A blood glucose control system is configured to modify therapy provide to a subject and determine whether the modified therapy results in a statistically significant improvement in glycemic control. The system obtains glycemic control information resulting from delivery of first therapy using a first value of a control parameter and determines a first effect corresponding to the first therapy. The control parameter is set to a second value that differs from the first value. The system obtains glycemic control information resulting from the delivery of the second therapy using the second value of the control parameter and determines a second effect corresponding to the second therapy. The system can perform a comparative assessment and determine whether the second value for the control parameter results in a statistically significant improvement in glycemic control for the subject.

A repeater system may control a pump by using a repeater and a user interface. An adhesive patch system may be used for affixing a pump or other object to a human body. Such an adhesive patch system may include two sets of adhesive members, each member including an adhesive material on at least one side so as to attach to the body. The members of the first set are spaced to allow the members of the second set to attach to the body in spaces provided between the members of the first set, and the members of the second set are spaced to allow members of the first set to detach from the body without detaching the members of the second set. Also, fill stations and base stations are provided for personal pump systems.

An apparatus for insertion of a medical device in the skin of a subject is provided.

A drug delivery system includes a substrate, an integrated sensor disposed on the substrate, a drug delivery element disposed on the substrate, and a control unit coupled to the integrated sensor and the drug delivery element. The integrated sensor includes first and second electrodes disposed on a first surface of the substrate. The drug delivery element includes a reservoir disposed on the first surface of the substrate, a thermally active polymer enclosing the reservoir, and a heating coil disposed over the thermally active polymer. The control unit is configured to measure a biological parameter by measuring a voltage difference between the first and second electrodes of the integrated sensor, and to apply a trigger signal to the heating coil of the drug delivery element responsive to the measured biological parameter indicating a designated condition to heat up the thermally active polymer to selectively release a drug from the reservoir.

Methods and systems for sensor calibration and sensor glucose (SG) fusion are used advantageously to improve the accuracy and reliability of orthogonally redundant glucose sensor devices, which may include optical and electrochemical glucose sensors. Calibration for both sensors may be achieved via fixed-offset and/or dynamic regression methodologies, depending, e.g., on sensor stability and Isig-Ratio pair correlation. For SG fusion, respective integrity checks may be performed for SG values from the optical and electrochemical sensors, and the SG values calibrated if the integrity checks are passed. Integrity checks may include checking for sensitivity loss, noise, and drift. If the integrity checks are failed, in-line sensor mapping between the electrochemical and optical sensors may be performed prior to calibration. The electrochemical and optical SG values may be weighted (as a function of the respective sensor's overall reliability index (RI)) and the weighted SGs combined to obtain a single, fused SG value.

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.

Infusion systems, infusion devices, and related operating methods are provided. A method of operating an infusion device involves obtaining an input qualitative event attribute, such as a meal size, obtaining a quantitative event attribute associated with the qualitative event attribute that is representative of a subset of historical events for a patient associated with the qualitative event attribute, such as a representative carbohydrate amount for the qualitative meal size, and thereafter determine a dosage of fluid based at least in part on the quantitative event attribute and operate the infusion device to deliver the dosage of the fluid to the patient.

An intravenous infusion system with real-time infusion rate monitoring and closed-loop infusion rate control is disclosed. The intravenous infusion system comprises: an infusion module, providing drug solution through an intravenous catheter; a flow sensor module, installed around an outer periphery of the intravenous catheter, transmitting ultrasounds to the intravenous catheter and receiving ultrasounds reflected or penetrated therefrom to determine a real-time volumetric flow rate of the drug solution in the intravenous catheter, and converting the real-time volumetric flow rate into a flow rate electronic signal; and a communicating module, electrically and signally connected with the flow sensor module, receiving the flow rate electronic signal and delivering the flow rate electronic signal to an external agent connected thereto.

The invention discloses a closed-loop artificial pancreas device with integrated detection and infusion, comprising: infusion unit configured to deliver drugs; program unit comprising input end and output end, and the input end comprises a plurality of electrically connective regions for receiving signals of analyte data in the body fluid, after the output end is electrically connected to the infusion unit, according to the received signals of analyte data in the body fluid, the program unit controls whether the infusion unit delivers drugs; an infusion cannula with conductive area, the infusion cannula is the drug infusion channel; and a plurality of electrodes for detecting analyte data in body fluid, the electrode comprising conductive-area electrode and cannula-wall electrode, the conductive area of the infusion cannula being at least as a conductive-area electrode, and one or more cannula-wall electrodes being located on/in the wall of the infusion cannula.

Systems and methods are disclosed herein for providing a configuration code for customizing a glucose level control system for at least an initial period. The configuration code can be based on one or more dosing parameters from a tracked medicament therapy administered to a subject over a tracking period by the glucose level control system. The configuration code includes encoded dosing parameters including a correction dosing parameter based on at least some of the correction boluses of medicament administered during the tracking period, a food intake dosing parameter comprising an indication of a food intake bolus size of medicament based on one or more food intake boluses provided during the tracking period, and a basal dosing parameter based on at least some of the basal doses of medicament administered during the tracking period.