Abstract: Methods are provided for correcting an analyte concentration measurement that may be influenced by hematocrit (HCT), especially a glucose concentration measurement. The methods include determining by means of a reference instrument a HCT reference value of a reference blood sample taken from a specific user, applying a fresh blood sample of the user on a disposable analytical test element, measuring the glucose value of the fresh blood sample by single use of the test element in a glucose meter, determining a HCT correction value using at least the HCT reference value, and adjusting the measured glucose value using the HCT correction value to receive an adjusted glucose value. Also provided are devices and system incorporating or for performing the methods.

Abstract: A method is provided for verifying test element integrity includes providing a biosensor having an electrode-support substrate. A first electrode is provided on the substrate that includes a first body and a neck extending from the first body. A second electrode is provided on the substrate that includes a second body and an opposite pair of necks. Each of the necks extends from a respective end of the second body. A spacer is positioned on the substrate and has an edge defining a boundary of a capillary channel formed between a cover and the substrate. The method also includes applying a signal across the necks of the second electrode to verify continuity along the second electrode. The second body of the second electrode and the pair of connective necks surround the first electrode in the capillary channel forming a loop circuit around the first electrode.

Abstract: A sensor device for determining the concentration of an analyte under in-vivo conditions that includes an electrode system having an electrode with immobilized enzyme molecules and a diffusion barrier that controls diffusion from the exterior of the electrode system to the immobilized enzyme molecules. The diffusion barrier may include an aliphatic polyurethane. A process of manufacturing such a sensor device is also disclosed.

Abstract: This disclosure provides a method of determining a cartridge type of a cartridge used with a fluid drug injection system having a pump that receives a fluid drug cartridge. The fluid drug cartridge has a barrel filled with a fluid drug solution and a plunger within the barrel that forces the fluid drug solution through an outlet. An actuator of the pump is moved to contact or to move the plunger and a force sensor is used to measure force data during the movement. The force data is descriptive of the force applied to the plunger. A feature signal is determined from the force data. The feature signal can be a force modulation amplitude, a force modulation duration or a force modulation number. The cartridge type is assigned using the feature signal. Also disclosed is a fluid drug injection system and a cartridge for use therewith.

Abstract: A method for evaluating the suitability of a mobile device having a camera for performing an analytical measurement is disclosed. The method includes providing the mobile device and providing a reference object having a predefined spatial extension in a spatial dimension. An image is taken of at least part of the reference object using the camera and is used to derive spatial resolution information that includes one or more numerical values that quantify the capability of the camera to resolve two or more objects in the image. A threshold value based on a minimum number of pixels in the spatial dimension within a region of interest in the image is provided and the spatial resolution information is compared with the threshold value. It is determined from the comparison whether the mobile device is suitable for performing the analytical measurement.

Abstract: The present invention relates to a test element for the detection of an analyte comprising an enzyme, wherein the enzyme is incorporated in a nanocapsule.

Abstract: A sensor system (110), a method of manufacturing a flexible electronics patch (114) for use in a sensor system (110) and a method of manufacturing a sensor system (110). The sensor system (110) comprises—at least one analyte sensor (112) configured for at least partial implementation into a body tissue of a user; —at least one flexible electronics patch (114), the flexible electronics patch (114) comprising—at least one applicator unit (134) for applying the flexible electronics patch (114) to the skin (132) of the user; and —at least one second adhesive layer (136) for adhering the flexible electronics patch (114) to the applicator unit (134) before applying the flexible electronics patch (114) to the skin (132) of the user.

Abstract: Management of a diabetic condition may be performed by detecting a mealtime and/or an increased level of activity associated with a user. The mealtime is detected based one or more mealtime indicators that may indicate a likelihood of an occurrence of a mealtime. Each mealtime indicator provides additional context around the likelihood of a mealtime. To assist in managing the diabetic condition, a user's elevated activity levels may be detected. The activity level of a user is detected based on one or more activity indicators. Each activity indicator provides additional context around the likelihood of an increased level of activity by the user. Management of the diabetic condition may be performed proximate a mealtime or a user exercising to increase the efficacy of management of the diabetic condition.

Abstract: A method for testing enzyme based electrochemical sensors wherein an electrochemical sensor is provided. A measurement setup is provided, which is operatively coupled to the electrochemical sensor, providing an output signal Z, e.g. a measured signal current, of the electrochemical sensor; and the electrochemical sensor is suitably contacted with a test solution comprising a certain concentration of the primary analyte. The electrochemical sensor is subjected to a certain swept range of temperatures T; an output signal Z is measured for different temperature values T; a derivative Z? of the output signal Z as a function of temperature T, or inverse temperature 1/T, is determined; and a relative derivate Z?/Z at a temperature T, or inverse temperature 1/T, is determined as the ratio between derivative Z? and output signal Z.

Abstract: A method providing a signal quality degree associated with an analyte value measured in a continuous monitoring system is disclosed. The method includes: receiving a measured analyte value from a biosensor; determining at least two impact parameters, wherein each of the impact parameters is influenced by an operational status of the continuous monitoring system and wherein each of the impact parameters is capable of exerting an influence on the signal quality of the biosensor and wherein the influence of each of the impact parameters on the signal quality of the biosensor is expressed by a weight assigned to each of the impact parameters; and determining the signal quality degree associated with the measured analyte value as a function of the weights and the corresponding impact parameters; and providing the signal quality degree associated with the analyte value. A method of calibration using the signal quality degree is also disclosed.

Abstract: Disclosed is an infusion device drive unit that includes a pump drive configured to operatively mechanically couple to a dosing unit to control operation of the dosing unit. The infusion device drive unit further includes a blocking member that is movable between a blocking configuration and a enabling configuration, the blocking member enabling the establishing and/or the releasing of an operative mechanical coupling between the pump drive and the dosing unit in the enabling configuration and preventing the establishing and/or the releasing of an operative mechanical coupling between the pump drive and the dosing unit in the blocking configuration. The infusion device drive unit controls the blocking member to take on the enabling configuration if the pump drive is in at least one pre-determined configuration and to take on the blocking configuration if the pump drive is in a configuration different from a pre-determined configuration.

Abstract: A method for manufacturing a test element for detecting at least one analyte in a body fluid, a test element for detecting at least one analyte in a body fluid, a method for detecting at least one analyte in a body fluid, a system for detecting at least one analyte in a body fluid and a method for manufacturing a test element for detecting at least one analyte in a body fluid are disclosed.

Abstract: Disclosed is a fluid dispensing device that includes at least one reservoir to hold the therapeutic fluid, at least one other unit requiring communication with ambient air, at least partly, to operate, and at least one housing defining an interior to retain the at least one reservoir and the at least one other unit. The at least one housing has at least one vent port formed on one or more of its walls. The at least one vent port is adapted to direct or communicate air to maintain pressure equilibrium between the air pressure in the interior of the at least one housing and the ambient air pressure outside the at least one housing, and provide communication with the ambient air to the at least one other unit requiring air to enable operation of the at least one other unit.

Abstract: Disclosed is an ambulatory therapeutic fluid delivery device. The device includes at least one housing connectable to a cannula, the at least one housing retaining a reservoir to hold the therapeutic fluid. The device also includes a mechanically powered pumping mechanism to cause delivery of at least some of the fluid from the reservoir, and a power-transfer mechanism to transfer manually-delivered power provided by a user to mechanically actuate the pumping mechanism.

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: A portable therapeutic fluid delivery device with a flow detector comprising a heating element and two temperature sensors is presented. Upon activation of the heating element, a flow condition of the fluid inside the delivery tube is determined based on a signal provided by the temperature sensors. A temperature gradient within the therapeutic fluid is detected. The determined flow condition can be one of: air bubbles within the delivery tube, occlusion within the delivery tube, or leakage within the delivery tube. The device can have two parts, for example, a reusable part and a disposable part. Upon pairing of these parts, the heating element and the temperature sensors touch the delivery tube.

Abstract: Medical device data manager configuration methods and systems including a medical device, a smart mobile device including a camera, a processor, a memory communicatively coupled to the processor, and machine readable instructions stored in the memory that may cause a system to perform at least the following when executed by the processor: use the camera of the smart mobile device to capture an image of the medical device; apply an identification algorithm to the image of the medical device; identify the medical device as an identified medical device based on the image of the medical device and the identification algorithm; and automatically configure a software application tool on the smart mobile device to retrieve data associated with one or more requirements of the identified medical device.

Abstract: The present invention relates to a composition for forming an electrode, an electrochemical sensor comprising the same, and a method for determining an analyte using the electrochemical sensor.

Abstract: A system and method for considering the effects of aerobic exercise on blood glucose levels for individuals is described. In at least one embodiment of the system of the present disclosure, the system comprises a computing device for generating a prediction of future blood glucose levels for the individual at least partly based on an exercise model, wherein the exercise model is based on parameters that are independent of intensity of the aerobic exercise, and a means for taking an action at least based on the prediction from the exercise model.

Abstract: Disclosed is a valve drive unit that has first and second SMA wires that can be alternatively activated. The valve drive unit further includes a pivoting member pivotably arranged around a pivoting member axis, the pivoting member including a valve driver arranged at a distance from the pivoting member axis. The first and second SMA wires are coupled to the pivoting member such that an activation of the first SMA wire causes the pivoting member to pivot into a first direction and an activation of the second SMA wire causes the pivoting member to pivot into a second direction, the second direction being opposite to the first direction. The valve driver is configured to releasably engage a valve driver coupler of a valve unit, such that, in the engaged state, a pivoting of the pivoting member is transmitted to the valve driver coupler via the valve driver.