Abstract: Methods and systems are disclosed for estimating a glucose level of a person having diabetes and selecting automatically open-loop and closed-loop control for a connected therapy delivery device. The method may comprise analyzing measured glucose results and corresponding impedance values received from a glucose sensor coupled to the person with a probability analysis tool implemented by a microcontroller to determine a total quality score that is based on the minimum constraint of a probability of glucose sensor accuracy determined measured glucose results and a probability of sensing quality determined from the impedance values. The microcontroller may estimate the glucose level of the person with a recursive filter based on the plurality of measured glucose results weighted with the total quality score and select automatically either open-loop control or closed-loop control for the connected therapy delivery device based on the value of the total quality score.

Abstract: Systems and methods for multiple analyte analysis are provided. In one embodiment, a method includes determining concentrations of first and second analytes in a sample. The first and second analytes may be, for example, glucose and hydroxybutyrate. In this form, an indication related to the measured concentration of hydroxybutyrate is provided in response to determining that the concentration of hydroxybutyrate is above a predetermined value. In a further aspect of this form, a quantitative indication representative of the measured glucose concentration is automatically provided regardless of the value of the measured glucose concentration. In another embodiment, a system includes a meter configured to interact with a test element to assess first and second analytes in a sample. Further embodiments, forms, objects, features, advantages, aspects, and benefits shall become apparent from the description and drawings.

Abstract: A system and method is provided for analyzing a glucose state. A method may include identifying a target glucose state and an initial glucose state. The method may include calculating a target return path for a transition from the initial glucose state to the target glucose state. The target return path may comprise at least one intermediate glucose state associated with the transition from the initial glucose state to the target glucose state. The target return path may be calculated based on a hazard associated with the at least one intermediate glucose state of the target return path.

Abstract: Embodiments related to a self-administered, behavior modification program facilitated through a structured tailoring method and system thereof which accelerates and enhances the internalization process of the individual, and which provides help when the individual begins to fail in adhering or continuing with the behavior modification are disclosed. Program instructions that when executed by a processor causes a processor to initiate automatically a schedule of events of a structured tailoring procedure upon entry criteria being met at some unknown time, provide intervention according to the intervention preferences when the adherence criteria for one of the events has not been met, and end automatically the structured collection procedure upon exit criteria being met at some unknown time.

Abstract: An apparatus for obtaining and analyzing a blood sample is presented. The apparatus comprises an integrated drive unit having a common drive source and a drive force transmission gearing that couples a lancet drive, a device for advancing a magazine, and a sample transfer device to the drive source. A tensioning rotor and a drive rotor are mounted so that they are rotatable coaxially to one another. A first cam control converts the rotation of the drive rotor into a radial forward and reverse movement of a drive rod. A second cam control converts the rotational movement of the tensioning rotor into a linear movement of a link slide. A switching link moved by the link slide rotates the magazine an additional step. A third cam control converts the rotational movement of the tensioning rotor into a linear movement of a pressure tappet perpendicular to the piercing axis.

Abstract: According to some embodiments of the present disclosure, a device and method for determining an allowable amount of blood glucose (bG) of a patient is disclosed. The method further includes receiving a current bG measurement, determining a target bG value, and determining a correction delta bG value based on one or more advice history records. The method includes determining a correction meal rise value and determining a maximum allowed bG value based on the target bG value, the correction delta bG value, and the correction meal rise value. The method includes setting the allowable amount of bG value equal to the maximum allowed bG value when the current bG measurement is greater than the target bG value and determining the allowable amount of bG value using the target bG value and the correction delta bG value when the current bG measurement is less than the target bG value.

Abstract: Disclosed is a method for initializing an ambulatory infusion system. The method includes providing a liquid drug cartridge including a cartridge body, and a cartridge piston. The method further includes providing a dosing unit including a metering pump unit with a dosing cylinder and a dosing piston. The dosing unit further includes a valve unit configured for switching between a filling state and a draining state. The filling port being fluidically coupled with the dosing cylinder in the filling state and the draining port is fluidically coupled with the dosing cylinder in the draining state. The method further includes a) exerting an initialization force displacing the cartridge piston, and b) increasing a fluidic volume of the dosing cylinder by displacing the dosing piston, thereby sucking liquid out of the liquid drug cartridge into the dosing cylinder and further displacing the cartridge piston, without the initialization pushing force being exerted.

Abstract: A method for analyzing diabetes related information by a diabetes management application residing on a computing device. The method may include: receiving a data entry over a communication link from a blood glucose meter, where the data entry includes a glucose measurement and an indicator of a pre-established activity associated with the glucose measurement; evaluating the data entry in relation to a subject structured test based in part by comparing the indicator from the data entry with collection events associated with the subject structured test; identifying the data entry as compatible with the subject structured test when the data entry correlates with a given collection event specified by the subject structured test; identifying the data entry as non-compatible with the subject structured test when the data entry does not correlate with the given collection event specified by the subject structured test; and inputting the data entry into a logbook.

Abstract: A method is provided for constructing a structured test having user-defined adherence criteria. The method includes: presenting a patient with a plurality of contextual criterion for a structured test; receiving selection of one or more contextual criterion from the plurality of contextual criterion; and constructing a structured test that includes the contextual criterion selected by the patient. During administration of the structured test, each of the contextual criteria selected by the patient is evaluated. Sample data acquired during the structured test is reported as compliant when each of the context criterion selected by the patient was met during the administration of the structured test or tagged as non-compliant when at least one contextual criterion was not met during the administration of the structured test.

Abstract: The invention concerns a method and an apparatus for transferring an amount of a liquid drug (11) from a supply container (1) having stored the liquid drug (11) to a collapsible reservoir (2), the method including and the apparatus enabling the steps of: a) providing a fluid connection (3) between the supply container (1) and the collapsible reservoir (2); b) subjecting the liquid drug (11) stored in the supply container (1) to an environmental pressure; c) subjecting the collapsible reservoir (2) to a positive pressure relative to the environmental pressure, thereby collapsing the collapsible reservoir (2) and transferring gas comprised in the collapsible reservoir (2) from the collapsible reservoir (2) to the supply container (1); d) subjecting the collapsible reservoir (2) to a negative pressure relative to the environmental pressure, thereby expanding the collapsible reservoir (2) and transferring the amount of the liquid drug (11) from the supply container (1) to the collapsible reservoir (2).

Abstract: Embodiments related to a system and method managing the implementation, execution, data collection, data analysis and status reporting of a structured collection procedure running on a portable, hand-held collection device are disclosed. The collection device performing the structured collection procedure has program instructions that when executed by a processor cause the processor to initiate automatically a schedule of events of the structured collection procedure upon one or more entry criteria being met at some unknown time, store in memory patient data collected in accordance to the schedule of events, end automatically the structured collection procedure upon one or more exit criteria being met at some unknown time. Status reporting can be provided throughout the execution of the collection procedure.

Abstract: An insulin pump is configurable by a configurator. The pump has parameter blocks, each with a respective parameter and an associated restriction setting, and the configurator has an authorization level. Configuring the pump includes receiving, by the configurator, a request to access a parameter on the pump. The method also includes identifying, by the configurator, the parameter block that includes the parameter. Moreover, the method includes retrieving, by the configurator from the pump, the parameter and the associated restriction setting, and comparing, by the configurator, the authorization level of the configurator to the restriction setting. Also, the method includes determining, by the configurator, whether the configurator is authorized to write to the parameter block based on the comparison. Additionally, the method includes writing, by the configurator, to the parameter block on the insulin pump in response to a determination that the configurator is authorized to write to the parameter block.

Abstract: There is provided a test method for analysing a body fluid in which a test tape is used in a test device to successively provide analytical test fields stored on the test tape, wherein body fluid is applied by a user to the test field provided at a time and the said test field is photometrically scanned using a measuring unit of the device to record measurement signals. To increase the measurement reliability, it is proposed that a control value is determined from a time-dependent and/or wavelength-dependent change in the measurement signals and that the measurement signals are processed as valid or discarded as erroneous depending on the control value.

Abstract: A blood glucose measuring device and method for transmitting measured bG values to an external device such as a computer with improved data integrity for greater reliability is disclosed. The measuring device comprises a measuring means for determining measured blood glucose values, a measured value memory in which the measured blood glucose values are stored, a data interface that is configured for a data exchange with an external data reading apparatus, and a data file system which comprises a data reading application which can be accessed by the external data reading apparatus in order to read the stored measured blood glucose values, wherein the data system file further comprises a test application that is configured to execute an integrity test for the data reading application by forming a current digital signature for the data reading application and comparing this with a digital test signature provided in the data file system.

Abstract: A method for setting up a medical network for carrying out at least one medical function is disclosed. The medical network comprises network nodes and the network nodes are set up for communicating with one another by an initialization step, wherein the network nodes exchange initialization information that includes information characterizing the network nodes and a self-organization step where the network nodes define their role distribution. A work step where the network carries out the medical function and the two network nodes interact in the role of distribution defined in the self-organization step.

Abstract: Medical device alarm systems and methods of use including a medical device, a processor, a memory communicatively coupled to the processor, and machine readable instructions stored in the memory may perform at least the following when the instructions are executed by the processor: detect a predefined medical device condition associated with the medical device to determine a detected predefined medical device condition, and generate a high frequency sound alarm based on the detected predefined medical device condition. The high frequency sound alarm may be configured to be tailored to a living entity and be in an upper sound register such that the high frequency sound alarm is configured to alert the living entity capable of hearing the upper sound register of the detected predefined medical device condition.

Abstract: A sensor module (112) for determining a concentration of at least one analyte in a body fluid of a user is disclosed. The sensor module (112) includes at least one sensor element (116) adapted to determine the concentration of the analyte, wherein the sensor element (116) is at least partly implantable into a body tissue of the user; at least one control device (118) connected to the sensor element (116), wherein the control device (118) includes at least one data collection device (122) adapted to collect measurement data acquired by using the sensor element (116). The control device (118) further includes at least one wireless near-field communication device (124) adapted to transmit measurement data. The control device (118) further includes a rechargeable energy storage device (134) and is adapted to transmit at least one demand for recharging the rechargeable energy storage device (134) via the near-field communication device (124).

Abstract: The invention provides for method of operating a medical instrument (100, 200, 400, 500, 600, 700) comprising a battery powered medical appliance (104) and a control unit (102). Both have Bluetooth communication modules. A first memory of the medical appliance contains a onetime password (210) and of a password-authenticated key agreement algorithm (212). The control unit has a second memory (223) with an implementation of the password-authenticated key agreement algorithm (212?). The method comprises entering (300) the onetime password into the data entry interface (140, 221, 504, 604) of the control unit. The method further comprises generating (302) a Bluetooth encryption key (218) by the medical appliance and the control unit with the onetime password by exchanging data across the wireless communication channel by executing the password-authenticated key agreement algorithm. The method further comprises storing (304) the Bluetooth encryption key in the first memory.

Abstract: Electrode systems are disclosed for measuring the concentration of an analyte under in vivo conditions, where the systems includes an electrode with immobilized enzyme molecules and an improved diffusion barrier that controls diffusion of the analyte from body fluid surrounding the electrode system to the enzyme molecules. Methods of making and using the system also are disclosed.