Abstract: Protective coverings are provided for hand-held medical devices that have a measuring port for a disposable analytical test element. The coverings also include a sleeve having a reception opening and can be slipped over the devices to at least partially enclose the devices in a usable protected state. The coverings further include a test element adapter formed as an integral part of the sleeve to receive the test element in alignment with a measuring port, where the sleeve includes the test element adapter and is arranged as a sealing barrier between the test element and the device port in a protected state.

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: A structured testing method for diagnostic or therapy support of a patient with a chronic disease and devices thereof are disclosed which implement a structured collection procedure based on a medical use case and/or question which provides at least one or more parameters defining entry criterion, a schedule of events, adherence criterion, and exit criterion. The entry criterion establish conditions needed to be met prior to obtaining biomarker data from the patient. Each event can include one or more of a performance time, patient guidance to perform the event, a request for information from the patient a request for patient action, and a request for collection of biomarker data from the patient. The adherence criterion can be used to assess whether an event performed is acceptable to addressing the medical use case and/or question, and the exit criterion establishes conditions needed to be met prior to exiting the collection procedure.

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 slot die shim for use with a slot die, the slot die shim including a first channel configured to receive a first coating, a second channel configured to receive a second coating, and a third channel configured to receive a third coating. The slot die shim simultaneously dispenses the first coating through the first channel, the second coating through the second channel, and the third coating through the third channel onto a substrate. The coatings can be applied at different flow rates and include different test reagents. A vacuum force is applied to the first, second, and third coatings to control a width and a thickness of each of the coatings and a gap or distance between the coatings. The first, second, and third coatings are placed near one another or directly in contact with one another to minimize the area required for the coatings.

Abstract: The disclosure relates to a method and a system for a wireless data communication between a sensor system and a receiver capable of receiving analyte values sensed by the sensor system in a continuous analyte monitoring. The method includes establishing an unconnected mode operation for the system. The receiver receives a first data package broadcasted by the sensor system that has first status data indicative of a device status and/or an analyte value status. The first status data is processed by a receiver controller. A connected mode operation is established for the system responsive to determining at least one of a critical device status and a critical analyte value status. The establishing includes establishing a communication channel between the sensor system and the receiver and receiving a second data package transmitted by the sensor system in the receiver, the second data package comprising one or more analyte values.

Abstract: Embodiments of the present invention are directed to devices, systems and methods for delivering therapeutic fluid (e.g., insulin) into the body, including a skin adherable cradle, for retaining a therapeutic fluid dispenser for delivering a therapeutic fluid to a user.

Abstract: A device and method of providing instruction to a patient regarding the dosing of insulin is provided.

Abstract: The present invention relates to a computer-implemented method for aiding in the guidance of diabetes drug therapy of an individual suffering from diabetes mellitus. The method is based on glucose data from said individual that are received at a processing unit, wherein said glucose data comprise at least three fasting glucose measurement values from said individual, and/or at least three matched pre-prandial glucose measurement values and postprandial glucose measurement values at the same meal from said individual. Further contemplated by the present invention is a device for aiding in the guidance of drug diabetes therapy of an individual suffering from diabetes, said device comprising a processing unit, and a computer program including computer-executable instructions, wherein said instructions, when executed by the processing unit, causes the processing unit to perform the computer-implemented method of the present invention.

Abstract: Detection reagents, multi-analyte test elements, test systems, and multi-analyte measuring methods are provided. In particular, multi-analyte test elements have (1) a first working electrode and first counter electrode pair covered with a first analyte-specific reagent that includes an enzyme, a coenzyme and a first mediator and have (2) a second working electrode covered with a second analyte-specific reagent that includes an enzyme, a coenzyme and a second mediator, where the second mediator is different than the first mediator. The single counter electrode can be used as the counter electrode for both the first and second analyte measurements at their respective working electrodes. Moreover, the mediator concentrations, measurement ranges, and applied potential differences are not the same for each analyte-specific measurement.

Abstract: Disclosed is a method of using a handheld meter configured for determining an analyte concentration in a body fluid. In the inventive method, a handheld meter with a disposable test element is provided and the test element is positioned at an application site of the meter. A body fluid from a user's body part is applied to a reaction area of the test element and a series of measurement values from the reaction area of the test element is detected. A proximity sensor senses the presence of the body part in a monitored space in proximity to the reaction area of the test element. The measured values are processed as a function of an output signal of the proximity sensor. Consequently, bias in the determination of the analyte concentration caused by the presence of the body portion is reduced or eliminated. An associated handheld meter is also disclosed.

Abstract: A diabetes management system includes a handheld medical device, a mobile computing device, and a diabetes management application. The handheld medical device is configured to measure glucose in a sample of fluid residing in a test strip and associate a measurement time with the glucose measurement. The diabetes management application is configured to request a current device time from the RTC, determine a first device delta time by determining a difference between the current device time and an internal clock time, and associate a first timestamp with a glucose measurement, wherein the first timestamp is equal to the measurement time plus the first device delta time.

Abstract: A test strip eject mechanism for a fluid testing device comprising an actuation button and a lever having a distal end movably engaged with the button, the lever configured to rotate about a fulcrum, wherein the lever has a proximal end movably engaged with a sled which slides to transport the test strip, the device configured such that a user's insertion of a test strip onto the sled and in an insertion direction into the device causes the sled to contact the lever arm and the lever arm to contact and move the actuation button in an outward direction of the medical device and into a position where the actuation button can be actuated by the user.

Abstract: The invention concerns an analyte measuring system comprising a test tape (22) having a plurality of functional elements (20) including a test field (46), a further comprising a meter (12) having a tape drive (24) operable to advance the test tape (22), a light source (30) adapted to illuminate at least one measuring spot at a measuring position, and a measuring engine (32) to receive optical signals from the at least one measuring spot for detection of the analyte in the body fluid. For tape positioning, it is proposed that the measuring engine (32) comprises a signal processor (34) operable to determine if a test field (46) is in the measuring position, said determination comprising an identification of a pre-determined distance between at least two functional elements (20) in the optical signals obtained while advancing the test tape (22).

Abstract: A method for detecting an interferent contribution in a biosensor is disclosed. Herein, the biosensor has a first electrode (112), a second electrode, and a third electrode (114), wherein the first electrode (112) and the second electrode are covered by a membrane, wherein the first electrode (112) further includes an enzyme or wherein the first electrode (112) is covered by an enzyme layer. Further, the first electrode (112), the second electrode, and the third electrode (114) are connected via a potentiostat, wherein, in a normal operational mode, via the potentiostat an electrical potential difference is applied between the first electrode (112) and the second electrode in a manner that the first electrode (112) allows for oxidative processes and the third electrode (114) allows for reductive processes.

Abstract: A method and an apparatus are described for the generation of microparticles containing an immobilized functional component, where the following measures are proposed: spraying a liquid (32) containing a soluble alginate and a functional component consisting of molecules or nanoparticles to generate a stream (60) of droplets, directing the stream (60) of droplets onto a precipitation bath (16) and capturing the droplets therein by application of high voltage (14), precipitating the droplets in the precipitation bath (16) via a precipitation liquid (18) containing an alginate complexing agent, such that the droplets are solidified to form microparticles (10) containing the functional component and extracting the microparticles (10) from the precipitation bath (16).

Abstract: A sensor assembly for detecting at least one analyte in a body fluid includes an electrochemical sensor, a body mount that attaches to a body of a user and an inserter that transfers the sensor to the body mount. A first adhesive is attached to one or both of the body mount or the sensor, and the first adhesive attaches the sensor to the body mount. A second adhesive is attached to one or both of the sensor or the inserter and releasably attaches the sensor to the inserter. The assembly has an initial position in which the sensor is attached to the inserter via the second adhesive and a final position in which the sensor is attached to the body mount via the first adhesive. Transferring the sensor from the initial position to the final position releases the sensor from the inserter.