if the user is not signed into an account. The types of data shared and/or stored when the user is not signed into an account may differ from the types of data shared and/or stored when the user is signed into an account.
G06F 11/07 - Responding to the occurrence of a fault, e.g. fault tolerance
G16H 20/17 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
H04W 4/80 - Services using short range communication, e.g. near-field communication [NFC], radio-frequency identification [RFID] or low energy communication
G06F 9/451 - Execution arrangements for user interfaces
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
G16H 15/00 - ICT specially adapted for medical reports, e.g. generation or transmission thereof
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
09 - Scientific and electric apparatus and instruments
Goods & Services
Downloadable software for diabetes management; downloadable software for health data management in the field of diabetes management; health software for use in connection with diabetes management; diabetes management software for receiving, storing, displaying, tracking, sharing, reporting, maintaining, managing, monitoring, and analyzing health data and information; software for receiving, storing, displaying, tracking, sharing, reporting, maintaining, managing, monitoring, and analyzing analyte data; diabetes management software for facilitating communication and collaboration between clinicians, caregivers, and patients; downloadable software for enabling users to receive personalized recommendations related to diabetes management; downloadable software for providing education in the field of diabetes management; downloadable software to facilitate social networking in the field of diabetes management; downloadable software to facilitate support and sharing of information in the field of diabetes management; downloadable electronic newsletters delivered by e-mail in the field of diabetes management.
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.
G01N 33/487 - Physical analysis of biological material of liquid biological material
G06F 11/14 - Error detection or correction of the data by redundancy in operation, e.g. by using different operation sequences leading to the same result
11.
CONNECTORS FOR MAKING CONNECTIONS BETWEEN ANALYTE SENSORS AND OTHER DEVICES
Glucose monitoring devices and related systems and methods, the glucose monitoring devices including a sensor electronics unit having a housing and a printed circuit board disposed within the housing, a transcutaneous glucose sensor assembly, and a conductive sensor connector. The printed circuit board includes a first electrical contact, the transcutaneous glucose sensor assembly includes a distal portion having a working electrode and proximal portion having a working-electrode contact in electrical communication with the working electrode, and the conductive sensor connector electrically connects the working-electrode contact with the first electrical contact. Further, the conductive sensor connector extends through a hole in the proximal portion of the transcutaneous glucose sensor assembly and through a hole in the printed circuit board.
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using enzyme electrodes, e.g. with immobilised oxidase
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
A61B 5/1468 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using chemical or electrochemical methods, e.g. by polarographic means
A61B 5/1473 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
H05K 3/32 - Assembling printed circuits with electric components, e.g. with resistor electrically connecting electric components or wires to printed circuits
12.
SYSTEMS, DEVICES, AND METHODS FOR DUAL ANALYTE SENSOR
Systems, devices, and methods for a dual analyte sensor using glucose history from a glucose sensor in combination with data from a ketone sensor to control operation of a user interface device or insulin pump are provided. In some embodiments, the systems, apparatus or methods may make use of combination of glucose history and a β-hydroxybutyrate physiological model to better predict diabetic ketoacidosis (DKA), in comparison to a prediction based on a simple high glucose threshold. In other embodiments, the systems, apparatus or method may include features for generating an estimate of the patient's medication state and/or knowledge of medication information, such as a patient with T1 diabetes mellitus (DM) using an SGLT-2 inhibitor.
Improved graphical user interfaces for analyte monitoring systems are provided. For example, disclosed herein are various embodiments of GUIs, each of which include a graph portion comprising a trend line indicative of a user's analyte levels over a predetermined time period, and a plurality of summary metrics comprising a plurality of minimum analyte levels and maximum analyte levels associated with a plurality of time increments within the predetermined time period. In many embodiments, the plurality of minimum analyte levels and maximum analyte levels are aligned with an x-axis of the graph portion.
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
G16H 50/20 - ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
Medical apparatus and instruments for diabetes management use; medical apparatus and instruments for monitoring glucose; medical apparatus and instruments for monitoring ketones; sensor-based glucose monitors; sensor-based ketone monitors; glucose and ketone monitoring systems; continuous glucose monitoring systems; continuous ketone monitoring systems; medical apparatus for determination of analyte concentrations for diabetes management purposes; medical apparatus for monitoring analyte concentrations for diabetes management purposes; patient monitoring sensors for diabetes management; diabetes management monitoring devices; sensors for diabetes management.
15.
METHOD AND SYSTEM FOR PROVIDING CONTINUOUS CALIBRATION OF IMPLANTABLE ANALYTE SENSORS
Method and system for providing continuous calibration of analyte sensors includes calibrating a first sensor, receiving data associated with detected analyte levels from the first sensor, and calibrating a second sensor based on a predetermined scaling factor and data associated with detected analyte levels from the first sensor, is disclosed.
A61B 5/1495 - Calibrating or testing in vivo probes
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
A61M 5/172 - Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters electrical or electronic
G16H 50/20 - ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
H04L 67/12 - Protocols specially adapted for proprietary or special-purpose networking environments, e.g. medical networks, sensor networks, networks in vehicles or remote metering networks
16.
SYSTEM, APPARATUS, AND DEVICES FOR ANALYTE MONITORING
A continuous analyte sensor system for monitoring a level of an analyte in a bodily fluid of a user. The system comprises a sensor electronics system and an analyte sensor. The sensor comprises a distal portion for positioning under a user's skin surface in contact with a bodily fluid for monitoring a level of an analyte in the bodily fluid and a proximal portion for positioning above the skin surface and in operative connection with the sensor electronics system. The sensor electronics system receives sensor signals indicative of the analyte level from the analyte sensor and generates data relating to the analyte level. The sensor electronics system comprises a transceiver for transmitting outgoing signals including the data relating to the analyte level and for receiving incoming signals. The transceiver comprises an electromagnetic signal generating component having first and second signal feed points. The sensor electronics system operates in a first and/or second communication mode. In the first communication mode, the sensor electronics system supplies first outgoing signals to the first signal feed point. In the second communication mode, the sensor electronics system supplies second outgoing signals to the second signal feed point.
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using enzyme electrodes, e.g. with immobilised oxidase
H01Q 5/35 - Individual or coupled radiating elements, each element being fed in an unspecified way for different propagation modes using two or more simultaneously fed points
17.
SYSTEM, APPARATUS, AND DEVICES FOR ANALYTE MONITORING
A continuous analyte sensor system for monitoring a level of an analyte in a bodily fluid of a user. The system comprises a sensor electronics system and an analyte sensor. The sensor electronics system comprises a transceiver for transmitting outgoing signals including the data relating to the analyte level and for receiving incoming signals. The transceiver comprises an electromagnetic signal generating component having first and second signal feed points. The sensor electronics system operates in a first and/or second communication mode. In the first communication mode, the sensor electronics system supplies first outgoing signals to the first signal feed point. In the second communication mode, the sensor electronics system supplies second outgoing signals to the second signal feed point.
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using enzyme electrodes, e.g. with immobilised oxidase
H04W 4/80 - Services using short range communication, e.g. near-field communication [NFC], radio-frequency identification [RFID] or low energy communication
18.
SYSTEMS, DEVICES, AND METHODS FOR REVISING OR SUPPLEMENTING ROM-BASED RF COMMANDS
Systems, devices, and methods are provided that enable the revision of RF command handling software stored in ROM, and that enable to supplementation of RF command handling software stored in ROM. Examples of the systems, devices, and methods make use of a lookup data structure stored within writable non-volatile memory.
G16H 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
G06F 13/16 - Handling requests for interconnection or transfer for access to memory bus
G06F 13/42 - Bus transfer protocol, e.g. handshake; Synchronisation
19.
METHOD AND APPARATUS FOR PROVIDING DATA PROCESSING AND CONTROL IN A MEDICAL COMMUNICATION SYSTEM
Techniques for data processing and control for a glucose monitoring system are provided, including obtaining a first sensitivity of a glucose sensor; obtaining a second sensitivity of the glucose sensor; comparing a difference between the first sensitivity and the second sensitivity to a predetermined range of values; if the difference is outside the predetermined range of the values, causing a calibration routine for the glucose sensor to be performed; and if the difference is within the predetermined range of values determining a composite sensitivity for a current calibration of the glucose sensor based on the first sensitivity and the second sensitivity and calculating the glucose level based on the current calibration of the glucose sensor.
G01N 33/49 - Physical analysis of biological material of liquid biological material blood
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
A61B 5/1473 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
A61B 5/1495 - Calibrating or testing in vivo probes
G16H 10/40 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
G16H 20/10 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor has, for example, a substrate, a recessed channel formed in the substrate, and conductive material disposed in the recessed channel to form a working electrode. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte. The analyte monitor may also be part of a drug delivery system to alter the level of the analyte based on the data obtained using the sensor.
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using enzyme electrodes, e.g. with immobilised oxidase
A61B 5/1473 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
21.
Display screen or portion thereof with graphical user interface
Systems, devices and methods are provided that allow for enhanced performance, power efficiency, interoperability, data security and user privacy for in vivo analyte monitoring systems that utilize wireless communications. The in vivo analyte monitoring systems can include a Bluetooth or Bluetooth Low Energy enabled handheld relay device for wirelessly relaying analyte data between a sensor unit device and one or more reader devices. The in vivo analyte monitoring systems can employ advertisement and encryption schemes for wirelessly transmitting data in a manner that allows for improved security, efficiency and privacy.
G01N 33/49 - Physical analysis of biological material of liquid biological material blood
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
H04W 4/80 - Services using short range communication, e.g. near-field communication [NFC], radio-frequency identification [RFID] or low energy communication
H04W 4/38 - Services specially adapted for particular environments, situations or purposes for collecting sensor information
H04W 12/02 - Protecting privacy or anonymity, e.g. protecting personally identifiable information [PII]
Medical apparatus and instruments for diabetes management use; medical apparatus and instruments for monitoring glucose; medical apparatus and instruments for monitoring ketones; sensor-based glucose monitors; sensor-based ketone monitors; glucose and ketone monitoring systems; continuous glucose monitoring systems; continuous ketone monitoring systems; medical apparatus for determination of analyte concentrations for diabetes management purposes; medical apparatus for monitoring analyte concentrations for diabetes management purposes; patient monitoring sensors for diabetes management; diabetes management monitoring devices; sensors for diabetes management.
Systems, devices and methods are provided for incorporating a medication delivery device into an integrated management system. The integrated management system may be an integrated diabetes management system and may include a glucose monitor, a connected insulin pen, and software. The integrated management system may produce a plurality of reports that may include data related to analyte levels (e.g., glucose levels) and medication delivered (e.g., insulin delivered). The medication delivery device may also provide feedback to the user.
G16H 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
G16B 50/00 - ICT programming tools or database systems specially adapted for bioinformatics
G16B 50/30 - Data warehousing; Computing architectures
G06K 7/10 - Methods or arrangements for sensing record carriers by corpuscular radiation
26.
Dynamic Discovery Window for Wireless Communication Between Devices
Embodiments described herein include a data receiving device for an analyte monitoring system. The data receiving device detects a disconnect between the data receiving device and a sensor control device of the analyte monitoring system. The data receiving device sets a duration of a scan window for receiving connection data packets from the sensor control device to a current length and initiates the scan window. In response to determining that a connection between the data receiving device and sensor control device has not been established based on connection data packets received during the scan window, the data receiving device performs iterations of a process to adjust the scan window, involving increasing a duration of the scan window to a new length that is greater than the current length and initiating the scan window based on the duration of the scan window at the new length.
Method and system for providing an integrated analyte monitoring system and on-body patch pump with multiple cannulas and a sensor combination is provided.
A61M 5/172 - Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters electrical or electronic
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
A61B 5/1473 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
Systems, devices and methods are provided for incorporating a medication delivery device into an integrated management system. The integrated management system may be an integrated diabetes management system and may include a glucose monitor, a connected insulin pen, and software. The integrated management system may produce a plurality of reports that may include data related to analyte levels (e.g., glucose levels) and medication delivered (e.g., insulin delivered). The medication delivery device may also provide feedback to the user.
G16H 20/17 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
A61M 5/172 - Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters electrical or electronic
G16H 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
09 - Scientific and electric apparatus and instruments
Goods & Services
Downloadable health software for viewing, sharing, reporting, maintaining, managing, monitoring, and analyzing analyte data. None of the foregoing in the field of personal emergency response systems (PERS) or mobile personal emergency response systems (MPERS) except in connection with management of diabetes. Downloadable software used for the management of diabetes; downloadable software for use with glucose sensors; downloadable software for use with ketone sensors; downloadable glucose reporting software; downloadable ketone reporting software; downloadable software for use with glucose monitoring systems; downloadable software for use with ketone monitoring systems; downloadable software for glucose monitoring, tracking, reporting, analysis, sharing, and management; downloadable software for ketone monitoring, tracking, reporting, analysis, sharing, and management; downloadable software for health data management in the field of diabetes management; downloadable health and lifestyle software for use in connection with diabetes management; downloadable software for viewing, sharing, reporting, maintaining, managing, monitoring, and analyzing data and information in the field of diabetes management; downloadable software for providing education in the field of diabetes management; downloadable software to facilitate support and sharing of information in the field of diabetes management
Medical apparatus for monitoring, tracking, and determining analyte concentrations; sensors for monitoring, tracking, and determining analyte concentrations for health purposes. None of the foregoing in the field of personal emergency response systems (PERS) or mobile personal emergency response systems (MPERS) except in connection with management of diabetes. Medical apparatus and instruments for diabetes management use; medical apparatus and instruments for monitoring glucose; medical apparatus and instruments for monitoring ketones; instruments and apparatus for monitoring glucose for health purposes; instruments and apparatus for monitoring ketones for health purposes; patient monitoring sensors for monitoring glucose concentrations; patient monitoring sensors for monitoring ketone concentrations; sensor-based glucose monitors for medical purposes; sensor-based ketone monitors for medical purposes; analyte monitoring systems for monitoring glucose; analyte monitoring systems for monitoring ketones
Systems, devices, and methods are provided for a non-rigid wearable device comprising electrical circuitry and a support structure supporting the electrical circuitry. The support structure having rigid sections that rigidly support components of the electrical circuitry to protect components and/or solder joints from stress due to deflection and having non-rigid or flexible sections where there are no solder connections present on the electrical circuitry and/or where there are interconnecting traces present on the electrical circuitry that can tolerate stress due to deflection.
Analyte sensor comprises a substrate having an upper surface including a first portion and a second exposed portion, an electrode layer disposed on the first portion and having an elongate body comprising a proximal end and a distal end, the electrode layer including an active working electrode area having a surface area of between 0.15 mm2 to 0.25 mm2, at least one sensing spot with at least one analyte responsive enzyme disposed on the active working electrode area. Additional analyte sensors are disclosed.
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 analyte sensor automatically or on demand upon request from a user.
C12Q 1/00 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
H04L 67/12 - Protocols specially adapted for proprietary or special-purpose networking environments, e.g. medical networks, sensor networks, networks in vehicles or remote metering networks
A61M 5/172 - Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters electrical or electronic
34.
Methods and apparatuses for providing adverse condition notification with enhanced wireless communication range in analyte monitoring systems
Methods, devices, systems, and kits are provided that buffer the time spaced glucose signals in a memory, and when a request for real time glucose level information is detected, transmit the buffered glucose signals and real time monitored glucose level information to a remotely located device, process a subset of the received glucose signals to identify a predetermined number of consecutive glucose data points indicating an adverse condition such as an impending hypoglycemic condition, confirm the adverse condition based on comparison of the predetermined number of consecutive glucose data points to a stored glucose data profile associated with the adverse condition, where confirming the adverse condition includes generating a notification signal when the impending hypoglycemic condition is confirmed, and activate a radio frequency (RF) communication module to wirelessly transmit the generated notification signal to the remotely located device only when the notification signal is generated.
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
G16H 40/20 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
G16H 50/20 - ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
35.
METHOD, SYSTEM AND COMPUTER PROGRAM PRODUCT FOR REAL-TIME DETECTION OF SENSITIVITY DECLINE IN ANALYTE SENSORS
Method, system and computer program product for providing real time detection of analyte sensor sensitivity decline is continuous glucose monitoring systems are provided.
Embodiments described herein include a data receiving device for an analyte monitoring system. The data receiving device detects a disconnect between the data receiving device and a sensor control device of the analyte monitoring system. The data receiving device sets a duration of a scan window for receiving connection data packets from the sensor control device to a current length and initiates the scan window. In response to determining that a connection between the data receiving device and sensor control device has not been established based on connection data packets received during the scan window, the data receiving device performs iterations of a process to adjust the scan window, involving increasing a duration of the scan window to a new length that is greater than the current length and initiating the scan window based on the duration of the scan window at the new length.
G16H 10/20 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for electronic clinical trials or questionnaires
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
G16H 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
H04L 67/12 - Protocols specially adapted for proprietary or special-purpose networking environments, e.g. medical networks, sensor networks, networks in vehicles or remote metering networks
H04W 4/38 - Services specially adapted for particular environments, situations or purposes for collecting sensor information
H04W 4/80 - Services using short range communication, e.g. near-field communication [NFC], radio-frequency identification [RFID] or low energy communication
Analyte sensor comprises a substrate having an upper surface including a first portion and a second exposed portion, an electrode layer disposed on the first portion and having an elongate body comprising a proximal end and a distal end, the electrode layer including an active working electrode area having a surface area of between 0.15mm2 to 0.25mm2, at least one sensing spot with at least one analyte responsive enzyme disposed on the active working electrode area. Additional analyte sensors are disclosed.
Systems, devices and methods are provided for power-efficient wireless communications between electronic devices. In particular, the embodiments disclosed herein can reduce battery consumption in a transmitting electronic device and enhance data integrity of data received by a receiving electronic device. According to the embodiments, a first electronic device transmits advertising packets according to a wireless communications protocol, wherein the advertising packets include a first payload data. In response to receiving the advertising packets, a second electronic device can transmit a scan request to the first electronic device which, in turn, terminates the transmission of advertising packets.
An analyte monitoring system with a sensor control device including an electronics housing. The housing can include a shell disposed opposite a mount, each including an aperture which is axially aligned with the other aperture. The inner surfaces are aligned, and a seal is disposed within the interior space. The housing also includes a circuit board disposed within the interior space of the housing, and an analyte sensor having a proximal portion and a distal portion, the proximal portion coupled with the circuit board, and the distal portion configured to measure a glucose level in a bodily fluid and extending from a bottom of the electronics housing.
A61B 5/1473 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
41.
SYSTEMS, DEVICES, AND METHODS FOR ANALYTE MONITORING
An analyte monitoring system with a sensor control device including an electronics housing. The housing can include a shell disposed opposite a mount, each including an aperture which is axially aligned with the other aperture. The inner surfaces are aligned, and a seal is disposed within the interior space. The housing also includes a circuit board disposed within the interior space of the housing, and an analyte sensor having a proximal portion and a distal portion, the proximal portion coupled with the circuit board, and the distal portion configured to measure a glucose level in a bodily fluid and extending from a bottom of the electronics housing.
A medical system comprising: an analyte sensor for receiving an analyte signal corresponding to an analyte concentration of a user; a health monitor device comprising a display unit and in communication with the analyte sensor, the health monitor device comprising a processor and memory communicably coupled to the processor, the memory including instructions stored therein that, when executed by the processor, cause the processor to: receive the analyte signal from the analyte sensor; determine the analyte concentration based on the analyte signal; calculate a recommended medication dosage based on the analyte concentration; associate a current parameter type with the recommended medication dosage; associate the current parameter type to at least one corresponding stored historical parameter type associated with a historical medication dosage; and display, on the display unit, the recommended medication dosage and the historical medication dosage.
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
A61B 5/1473 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
A61B 5/1495 - Calibrating or testing in vivo probes
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
G16H 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
G16H 20/10 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
G16H 10/40 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
46.
FLEXIBLE PATCH FOR FLUID DELIVERY AND MONITORING BODY ANALYTES
A wearable, conductive textile patch is provided that may include any of a number of features for monitoring body analytes and/or delivering fluids to a body. In one embodiment of the invention, a single, patch-mounted system monitors glucose levels of a diabetic person and provides appropriate doses of insulin in response to the glucose measurements. A hand-held user interface can be provided for wirelessly controlling the system and/or receiving information from it. Conductive pathways can be formed in the fabric of the patch. Components that can be integrated into the flexible patch include a power source, controller, transmitter, antenna, temperature and other sensors, fluid pump, infusion set, electrical pathways, switches, controls, electrodes, connectors, resistors and other circuit elements. Such components can be embedded, interwoven or coated on to the flexible patch instead of or in addition to surface mounting. Methods associated with use of the flexible patch system are also covered.
Medical apparatus and instruments for diabetes management use; medical apparatus and instruments for monitoring interstitial fluid glucose; medical apparatus and instruments for monitoring ketones; patient monitoring sensors for diabetes management; diabetes management monitoring devices; sensor-based glucose monitors for medical purposes; sensor-based ketone monitors for medical purposes; continuous glucose monitoring systems; biosensors for tracking analytes; medical diagnostic apparatus for determination of analyte concentrations; medical apparatus for monitoring analyte concentrations in interstitial fluid; patient monitoring sensors for monitoring analyte concentrations; sensors for monitoring analyte concentrations for health purposes; patient monitoring sensors for determination of analyte concentrations in interstitial fluid; sensors for determination of analyte concentrations in interstitial fluid for health purposes; medical apparatus and instruments for use in monitoring and managing health, wellness, and nutrition; health monitoring devices for use in monitoring and managing health, wellness, and nutrition; patient monitoring devices for use in monitoring and managing health, wellness, and nutrition; patient monitoring sensors for measuring analyte levels; health monitoring sensors for measuring analyte levels.
48.
SYSTEMS, DEVICES, AND METHODS FOR MEAL-RELATED ANALYTE RESPONSE MONITORING
Systems, devices, and methods for detecting, measuring and classifying meals for an individual based on analyte measurements. These results and related information can be presented to the individual to show the individual which meals are causing the most severe analyte response. These results can be organized and categorized based on preselected criteria or previous meals and results so as to organize and present the results in a format with reference to glucose as the monitored analyte. Various embodiments disclosed herein relate to methods, systems, and software applications intended to engage an individual by providing direct and timely feedback regarding the individual's meal-related glycemic response.
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
G16H 20/60 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to nutrition control, e.g. diets
Methods and devices to detect analyte in body fluid are provided. Embodiments include positioning an analyte sensor in fluid contact with an analyte, detecting an attenuation in a signal from an analyte sensor after positioning during a predetermined time period, receiving the data corresponding to an analyte level, providing a notification on the user interface that comprises a request for a blood analyte measurement, receiving an indication, based on the blood analyte measurement, of an absence of the error condition, and in response to receiving the indication, configuring the user interface to report the data corresponding to the analyte level, where the user interface was previously configured to not report the data corresponding to the analyte level.
A61B 5/1495 - Calibrating or testing in vivo probes
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using enzyme electrodes, e.g. with immobilised oxidase
G16H 40/40 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
50.
CONTINUOUS ANALYTE MEASUREMENT SYSTEMS AND SYSTEMS AND METHODS FOR IMPLANTING THEM
Systems, devices, kits, and methods are provided herein in the form of example embodiments that relate to calibration of medical devices. The medical devices can be sensors adapted to sense a biochemical attribute. The embodiments can be used to determine calibration information specific to an individual medical device. The embodiments can determine the calibration information by reference to one or more parameters obtained during manufacturing of the medical device. The embodiments can also determine the calibration information by reference to in vitro testing of the medical devices. The embodiments also apply to systems incorporating those medical devices in their use in the field. Also described are embodiments of modifications to surfaces of sensor substrates, such as through applied radiation and/or the creation of a well, to aid in the placement and/or sizing of a sensor element on the substrate.
Membranes permeable to an analyte may overlay the active sensing region of a sensor to limit the analyte flux and improve the response linearity of the sensor. Temperature variation of the analyte permeability can be problematic in some instances. Polymeric membrane compositions having limited variation in analyte permeability as a function of temperature may comprise: a polymer backbone comprising one or more side chains that comprise a heterocycle; and an amine-free polyether arm appended, via an alkyl spacer or a hydroxy-functionalized alkyl spacer, to the heterocycle of at least a portion of the one or more side chains.
C08G 81/02 - Macromolecular compounds obtained by interreacting polymers in the absence of monomers, e.g. block polymers at least one of the polymers being obtained by reactions involving only carbon-to-carbon unsaturated bonds
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using enzyme electrodes, e.g. with immobilised oxidase
C08G 65/333 - Polymers modified by chemical after-treatment with organic compounds containing nitrogen
Methods and system to provide glycemic control and therapy management based on monitored glucose data, and current and/or target HbA1C levels are provided.
G16H 10/40 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using enzyme electrodes, e.g. with immobilised oxidase
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
A61B 5/1495 - Calibrating or testing in vivo probes
G16H 20/40 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
G16H 20/10 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
58.
TEMPERATURE-COMPENSATED ANALYTE MONITORING DEVICES, SYSTEMS, AND METHODS THEREOF
Methods of compensating for ambient temperature using temperature sensors, the method comprising: sampling at a first sampling rate, with a processor, first temperature measurements from a first temperature sensor on an on-body sensor. Then determining, with a processor, first ambient-compensated temperatures from the first temperature measurements; and determining, with a processor, final ambient-compensated temperatures by applying a correction gain or factor to the first ambient-compensated temperatures. Wherein the correction gain or factor changes value at a slower rate than the sampling rate.
Systems, devices, and methods for detecting, measuring and classifying meals for an individual based on analyte measurements. These results and related information can be presented to the individual to show the individual which meals are causing the most severe analyte response. These results can be organized and categorized based on preselected criteria or previous meals and results so as to organize and present the results in a format with reference to glucose as the monitored analyte. Various embodiments disclosed herein relate to methods, systems, and software applications intended to engage an individual by providing direct and timely feedback regarding the individual's meal-related glycemic response.
G16H 20/70 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to mental therapies, e.g. psychological therapy or autogenous training
60.
SYSTEMS, DEVICES, AND METHODS FOR WELLNESS AND NUTRITION MONITORING AND MANAGEMENT USING ANALYTE DATA
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.
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
G16H 20/60 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to nutrition control, e.g. diets
G16H 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
An interactive graphical user interface associates information configured for interactive display and input, including patient identifying information for each patient in a patient list, a medication schedule for the each patient, and a treatment assessment worksheet comprising a display indicating the medical monitoring data for the each patient. The worksheet enables comparing monitoring results over different periods of time and development of treatment plans.
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
G16H 50/70 - ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for mining of medical data, e.g. analysing previous cases of other patients
G16H 15/00 - ICT specially adapted for medical reports, e.g. generation or transmission thereof
63.
SYSTEMS, DEVICES, AND METHODS FOR ANALYTE MONITORING
An analyte measurement device including an analyte sensor configured to measure an analyte level, the analyte sensor including a tail portion for subcutaneous placement, the tail portion having an analyte-responsive enzyme disposed thereon; an applicator for delivery of the analyte sensor, the applicator having a housing defining a hermetically-sealed chamber, the tail portion disposed within the chamber prior to subcutaneous placement; and a scavenger material disposed within the chamber, the scavenger material comprising at least one of activated carbon, molecular sieve, and silica gel and configured to adsorb at least one substance within the chamber. A method of packaging an analyte sensor is also disclosed.
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
Embodiments described herein include a glucose monitoring system. The glucose monitoring system is configured to use various methods and additional systems to facilitate the transfer of glucose data from a data receiving device without wireless network capabilities. Certain embodiments facilitate the transfer of data to multi-purpose devices, user devices, and electronic medical records (EMR) systems. Certain embodiments facilitate the transfer of data to report generating systems that interpret the provided data and reports based on the glucose data. Certain embodiments relate to techniques for facilitating the integration of EMR system data management and reporting.
G16H 10/65 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records stored on portable record carriers, e.g. on smartcards, RFID tags or CD
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
G16H 15/00 - ICT specially adapted for medical reports, e.g. generation or transmission thereof
G06F 21/62 - Protecting access to data via a platform, e.g. using keys or access control rules
Embodiments described herein include a glucose monitoring system. The glucose monitoring system is configured to use various methods and additional systems to facilitate the transfer of glucose data from a data receiving device without wireless network capabilities. Certain embodiments facilitate the transfer of data to multi-purpose devices, user devices, and electronic medical records (EMR) systems. Certain embodiments facilitate the transfer of data to report generating systems that interpret the provided data and reports based on the glucose data. Certain embodiments relate to techniques for facilitating the integration of EMR system data management and reporting.
G16H 10/40 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
G16H 10/60 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
G16H 15/00 - ICT specially adapted for medical reports, e.g. generation or transmission thereof
66.
SYSTEMS AND DEVICES FOR RECEIVING DATA AND METHODS FOR CONTROL THEREOF
Embodiments described herein include an analyte monitoring device for receiving data in an analyte monitoring system. The analyte monitoring device includes a microprocessor, one or more communications integrated circuits electrically coupled to the microprocessor, wherein the one or more communications integrated circuits are further electrically coupled to at least one respective antenna, an input-output (IO) expander electrically coupled to the microprocessor, and one or more storage memories comprising instructions that, when operable by the microprocessor, cause the microprocessor to receive analyte data from a sensor control device of an analyte sensor in the analyte monitoring system. The IO expander increases an amount of pins of the microprocessor.
Method and apparatus including calling, retrieving and/or initiating a programmed function in conjunction with execution of one or more commands related to a closed loop control algorithm, receiving one or more data in response to the one or more commands over a data interface, and executing the one or more commands related to the closed loop control algorithm based on the received one or more data are provided.
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
A61M 5/172 - Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters electrical or electronic
G16H 20/17 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
69.
SYSTEMS, DEVICES, AND METHODS FOR ANALYTE MONITORING
Systems, devices and methods are provided for inserting at least a portion of an in vivo analyte sensor for sensing an analyte level in a bodily fluid of a subject. In particular, disclosed herein are various embodiments of applicators, and components thereof, designed to reduce trauma to tissue of a sensor insertion site and to increase the likelihood of a successful sensor insertion.
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.
An analyte measurement device including an analyte sensor configured to measure an analyte level, the analyte sensor including a tail portion for subcutaneous placement, the tail portion having an analyte-responsive enzyme disposed thereon; an applicator for delivery of the analyte sensor, the applicator having a housing defining a hermetically- sealed chamber, the tail portion disposed within the chamber prior to subcutaneous placement; and a scavenger material disposed within the chamber, the scavenger material comprising at least one of activated carbon, molecular sieve, and silica gel and configured to adsorb at least one substance within the chamber. A method of packaging an analyte sensor is also disclosed.
An application program stored in a ROM includes a function lookup data structure in which functions called by the application program have identifiers and memory addresses at which the function is located and can be executed. Upon startup, the function lookup data structure is copied to a RAM as a revised lookup data structure and is compared to a revision lookup data structure also written to that RAM or elsewhere. If the revision lookup data structure contains replacement functions having the same function identifiers but new memory addresses, these new memory addresses are written over the existing addresses in the revised lookup data structure for those replacement functions. The application program refers to the revised lookup data structure to find and execute the functions; thus the original application program on the ROM can continue to be used with revised functions.
A method comprising receiving a plurality of analyte data over a first time period monitored by an analyte sensor in fluid contact with bodily fluid under a skin surface, the plurality of analyte data corresponding to an analyte level, receiving a plurality of temperature data over the first time period from a temperature sensor, determining a rate of change of the plurality of temperature data over the first time period, if the determined rate of change of the plurality of temperature data is above a predetermined threshold, receiving user input to confirm exposure to radiologic procedure during the first time period, and adjusting the plurality of analyte data over the first time period based on the confirmed exposure to radiologic procedure.
A61B 5/055 - Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
75.
ANALYTE MONITORING SYSTEM AND METHODS FOR MANAGING POWER AND NOISE
Disclosed herein are methods and systems for conserving energy of a power source of an analyte monitoring device, including entering a power saving mode based on at least one of a temperature level of a power source, a level of power of a power source, or an amount of power needed by at least one component. Also disclosed herein are methods and systems for reducing noise during data transmissions to and from the analyte monitoring device.
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.
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
G01N 33/487 - Physical analysis of biological material of liquid biological material
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using enzyme electrodes, e.g. with immobilised oxidase
G16H 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
78.
CLOSED LOOP CONTROL AND SIGNAL ATTENUATION DETECTION
Methods, system and devices for monitoring a plurality of parameters associated with a closed loop control operation including continuously monitoring a physiological condition and automatic administration of a medication, detecting a signal level associated with the monitored physiological condition deviating from a predetermined threshold level, retrieving the medication level administered associated with a time period of the detected signal level, applying the retrieved medication level to the detected signal based on a predefined predictive model to generate a predictive signal, and comparing the detected signal to the predictive signal to determine whether a condition associated with the detected signal level is present are provided.
G16H 20/17 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
79.
METHOD AND DEVICE FOR PROVIDING OFFSET MODEL BASED CALIBRATION FOR ANALYTE SENSOR
Methods and devices to detect analyte in body fluid are provided. Embodiments include processing sampled data from analyte sensor, determining a non-attenuated sensitivity value associated with the analyte sensor, determining a representative sensitivity of the sensor for each group of multiple groups of data points from the analyte sensor, wherein the representative sensitivity is based on the corresponding sensitivities of pairs of data points in the group, selecting one or more of the representative sensitivities based on the selected representative sensitivities satisfying one or more criteria, determining a non-attenuated sensitivity based on a weighted average of the selected representative sensitivities, and applying the determined non-attenuated sensitivity to the data points obtained from the analyte sensor to estimate an analyte level.
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using enzyme electrodes, e.g. with immobilised oxidase
A61B 5/1495 - Calibrating or testing in vivo probes
G16H 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
G16H 10/20 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for electronic clinical trials or questionnaires
G16H 10/40 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
80.
SYSTEMS AND METHODS FOR MANAGING DIABETES CARE DATA
A host-client data sharing system manages diabetes care data. A host database, preferably web or internet based, is implemented for storing diabetes care data relating to multiple diabetics. A client or local database stores the diabetes care data relating to multiple diabetics on a personal appliance such as a PC, or a portable or handheld microprocessor-based computing device. The host database uses multiple servers for handling client interactions with the system.
G06F 13/42 - Bus transfer protocol, e.g. handshake; Synchronisation
G16H 15/00 - ICT specially adapted for medical reports, e.g. generation or transmission thereof
G16H 10/60 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
G06F 13/10 - Program control for peripheral devices
G06F 13/20 - Handling requests for interconnection or transfer for access to input/output bus
Generally, methods, devices, and systems related to analyte monitoring and data logging are provided—e.g., as related to in vivo analyte monitoring devices and systems. In some aspects, methods, devices, and systems are provided that relate to enable related settings based on an expected use of an in vivo positioned sensor; logging or otherwise recording analyte levels acquired or derived—e.g., sample analyte levels more frequently than they are logged or otherwise recorded in memory; dynamically adjust the data logging frequency; randomly determine times of acquiring or storing analyte levels from the in-vivo positioned analyte sensors; and enable recording related settings when the system is operable.
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
G16H 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
G16H 10/40 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
82.
SYSTEMS, DEVICES, AND METHODS FOR AN ANALYTE SENSOR
A system for measurement of an analyte level including an analyte sensor having an in vivo portion in contact with the interstitial fluid of a user and an ex vivo portion. The sensor further includes at least one working electrode and a reference electrode located on the in vivo portion, and a first substrate. The at least one working electrode and reference electrode sense signals associated with a measured analyte level in the interstitial fluid of a user. Further, the ex vivo portion includes a plurality of electronic components mounted thereon, and at least one of the electronic components are configured to receive the generated signals associated with the measured analyte level. The electronic components are mounted to the ex vivo portion using photonic soldering.
Systems, devices and methods for the management of glucose levels in the body of patient featuring user interface input mechanisms configured to provide haptic feedback to the user are provided.
G06F 3/0362 - Pointing devices displaced or positioned by the user; Accessories therefor with detection of 1D translations or rotations of an operating part of the device, e.g. scroll wheels, sliders, knobs, rollers or belts
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
A61M 5/172 - Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters electrical or electronic
G06F 3/01 - Input arrangements or combined input and output arrangements for interaction between user and computer
Analyte sensors are being increasingly employed for monitoring various analytes in vivo. Analyte sensors configured to monitor multiple analytes are also in development. Sufficient sensitivity for low-abundance analytes and multiple analytes having differing membrane permeability values may complicate analyte detection in some cases. Analyte sensors may feature enhancements to address one or both of these issues. Some analyte sensors may comprise a carbon working electrode comprising a dielectric substrate, one or more apertures extending through the dielectric substrate and filled with a carbon conductor pillar, a carbon conductor coating on a first face of the dielectric substrate in direct contact with each carbon conductor pillar, and one or more active areas on a second face of the dielectric substrate in electrical communication with the carbon conductor pillars. Photopolymerized mass transport limiting membranes may be used in combination with such carbon working electrodes or with other working electrode types.
A system for measurement of an analyte level including an analyte sensor having an in vivo portion in contact with the interstitial fluid of a user and an ex vivo portion. The sensor further includes at least one working electrode and a reference electrode located on the in vivo portion, and a first substrate. The at least one working electrode and reference electrode sense signals associated with a measured analyte level in the interstitial fluid of a user. Further, the ex vivo portion includes a plurality of electronic components mounted thereon, and at least one of the electronic components are configured to receive the generated signals associated with the measured analyte level. The electronic components are mounted to the ex vivo portion using photonic soldering.
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.
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
G01N 33/487 - Physical analysis of biological material of liquid biological material
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
A61B 5/1486 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using enzyme electrodes, e.g. with immobilised oxidase
G16H 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
88.
OPTIMIZING MEDICATION DOSAGE BASED ON ANALYTE SENSOR DATA
Methods, apparatuses, and systems are provided for determining whether to administer a medication dose as a single dose or whether to fractionate the single dose to be administered as at least two discrete doses. Embodiments include determining a first analyte level and a first rate of change of the analyte level; determining an initial medication dose based on one or more anticipated subsequent medication doses, the first analyte level relative to an analyte level threshold, and the first rate of change of the analyte level relative to a rate of change threshold; administering the initial medication dose; determining a second analyte level and a second rate of change of the analyte level based on subsequent analyte data; and determining a subsequent medication dose based on the second analyte level relative to the analyte level threshold and the second rate of change relative to the rate of change threshold.
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
A61M 5/172 - Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters electrical or electronic
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
G16H 20/17 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
G16H 20/10 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
89.
SYSTEMS, DEVICES, AND METHODS FOR IMPROVED ANALYTE SENSOR ACCURACY AND FAULT DETECTION
Various embodiments of systems, devices and methods for improving the accuracy of an analyte sensor and for detecting sensor fault conditions are disclosed. According to some embodiments, these systems, devices, and methods can utilize a first data collected by a glucose sensor and a second data collected by a secondary sensing element. In some embodiments, the secondary sensing element can be one of a lactate sensing element, a ketone sensing element, or a heart rate monitor, among others.
Systems, devices and methods are provided for inserting at least a portion of an in vivo analyte sensor for sensing an analyte level in a bodily fluid of a subject. In particular, disclosed herein are various embodiments of applicators, and components thereof, designed to reduce trauma to tissue of a sensor insertion site and to increase the likelihood of a successful sensor insertion.
A device includes a multiple analyte sensor, a transimpedance amplifier, and a differential amplifier. The multiple analyte sensor includes a first working electrode, a second working electrode, a counter electrode, and a reference electrode. Each of the first working electrode and the second working electrode is configured to receive a signal indicative of a presence of a respective analyte. The counter electrode is a sum of the received signal of each of the first working electrode and the second working electrode. The transimpedance amplifier is configured to receive a first signal of the received signals from the first working electrode and a second signal of the received signals from the second working electrode. The transimpedance amplifier converts the received first signal and the received second signal to an output including a variable bias offset. The differential amplifier is configured to subtract the variable bias offset from the output.
Embodiments described herein include a device and a non-transitory computer-readable medium. The device includes one or more processors, an analyte sensor, a communication module, and memories. The processors are configured to generate analyte data indicative of a monitored analyte level measured by the analyte sensor corresponding to a first time, generate analyte data indicative of the monitored analyte level measured by the analyte sensor corresponding to a second time, calculate a correction parameter based on the analyte data corresponding to the analyte data corresponding to the first time and analyte data corresponding to the second time, and perform a lag correction to obtain the monitored analyte level using at least the calculated correction parameter. The calculated correction parameter comprises a lag time determined from the analyte data. The performed lag correction comprises a linear correction model based on the calculated correction parameter.
A device includes a multiple analyte sensor, a transimpedance amplifier, and a differential amplifier. The multiple analyte sensor includes a first working electrode, a second working electrode, a counter electrode, and a reference electrode. Each of the first working electrode and the second working electrode is configured to receive a signal indicative of a presence of a respective analyte. The counter electrode is a sum of the received signal of each of the first working electrode and the second working electrode. The transimpedance amplifier is configured to receive a first signal of the received signals from the first working electrode and a second signal of the received signals from the second working electrode. The transimpedance amplifier converts the received first signal and the received second signal to an output including a variable bias offset. The differential amplifier is configured to subtract the variable bias offset from the output.
A method of providing personalized treatment for a diabetes patient including a remote device which is configured to receive a first data indicative of an analyte level of a subject during a first time period, retrieve a first glycated hemoglobin level for the subject associated with the first time period, calculate a first personal apparent glycation ratio for the first time period using the received first data and the retrieved first glycated hemoglobin level, compare the calculated first personal apparent glycation ratio to a representative apparent glycation ratio, generate a recommendation based on the comparison, and display a graphical interface comprising the calculated first personal apparent glycation ratio, the representative apparent glycation ratio, and the comparison.
G16H 10/40 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
G16H 10/60 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
Embodiments described herein include a device and a non-transitory computer-readable medium. The device includes one or more processors, an analyte sensor, a communication module, and memories. The processors are configured to generate analyte data indicative of a monitored analyte level measured by the analyte sensor corresponding to a first time, generate analyte data indicative of the monitored analyte level measured by the analyte sensor corresponding to a second time, calculate a correction parameter based on the analyte data corresponding to the analyte data corresponding to the first time and analyte data corresponding to the second time, and perform a lag correction to obtain the monitored analyte level using at least the calculated correction parameter. The calculated correction parameter comprises a lag time determined from the analyte data. The performed lag correction comprises a linear correction model based on the calculated correction parameter.
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
A61B 5/1473 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
96.
ANALYTE MONITORING AND MANAGEMENT DEVICE AND METHOD TO ANALYZE THE FREQUENCY OF USER INTERACTION WITH THE DEVICE
Devices associated with on-body analyte sensor units are disclosed. These devices include any of packaging and/or loading systems, applicators and elements of the on-body sensor units themselves. Also, various approaches to connecting electrochemical analyte sensors to and/or within associated on-body analyte sensor units are disclosed. The connector approaches variously involve the use of unique sensor and ancillary element arrangements to facilitate assembly of separate electronics assemblies and sensor elements that are kept apart until the end user brings them together.
A61B 5/151 - Devices for taking samples of blood specially adapted for taking samples of capillary blood, e.g. by lancets
A61B 5/157 - Devices for taking samples of blood characterised by integrated means for measuring characteristics of blood
H04L 67/12 - Protocols specially adapted for proprietary or special-purpose networking environments, e.g. medical networks, sensor networks, networks in vehicles or remote metering networks
A61B 50/30 - Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
98.
SYSTEMS, DEVICES, AND METHODS FOR WELLNESS MONITORING WITH PHYSIOLOGICAL SENSORS
Systems and methods for monitoring glucose variability in a subject are described. Data indicative of glucose levels of the subject is received from a sensor control device. A first glucose variability metric of the subject in a first time period is determined. The first glucose variability metric may be compared to a threshold. A first indicator is displayed if the first glucose variability metric does not exceed the threshold and a second indicator is displayed if the first glucose variability metric exceeds the threshold. Additional glucose variability metrics may be determined for subsequent time periods according to a rolling window, and the indicators may be displayed real time or in a report. The glucose variability metric may be a measure of variability compared to a baseline, a difference between a maximum and minimum glucose level, or time in or out of a target range
Methods and apparatus including determining a rate of occurrence of a glycemic excursion event, determining a frequency of an alarm activation associated with the glycemic excursion event, determining an analyte level associated with the alarm activation, and setting an alarm parameter based on one or more of the determined rate of occurrence of the glycemic excursion event, the frequency of the alarm activation associated with the glycemic excursion event or the determined analyte level are provided.
Systems, devices, and methods for identifying and managing medication dosage patterns to assist in decisions for administration at, e.g., the time a meal is being consumed, are described. The application can include a new mealtime insulin dose-decisioning feature that is accessible through or in conjunction with an analyte monitoring application. Using retrospective analyte and medication dosing data only, the dosing pattern management application can display patterns in past dose administrations to facilitate easy and better dose decisions for diabetics on a regimen of multiple daily injections.
G16H 20/17 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
