Abstract: A medical device for detecting at least one analyte in a body fluid, a method for assembling the medical device and a method of using the medical device are disclosed. The medical device comprises: an analyte sensor having an insertable portion; an insertion cannula receiving the insertable portion of the analyte sensor; an electronics unit connected with the analyte sensor; and a housing comprising an electronics compartment receiving the electronics unit and a sensor compartment receiving the analyte sensor, the sensor compartment forming a sealed compartment receiving the insertable portion of the analyte sensor, the sealed compartment comprising detachable upper and lower caps, the lower cap configured for detachment before insertion, the insertion cannula being attached to the upper cap, wherein detaching the upper cap after insertion removes the insertion cannula, wherein the electronics compartment at least partially surrounds the sensor compartment.

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: A medical device for detecting, at least one analyte, in a body fluid is disclosed.

Abstract: A method for manufacturing at least one electrode (110) of an analyte sensor (112) is disclosed.

Abstract: The present disclosure refers to a method for operating a system, the system comprising a medical device, having at least one of a sensor device for sensing medical data and a medication delivery device for delivering medication, a portable electronic consumer device, an intermediate device provided with a first communication protocol for data communication with the portable electronic consumer device and a second communication protocol for data communication with the medical device, and a control module provided in the intermediate device, the method comprising, in the control module, receiving control data from the portable electronic consumer device by a receiving functionality provided in the control module, the control data being configured for controlling operation of the medical device, determining whether the control data can be confirmed by a confirmation functionality provided in the control module, and if the control data are confirmed, transmitting the control data to the medical device by a trans

Abstract: The present invention relates to a method for the preparation of a working electrode, the method comprising application of a sensing material in several steps. Further, the present invention relates to an analyte sensor comprising the working electrode as well as to the use of the analyte sensor for detecting at least one analyte in a sample.

Abstract: A system for bidirectional device authentication between two computing devices is disclosed. A first processor generates a first random number sequence, performs a first operation on the first random number sequence to determine a first table address, and retrieves a first entry in the first table based on the first table address. The processor also executes a first transformation function on the first entry to generate a first transformed entry, transmits the first random number sequence to the second computing device, receives an encoded entry from a second computing device in response to transmission of the first random number sequence, and decodes the encoded entry to determine a second transformed entry. The first transformed entry matches the second transformed entry, and the first processor performs an update to a dynamic table by replacing each entry of the dynamic table with an associated transformed entry.

Abstract: An alert is used to inform a user that their blood glucose level has dropped below a threshold (e.g., the user is hypoglycemic) or has increased above a threshold (e.g., the user is hyperglycemic). There is a hierarchy of alerts from lowest priority to highest priority. The alert is communicated by a user device (e.g., a mobile device), which is, for example, a smartphone, smart watch, home automation device, or the like. The alert is modified in order to increase the likelihood that the user receives or acknowledges the alert within a minimal amount of time. An intensity level (e.g., a volume) of an alert is modified based on, for example, whether the user has acknowledged a previous alert. A modality or a sensory channel of an alert is changed if an initial alert does fails to elicit a response from the user.

Abstract: An analyte sensor system (110) and a method (160) for producing an analyte sensor system (110) are disclosed. Herein, the analyte sensor system (110) comprises: an analyte sensor having a first contact pad, and a second contact pad; a circuit carrier having a first contact area, and a second contact area, wherein the second contact area comprises at least two individual electrically conductive surfaces; and a connecting element electrically connecting the second contact pad of the analyte sensor with each of the at least two individual electrically conductive surfaces of the second contact area of the circuit carrier. The analyte sensor system (110) as proposed herein allows a reliable and persistent electrical contact between the analyte sensor (112) and the circuit carrier (114) which minimizes a risk of short circuits.

Abstract: An electrode system is disclosed for measuring a concentration or presence of an analyte under in-vivo conditions, where the electrode system includes at least one 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. The diffusion barrier includes a hydrophilic polyurethane or a block copolymer having at least one hydrophilic block and at least one hydrophobic block. The electrode system also can include a spacer membrane that includes a hydrophilic copolymer of acrylic and/or methacrylic monomers.

Abstract: Systems and methods are provided for improving nutritional element content estimates from one or more individuals and/or determining a therapy or treatment based on a nutritional element content estimate and improving diabetes management. The systems and methods include a therapy or treatment display based on at least one nutritional element content estimate and at least one proficiency index respectively assigned to an individual to improve accuracy and reliability when estimating nutritional element content in foods and/or therapy or treatment based therefrom.

Abstract: The present disclosure relates to a device configuration method for configuring a diabetes management device by a diabetes management system, the diabetes management system residing on a server computer, the method comprising: receiving, by the diabetes management system, a therapy setting instruction from a computing device, validating, by the diabetes management system, the credentials of the healthcare provider by way of a validation service based on the identification information, determining, by the diabetes management system, whether the therapy setting instruction is valid based on an association between the diabetes management system, the patient, and the healthcare provider; transmitting, by the diabetes management system, one or more parameters for configuring the feature defined by the therapy setting to the subject diabetes management device; and canceling, by the diabetes management system, the therapy setting instruction in response to the therapy setting instruction being invalid.

Abstract: A method for detecting in-vivo properties of a biosensor. In the inventive method, a sensitivity-to-admittance relation is provided and a raw current in the biosensor is measured. An in-vivo current response is also measured at first and second operating points. A time constant ? is determined by the electrical capacitance C of the working electrode and the electrical resistance RM of the membrane by ?=RM·C. The first and second operating points are selected below and above ?, respectively. An analyte value in a sample of a body fluid is determined by using the raw current and compensating sensitivity drift in the biosensor, which in turn is compensated by using the measured value for the raw current and a corrected value for the sensitivity. The failsafe operation of the biosensor is monitored by using the in-vivo current response measured at the first and second operating points.

Abstract: The invention concerns an analyte meter (10) for medical tests having a meter housing (12), a strip port (14) mounted in an opening of the meter housing (12) and configured to receive a measuring part of a test strip (18), and a sealing insert (16) which is arranged within the strip port (14) and provides an insertion path for the test strip (18). For improved screening against contamination, it is proposed that the sealing insert (16) comprises a plurality of sealing elements (42) which are arranged consecutively along the insertion path, wherein each of the sealing elements (42) has a slit (46) that forms a sealed aperture for the test strip (18) to pass through.

Abstract: The present invention relates to a biosensor for determining an analyte comprising a substrate, a working electrode comprising an electrically conductive pad in conductive contact with a mediator layer, and an enzyme layer in diffusion-enabling contact with said mediator layer, wherein said mediator layer is an electrodeposited mediator layer, and wherein said mediator layer comprises, in an embodiment consists of, an electrocatalytic agent. The present invention further relates to a method for manufacturing a biosensor, comprising providing a substrate having at least one conductive pad, electrodepositing a mediator layer onto at least part of said conductive pad, wherein said mediator layer comprises, in an embodiment consists of, an electrocatalytic agent, and depositing an enzyme layer onto at least part of said mediator layer. Moreover, the present invention relates to uses and methods related to the biosensor of the present invention.

Abstract: A method and device for testing a battery that powers a body-wearable medical device. The battery is contacted via battery contacts and a capacitor is arranged in parallel with the battery contacts. During the battery test, a first capacitor voltage U1 is determined at a first time t1 and a second capacitor voltage U2 is determined at a second time t2 subsequent to time t1. A test current is drawn between time t1 and time t2. t1 is determined by the beginning of drawing the test current and time t2 is determined such that the capacitor voltage at time t2 is in a steady state and is substantially constant while the test current is being drawn. A charging state of the battery is determined from the difference in voltage between U1 and U2 and/or from a time difference between the time t1 and time t2.

Abstract: A device and method for controlling operation of an ambulatory infusion device drive. The drive may have a spindle drive with a stepper motor, a drive member operatively coupled to a rotary encoder, and a driver controller that executes several steps, including actuating the stepper motor to execute a requested number of steps in a current drive control sequence, receiving a drive member position that indicates an actual position of a drive member following the actuation, computing an executed steps number from the drive member position, computing a missed steps number for the current drive control sequence, which is the difference between the requested number of steps and the executed steps number, determining when the ambulatory infusion device drive is blocked based on a statistical evaluation of a time-distribution of the missed steps number over a history of drive control sequences, and generating a blockage alarm signal.

Abstract: A method for operating a medical device includes activating a processor that receives electrical power from a battery in the medical device, measuring a temperature within a housing of the medical device, identifying a low battery voltage threshold based on the temperature, measuring a first voltage level of the battery, commencing an operation sequence after measuring the first voltage level of the battery, generating a plurality of voltage comparisons between a reference voltage level and a voltage level delivered from the battery during the operation sequence, and generating, an output indicating a low battery condition if at least one of the first voltage level of the battery is less than the low battery voltage threshold and above a predetermined minimum operating voltage threshold, or at least one voltage comparison indicating the voltage level of the battery is less than the reference voltage level during the operation sequence.

Abstract: A sensor assembly (226) for detecting at least one analyte in a body fluid, a sensor patch (134) for use in a sensor assembly (226), an electronics unit (188) for use in a sensor assembly (226) and a method for producing a sensor assembly (226) are disclosed.

Abstract: The present disclosure refers to a method for operating a system, the system comprising a medical device (1), having at least one of a sensor device for sensing medical data and a medication delivery device for delivering medication, a portable electronic consumer device (2), an intermediate device (3) provided with a first communication protocol for data communication with the portable electronic consumer device (2) and a second communication protocol for data communication with the medical device (1), and a control module (6) provided in the intermediate device (3), the method comprising, in the control module (6), receiving control data from the portable electronic consumer device (2) by a receiving functionality provided in the control module (6), the control data being configured for controlling operation of the medical device (1), determining whether the control data can be confirmed by a confirmation functionality provided in the control module (6), and if the control data are confirmed, transmitting t