Abstract: An automated system for regulating a patient's blood glucose, including a blood glucose sensor, an insulin injection device, and a processing and control unit.

Abstract: A system for the delivery of insulin to a patient is provided. The systems and methods disclose include an insulin delivery device configured to deliver insulin to a patient in response to control signals. The system also includes a controller programmed to receive the sensor glucose measurement signal from the glucose sensor. The sensor glucose measurement signal received indicates a concentration of the real time glucose concentration in a bloodstream. The controller is further configured to enact an impeding glycemia protocol based on a zone model predictive control (MPC) algorithm in response to the real time glucose concentration. The impeding glycemia protocol includes in determining a relationship between predicted glucose concentrations, a rate of change of the predicted glucose concentrations, and a set of control parameters that determine insulin doses above and below a patient-specific basal rate.

Abstract: A model-based control scheme consisting of either a proportional-integral-derivative (IMC-PID) controller or a model predictive controller (MPC), with an insulin feedback (IFB) scheme personalized based on a priori subject characteristics and comprising a lower order control-relevant model to obtain PID or MPC controller for artificial pancreas (AP) applications.

Abstract: Some embodiments of an infusion pump system may be configured to wirelessly communicate with other devices using near field communication (NFC). In particular embodiments, by incorporating near field communication capabilities into the infusion pump system, user communications with the infusion pump system can be enhanced and simplified.

Abstract: Some embodiments of an infusion pump assembly may be equipped with one or more components to facilitate wireless operation of an infusion pump via a user-operated mobile device. In some embodiments, the mobile device and/or the infusion pump may prompt the user to confirm acceptance of a wirelessly communicated command to prevent an operation by the infusion pump (e.g., a dispensation of medicine) that is not desired by the user.

Abstract: Methods and apparatus, including computer program products, are provided for processing analyte data. In some example implementations, a method may include generating glucose sensor data indicative of a host's glucose concentration using a glucose sensor; calculating a glycemic variability index (GVI) value based on the glucose sensor data; and providing output to a user responsive to the calculated glycemic variability index value. The GVI may be a ratio of a length of a line representative of the sensor data and an ideal length of the line. Related systems, methods, and articles of manufacture are also disclosed.

Abstract: Techniques disclosed herein relate to continuous analyte sensor quality measures. In some embodiments, the techniques may involve obtaining a current sensor-generated value that is indicative of a physiological characteristic of a user of a medical device, the current sensor-generated value produced in response to operation of a continuous analyte sensor device. The techniques may further involve obtaining a sensor quality metric that indicates accuracy of the current sensor-generated value. The techniques may further involve causing, in response to obtaining the sensor quality metric, configuration of a quality-specific operating mode of the medical device, the quality-specific operating mode comprising separate regulation of basal and bolus deliveries of a fluid medication based on the obtained sensor quality metric.

Abstract: Detection of anomalous computing environment behavior using glucose is described. An anomaly detection system receives glucose measurements and event records during a first time period. Missing events that are missing from the event records during the first time period are identified by processing the glucose measurements using an event engine simulator. An anomaly detection model is generated based on the missing events during the first time period. Subsequently, the anomaly detection system receives additional glucose measurements and additional event records during a second time period. Missing events that are missing from the additional event records during the second time period are identified by processing the additional glucose measurements using the event engine simulator. Anomalous behavior is detected if the identified missing events that are missing from the event records during the second time period are outside a predicted range of missing events of the anomaly detection model.

Abstract: An infusion pump includes a housing, a wireless transceiver, a pump motor mounted within the housing, a location sensor configured to provide information associated with a location of the infusion pump, a battery conductively coupled to the wireless transceiver, the pump motor, the location sensor and processor(s), and memory. The infusion pump is configured to monitor, using the location sensor, a geofence parameter of the infusion pump, determine a change in the location of the infusion pump based on the geofence parameter, identify an operation mode of the infusion pump associated with the geofence parameter, and automatically switch, responsive to the changed location, the operation mode of the infusion pump from a first mode currently programmed for care of a patient to a second mode, the second mode using different parameters than the first mode to control elements of the infusion pump.

Abstract: Apparatuses and methods for transitioning to sleep mode or otherwise modified glucose target range in automated insulin delivery systems. For example, sleep mode can include a lower glucose target and/or lower and narrower glucose target range because of fewer variables that affect glucose values during sleep such as eating and exercise. Due to increased stability provided by the sleep mode target range, it is desirable to transition to the sleep mode target range as quickly as possible, while ensuring the transition is done safely and does not risk low glucose or hypoglycemia by too quickly switching to the lower and narrower target range. Systems and methods disclosed herein therefore provide various approaches for safely and quickly transitioning to sleep mode or other modified target ranges in order to improve time in range by being more aggressive to get to the lower sleep mode or other target faster without risking hypoglycemia.

Abstract: Techniques disclosed herein relate to determining a calibrated measurement value indicative of a physiological condition of a patient using sensor calibration data and a performance model. In some embodiments, the techniques involve obtaining one or more electrical signals from a sensing element of a sensing arrangement, where the one or more electrical signals are influenced by a physiological condition in a body of a patient. The techniques also involve obtaining calibration data associated with the sensing element from a data storage element of the sensing arrangement, converting the one or more electrical signals into one or more calibrated measurement parameters using the calibration data, obtaining a performance model associated with the sensing element, obtaining personal data associated with the patient, and determining, using the performance model and based on the personal data and the one or more calibrated measurement parameters, a calibrated output value indicative of the physiological condition.

Abstract: A processor-implemented method comprises obtaining current operational context information associated with a sensing device; obtaining an expected calibration factor parameter model associated with a patient; calculating an expected calibration factor value based on the expected calibration factor parameter model and the current operational context information; obtaining one or more electrical signals from the sensing device, the one or more electrical signals having a signal characteristic indicative of a physiological condition; converting the one or more electrical signals into a calibrated measurement value for the physiological condition using the expected calibration factor value; and outputting the calibrated measurement value for the physiological condition.

Abstract: A method of adaptively determining one or more compensation factors in a closed-loop insulin delivery system comprising a continuous glucose level sensor, an insulin pump, and an insulin reservoir, where the system determines an insulin meal bolus taking into account an estimated amount of carbohydrates to be ingested, CHO, a difference between a currently sensed glucose level, G, and a glucose set point, Gsp, and at least one compensation factor, ICR.

Abstract: In some embodiments, an apparatus may comprise a first insertion needle and a second insertion needle. The first insertion needle may be configured to carry a first medical device (e.g., a sensor) through an opening in an apparatus housing. The second insertion needle may be configured to carry a second medical device (e.g., a cannula) along a curved path that passes through the opening in the apparatus housing such that a distal end of the first medical device becomes increasingly displaced from the distal end of the second medical device as the distal end of the second medical device is carried along the curved path.

Abstract: A method for insulin therapy includes obtaining a current glucose measurement value of a user from a sensing arrangement, obtaining a determination of a current amount of active insulin in the body of the user, identifying an amount of future insulin deliveries to be delivered by an infusion device, determining a homeostasis metric based at least in part on the current glucose measurement value, the current amount of active insulin in the body of the user, and the amount of future insulin deliveries, wherein determining the homeostasis metric comprises predicting a change in the current glucose measurement value based on accounting for metabolism of the current amount of active insulin and the amount of future insulin deliveries, and generating an alert based at least in part on the homeostasis metric.

Abstract: The present disclosure relates to a device configuration method for configuring a diabetes management device by a diabetes management system, the diabetes management system residing on a server computer, the method comprising: receiving, by the diabetes management system, a therapy setting instruction from a computing device, validating, by the diabetes management system, the credentials of the healthcare provider by way of a validation service based on the identification information, determining, by the diabetes management system, whether the therapy setting instruction is valid based on an association between the diabetes management system, the patient, and the healthcare provider; transmitting, by the diabetes management system, one or more parameters for configuring the feature defined by the therapy setting to the subject diabetes management device; and canceling, by the diabetes management system, the therapy setting instruction in response to the therapy setting instruction being invalid.

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 a signal level associated with the monitored physiological condition deviating from a predetermined threshold level, retrieving the medication level administered associated with a time period of the detected signal level, applying the retrieved medication level to the detected signal based on a predefined predictive model to generate a predictive signal, and comparing the detected signal to the predictive signal to determine whether a condition associated with the detected signal level is present are provided.

Abstract: Computer implemented methods are disclosed. The methods may include receiving historical data comprising at least one of provider data and patient data, and processing, using a processor, the historical data to identify one or more patterns. The method also may include generating one or more decision models from the historical data and the decision patterns, and providing one or more recommendations based on the one or more decision models.

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: Analyte monitoring systems, devices, and methods associated with analyte monitoring devices, and devices incorporating the same are provided. Various graphical user interfaces (GUI) and navigation flows are provided for performing various features, activities, functions, etc., associated with the analyte monitoring device or system. Intuitive navigation is provided to enhance the interpretation of analyte measurements.

Abstract: An implantable intraocular physiological sensor for measuring intraocular pressure, glucose concentration in the aqueous humor, and other physiological characteristics. The implantable intraocular physiological sensor may be at least partially powered by a fuel cell, such as an electrochemical glucose fuel cell. The implantable intraocular physiological sensor may wirelessly transmit measurements to an external device. In addition, the implantable intraocular physiological sensor may incorporate aqueous drainage and/or drug delivery features.

Abstract: Computer implemented methods are disclosed. The methods may include receiving historical data comprising at least one of provider data and patient data, and processing, using a processor, the historical data to identify one or more patterns. The method also may include generating one or more decision models from the historical data and the decision patterns, and providing one or more recommendations based on the one or more decision models.

Abstract: A method of managing insulin includes receiving blood glucose measurements on a computing device from a glucometer. The blood glucose measurements are separated by a time interval. The method includes determining, by the computing device, an insulin dose rate based on the blood glucose measurements and determining a blood glucose drop rate based on the blood glucose measurements and the time interval. The method also includes determining a blood glucose percentage drop based on the blood glucose measurements. The method includes decreasing the time interval between blood glucose measurements by the glucometer when the blood glucose drop rate is greater than a threshold drop rate, and decreasing the time interval between blood glucose measurements by the glucometer when the blood glucose percentage drop is greater than a threshold percentage drop.

Abstract: Medical devices and related patient management systems and parameter modeling methods are provided. An exemplary method of operating a sensing device associated with a patient involves obtaining current operational context information associated with the sensing device, obtaining a parameter model associated with the patient, calculating a current parameter value based on the parameter model and the current operational context information, obtaining one or more signals from a sensing element configured to measure a condition in a body of the patient, and providing an output that is influenced by the calculated current parameter value and the one or more signals.

Abstract: Some embodiments of 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: Systems and methods are provided for adjusting a standing insulin medicament dosage regimen for a subject. Fasting events are identified using autonomous timestamped glucose measurements of the subject in a first data set. A second data set, from one or more insulin pens used to apply the standing regimen, comprises records, each record comprising a timestamped event specifying an amount of injected insulin medicament. Each fasting event is characterized as adherent or nonadherent. A fasting event is adherent when the second data set includes one or more records that temporally and quantitatively establish adherence with the standing regimen during the fasting event. Conversely, a fasting event is nonadherent when the second data set fails to temporally and quantitatively establish adherence with the standing regimen.

Abstract: A continuous glucose monitoring system may utilize externally sourced information regarding the physiological state and ambient environment of its user for externally calibrating sensor glucose measurements. Externally sourced factory calibration information may be utilized, where the information is generated by comparing metrics obtained from the data used to generate the sensor's glucose sensing algorithm to similar data obtained from each batch of sensors to be used with the algorithm in the future. The output sensor glucose value of a glucose sensor may also be estimated by analytically optimizing input sensor signals to accurately correct for changes in sensitivity, run-in time, glucose current dips, and other variable sensor wear effects.

Abstract: An automated system of regulation of a patient's blood glucose, including: a blood glucose sensor; an insulin injection device; and a processing and control unit capable of predicting, from a physiological model, the future evolution of the patient's blood glucose over a prediction period, and of controlling the insulin injection device by taking the prediction into account, wherein the processing and control unit is capable of: a) calibrating the physiological model, taking into account the blood glucose measured by the sensor during a past observation period; b) at the end of the calibration, calculating an indicator representative of the error between the blood glucose estimated from the model and the real blood glucose measured by the sensor; and c) adjusting the prediction period by taking into account the value of the indicator.

Abstract: Medical devices and related augmented reality systems and methods are provided. A method of operating an infusion device involves analyzing one or more images captured by an imaging device to identify image content indicative of an activity capable of influencing the physiological condition of the patient and in response to identifying the activity based at least in part on the one or more images, automatically adjusting delivery of the fluid to the patient based at least in part on the activity. An expected nutritional characteristic for a meal is determined based at least in part on the image content, and a delivery adjustment for delivering the fluid is determined based on the expected nutritional characteristic. A graphical indication of the delivery adjustment may also be provided using augmented reality.

Abstract: Computer implemented methods are disclosed. The methods may include receiving historical data comprising at least one of provider data and patient data, and processing, using a processor, the historical data to identify one or more patterns. The method also may include generating one or more decision models from the historical data and the decision patterns, and providing one or more recommendations based on the one or more decision models.

Abstract: A patient health management platform determines of a metabolic state for a first time period. The platform generates a patient-specific treatment recommendation for a second time period following the first time period that identifies objectives for the patient to complete to improve the metabolic state determined for the first time period. Periodically during the second time period, the platform receives recordings of patient data indicating foods consumed by the patient, medication taken by the patient, and/or symptoms experienced by the patient. The platform compares the received recordings of patient data from the second time period to the generated patient-specific treatment recommendation to determine a number of objectives completed by the patient and updates a score representing n adherence of the patient to the patient-specific treatment recommendation based the number of completed objectives.

Abstract: Embodiments provide systems, methods, and apparatus for a medication delivery device. The device includes a dose selector for selecting an amount of medication to deliver; a first capacitive sensor adjacent the dose selector and operative to detect linear displacement of the dose selector during medication delivery; a screw coupled to the dose selector; a second capacitive sensor adjacent the screw and operative to detect linear displacement of the screw during medication delivery; and a processor coupled to the first and second capacitive sensors and operative to determine an amount of medication actually delivered by the medication delivery device. Numerous other aspects are provided.

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: A method, system, and computer program product for predictive maintenance. A method may include receiving operation data associated with one or more injection systems, wherein the operation data includes one or more operation parameters associated with one or more operations of the one or more injection systems; determining one or more prediction scores for the one or more injection systems based on the operation data, wherein the one or more prediction scores include one or more predictions of one or more operation failures or misuses for the one or more injection systems; and providing maintenance data associated with the one or more operation failures or misuses, wherein the maintenance data is based on the one or more prediction scores.

Abstract: Methods and systems for delaying alarms that include detecting an analyte level using an analyte sensor; and delaying the annunciation of an analyte alarm after the analyte level crosses an analyte threshold, wherein the delay is based on one or both of (1) a magnitude of difference between the analyte level and the analyte threshold and (2) a duration of time in which the analyte level has crossed the analyte threshold.

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: Disclosed are systems and methods for secure and seamless set up and modification of bolus calculator parameters for a bolus calculator tool by a health care provider (HCP). In one aspect, a method for enabling HCP set up of a bolus calculator includes providing a server accessible by both an HCP and a patient; upon login by the HCP, displaying, or transmitting for display, a fillable form, the fillable form including one or more fields for entry of one or more bolus calculator parameters; receiving data from the fillable form, the data corresponding to one or more bolus calculator parameters; and upon login by the patient, transmitting data to a device associated with the patient, the transmitted data based on the received data, where the transmitted data corresponds to one or more of the bolus calculator parameters in a format suitable for entry to a bolus calculator.

Abstract: Systems and methods for diabetes management with automatic basal and manual bolus insulin control are presented. An exemplary system includes a delivery device, a glucose sensor, and a controller. The delivery device delivers insulin and the glucose sensor measures glucose levels of the subject. A basal insulin dose is calculated using a model predictive control algorithm and physiological data of the subject including desired glucose levels, amounts of the delivered insulin and the measured glucose levels. A manual bolus insulin dose is initiated by the subject. The manual bolus insulin dose is modified based on one or both of the model predictive control algorithm and the physiological data of the subject. A total insulin dose is determined based on the modified manual bolus insulin dose and the calculated basal insulin dose, and delivered to the subject.

Abstract: A method may include generating a first plurality of insulin delivery profiles that include a first series of insulin delivery actions spanning a first time interval, projecting a first plurality of future blood glucose values for each profile of the first plurality of profiles using up-to-date blood glucose levels, selecting one of the first plurality of profiles based upon comparing future blood glucose values for each profile and target blood glucose levels, delivering insulin for a second time interval that corresponds to a first action of the first profile, generating a second plurality of insulin delivery profiles for a third time interval, projecting a second plurality of future blood glucose values for each profile of the second plurality of profiles for the third time interval, and delivering a second dose of insulin for a fourth time interval shorter than the third time interval.

Abstract: This disclosure teaches the concept, and method of creating, a dual use device intended for persons who take insulin. In one embodiment, the novel device is an insulin delivery cannula, the outer wall of which contains electrodes, chemical compounds and electrical interconnects that allow continuous glucose sensing and delivery of data to a remote device. Heretofore, the main problem in attempting to sense glucose at the site of insulin delivery has been the high current resulting from oxidation by the sensor of the preservatives in the insulin formulations. One means of eliminating these interferences is to poise the indicating electrode(s) of the sensor at a bias sufficiently low to avoid the signal from oxidation of the preservatives. One way of obtaining a glucose signal at a low bias is to use an osmium-ligand-polymer complex instead of conventional hydrogen peroxide sensing.

Abstract: The present application provides a new type of glucose fuel cell in which a layer of proton-conducting metal oxide is interposed between the anode and cathode electrodes. Such metal oxides can serve in the form of thin-layer fuel cell membrane materials for novel, all-solid state fuel cell designs.

Abstract: Example biosensor devices having wake-up batteries and associated methods are disclosed. One example device includes a biosensor that has a first electrode for insertion into a subcutaneous layer beneath a patient's skin, and a second electrode coupled to the first electrode for insertion into the subcutaneous layer, and a first battery to apply a voltage across the first and second electrodes, the first battery at least partially electrically decoupled from the electrodes. The device also includes a second battery having an anode material coupled to the first electrode for insertion into the subcutaneous layer, and a portion of the second electrode. The second battery is activatable upon immersion in an electrolytic fluid. The device also includes a wake-up circuit to receive a signal from the second battery and, in response, to electrically couple the first battery to the first and second electrodes to activate the biosensor.

Abstract: A remote monitoring system for medical data collection can include a data-flagging process embeds authorization and settings information into a file containing the test results. Such data flagging can occur at a medical device or testing site, and may be based in policy settings received from a remote system. A file containing the test results can also include data category information that can be used to protect sensitive information by preventing such information from being communicated to the wrong server.

Abstract: Some embodiments of an infusion pump assembly may be equipped with one or more components to facilitate wireless operation of an infusion pump via a user-operated mobile device. In some embodiments, the mobile device and/or the infusion pump may prompt the user to confirm acceptance of a wirelessly communicated command to prevent an operation by the infusion pump (e.g., a dispensation of medicine) that is not desired by the user.

Abstract: In one aspect the present disclosure relates to a sensor for measuring at least one physical or chemical parameter of a cartridge or syringe filled with a liquid substance. In further aspects the disclosure relates to a cartridge equipped with such a sensor as well as to a drug delivery device equipped with such a cartridge, wherein the sensor comprises: a planar flexible foil arrangeable to an outer circumference of a barrel of the cartridge or syringe, at least a first and a second measuring electrode arranged on said foil, and at least a first and a second contact electrode arranged on said foil, wherein the first contact electrode is connected to the first measuring electrode and wherein the second contact electrode is connected to the second measuring electrode.

Abstract: An analyte monitoring system and method. The analyte monitoring system may include an analyte sensor and a transmitter. The analyte sensor may include an indicator element that exhibits one or more detectable properties based on an amount or concentration of an analyte in proximity to the indicator element. The transmitter may be configured to receive measurement information from the analyte sensor. The transmitter may be configured to assess in real time a performance of the analyte sensor based on at least the measurement information. The transmitter may be configured to determine whether the performance of the analyte sensor is deficient based at least on the assessed performance of the analyte sensor. The transmitter may be configured to predict an amount of time remaining before the performance of the analyte sensor becomes deficient based on at least the assessed performance of the analyte sensor.

Abstract: Systems and methods are described that provide a dynamic reporting functionality that can identify important information and dynamically present a report about the important information that highlights important findings to the user. The described systems and methods are generally described in the field of diabetes management, but are applicable to other medical reports as well. In one implementation, the dynamic reports are based on available data and devices. For example, useless sections of the report, such as those with no populated data, may be removed, minimized in importance, assigned a lower priority, or the like.

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: 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: A medicament delivery device is provided having a proximal part and a distal part, the proximal part being arranged to accommodate a medicament container, an information carrier reader arranged to the distal part, provided with at least one antenna, an information carrier arranged to the proximal part, provided with an antenna, an attachment arrangement for attaching the proximal part to the distal part, which attachment arrangement is designed such that said information carrier may assume at least two different positions when the proximal part is attached to the distal part, wherein said at least one antenna of said information carrier reader is arranged such that it is capable of reading information from said information carrier in any of the different positions that the information carrier may assume.