Abstract: Various embodiments of a “smart” drug delivery pen are provided which include a drug delivery pen having an inertial sensor or accelerometer. A system is also provided that includes the smart drug pen in conjunction with a data management unit(s) DMU. Various exemplary methods for use of the pens and systems are also described and illustrated.

Abstract: A method of operating a glucose test meter is provided. The method can be achieved by storing a plurality of glucose readings to a first memory of the test meter, each of the glucose readings having a time stamp and an order index, the time stamp comprising a date and a time when the glucose reading was performed, the order index indicating an order in which the plurality of glucose readings was saved to the first memory; determining whether successively saved glucose readings have time stamps in chronological order consistent with the order index; and indicating that the date and the time setting in the test meter is incorrect if there are successively saved glucose readings having time stamps inconsistent with the order index.

Abstract: A disease management system, methods, and devices are shown and described. In one embodiment, the system includes an infusion pump and a remote controller with the ability to be paired to each other. A method to verify a wireless connection between an infusion pump and a remote controller is shown and described herein. In a further embodiment, a method to verify a wireless connection between an infusion pump and a remote controller is provided. In addition, a method of operating a diabetes management system is provided in which the system includes an infusion pump and at least a remote controller.

Abstract: The present invention relates to a method for wireless transmission of data between components of a blood glucose system (1, I1) including a master controller (2, 2?) having a receiver (10) and a transmitter (9), and at least one slave device (3) having a receiver (19) and a transmitter (18). The slave device (3) is normally operated in a power saving mode and its receiver (19) is only activated intermittently at a receiver activation frequency for a predetermined listening period. The controller (2, 21) transmits a communication initiation data frame to the slave device (3) via a preamble signal transmitted for a preamble period. Upon receipt of the communication initiation data frame, the slave device (3) is switched to a communication mode in which it transmits a response to the controller (2, 21), and the slave device (3) is switched from the communication mode to the power saving mode.

Abstract: A hand-held test meter for use with an analytical test strip in the determination of an analyte in a bodily fluid sample includes a housing; a microcontroller block disposed in the housing; and a phase-shift-based hematocrit measurement block. The phase-shift-based hematocrit measurement block includes a signal generation sub-block, a low pass filter sub-block, an analytical test strip sample cell interface sub-block, a transimpedance amplifier sub-block, and a phase detector sub-block. In addition, the phase-shift-based hematocrit measurement block and microcontroller block are configured to measure the phase shift of a bodily fluid sample in a sample cell of an analytical test strip inserted in the hand-held test meter and the microcontroller block is configured to compute the hematocrit of the bodily fluid sample based on the measured phase shift.

Abstract: The present invention relates to a method for wireless transmission of data between components of a blood glucose system (1, I1) including a master controller (2, 2?) having a receiver (10) and a transmitter (9), and at least one slave device (3) having a receiver (19) and a transmitter (18). The slave device (3) is normally operated in a power saving mode and its receiver (19) is only activated intermittently at a receiver activation frequency for a predetermined listening period. The controller (2, 21) transmits a communication initiation data frame to the slave device (3) via a preamble signal transmitted for a preamble period. Upon receipt of the communication initiation data frame, the slave device (3) is switched to a communication mode in which it transmits a response to the controller (2, 21), and the slave device (3) is switched from the communication mode to the power saving mode.

Abstract: Various embodiments of a “smart” drug delivery system are provided which includes an add-on module and a reusable or disposable drug pen. Upon attachment to the pen, the add-on module may: determine dosage selected, injection of selected dosage, duration of injection, time of injection, whether the pen has been primed or shaken to thoroughly mix up insulin mixtures, transmit information relating to insulin dosage and injection to a data management unit, provide reminders, error warning or messages on improper usage or reusage of needles, track amount of drug remaining on board the pen or duration of usage of pen with respect to expiry of the drug on board, or provide an audible alarm for locating misplaced pen and module.

Abstract: Various embodiments of a medical module are provided which includes a primary module housing, a secondary module housing, a dosage sensor, a power source, and a microcontroller. The module is configured to be attached to a disposable drug delivery pen or a reusable drug delivery pen so that the module may: determine dosage selected, injection of selected dosage, duration of injection, time of injection, whether the pen has been primed or shaken to thoroughly mix up insulin mixtures, transmit information relating to insulin dosage and injection to a data management unit, provide reminders, error warning or messages on improper usage or reusage of needles, track amount of drug remaining on board the pen or duration of usage of pen with respect to expiry of the drug on board, or provide an audible alarm for locating misplaced pen and module.

Abstract: Various embodiments of a “smart” drug delivery system are provided which includes an add-on module and a reusable or disposable drug pen in conjunction with a data management unit(s) DMU. Upon attachment to the pen, the add-on module may: determine dosage selected, injection of selected dosage, duration of injection, time of injection, whether the pen has been primed or shaken to thoroughly mix up insulin mixtures, transmit information relating to insulin dosage and injection to a data management unit, provide reminders, error warning or messages on improper usage or reuse of needles, track amount of drug remaining on board the pen or duration of usage of pen with respect to expiry of the drug on board, or provide an audible alarm for locating misplaced pen and module. Methods of using the drug delivery system are also described.

Abstract: A method for wireless transmission of data between a master controller (2, 2?) having a receiver (10) and a transmitter (9), and at least one slave device (3) having a receiver (19) and a transmitter (18), and to a corresponding blood glucose system (1, 1?). The slave device (3) is normally operated in a power saving mode in which its receiver (19) is only activated intermittently at a receiver activation frequency for a predetermined listening period. The controller (2, 21) transmits a communication initiation data frame to the slave device (3) by means of a signal comprising a preamble signal transmitted for a preamble period. Upon receipt of the communication initiation data frame, the slave device (3) is switched to a communication mode in which it transmits a response to the controller (2, 21), and the slave device (3) is switched from the communication mode to the power saving mode.

Abstract: A disease management system, methods, and devices are shown and described. In one embodiment, the system includes an infusion pump and a remote controller with the ability to be paired to each other. A method to verify a wireless connection between an infusion pump and a remote controller is shown and described herein. In a further embodiment, a method to verify a wireless connection between an infusion pump and a remote controller is provided. In addition, a method of operating a diabetes management system is provided in which the system includes an infusion pump and at least a remote controller.

Abstract: A hand-held test meter for use with an analytical test strip in the determination of an analyte in a bodily fluid sample includes a housing; a microcontroller block disposed in the housing; and a phase-shift-based hematocrit measurement block. The phase-shift-based hematocrit measurement block includes a signal generation sub-block, a low pass filter sub-block, an analytical test strip sample cell interface sub-block, a transimpedance amplifier sub-block, and a phase detector sub-block. In addition, the phase-shift-based hematocrit measurement block and microcontroller block are configured to measure the phase shift of a bodily fluid sample in a sample cell of an analytical test strip inserted in the hand-held test meter and the microcontroller block is configured to compute the hematocrit of the bodily fluid sample based on the measured phase shift.

Abstract: A hand-held test meter for use with an analytical test strip in the determination of an analyte (such as glucose) in a bodily fluid sample (for example, a whole blood sample) includes a housing, a test meter control circuit block, and an electromagnetic interference detection circuit block with an antenna configured to sense electromagnetic fields of a predetermined frequency. The electromagnetic interference detection circuit block is configured to generate a signal representative of an electromagnetic field sensed by the antenna and to provide that signal to the test meter control circuit block. In addition, the test meter control circuit block is configured to interrupt operation of the hand-held test meter when the signal received from the electromagnetic interference detection circuit block is represents an electromagnetic field that interferes with the hand-held test meter's operation.

Abstract: A hand-held test meter for use with an analytical test strip in the determination of an analyte (such as glucose) in a bodily fluid sample (for example, a whole blood sample) includes a housing, a test meter control circuit block, and a Universal Serial Bus (USB) connector block that includes an unpowered USB connection detection circuit block. The unpowered USB connection detection circuit block is configured to provide a shielding signal of a first potential (for example, a high-level signal) to the test meter circuit control block when a USB connection to an external device has been made to the USB connector block and a shielding signal of a second potential (such as a low-level signal representative of ground) to the test meter control circuit block when a USB connection to a an device has been made to the USB connector block.

Abstract: An electronics device (“ED”) includes a housing, a buttons electrical circuit block, at least one user operable button in operable communication with the buttons electrical circuit block, a microcontroller block, and a first-time-on (FTO) electrical circuit block, disposed within the housing. The FTO electrical circuit block includes an activation node and a signal reception contact, and is configured: (i) to place the ED into a deep power conservation mode (“DPCM”) upon either the direct application of an electrical signal to the activation node by an ED or a deactivation signal received at the signal reception contact; (ii) to terminate the DPCM and place the ED into a normal operating mode upon receiving a predetermined user triggered signal from the at least one user operable button; and (ii) to generate the deactivation signal received at the signal reception contact in response to an external command signal received by the microcontroller block.

Abstract: A hand-held test meter for use with an analytical test strip in the determination of an analyte (such as glucose) in a bodily fluid sample (for example, a whole blood sample) includes a housing, a buttons electrical circuit block, at least one user operable button in operable communication with the buttons electrical circuit block, a microcontroller block, and a first-time-on (FTO) electrical circuit block. The FTO electrical circuit block is disposed within the housing and includes an activation node and a signal reception contact. In addition, the FTO electrical circuit block is configured to place the hand-held test meter into a deep power conservation mode upon either the direct application of an electrical signal to the activation node by an external device (e.g., a manufacturing tester) or a deactivation signal received at the signal reception contact.

Abstract: A method for wireless transmission of data between a master controller (2, 2?) having a receiver (10) and a transmitter (9), and at least one slave device (3) having a receiver (19) and a transmitter (18), and to a corresponding blood glucose system (1, I1). The slave device (3) is normally operated in a power saving mode in which its receiver (19) is only activated intermittently at a receiver activation frequency for a predetermined listening period. The controller (2, 21) transmits a communication initiation data frame to the slave device (3) by means of a signal comprising a preamble signal transmitted for a preamble period. Upon receipt of the communication initiation data frame, the slave device (3) is switched to a communication mode in which it transmits a response to the controller (2, 21), and the slave device (3) is switched from the communication mode to the power saving mode.

Abstract: The invention relates to a method for wireless transmission of data between components of a blood glucose system including a master controller (i.e., “master”) and a slave device (i.e., “slave”). The master and slave each have a receiver and transmitter. The method comprises operating the slave normally in a power saving mode, activating the transmitter of the master for a transmission period and subsequently activating the receiver of the master for a response period. When the slave receives a preamble signal during a listening period the slave receiver is activated until a portion of a transmitted data frame from the master is received, switched into a communication mode to transmit a response to the master and switched from the communication mode to the power saving mode. In the power saving mode the activation frequency of the slave receiver and the transmission of the data frame are controlled to save power.

Abstract: A system and method of processing a test current for an analyte measurement in a fluid using a test strip and a test meter are disclosed. The method comprises sampling the test current at a pre-determined sampling rate to acquire a plurality of A/D conversions. The method also comprises filtering out at least a highest magnitude A/D conversion and a lowest magnitude A/D conversion leaving a plurality of accepted A/D conversions. Further, the method comprises calculating an average or a summation of the plurality of accepted A/D conversions and converting the average or the summation into a glucose concentration.

Abstract: Various embodiments of a “smart” drug delivery system are provided which includes an add-on module and a reusable or disposable drug pen in conjunction with a data management unit(s) DMU. Upon attachment to the pen, the add-on module may: determine dosage selected, injection of selected dosage, duration of injection, time of injection, whether the pen has been primed or shaken to thoroughly mix up insulin mixtures, transmit information relating to insulin dosage and injection to a data management unit, provide reminders, error warning or messages on improper usage or reuse of needles, track amount of drug remaining on board the pen or duration of usage of pen with respect to expiry of the drug on board, or provide an audible alarm for locating misplaced pen and module. Methods of using the drug delivery system are also described.