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 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.

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 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: 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: 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: 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: A method of delivering insulin to compensate for suspension of basal insulin delivery and an insulin pump are disclosed. The method includes prompting a user to input a period in which to suspend delivery of insulin from an insulin pump. The method also includes calculating an amount of insulin to be delivered during the period. The method further includes prompting the user to select a portion of the amount of insulin. The method includes delivering the portion of the amount of insulin to the patient. The method also includes suspending basal delivery of insulin from the pump.

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: 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: 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: 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: 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: Glucose sensor signals and medication delivery control signals are monitored and these signals are modified for compatibility and safety purposes. In one application, output control signals from a controller directed to a delivery device are modified as a function of an actual amount of insulin delivered to the user. The safety layer method allows for an increased level of safety in an integrated delivery management (“IDM”) system and permits the development of separate hardware and software upgrades for components of the IDM system while assuring that compatibility between components will continue and safety is increased.

Abstract: A system and method for automatically adjusting parameters for predicting blood glucose levels and/or controlling the dispensing of insulin. In one embodiment, the system is a stand-alone system. In one embodiment, the system is part of a system for controlling the dispensing of insulin.

Abstract: Stabilized glucagon solutions, methods of storing and using the stabilized glucagon solutions, and drug delivery devices containing the stabilized glucagon solutions. In some embodiments, the glucagon solutions may be alkaline, such as with a pH of at least about 9. The glucagon solutions may be resistant to aggregation of glucagon when the solutions are stored for a prolonged period, such as at least about three days, at room temperature and/or physiological temperature.

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: 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: Described and illustrated is a diabetes management system 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 receive 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 and also configured to deliver at least the basal amount of insulin whenever the subject has initiated a manual bolus of insulin and a sensed or measured glucose level is at least a first threshold within a first duration of time.

Abstract: A method, computer usable program product, or a system for managing a blood glucose level of a person including providing a device worn exterior to the person for monitoring a set of treatment factors and a set of environmental factors associated with the person, predicting a blood glucose level for the person based on the set of treatment factors and the set of environmental factors, and responsive to predicting a blood glucose level for the person dropping lower than a predetermined minimum value, supplying carbohydrates to the person.

Abstract: An electronic computing device as presented here includes a device communications layer, a processor device, and a reporting layer. The device communications layer receives sensor data for a user of an insulin infusion device, wherein the sensor data indicates blood glucose levels of the user for a specified period of time, and over a plurality of days. The processor device analyzes the received sensor data to detect an event occurrence indicative of a correctable basal rate setting of the insulin infusion device. The reporting layer generates a report containing a graphical representation of the received sensor data and a recommendation to adjust a basal rate setting of the insulin infusion device, wherein the recommendation is intended to address the detected event occurrence.

Abstract: A method of managing use of an insulin infusion device are provided. The method receives glucose data for a user of the infusion device, wherein the glucose data indicates blood glucose levels of the user for a period of time during which the insulin infusion device is regulating delivery of insulin to the user. The received glucose data is received to detect certain event occurrences, which may be indicative of a correctable basal rate setting of the insulin infusion device and/or indicative of potential maladjustment of a user-specific setting of a bolus calculator setting of the insulin infusion device. The method outputs a recommendation to adjust the basal rate setting and/or the bolus calculator setting as needed to address the detected event occurrences.

Abstract: An environmentally sensitive hydrogel material swells or collapses in response to a parameter such as pH level associated with consumption of food by a patient. This swelling or collapsing is harnessed to treat morbid obesity or some other condition of the patient. The swelling or collapsing of the hydrogel may be used to tighten a gastric band or gastric valve when the patient starts eating; then loosen the band or valve when the patient is between meals. The swelling or collapsing of the hydrogel may also be used to increase the size of a space occupying device in the patient's stomach when the patient starts eating; then decrease the size of the space occupying device when the patient is between meals. The swelling or collapsing of the hydrogel may also be used to selectively restrict the absorption of nutrients within a patient's gastrointestinal tract, such as in the duodenum.

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

Abstract: Method and apparatus for performing a discrete glucose testing and bolus dosage determination including a glucose meter with bolus calculation function are provided.

Abstract: Wound compression dressings of the invention comprise: an elastic layer comprising an extensible material having recovery of greater than 90% when tested according to ASTM D412 at elongations up to about 150%; an adhesive layer on at least a portion of a first side of the elastic layer; and a release layer on at least a portion of a second side of the elastic layer opposite from the first side thereof. According to a method of providing direct compression to a wound, a wound compression dressing of the invention is provided, and the wound compression dressing is wrapped around the wound to provide the direct compression to the wound.

Abstract: A modular external infusion device that controls the rate a fluid is infused into an individual's body, which includes a first module and a second module. More particularly, the first module may be a pumping module that delivers a fluid, such as a medication, to a patient while the second module may be a programming module that allows a user to select pump flow commands. The second module is removably attachable to the first module.

Abstract: An aspect of an embodiment or partial embodiment of the present invention (or combinations of various embodiments in whole or in part of the present invention) comprises, but not limited thereto, a method and system (and related computer program product) for continually assessing the risk of hypoglycemia for a patient and then determining what action to take based on that risk assessment. A further embodiment results in two outputs: (1) an attenuation factor to be applied to the insulin rate command sent to the pump (either via conventional therapy or via open or closed loop control) and/or (2) a red/yellow/green light hypoglycemia alarm providing to the patient an indication of the risk of hypoglycemia. The two outputs of the CPHS can be used in combination or individually.

Abstract: Methods, system and devices for monitoring a plurality of parameters associated with a closed loop control operation including continuously monitoring a physiological condition and automatic administration of a medication, detecting an adverse condition associated with the monitored physiological condition or the medication administration deviating from a predetermined safety level of the closed loop control operation, and initiating a non-zero pre-programmed medication delivery rate are provided.

Abstract: Method and system for providing an integrated analyte monitoring system and on-body patch pump with multiple cannulas and a sensor combination is provided.

Abstract: Systems and methods are disclosed for adjusting the delivery times of an insulin delivery profile of an insulin pump, wherein the insulin pump is operable to automatically deliver insulin to a person having diabetes based on an operating time of the internal clock and a delivery time of an insulin delivery profile. The method may comprise receiving a local time zone time from an external local clock, determining whether the operating time of the internal clock differs from the local time zone time by at least a first predetermined amount of time, requesting the person provide a time adjustment value when the operating time of the internal clock differs from the local time zone time by at least the first predetermined amount of time, receiving the time adjustment value from the person, and adjusting the delivery times of the insulin delivery profile based on the time adjustment value when received.

Abstract: Embodiments of the present disclosure include methods, systems and devices for selecting a bolus configuration and may include one or more of providing a user interface for selection of one or more user interface elements, where each element corresponds to a bolus configuration of a drug, each element is spatially positioned within a multi-dimensional space corresponding to at least three dimensions and the element's position corresponding to each dimension.

Abstract: Disclosed are methods and apparatus for determining analyte concentration in a sample such as bodily fluid. Systems and methods disclosed herein can also include a treatment dosing system to infuse or inject a treatment drug (e.g., insulin or glucose) and provide glycemic control. The dose of the treatment drug may be based on the concentration of the analyte or the average value for the concentration of the analyte and/or the rate of change of the value of the concentration of the analyte.

Abstract: In example methods and systems described, insulin therapy for a patient can be determined. At least one of a short-acting subcutaneous insulin dosage recommendation, a correction subcutaneous insulin dosage recommendation, an intravenous insulin dosage recommendation, a recommended amount of carbohydrates to be administered to the patient, or combinations thereof, can be determined. In addition, information indicating a confirmation of a nutrition intake for the patient, and a long-acting insulin-on-board for the patient can be received, and based on this information, a required long-acting subcutaneous or intravenous insulin dosage for the patient can be determined. The short-acting subcutaneous or intravenous insulin dosage recommendation can be adjusted based, at least in part, on a difference between the long-acting insulin-on-board and the required long-acting subcutaneous or intravenous insulin dosage.

Abstract: A system and method for monitoring and delivering medication to a patient includes a controller that has a control algorithm and a closed loop control that monitors the control algorithm. A sensor is in communication with the controller and monitors a medical condition. A rule base application in the controller receives data from the sensor and the closed loop control and compares the data to predetermined medical information to determine the risk of automation of therapy to the patient. The controller then provides a predetermined risk threshold where below the predetermined risk threshold automated closed loop medication therapy is provided. If the predetermined risk threshold is met or exceeded, automated therapy adjustments may not occur and user/clinician intervention is requested.

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: Systems, devices, and methods for monitoring an analyte in a subject.

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 handheld diabetes managing device that provides a secure and efficient communication link between an insulin pump and an external computing device. The handheld diabetes managing device can include a blood glucose meter, a processor and first and second communication modules. The handheld diabetes managing device can be configured to deliver data between an insulin pump and an external computing device over a secure communication path without a direct communication link between the insulin pump and the external computing device. The secure communication path can include a first secure bidirectional communication link between the handheld diabetes managing device and the insulin pump and a second secure bidirectional communication link between the handheld diabetes managing device and the external computing device.

Abstract: A closed loop/semi-closed loop infusion system provides therapy modification and safeguards against the over-delivery or under-delivery of insulin. A glucose sensor system is configured to obtain a measured blood glucose value. A controller is operationally connected with the glucose sensor system and configured to trigger an alarm based on a measured blood glucose value or amount of insulin delivered, selectively perform calibration of the glucose sensor system when the alarm is triggered, and adjust a therapy delivery parameter when the alarm is triggered, wherein the adjusted therapy delivery parameter is limited to be within a boundary. Thereafter, a delivery system delivers therapy at the adjusted therapy delivery parameter.

Abstract: Disclosed are methods and apparatus for determining analyte concentration in a sample such as bodily fluid. Systems and methods disclosed herein can also include a treatment dosing system to infuse or inject a treatment drug (e.g., insulin or glucose) and provide glycemic control. The dose of the treatment drug may be based on the concentration of the analyte or the average value for the concentration of the analyte and/or the rate of change of the value of the concentration of the analyte.

Abstract: A disease management system, methods, and devices are shown and described. In one embodiment, the system includes an infusion pump and a remote controller with the ability to be paired to each other. A method to verify a wireless connection between an infusion pump and a remote controller is shown and described herein. In a further embodiment, a method to verify a wireless connection between an infusion pump and a remote controller is provided. In addition, a method of operating a diabetes management system is provided in which the system includes an infusion pump and at least a remote controller.

Abstract: An apparatus for delivering a bolus of a medical agent to a patient. The apparatus comprises a pump mechanism, a data input device, and a processor in data communication with the keypad and arranged to control the pump mechanism. The processor is programmed to receive data specifying a bolus amount through the data port, receive data regarding duration through the data port, receive a percentage through the data port, the percentage defining a portion of the bolus amount to deliver immediately upon executing a deliver command and a remainder of the bolus amount to deliver over the duration upon executing a deliver command, and execute the deliver command thereby controlling the pump mechanism to deliver the bolus. Also a method of temporarily adjusting the delivery rate of an infusion pump. The infusion pump is programmed to deliver a basal rate.

Abstract: A diabetes care kit for providing diagnostics and therapy that is preconfigured to reduce initial setup by a user. The kit can include a handheld diabetes managing device and insulin pump. The handheld diabetes managing device and insulin pump can each be preloaded with an encryption key such that the handheld diabetes managing device and the insulin pump are paired and a secure bidirectional communication link exists between the handheld diabetes managing device and the insulin pump.

Abstract: An insulin delivery supervisor (IDS) with a safety analysis and supervision function that can reside between the insulin request and the insulin delivery and can intercept any excessive insulin requests before the insulin was delivered. The IDS can be implemented in any system based on insulin pump or pen and will work with either SMBG or CGM modes of blood glucose monitoring.

Abstract: A needle-free transdermal transport device for transferring a substance across a surface of a biological body includes a reservoir for storing the substance, a nozzle in fluid communication with the reservoir and a controllable electromagnetic actuator in communication with the reservoir. The actuator, referred to as a Lorentz force actuator, includes a stationary magnet assembly and a moving coil assembly. The coil assembly moves a piston having an end portion positioned within the reservoir. The actuator receives an electrical input and generates in response a corresponding force acting on the piston and causing a needle-free transfer of the substance between the reservoir and the biological body. The magnitude, direction and duration of the force are dynamically controlled (e.g., servo-controlled) by the electrical input and can be altered during the course of an actuation cycle. Beneficially, the actuator can be moved in different directions according to the electrical input.

Abstract: Glucose sensor signals and medication delivery control signals are monitored and these signals are modified for compatibility and safety purposes. In one application, output control signals from a controller directed to a delivery device are modified as a function of an actual amount of insulin delivered to the user. The safety layer method allows for an increased level of safety in an integrated delivery management (“IDM”) system and permits the development of separate hardware and software upgrades for components of the IDM system while assuring that compatibility between components will continue and safety is increased.

Abstract: A medical device system includes at least one controllable patient-worn or patient-carried medical device, and a plurality of controller devices that are capable of independently controlling features or functions of the patient medical device. Control commands and other data is wirelessly communicated among the patient medical device and the multiple controller devices. A number of techniques, protocols, and other measures are provided to coordinate wireless communication between the various devices in a medical device system. These control command coordination processes address situations where conflicting, redundant, or concurrent control commands might be independently issued by the multiple controller devices.

Abstract: A modular external infusion device that controls the rate a fluid is infused into an individual's body, which includes a first module and a second module. More particularly, the first module may be a pumping module that delivers a fluid, such as a medication, to a patient while the second module may be a programming module that allows a user to select pump flow commands. The second module is removably attachable to the first module.