Abstract: An infusion pump system can operate to control dispensation of medicine according to a closed-loop delivery mode and according to an open-loop delivery mode. In the closed-loop delivery mode, the system can determine user-specific settings. In the open-loop delivery mode, the system can determine insulin dosages for dispensation based at least in part on the user-specific settings that were determined during the closed-loop delivery mode.

Abstract: A therapeutic product delivery device is described which comprises a device body and a cartridge for holding a therapeutic product. An engagement structure is provided for releasably engaging the cartridge with the device body. A fault detector is provided for detecting a fault in the delivery of the therapeutic product from the cartridge. A release trigger is responsive to the detection of a fault to cause the engagement structure to release the cartridge from the device body. In this way, a fault causes the cartridge to be released from the device body, which will prevent any further delivery of the therapeutic product to the patient. This solution is strongly preferable to a solution in which a product delivery mechanism (e.g. a pump) is merely paused or stopped, since when the cartridge separates then no further delivery is possible at all, until the cartridge is reattached (or more probably replaced with a new cartridge in case the fault is with the cartridge).

Abstract: A method and system of determining a basal rate adjustment of insulin in a continuous glucose monitoring system of a person with diabetes is provided. The method includes receiving, by at least one computing device, a signal representative of at least one glucose measurement; detecting, by the at least one computing device, a glucose state of the person based on the signal, the detected glucose state including a glucose level of the person and a rate of change of the glucose level; determining, by the at least one computing device, a current risk metric, the current risk metric indicating a risk of at least one of a hypoglycemic condition and a hyperglycemic condition of the person; and calculating, by the at least one computing device, an adjustment to a basal rate of a therapy delivery device based on the current risk metric and a control-to-range algorithm comprising at least one aggressiveness parameter.

Abstract: Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of alerting a user associated with an infusion device delivering fluid to the body of the user involves obtaining a measurement value for a physiological condition being influenced by the fluid, obtaining a current amount of active fluid in the body of the user, determining a homeostasis metric based at least in part on the current amount of active fluid and the measurement value for the physiological condition, and generating an alert based at least in part on the homeostasis metric.

Abstract: Alarming cables, assemblies and systems for displaying and protecting a powered article of merchandise from theft include an alarm unit disposed between a first cable having a first connector for connection to a power source and a second cable having a second connector for connection to the merchandise. An alarm unit connector may connect the second cable to the alarm unit. The alarm unit and the alarm unit connector may each include a connection member to electrically connect the merchandise with the alarm unit and the power source when the alarm unit connector aligns with and engages the alarm unit.

Abstract: An operating method of an electronic device may include detecting that a strap with a blood sugar measuring device has been connected to the electronic device, receiving blood sugar related data from the blood sugar measuring device, and executing a health application based on the received data.

Abstract: Embodiments of the present disclosure provide techniques and configurations for an apparatus to reduce sensor power consumption, in particular, through predictive data measurements by one or more sensors. In one instance, the apparatus may include one or more sensors and a sensor management module coupled with the sensors and configured to cause the sensors to initiate measurements of data indicative of a process in a first data measurement mode, determine a pattern of events comprising the process based on a portion of the measurements collected by the sensors in the first data measurement mode over a time period, and initiate measurements of the data by the one or more sensors in a second data measurement mode. The second data measurement mode may be based on the pattern of events comprising the process. The pattern may indicate a prediction of appearance of events in the process. Other embodiments may be described and/or claimed.

Abstract: A system and method for automatically administering insulin based on a feedforward control. The automatic insulin delivery system may include a computing device comprising a processor, machine readable non-transitory media which stores the coupled-model of the invention, and a monitoring system. The machine readable transitory media may be configured to receive one or more inputs and the coupled-model may utilize a feedforward control to parameterize the inputs and generate an output that can be translated to a type and amount of insulin to be administered by the system. The input(s) received by the machine readable non-transitory media may be created by a user or received from one or more sensors. The method may include providing a model that is stored on a machine readable non-transitory media and administering insulin based on the output provided by the model.

Abstract: Infusion systems, infusion devices, and related operating methods are provided. An exemplary method involves operating an infusion device to deliver fluid to a user in accordance with a first operating mode of a plurality of operating modes, obtaining operational information pertaining to the first operating mode, and obtaining clinical information pertaining to the user. A destination operating mode of the plurality of operating modes is determined based at least in part on the operational information and the clinical information, and the infusion device is operated to deliver the fluid in accordance with the destination operating mode in a manner that is influenced by at least a portion of the operational information pertaining to the first operating mode.

Abstract: A method of administering insulin includes receiving subcutaneous information for a patient at a computing device and executing a subcutaneous outpatient program for determining recommended insulin dosages. The subcutaneous outpatient program includes obtaining blood glucose data of the patient from a glucometer in communication with the computing device, aggregating blood glucose measurements to determine a representative aggregate blood glucose measurement associated with at least one scheduled blood glucose time interval, and determining a next recommended insulin dosage for the patient based on the representative aggregate blood glucose measurement and the subcutaneous information. The method also includes transmitting the next recommended insulin dosage to a portable device associated with the patient. The portable device displays the next recommended insulin dosage.

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: Some embodiments an infusion pump system can be configured to control dispensation of medicine according to a closed-loop delivery mode that is responsive to feedback information provided from a monitoring device, and the infusion pump system permits a user to interrupt the closed-loop delivery mode for purposes of dispensing a user-selected manual bolus dosage.

Abstract: Techniques are used for adaptation of drug-administration parameters that control insulin delivery in a blood glucose control system. One technique provides long-term adaptation of a nominal basal infusion rate, adapting to longer-term changes in a patient's needs due to growth, illness, hormonal fluctuations, physical activity, aging, etc. Another technique provides adaptation of priming dose size at mealtimes for overall better glycemic control and also adapting to longer-term changes in a patient's needs. Adaptation calculations use a receding-horizon window of recent values of the adapted parameter. Doses of a counter-regulatory agent (e.g., glucagon) may also be delivered in response to information about estimated accumulation of exogenously infused insulin (subcutaneously, intramuscularly, intraperitoneally, or intravenously) and/or the effect insulin might have on glucose levels (blood glucose concentration or interstitial fluid glucose concentration).

Abstract: A glycemic control system includes a physician processor, remote processor, and a portable telephone having a data input mechanism, a display, and an internal processor for bi-directional communication with the physician's processor and the remote processor. A patient inputs data to the internal processor responsive to input from the physician's processor and then transmits the information to the remote processor where an optimized number of units to be administered is sent back and displayed on the portable telephone.

Abstract: A kit for individualized intravenous exogenous insulin-based therapy, which includes a portable data storage in communication with client device processor. The data storage can have computer instructions, a database of metabolic factors, a library of weight management protocols, a diabetic treatment model, and a library of care plan templates. The kit for individualized intravenous exogenous insulin-based therapy includes a blood glucose meter, a plurality of intravenous catheters fluidly engageable with a fluid source, and a plurality of metabolic enhancements.

Abstract: An analysis device is proposed for detecting an analyte in a liquid sample, in particular for detecting glucose in a bodily fluid. The analysis device comprises at least one control element, which is configured to provide a function menu with at least two menu items. The analysis device further comprises at least one adjustable selector element, in particular a mechanically adjustable selector element, which can be adjusted by a user to at least two different selection positions. The selector element is configured to remain in the adjusted selection position after being adjusted. The control element is configured to select a menu item corresponding to the adjusted selection position. The analysis device further comprises at least one operating element. At least one parameter in the selected menu item can be influenced by the user via the operating element.

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: In a blood sugar level measuring device, a blood-sugar-level predicting unit predicts a blood sugar level of a user. A light emitting unit irradiates measurement light to the inside of a living organism of the user. A light-emission control unit, a measurement-point-candidate setting unit, a light-amount-control-method determining unit, and a measurement-point selecting unit control a light amount of measurement light per one measurement on the basis of the predicted blood sugar level. A light-reception control unit, a light-absorption-spectrum generating unit, and a blood-sugar-value calculating unit receive reflected light from the user and measure a blood sugar level.

Abstract: A system for improving medical device management for a patient is also provided. The system can include a portable wireless device having an ECU, memory and an interactive remote patient monitoring module (IRPMM) for at least one medical device. The IRPMM has a medical device data request module that is operable to request and receive medical device data input from the at least one medical device. The medical device data can be input by the patient, or in the alternative, be automatically received without input from the patient. The IRPMM also has a medical device data supply module receives medical device information from an outside third party and provides the medical device information to the patient.

Abstract: A system that requests clinical data from a patient and then provides the clinical data wirelessly to be reviewed or analyzed with a certified medical algorithm and/or decision tree. The certified algorithm and/or decision tree can provide a summary of the data, indication of severity, “smart” decision or intervention protocol to a nurse, doctor, and the like. In addition, the system with the certified algorithm and/or decision tree can provide the summary of the data, indication of severity, “smart” decision or intervention protocol to the nurse, doctor, and the like within a short time frame, e.g. within 5 minutes from the data being provided by the patient. The certified decision and/or protocol can be agreed to or changed by an individual, e.g. a doctor, which can then be forwarded or sent back to the patient. If the patient doesn't respond to the certified decision within a short time frame, e.g. within 3 minutes from the data being provided to the patient, then a series of triggers can take place, e.g.

Abstract: Methods and systems for controlling analyte levels are described. An example method may include receiving a sensor measurement relating to an eye-mountable device. The method also may include determining an analyte concentration based on the one or more sensor measurements, and comparing the analyte concentration to a target analyte concentration. Based on the comparing, the method further may include providing instructions to a drug delivery device, where the instructions are configured to control a drug delivery rate by the drug delivery device.

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: Novel tools and techniques for assessing, predicting and/or estimating effectiveness of fluid resuscitation of a patient and/or an amount of fluid needed for effective resuscitation of the patient, in some cases, noninvasively.

Abstract: In one embodiment, an IDDC system utilizes an intelligent therapeutic agent delivery system comprised of one, but more likely an array of “cells” containing therapeutic agent(s) and/or diagnostic agents(s); an integrated bio-sensing system designed to sample and analyze biological materials using multiple sensors that include both hardware and software components. The software component involves biomedical signal processing to analyze complex liquid mixtures and a microcontrollers) acts as interface to the biosensors, to the therapeutic delivery elements, and to a communications system(s) for the purpose of controlling the amount of therapeutic agent to deliver and also to provide information in a useful form to interested parties on the progress of therapy and compliance thereto.

Abstract: The present invention is directed to an electrochemical sensor involving an electrode and a coating that surrounds the electrode, the coating comprising a structural component, a water immiscible solvent, a resistance decreasing component, and an ion exchange component, wherein the coating selectively partitions an electrochemically active drug from a fluid or vapor sample whereby an electrochemical signal within the coating can be measured using the electrode. Devices and methods for using this electrochemical sensor are also disclosed.

Abstract: An integrated diabetes management (IDM) system includes a safety layer which, in one configuration has two components, one located between a glucose sensor and a controller and a second component located between a controller and a pump, to monitor various aspects of signals and modify those signals for compatibility and safety purposes. In one application, the safety layer receives output control signals from a controller and modifies those control signals as a function of an actual amount of insulin delivered to the user. The safety layer allows for an increased level of safety in the IDM system and permits development of separate hardware and software upgrades with the safety layer assuring that compatibility between components will continue.

Abstract: Described and illustrated is a system for management of diabetes that includes an infusion pump, glucose sensor and controller with a method programmed in the controller. The infusion pump is configured to deliver insulin. The glucose sensor senses 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 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 (R) for a model predictive controller in the microcontroller as a conservative setting otherwise the system maintains a current tuning factor (R) for the controller.

Abstract: Methods of regulating blood glucose levels using an insulin pump are disclosed. A method includes receiving a current blood glucose level, and determining whether the current blood glucose level is above a threshold value. The method also includes calculating a correction bolus value based upon the current blood glucose.

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: An integrated diabetes management (IDM) system includes a safety layer which, in one configuration has two components, one located between a glucose sensor and a controller and a second component located between a controller and a pump, to monitor various aspects of signals and modify those signals for compatibility and safety purposes. In one application, the safety layer receives output control signals from a controller and modifies those control signals as a function of an actual amount of insulin delivered to the user. The safety layer allows for an increased level of safety in the IDM system and permits development of separate hardware and software upgrades with the safety layer assuring that compatibility between components will continue.

Abstract: A system and methods are described for improving the management of ischemic cardiac tissue during acute coronary syndromes or other ischemic conditions. A method and apparatus is described that allows mitigation of oxygen-related injury by precisely modulating the level of oxygen re-exposure during reoxygenation by a controlled feedback loop based on parameters of the tissue measured by a real-time tissue sensor or probe.

Abstract: A system for at least partial closed-loop control of a medical condition is disclosed. The system includes at least one medical fluid pump. The medical fluid pump including a sensor for determining the volume of fluid pumped by the pump. Also, at least one continuous analyte monitor, and a controller. The controller is in communication with the medical fluid pump and the at least one continuous analyte monitor. The controller includes a processor. The processor includes instructions for delivery of medical fluid based at least on data received from the at least one continuous analyte monitor.

Abstract: A method for calculating a bolus amount, wherein the bolus amount is calculated according to a basal rate, and a device for calculating a bolus amount according to the method, the device including an input unit used to input an amount of received carbohydrates, a computer coupled to the input unit and at least one interface used to transmit an actual blood glucose value and the value of the actual basal rate to the computer, wherein the at least one interface or another interface transmits a bolus amount calculated by the computer.

Abstract: A method includes receiving measurements from a sensor associated with a patient at a portable medication delivery device. The method also includes controlling delivery of medication to the patient at the portable medication delivery device using a single input, single output (SISO) model predictive control technique. The SISO model predictive control technique includes predicting a characteristic of the patient using the measurements and a model associated with the patient. The SISO model predictive control technique also includes determining whether the characteristic of the patient is predicted to fall outside of a desired range. In addition, the SISO model predictive control technique includes, if the characteristic of the patient is predicted to fall outside of the desired range, determining an amount of medication to deliver to the patient and delivering the determined amount of medication to the patient.

Abstract: Embodiments of the invention provide swallowable devices, preparations and methods for delivering drugs and other therapeutic agents within the GI tract. Some embodiments provide a swallowable device such as a capsule for delivering drugs into the intestinal wall or other GI lumen. The device comprises a capsule sized to be swallowed and pass through the intestinal tract. The capsule can include at least one guide tube, one or more tissue penetrating members positioned in the guide tube, a delivery member, an actuating mechanism and a release element. The release element degrades upon exposure to various conditions in the intestine so as to release and actuate the actuating mechanism. Embodiments of the invention are particularly useful for the delivery of drugs which are poorly absorbed, tolerated and/or degraded within the GI tract.

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

Abstract: A medical device system. The system includes a first medical device, a first remote interface, and a second remote interface in communication with the first remote interface and the first medical device, wherein the first medical device sends a command to the first medical device through the second remote interface, and wherein when the second remote interface receives the command, the command must be confirmed by the second remote interface before the command is send by the second remote interface to the first medical device.

Abstract: A noninvasive analyzer apparatus and method of use thereof is described using one or a plurality of sample illumination zones coupled to at least one two-dimensional detector array monitoring a plurality of detection zones. Control of illumination times and/or patterns along with selected detection zones yields pathlength resolved groups of spectra. Sectioned pixels and/or zones of the detector are optionally filtered for different light throughput as a function of wavelength. The pathlength resolved groups of spectra are subsequently analyzed to determine an analyte property. Optionally, in the mapping and/or collection phase, incident light is controllably varied in time in terms of any of: sample probe position, incident light solid angle, incident light angle, depth of focus, energy, intensity, and/or detection angle. Optionally, one or more physiological property and/or model property related to a physiological property is used in the analyte property determination.

Abstract: Methods and devices for the diagnosis and treatment of diabetes are disclosed in which an analyte concentration within a peritoneal fluid of a human subject may be determined by implanting an analyte sensor apparatus in the subject where the apparatus may comprise a housing and a flexible sensing catheter which has a lumen with a plurality of apertures and an exterior surface with an analyte sensor affixed thereto. The catheter may comprise a proximal end attached to the housing and the remaining end may be positioned freely within the peritoneal space to contact peritoneal fluid where an analyte concentration in the peritoneal fluid may be sensed. The housing may be anchored at a subcutaneous site proximate the peritoneal space. The sensed analyte concentration may then be transduced into a transmittable electrical signal.

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: The present disclosure provides a sensor port configured to receive a plurality of analyte sensors having different sizes, shapes and/or electrode configurations. Also provided are analyte meters, analyte monitoring devices and/or systems and drug delivery devices and/or systems utilizing the disclosed sensor ports.

Abstract: Techniques and devices are described for allowing a diabetes patient to safely disconnect an insulin infusion system device for a time period. In one aspect, the techniques and devices can be implemented by receiving a maximum glucose amount, a minimum glucose amount, and a contemplated disconnection time; receiving a current glucose amount of the user; determining an expected increase in glucose of the user based on the contemplated disconnection time, an insulin sensitivity of the user and a contemplated basal insulin dose; validating the contemplated disconnection time based on at least one of the expected increase in glucose, the maximum glucose amount, and the minimum glucose amount; and, administering a therapeutic action to the user based on the validation of the contemplated disconnection 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: Systems, methods and/or devices for treating diabetes mellitus by alleviating glucotoxicity and restoring pancreatic beta-cell function, comprising at least a first memory for storing data inputs corresponding at least to one or more components in a patient's present insulin dosage regimen, and data inputs corresponding at least to the patient's blood-glucose-level measurements determined at a plurality of times, and a processor operatively connected to the at least first memory. The processor is programmed at least to determine from the data inputs corresponding to the patient's blood-glucose-level measurements determined at a plurality of times whether and by how much to vary at least one of the components of the patient's present insulin dosage regimen.

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: Methods, structures, and systems are disclosed for biosensing and drug delivery techniques. In one aspect, a? device for detecting an analyte and/or releasing a biochemical into a biological fluid can include an array of hollowed needles, in which each needle includes a protruded needle structure including an exterior wall forming a hollow interior and an opening at a terminal end of the protruded needle structure that exposes the hollow interior, and a probe inside the exterior wall to interact with one or more chemical or biological substances that come in contact with the probe via the opening to produce a probe sensing signal, and an array of wires that are coupled to probes of the array of hollowed needles, respectively, each wire being electrically conductive to transmit the probe sensing signal produced by a respective probe.

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: Intrauterine fetal growth restriction (IUGR) is an affliction of a disparaging spectrum, placental insufficiency being the major inciting pathology. The resultant fetal hypoglycemia is alleviated by intravenous hypertonic D-glucose 25-50% maternal supplements, by improving the Vmax of placental transfer for D-glucose, in accordance with Michaelis-Menten model of substrate transfer. Fetal normoglycemia so restored in turn surprisingly improves fetal hypoxia, hypercapnia, hyperlacticemia, acidosis, hypertriglyceridemia, oliguria/hydromnios, and the fetal nutrient/mineral/vitamin acquisition. The list being phenomenal can only convince an inquiring reader by a biochemical sojourn into the aquatic world of the fetus, herein described. Maternal carbohydrate-predominant IUGR diet with maximal amounts of vitamin/mineral supplements are highly beneficial.

Abstract: An integrated diabetes management (IDM) system includes a safety layer which, in one configuration has two components, one located between a glucose sensor and a controller and a second component located between a controller and a pump, to monitor various aspects of signals and modify those signals for compatibility and safety purposes. In one application, the safety layer receives output control signals from a controller and modifies those control signals as a function of an actual amount of insulin delivered to the user. The safety layer allows for an increased level of safety in the IDM system and permits development of separate hardware and software upgrades with the safety layer assuring that compatibility between components will continue.

Abstract: A method of facilitating delivery of a discretionary dose of insulin to a user includes: enabling the user or a caregiver to specify, via a computer-based user interface, parameters associated with a discretionary delivery of insulin that may be delivered to the user; subsequently receiving data that represents the user's glucose level during a period of time associated with the discretionary delivery; automatically determining, with a computer-based processor, based on the received data, if, when and how much discretionary insulin should be delivered to the user during the period of time associated with the discretionary delivery; delivering insulin to the user during the period of time associated with the discretionary delivery according to the automatic determination; and delivering insulin to the user with the insulin delivery device according to a non-discretionary insulin delivery schedule unless a discretionary insulin delivery mode has been triggered.