Abstract: The present disclosure provides an orientation-nonspecific sensor port for use in analyte meters designed to detect and quantify analyte levels in a fluid sample along with methods of using the same. The present disclosure also provides compositions and methods for facilitating the correct insertion of a sensor into a corresponding analyte meter.

Abstract: A sensing assembly (10), including a body (12) and one or more first indicating electrodes disposed on the body (26). The first indicating electrodes include an electrochemically active layer (32) and a layer (38) of an active functioning enzyme of a first enzyme type on top of the electrochemically active layer. Also, one or more second indicating electrodes (24) are disposed on the body and include an electrochemically active layer (32) and a layer (36) of an inactivated enzyme of the first enzyme type on top of the electrochemically active layer. A reference electrode (22) is also disposed on the body. Finally, an electrical and data processing system (18) is adapted to bias the electrodes and measure electrical signals from the electrodes, and uses said signals to determine an analyte concentration and communicates the analyte concentration to a location apart from the first and second indicating electrodes.

Abstract: Disclosed is a medical device to treat diabetes. The medical device includes a bolus calculator to determine an insulin bolus based on, at least in part, a glycemic index value associated with an intake to be consumed by a user, the bolus calculator further adapted to determine the insulin bolus using one or more inputs selected from the group consisting of a carbohydrate load of the intake, a current glucose level of the user, a residual insulin of the user, a carbohydrate to insulin ration, an insulin sensitivity of the user and a target glucose level of the user. The bolus calculator is housed in one or more of, for example, an insulin dispensing pump, a handheld remote control unit for the insulin dispensing pump and/or a handheld glucose monitor.

Abstract: An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor has, for example, a substrate, a recessed channel formed in the substrate, and conductive material disposed in the recessed channel to form a working electrode. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte.

Abstract: This document discusses, among other things, an apparatus comprising a pump configured to deliver a fluid, an input and a controller. The controller is configured to receive via the input information related to physical activity of a user and to automatically calculate a change in insulin therapy based on an amount of carbohydrates metabolized by the physical activity.

Abstract: Embodiments are directed to infusion devices, systems, and methods to detect a capacity of a collapsible fluid reservoir of an infusion cartridge and/or a volume of a fluid disposed in the collapsible fluid reservoir or some other parameters of the infusion cartridge, and setting corresponding therapeutic parameters of an infusion device. Embodiments may include, obtaining data on the volume of fluid in the collapsible fluid reservoir, analyzing the obtained data to determine the setting of therapeutic parameters, and setting one or more therapeutic parameters of an infusion device.

Abstract: Methods and systems for controlling an insulin pump in response to glucose measurements are responsive to a base insulin delivery profile and a temporary insulin delivery profile. These can be used, e.g., to control blood glucose level of a subject using a continuous glucose monitor and an insulin infusion pump. During a selected time range, an insulin amount for the pump to supply is determined using the temporary insulin delivery profile. Outside that time range, the insulin amount is determined using the base insulin delivery profile. The temporary insulin delivery profile can specify an exact amount to be supplied (a “hard” profile), a nominal amount to be supplied if doing so does not drive glucose out of a desired zone (“soft”), or a soft profile with a minimum amount of insulin to be delivered (“semi-soft”).

Abstract: A computer implemented method of determining a clinical variables utilizing an insulin pump that includes initiating blood glucose measurements, initiating ingestion of carbohydrates and receiving input data based on the blood glucose measurements and the ingestion of carbohydrates and utilizing the data to calculate clinical variables. The invention may include presenting instructions to a patient to take various actions and to input various data. The clinical variables determined may be stored in memory and then used to calculate insulin doses and to send a signal to an insulin pump to infuse the insulin dose calculated.

Abstract: A local extremum of a function ƒ is determined by computing a Jacobian of ƒ at a test point x by adding an imaginary part to x and a Hessian of ƒ by adding two imaginary parts to a multicomplex copy of x and extracting a third imaginary part. Solving a system of equations defined by the Jacobian and Hessian yields a delta; the process is repeated until convergence. This method is used in each of a series of time intervals to compute an insulin-delivery amount for an insulin pump. ƒ is a model-predictive-control cost function; x is a set of successive candidate insulin delivery amounts beginning from a selected time interval. A system includes a glucose monitor and a controller using glucose measurement data therefrom to determine an insulin delivery amount for a time interval by minimizing ƒ; an insulin pump provides insulin corresponding to the delivery amount.

Abstract: Some embodiments of an infusion pump system can be configured to provide improved safety monitoring features so that a user receives proper dosage amounts.

Abstract: A pump for delivering insulin to a user comprises a pump mechanism, an alarm and a timer and an alarm program in data communication with the alarm and the timer. The alarm program module is programmed to operate a plurality of types of alerts and to associate a predetermined interval of time and a predetermined event with a selected type of alert. An alarm signal can be generated by the alarm program module based on the predetermined event and interval.

Abstract: An integrated system for the monitoring and treating diabetes is provided, including an integrated receiver/hand-held medicament injection pen, including electronics, for use with a continuous glucose sensor. In some embodiments, the receiver is configured to receive continuous glucose sensor data, to calculate a medicament therapy (e.g., via the integrated system electronics) and to automatically set a bolus dose of the integrated hand-held medicament injection pen, whereby the user can manually inject the bolus dose of medicament into the host. In some embodiments, the integrated receiver and hand-held medicament injection pen are integrally formed, while in other embodiments they are detachably connected and communicated via mutually engaging electrical contacts and/or via wireless communication.

Abstract: An arrangement for administering a predetermined amount of a substance into an organism is presented. The arrangement includes a member adapted to provide information indicative of a tissue resistance against flow of a fluid containing the substance upon administration into the tissue and a controller adapted to adjust an administration characteristic of the fluid based on the information such as to achieve an intended absorption rate of the substance.

Abstract: Techniques for controlling an insulin pump include determining values for parameters selected from a group including a first prediction time horizon, a predicted glucose threshold (Goff) for turning the insulin pump off, a maximum shut off time within a time window, and duration of the time window. A safety rule is determined based on the maximum shut off time within the duration. Glucose readings are collected up to a current time. An expected current glucose value G and glucose temporal rate of change are determined based only on the glucose readings and a Kalman filter configured for noisy glucose readings. A glucose level (Gh1) is predicted for a future time that is the prediction time horizon after the current time. A command is issued to shut off the insulin pump if it is determined both that Gh1 is less than Goff and that the safety rule is satisfied.

Abstract: Drug-delivery systems for local drug delivery to kidneys and associated systems and methods are disclosed herein. One aspect of the present technology is directed to drug-delivery systems that include a physiological sensor, an implantable medical device, and a control module configured to communicate with the physiological sensor and to control delivery of a drug in response to a physiological parameter measured by the physiological sensor. The implantable medical device can be configured to be surgically implanted in a patient with a delivery opening at or near a renal capsule of a kidney of the patient. Suitable drugs for local delivery to a kidney can include diuretics, aldosterone antagonists, vasodilators, renin inhibitors, and combinations thereof. In some embodiments, local drug delivery to a kidney can be used to treat hypertension, heart failure, or another condition associated with renal activity.

Abstract: Methods, system and devices for monitoring a closed loop control operation including signal levels received from an analyte sensor and automatic delivery of medication at least in part in response to the received analyte sensor signals, determining whether the signal level received from the analyte sensor is associated with one of a fault condition or a potential fault condition, and dynamically adjusting a current infusion rate executed by the closed loop control operation when it is determined that the signal level from the analyte sensor is associated with one of the fault condition or potential fault condition, where medication delivery rate is adjusted to a first predetermined range when the signal level is associated with the fault condition, and adjusted to a second predetermined range when the signal level is associated with a potential fault condition, and where the first predetermined range is narrower compared to the second predetermined range are provided.

Abstract: A system and method for providing closed loop infusion formulation delivery which accurately calculates a delivery amount based on a sensed biological state by adjusting an algorithm's programmable control parameters. The algorithm calculates a delivery amount having proportional, derivative, and basal rate components. The control parameters may be adjusted in real time to compensate for changes in a sensed biological state that may result from daily events. Safety limits on the delivery amount may be included in the algorithm. The algorithm may be executed by a computing element within a process controller for controlling closed loop infusion formulation delivery. The biological state is sensed by a sensing device which provides a signal to the controller. The controller calculates an infusion formulation delivery amount based on the signal and sends commands to an infusion formulation delivery device which delivers an amount of infusion formulation determined by the commands.

Abstract: A method of administering insulin to a user is provided. The method comprises providing a system comprising a glucometer configured to analyze a blood sample, a remote computing device separate from the glucometer, and an insulin pump separate from the remote computing device and glucometer, analyzing, by the glucometer, a blood sample from a user, and communicating the results to the remote computing device, determining, by the remote computing device and based on the results, an insulin dosage to be administered, communicating, by the remote computing device, a command to the insulin pump to administer a dose of insulin based on the determined dosage, and administering, by the insulin pump, the dose.

Abstract: A drug delivery device for delivery of medicament having a delivery pump system and a cartridge system, the delivery pump system operating electromagnetically by driving two disk magnets that are housed within pump body inserts of the cartridge system. The displacement of the magnets and an elastomer membrane placed between the magnets of the cartridge system results in a volumetric change within two reservoirs and the flow of medicaments. The medicament flows from the reservoirs to the inlet/outlet members via the pump body inserts and discharged to a patient user's body through an infusion set.

Abstract: A system and method for providing closed loop infusion formulation delivery which accurately calculates a delivery amount based on a sensed biological state by adjusting an algorithm's programmable control parameters. The algorithm calculates a delivery amount having proportional, derivative, and basal rate components. The control parameters may be adjusted in real time to compensate for changes in a sensed biological state that may result from daily events. Safety limits on the delivery amount may be included in the algorithm. The algorithm may be executed by a computing element within a process controller for controlling closed loop infusion formulation delivery. The biological state is sensed by a sensing device which provides a signal to the controller. The controller calculates an infusion formulation delivery amount based on the signal and sends commands to an infusion formulation delivery device which delivers an amount of infusion formulation determined by the commands.

Abstract: An infusion system, which may be a closed loop, or “semi-closed-loop”, infusion system, uses state variable feedback to control the rate at which fluid is infused into a user's body. The closed loop system includes a sensor system, a controller, and a delivery system. The “semi-closed-loop” system further includes prompts that provide indications to the user prior to fluid delivery. The sensor system includes a sensor for monitoring a condition of the user and produces a sensor signal which is representative of the user's condition. The delivery system infuses a fluid into the user at a rate dictated by the commands from the controller. The system may use three state variables, e.g., subcutaneous insulin concentration, plasma insulin concentration, and insulin effect, and corresponding gains, to calculate an additional amount of fluid to be infused with a bolus and to be removed from the basal delivery of the fluid.

Abstract: A system and method for providing closed loop infusion formulation delivery which accurately calculates a delivery amount based on a sensed biological state by adjusting an algorithm's programmable control parameters. The algorithm calculates a delivery amount having proportional, derivative, and basal rate components. The control parameters may be adjusted in real time to compensate for changes in a sensed biological state that may result from daily events. Safety limits on the delivery amount may be included in the algorithm. The algorithm may be executed by a computing element within a process controller for controlling closed loop infusion formulation delivery. The biological state is sensed by a sensing device which provides a signal to the controller. The controller calculates an infusion formulation delivery amount based on the signal and sends commands to an infusion formulation delivery device which delivers an amount of infusion formulation determined by the commands.

Abstract: In one embodiment, a miniaturized wearable nuclear magnetic resonance (NMR) apparatus is described. The example NMR apparatus accesses data (e.g., table, mathematical expression) that describes a relation between a nuclear magnetic resonance (NMR) signal decay rate and a known concentration of glucose in a fluid. The NMR apparatus acquires, non-invasively and in-vivo, an observed NMR signal decay rate from a fluid in a patient, and estimates a concentration of glucose in the fluid in the patient by comparing the observed NMR signal decay rate with the data that describes the relation between the NMR signal decay rate and the known concentration of glucose. The data may be generic to a population and a class of devices or may be customized to an individual patient and an individual device.

Abstract: In example methods and systems described, a medical device can store information locally and in a separate database on a server, for example. If the device fails, or a patient is moved to a second device, information may be transferred to the second device such that the second device can resume a complex therapy at a point where the initial medical device left off. The data necessary to restart the complex therapy system may include certain underlying patient-specific parameters according to a model capturing the patient's physiological response to the medication in question. As a result, it is not necessary for the second device to restart the complex therapy or regress to an initial set of baseline assumptions.

Abstract: Described and illustrated is a system for management of diabetes that includes an infusion pump, glucose sensor and controller with a method programmed into the controller. The infusion pump is configured to deliver insulin to a subject. The glucose sensor is configured to sense glucose levels in the subject and provide output signals representative of the glucose levels in the subject. The controller is programmed to switchover from one mode of MPC control based on a predetermined range of blood glucose values to another MPC mode based on a predetermined target.

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: A method, computer implemented method and associated apparatus for the management of diabetes comprises utilizing zone model predictive control (Zone-MPC) to control delivery of an insulin or insulin analog within a zone of desired values.

Abstract: Described and illustrated is a system for management of diabetes that includes an infusion pump, glucose sensor and controller with a method programmed into the controller. The infusion pump is configured to deliver insulin to a subject. The glucose sensor is configured to sense glucose levels in the subject and provide output signals representative of the glucose levels in the subject. The controller is programmed receives signals from at least one of the glucose sensor and the pump and configured to issue signals to the pump to deliver an amount of insulin determined by a feedback controller that utilizes a model predictive control of the subject based on desired glucose levels, insulin amount delivered and measured glucose levels of the subject. The controller is also configured to deliver insulin using a tuning factor based on either one of an omission index module or a calibration index module.

Abstract: Devices, systems and methods useable for dilating the ostia of paranasal sinuses and/or other passageways within the ear, nose or throat. A dilation catheter device and system is constructed in a manner that facilitates ease of use by the operator and, in at least some cases, allows the dilation procedure to be performed by a single operator. Additionally, the dilation catheter device and system may be useable in conjunction with an endoscope and/or a fluoroscope to provide for easy manipulation and positioning of the devices and real time visualization of the entire procedure or selected portions thereof. In some embodiments, an optional handle may be used to facilitate grasping or supporting a device of the present invention as well as another device (e.g., an endoscope) with a single hand.

Abstract: A system, method and apparatus for real time measurement and monitoring of various personal health parameters including controlled delivery of drugs/medications by intelligent pump appliances, intelligent inhalation appliances and intelligent skin patch appliances used in a standalone manner or in a wired or wireless networked configuration, in conjunction with various peripheral devices, other intelligent appliances, servers, RF ID Tags and stationary/mobile devices. The intelligent appliances relate to the measurement, monitoring and delivery of insulin/other drugs for the treatment of diabetes and other diseases. The method also additionally includes the application of intelligent appliances for pain management including visualization of organs and body locations exhibiting pain.

Abstract: Methods, system and devices for monitoring control parameters in a closed loop control operation including continuously monitoring glucose level and automatic administration of a medication, detecting a condition associated with hypoglycemia, determining whether a probability of the detected condition associated with hypoglycemia exceeding a threshold level, and outputting a notification based upon the determination are provided.

Abstract: A computer-implemented method is presented for synchronizing time between two handheld medical devices that interoperate with each other. The method includes: determining a first time as measured by a first clock residing in the first medical device; determining a second time as measured by a second clock residing in a second medical device; evaluating whether the first clock is synchronized with the second clock; determining whether at least one of the first clock and the second clock was set manually by a user; and setting time of the first clock in accordance with the second time when the second clock was set manually by the user.

Abstract: Systems and methods for integrating a continuous glucose sensor, including a receiver, a medicament delivery device, and optionally a single point glucose monitor are provided. Manual integrations provide for a physical association between the devices wherein a user (for example, patient or doctor) manually selects the amount, type, and/or time of delivery. Semi-automated integration of the devices includes integrations wherein an operable connection between the integrated components aids the user (for example, patient or doctor) in selecting, inputting, calculating, or validating the amount, type, or time of medicament delivery of glucose values, for example, by transmitting data to another component and thereby reducing the amount of user input required. Automated integration between the devices includes integrations wherein an operable connection between the integrated components provides for full control of the system without required user interaction.

Abstract: An infusion device comprising a fluid reservoir for containing a therapeutic fluid; and a transcutaneous access tool fluidly coupled to the fluid reservoir for delivering the therapeutic fluid subcutaneously and for introducing a monitoring test strip subcutaneously, and methods of use thereof.

Abstract: Disclosed are methods, apparatuses, etc. for glucose sensor signal purity analysis. In certain example embodiments, a series of samples of at least one sensor signal that is responsive to a blood glucose level of a patient may be obtained. Based at least partly on the series of samples, at least one metric may be determined to characterize one or more non-physiological anomalies of a representation of the blood glucose level of the patient by the at least one sensor signal. A reliability of the at least one sensor signal to represent the blood glucose level of the patient may be assessed based at least partly on the at least one metric. Other example embodiments are disclosed herein.

Abstract: Methods, system and devices for monitoring a closed loop control operation including signal levels received from an analyte sensor at a predetermined frequency, determining a variation in the monitored analyte level, determining a medication delivery rate adjustment frequency to deliver a medication based on the determined variation in the monitored analyte level, and adjusting the closed loop control operation to modify the medication delivery rate frequency are provided.

Abstract: Systems and methods for integrating a continuous glucose sensor 12, including a receiver 14, a medicament delivery device 16, a controller module, and optionally a single point glucose monitor 18 are provided. Integration may be manual, semi-automated and/or fully automated.

Abstract: Embodiments of the invention provide analyte sensors having optimized elements and/or configurations of elements as well as methods for making and using such sensors. Typical embodiments of the invention include glucose sensors used in the management of diabetes.

Abstract: A portable drug administration device includes a pump and a controller configured to control operation of the pump according to a standard administration mode and a suspend mode in which drug administration is temporarily suspended. The device is configured to generate an event trigger on the occurrence of at least one of an error condition and/or the beginning of a maintenance action by the user. The controller is configured to detect the occurrence of the event trigger, and to store, in response to the event trigger, administration data, the administration data comprising all information that characterizes the current administration according at the time of occurrence of the event trigger automatically in a memory and to switch the device from the standard administration mode to the suspend mode.

Abstract: A pump for delivering insulin to a user. The pump comprises a pump mechanism and a meal-bolus program module. The meal-bolus program module is programmed to control the pump mechanism to deliver a meal bolus. An alarm program module is in data communication with the alarm, the timer, and the meal-bolus program module. The alarm module is programmed to generate an alarm signal when the meal-bolus program module does not control the pump mechanism to deliver a meal bolus within a predetermined period of time.

Abstract: Some embodiments of a wearable infusion pump system can include a pump device having a drive system to dispense a medicine to a user, an activity sensor that detects a possible change in an activity level of the user, and a controller to activate the drive system to dispense the medicine to the user. The controller device can query the user to indicate whether a detected activity level of the user represents an actual change in the activity level of the user. The controller device can alter the medicine dispensing schedule based on the user indicated changes in activity level.

Abstract: A closed-loop system for insulin infusion overnight uses a model predictive control algorithm (“MPC”). Used with the MPC is a glucose measurement error model which was derived from actual glucose sensor error data. That sensor error data included both a sensor artifacts component, including dropouts, and a persistent error component, including calibration error, all of which was obtained experimentally from living subjects. The MPC algorithm advised on insulin infusion every fifteen minutes. Sensor glucose input to the MPC was obtained by combining model-calculated, noise-free interstitial glucose with experimentally-derived transient and persistent sensor artifacts associated with the FreeStyle Navigator® Continuous Glucose Monitor System (“FSN”).

Abstract: Method and system for providing basal profile modification in insulin therapy for use with infusion devices includes periodically monitoring the analyte levels of a patient for a predetermined period of time in order to determine, based on the monitored analyte levels, an appropriate modification factor to be incorporated into the underlying basal profile which was running at the time the periodic monitoring of the analyte levels were performed.

Abstract: Processor-implemented methods of controlling an insulin infusion device for a user are provided here. A first method obtains and analyzes calibration factors (and corresponding timestamp data) for a continuous glucose sensor, and regulates entry into a closed-loop operating mode of the infusion device based on the calibration factors and timestamp data. A second method obtains a most recent sensor glucose value and a target glucose setpoint value for the user at the outset of the closed-loop mode. The second method adjusts the closed-loop insulin infusion rate over time, in response to the sensor glucose value and the setpoint value. A third method calculates an upper insulin limit that applies to the insulin infusion rate during the closed-loop mode. The insulin limit is calculated based on a fasting blood glucose value of the user, a total daily insulin value of the user, and fasting insulin delivery data for the user.

Abstract: An electronic controller for an insulin infusion device includes at least one processor device and at least one memory element that cooperate to provide a processor-implemented closed-loop initiation module. The initiation module is operated to obtain a most recent calibration factor for a continuous glucose sensor, the most recent calibration factor representing a first conversion value applicable to convert a first sensor value to a first blood glucose value. The initiation module also obtains a prior calibration factor for the sensor, and calibration timestamp data for the most recent calibration factor and the prior calibration factor. The initiation module regulates entry into a closed-loop operating mode of the insulin infusion device, based on the most recent calibration factor, the prior calibration factor, and the calibration timestamp data.

Abstract: A controller for an insulin infusion device includes at least one processor device and at least one memory element that cooperate to provide a processor-implemented closed-loop start-up module. The start-up module is operated to initiate a closed-loop mode of the infusion device and to obtain a most recent sensor glucose value for the user. The start-up module also calculates a difference between the most recent sensor glucose value and a target glucose setpoint value. When the difference is less than or equal to a threshold value, the closed-loop insulin infusion rate is adjusted over time, based on a fixed final target glucose value that is derived from the target glucose setpoint value. When the difference is greater than the threshold, the infusion rate is adjusted over time, based on a dynamic final target glucose value that decreases over time toward the target glucose setpoint value.

Abstract: A controller for an insulin infusion device includes a processor device and a memory element that cooperate to provide a processor-implemented closed-loop insulin limit module. The insulin limit module is operated to obtain: a fasting blood glucose value of a user; a total daily insulin value of the user; and fasting insulin delivery data that is indicative of insulin delivered to the user during a fasting period. The insulin limit module calculates a maximum insulin infusion rate for the user based on the fasting blood glucose value, the total daily insulin value, and the fasting insulin delivery data. The maximum insulin infusion rate is applicable during a period of closed-loop operation of the insulin infusion device.

Abstract: An electronic device includes a processor architecture and a memory element that stores instructions that, when executed by the processor architecture, perform a method of controlling an insulin infusion device for a user. The method operates the device in a closed-loop mode to deliver insulin to the user, obtains current insulin-delivered data and current glucose sensor data for the user, and processes historical insulin-delivered data and historical sensor data, to obtain predicted sensor glucose values for a historical time period. The method continues by calculating a difference between the current sensor glucose value and a predicted current sensor glucose value for the most recent sampling period. An alert is generated when the difference exceeds a threshold error amount.

Abstract: Various systems and methods for improving the usability of continuous glucose monitors and drug delivery pumps are described.

Abstract: Processor-implemented methods of controlling an insulin infusion device for a user are provided here. A first method obtains a current insulin on board (IOB) value that estimates active insulin in the user, and compensates a calculated insulin infusion rate in response to the obtained IOB value. A second method supervises the operation of a glucose sensor by obtaining and processing insulin-delivered data and glucose sensor data for the user. An alert is generated if the second method determines that a current glucose sensor value has deviated from a predicted sensor glucose value by at least a threshold amount.