Abstract: An assembly includes a sealed drug reservoir unit, a subcutaneous flow conducting device in the form of a needle unit or an infusion set, and a flow communication unit. The flow communication unit includes a proximal hollow needle adapted to penetrate a needle-penetrable septum of the reservoir, a first flow-way inflow communication with the proximal needle and comprising a pressure-controlled valve, a second flow-way in flow communication with the first flow-way, an amount of preservative arranged to react with a substance received by the second flow-way, and distal flow communication structure adapted to provide flow communication between the second flow-way and the needle unit. The valve is controlled to open when the reservoir is pressurized, the preservative being provided to react with substances introduced to the second flow way via the needle unit.

Abstract: A device configured to enhance user operation of an exercise machine. The device includes control circuitry including logic configured to obtain a stroke measure associated with an exercise motion performed by the user operating the exercise machine; obtain a speed value associated with a target speed for the exercise motion; determine a target period for the exercise motion, based on the stroke measure and the speed value; and output a guide indicator representing the target period on a display.

Abstract: A device (250) for estimating the risk of a future hypoglycemic event for a subject with a standing insulin regimen (206), wherein the standing insulin regimen comprises one or more types of insulin medicament dosage regimen (208), wherein each of the one or more types of insulin medicament dosage regimen (208) comprises a type of insulin medicament (210) defining one or more types of insulin medicaments. Using the evaluation of a glucose concentration, a first time derivative and an insulin on board for the subject in a current metabolic state, and the evaluation of a glucose concentration, a first derivative and a historical insulin on board to estimate a hypoglycemic risk measure.

Abstract: Systems and methods are provided for adjusting long acting insulin medicament dosages for a subject. A plurality of timestamped glucose measurements of the subject and insulin injection data is obtained. A first glycaemic risk measures is determined, where the first risk glycaemic risk measure is i) glucose level variability across the glucose measurements, (ii) a variability in fasting glucose levels calculated from the glucose measurements, (iii) a minimum observed glucose measurement in the plurality of glucose measurements (iv) rate of change in ISF, or (v) adherence values. A fasting blood glucose target function is computed based upon at least the first glycaemic risk measure thereby obtaining an updated target fasting blood glucose level that is between a minimum and maximum target fasting blood glucose level. The long acting insulin medicament dosage is adjusted based upon the updated target fasting blood glucose level.

Abstract: Systems and methods are provided for adjusting long acting insulin medicament dosages for a subject. A plurality of timestamped glucose measurements of the subject is obtained. A titration glucose level (246) is computed as a measure of central tendency (244, 268, 274) of a titration subset of small glucose measurements (240, 269, 273) identified within the timestamped glucose measurements, wherein the measure of central tendency represents a measure of small glucose measurements for the primary time window. A long acting insulin medicament dosage (216) is adjusted or maintained based upon the obtained titration glucose level (246).

Abstract: The present invention provides a drug delivery device (1) of the type in which a piston rod (10, 110) extends along a reference axis and is forced to rotate in an expelling direction about the reference axis during a dose expelling event to cause an expelling of drug from a drug reservoir (30, 130), and a resilient ratchet element (12) is operatively coupled with the piston rod (10, 110) and undergoes a deflecting motion comprising elastic deformation and recovery in response to an expelling of a predetermined dose increment, which deflecting motion occasions a velocity fluctuation of the piston rod (10, 110), comprising: a rotator module (50, 150) operatively coupled with the piston rod (10, 110) and configured to rotate about the reference axis against a rotation resisting force in response to a rotation of the piston rod (10, 110) in the expelling direction, the rotator module (50, 150) comprising a sensor system (70, 71; 170, 183; 270, 183) for monitoring a torque transferred by the piston rod (10, 110) d

Abstract: Systems and methods are provided for adjusting long acting insulin medicament dosages for a subject. A plurality of timestamped glucose measurements of the subject is obtained. A titration glucose level (246) is computed as a measure of central tendency (244, 268, 274) of a titration subset of small glucose measurements (240, 269, 273) identified within the timestamped glucose measurements, wherein the measure of central tendency represents a measure of small glucose measurements for the primary time window. A long acting insulin medicament dosage (216) is adjusted or maintained based upon the obtained titration glucose level (246).

Abstract: Systems and methods are provided for optimizing basal administration timing in a standing basal insulin regimen of a subject. The regimen specifies a total amount of basal insulin medicament, one or more basal injection event types for a recurring period, and an apportionment of the total amount of medicament between the injection event types. Time stamped glucose measurements of the subject are obtained over a past time course comprising a plurality of instances of the recurring period. When the glucose measurements satisfy a stop condition, a recommended adjustment is determined that comprises a change in the number of injection event types in the regimen and/or a change in the apportionment of insulin medicament between injection event types. The recommended adjustment is communicated to the subject for manual adjustment of the regimen, an insulin pen charged with delivering the regimen to the subject, or a health care practitioner associated with the subject.

Abstract: Systems and methods for treating a subject are provided. A first dataset comprising timestamped autonomous glucose measurements of the subject over a first time course is obtained. A second dataset, associated with a standing insulin regimen for the subject over the first time course and comprising insulin medicament records, is also obtained. Each record comprises a timestamped injection event including an amount and type of insulin medicament injected into the subject by an insulin pen. The first and second datasets serve to calculate a glycaemic risk measure and an insulin sensitivity factor of the subject during the first time course, which are used to obtain a basal titration schedule and a fasting blood glucose profile model over a subsequent second time course for the subject. The model predicts the fasting blood glucose level of the subject based upon amounts of basal insulin medicament injected into the subject.

Abstract: An electronic tag, which may be used in a data management system, comprises a Bluetooth transmitter and an RFID transmitter. The Bluetooth transmitter is operable to transmit first data packets. The RFID transmitter is operable to transmit second data packets. The first data packets comprise a first identifier, ID1, and the second data packets comprise a second identifier, ID2, which is different from ID1. A portable electronic device is configured to, upon receiving one of the first data packets by a Bluetooth receiver, selectively activate an RFID receiver for the second data packets, thereby enabling transfer of ID2 from the electronic tag irrespective of the data transfer capacity of the first data packets.

Abstract: The present invention provides a needle unit (10) for use with a pen injection device, wherein the needle unit (10) comprises a needle shield (50) and an axially movable needle hub (25).

Abstract: Systems and methods for treating a subject are provided. A first dataset comprising timestamped autonomous glucose measurements of the subject over a first time course is obtained. A second dataset, associated with a standing insulin regimen for the subject over the first time course and comprising insulin medicament records, is also obtained. Each record comprises a timestamped administration event including an amount and type of insulin medicament administered into the subject by an insulin delivery device. The first and second datasets serve to calculate a glycemic risk measure and an insulin sensitivity factor of the subject during the first time course, which are used to obtain a basal rate titration schedule and a fasting blood glucose profile model over a subsequent second time course for the subject. The model predicts the fasting blood glucose level of the subject based upon amounts of insulin medicament administered into the subject.

Abstract: A subject is prescribed short and long acting insulin medicament regimens. When a qualified fasting event occurs, the basal insulin sensitivity estimate of the subject is updated using (i) an expected fasting blood glucose level based upon the long acting insulin medicament dosing specified by the long acting regimen during the fasting event, (ii) glucose measurements contemporaneous with the fasting event and (iii) a prior insulin sensitivity factor. A basal insulin sensitivity factor curve is calculated from the updated basal insulin sensitivity estimate. A bolus insulin sensitivity estimate of the subject is updated upon occurrence of a correction bolus with a short acting insulin medicament using (i) an expected blood glucose level based upon the correction bolus, (ii) glucose measurements after occurrence of the correction bolus, and (iii) a prior insulin sensitivity factor. A bolus insulin sensitivity factor curve is calculated from the updated bolus insulin sensitivity estimate.

Abstract: A multi-use needle assembly (200) for an injection device (50), wherein the injection device (50) comprises: a housing (52) and a cartridge (54) for storing a liquid drug for multiple injections, the multi-use needle assembly comprises: a support structure (201), needle cannula (210), a movable shield assembly comprising a movable shield (220) and an actuation member (222) fixed to the shield (220), and a cleaning assembly (230) adapted to change configuration by deformation.

Abstract: Systems and methods are provided for optimizing basal administration timing in a standing basal insulin regimen of a subject. The regimen specifies a total amount of basal insulin medicament, one or more basal injection event types for a recurring period, and an apportionment of the total amount of medicament between the injection event types. Time stamped glucose measurements of the subject are obtained over a past time course comprising a plurality of instances of the recurring period. When the glucose measurements satisfy a stop condition, a recommended adjustment is determined that comprises a change in the number of injection event types in the regimen and/or a change in the apportionment of insulin medicament between injection event types. The recommended adjustment is communicated to the subject for manual adjustment of the regimen, an insulin pen charged with delivering the regimen to the subject, or a health care practitioner associated with the subject.

Abstract: The present invention relates to a drug delivery device that houses a piston equipped cartridge and a drive mechanism comprising a piston rod (170) configured for axially moving the piston in a distal direction. An adjustment member (150) connects to the member (150) comprises a first contour system (175) defining a plurality of steps (175?, 175?, 175??) being circumferentially disposed and arranged axially offset from one another. The other of the piston rod (170) and the adjustment member (150) comprises at least one radially disposed protrusion (155). For eliminating an axial clearance between the piston rod (170) and the piston of the cartridge the at least one radially disposed protrusion (155) axially engages a selective one of said plurality of steps (175?, 175?, 175??) so that the relative rotational position between the piston rod (170) and the adjustment member (150) is decisive for the axial position of the adjustment member (150) relative to the piston rod (170).

Abstract: The present invention relates to a drug delivery device for expelling a dose of drug from a held cartridge and that defines a distal drug outlet end and an opposite proximal end. The drug delivery device comprises: a distal housing component (110) holding a cartridge (113) comprising a liquid drug and a piston slideable arranged therein in an axial direction, and a proximal housing component (101) housing a dose setting and expelling mechanism comprising a piston rod for exerting a force on the piston of the cartridge (113) in a distal direction for expelling a dose. The distal housing component (110) and the proximal housing component (101) are displaceably arranged in axial direction relative to each other for reducing an axial distance between the piston rod (120) and the piston of the cartridge (113).

Abstract: Systems and methods for communicating a dose history configured for representing an average and a variability of a distribution of injections with a blood glucose regulating medicament applied by a subject with a treatment regimen. Past records are obtained from insulin pens applying the treatment regimen. Each record specifies an amount and type of medicament injected, the type being one of a blood glucose regulating medicament, and a timestamp. Assigning single-shape polygons (231) to each record, wherein single-shape polygons (231) is configured for visualizing a polygon (261) with a two-dimensional shape, in a displayed mode. The single-shape polygons are used to create a set of multi-shape data structures comprising corresponding multi-shape polygons (244), configured for visualizing a polygon (265) with a two-dimensional shape, in the displayed mode (260).

Abstract: A multi-use injection device (100) for multiple subcutaneous injections, wherein the injection device comprises a device main portion (110) and a multi-use needle unit (150) adapted to prevent unintended introduction of living microorganisms into a reservoir (114) of the device main portion during use of the injection device, and thereby promote bacteriostasis of a multiple-use drug preparation (115) during a use period with multiple injections. The drug delivery device (100) is adapted to enable multiple injections, without accidentally introducing living microbial contaminations into the reservoir during use, by adapting the multi-use needle to: (i) sterilize contaminations introduced into the distal needle after each exposure of a distal injection needle (156), (ii) restrict diffusion and flow from the distal needle (156) to the reservoir (114) with a valve (170), (iii), and by allowing the needle unit to remain mounted in the in-use configuration during the use period with multiple injections.

Abstract: The present invention relates to a pre-filled disposable injection device and a needle cannula in combination. The prefilled disposable injection device (1) is made from a housing (2) containing a non-exchangeable cartridge (10) for storing a liquid drug sufficient for a number of injections. The proximal end of the pre-filled injection device (1) carries the dose setting button (3) and the distal end carries the needle cannula (20) having a lumen (21) through which the settable dose is expelled. The distal end (23) of the needle cannula (20) is covered by a telescopic needle covering shield (30) which shield (30) can operate between a first position covering the tip (24) of the needle cannula (20) and a second retracted position allowing an injection to be performed.