Abstract: Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device to deliver fluid to a body of a user involves identifying a current site location on the body of the user associated with a sensing arrangement providing sensed measurements of a physiological condition in the body of the user at the current site location, determining one or more performance metrics associated with the current site location corresponding to operation of the infusion device to deliver the fluid in response to the sensed measurements, and providing sensor site feedback in a manner that is influenced by the one or more performance metrics. In one or more embodiments, the sensor site feedback includes recommended sensor site locations for rotation or replacement of the sensing arrangement determined based on historical data associated with the user for different sensor site locations.

Abstract: A flexible, fluid flow tubing is configured to be kink resistant, and a medical device is configured with such kink resistant tubing. The tubing has a length L and a circular cross-section shape taken perpendicular to the length dimension. The tubing has an inside radius r and an outside radius R, wherein L/R?34.8, and wherein R/r?1.5. The tubing may be made of a polyether block amide (PEBA) or other thermoplastic elastomer (TPE). The tubing may be received in a channel of a hollow needle, wherein the needle is slideable in the axial dimension relative to the tubing, to selectively slide off of at least a portion of the tubing.

Abstract: An insertion set system includes a base configured to be secured to a patient, and a flexible tubing on the base. The flexible tubing has a distal end portion forming a cannula to be inserted into the patient. An inserter having a needle is received by the base. The needle has a channel in which the distal end portion of the flexible tubing is received. The needle is able to slide relative to the flexible tubing, to selectively withdraw the needle off of the distal end portion of the flexible tubing. The base may include a passage for fluid flow arranged transverse to the axial dimension of the distal end portion of the flexible tubing.

Abstract: Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device to deliver fluid to a body of a user involves obtaining measurement values for a physiological condition influenced by the fluid, autonomously operating the infusion device to deliver the fluid based at least in part on the measurement values, and detecting a nonactionable condition based on the measurement values. In response to detecting the nonactionable condition, delivery of the fluid is limited while maintaining autonomous operation of the infusion device. In one exemplary embodiment, the nonactionable condition is a rescue condition indicative of the user having consumed fast-acting carbohydrates, and thus insulin delivery may be automatically limited in response to detecting the rescue carbohydrate consumption.

Abstract: Described here are patches and methods for measuring glucose in sweat (and tears and the like). In general, the patches comprise an adhesive layer adapted to bond to skin of an individual, a substrate layer disposed over the adhesive layer and comprising a glucose sensing complex including a chromogen that changes color in the presence of certain concentrations of glucose, and a cover. In typical embodiments, the substrate layer has elements formed to direct and accumulate sweat that migrates from the skin of the individual to the glucose sensing complex. Methods of using the invention can comprise cleaning the skin surface, collecting sweat in a patch comprising this microfluidic constellation of elements, and observing concentrations of glucose collected in the sweat, for example either visually, or by using a smartphone or other computer processing device.

Abstract: An introducer is provided for introducing a sensor into the body of a patient. The introducer connects to a sensor hub. When the sensor hub and introducer are connected, the introducer needle is exposed. When the sensor hub and introducer are disconnected, a needle cover and the needle move with respect to each other so that the needle cover substantially covers the needle, protecting a user from being injured by the needle.

Abstract: Described here are patches and methods for measuring glucose in sweat (and tears and the like). In general, the patches comprise an adhesive layer adapted to bond to skin of an individual, a substrate layer disposed over the adhesive layer and comprising a glucose sensing complex including a chromogen that changes color in the presence of certain concentrations of glucose, and a cover. In typical embodiments, the substrate layer has elements formed to direct and accumulate sweat that migrates from the skin of the individual to the glucose sensing complex. Methods of using the invention can comprise cleaning the skin surface, collecting sweat in a patch comprising this microfluidic constellation of elements, and observing concentrations of glucose collected in the sweat, for example either visually, or by using a smartphone or other computer processing device.

Abstract: An introducer is provided for introducing a sensor into the body of a patient. The introducer connects to a sensor hub. When the sensor hub and introducer are connected, the introducer needle is exposed. When the sensor hub and introducer are disconnected, a needle cover and the needle move with respect to each other so that the needle cover substantially covers the needle, protecting a user from being injured by the needle.

Abstract: Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device involves obtaining one or more measurement values of a physiological condition in the body of a user during an initial monitoring period and determining a fasting reference value for a metric based on the one or more measurement values. After the initial monitoring period, the method continues by obtaining an updated measurement value during a fasting period, determining a current value for the metric based at least in part on the updated measurement value, and generating a notification in response to a deviation between the current value and the fasting reference value exceeding a threshold indicative of insertion site loss or other loss of effectiveness.

Abstract: Disclosed is a medical device component for delivering medication fluid to a patient. The medical device component includes a fluid infusion device to regulate delivery of medication fluid, a body-mountable base unit, and a top cover assembly that is removably couplable to the base unit and to the fluid infusion device. The base unit includes a cannula to deliver medication fluid under the control of the fluid infusion device, and a physiological analyte sensor to measure a physiological characteristic. The base unit also includes an electronics assembly electrically connected to sensor leads to obtain measurements in the analog domain, to convert measurements into digital sensor data, and to communicate conditioned digital sensor data to the fluid infusion device. The top cover assembly is configured to provide both fluid and electrical connections for the base unit, by way of an infusion tube having sensor conductors integrated therein or otherwise associated therewith.

Abstract: A method for providing blood glucose data is provided. In response to a suspension of a continuous basal insulin delivery, by an insulin delivery pump, the method identifies a condition indicating continuing hypoglycemia that continues when basal insulin delivery is suspended; and performs an action, by the insulin delivery pump, based on identifying the condition.

Abstract: Subject matter disclosed herein relates to monitoring and/or controlling levels of an analyte in bodily fluid. In particular, estimation of a concentration of the analyte in a first physiological compartment based upon observations of a concentration of the analyte in a second physiological compartment may account for a latency in transporting the analyte between the first and second physiological compartments.

Abstract: A simple sensing device includes a case with one or more indicators to indicate levels of an analyte such as glucose. The sensing device for self-monitoring an analyte includes a single, flexible case adapted to adhere to a skin of a patient. It also includes a printed circuit board assembly inside the case. It further includes a first sensor extending from the flexible case and electrically coupled to the printed circuit board, and one or more indicators in the flexible case, where the indicator(s) are adapted to indicate whether a level of an analyte is within a normal range.

Abstract: A thin film sensor, such as a glucose sensor, is provided for transcutaneous placement at a selected site within the body of a patient. The sensor includes several sensor layers that include conductive layers and includes a proximal segment defining conductive contacts adapted for electrical connection to a suitable monitor, and a distal segment with sensor electrodes for transcutaneous placement. The sensor electrode layers are disposed generally above each other, for example with the reference electrode above the working electrode and the working electrode above the counter electrode. The electrode layers are separated by dielectric layer.

Abstract: Disclosed are a system and method for determining a metric and/or indicator of a reliability of a blood glucose sensor in providing glucose measurements. In one aspect, the metric and/or indicator may be computed based, at least in part, on an observed trend associated with signals generated by the blood glucose sensor.

Abstract: Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device to deliver fluid to a body of a user involves obtaining measurement values for a physiological condition influenced by the fluid, autonomously operating the infusion device to deliver the fluid based at least in part on the measurement values, and detecting a nonactionable condition based on the measurement values. In response to detecting the nonactionable condition, delivery of the fluid is limited while maintaining autonomous operation of the infusion device. In one exemplary embodiment, the nonactionable condition is a rescue condition indicative of the user having consumed fast-acting carbohydrates, and thus insulin delivery may be automatically limited in response to detecting the rescue carbohydrate consumption.

Abstract: Subject matter disclosed herein relates to monitoring and/or controlling blood glucose levels in patients. In particular, times for obtaining metered blood glucose samples of a patient may be altered based, at least in part, on a blood glucose level of said patient observed from a blood glucose sensor.

Abstract: Disclosed are a system and method for determining a metric and/or indicator of a reliability of a blood glucose sensor in providing glucose measurements. In one aspect, the metric and/or indicator may be computed based, at least in part, on an observed trend associated with signals generated by the blood glucose sensor.

Abstract: Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device to deliver fluid to a body of a user involves identifying a current site location on the body of the user associated with a sensing arrangement providing sensed measurements of a physiological condition in the body of the user at the current site location, determining one or more performance metrics associated with the current site location corresponding to operation of the infusion device to deliver the fluid in response to the sensed measurements, and providing sensor site feedback in a manner that is influenced by the one or more performance metrics. In one or more embodiments, the sensor site feedback includes recommended sensor site locations for rotation or replacement of the sensing arrangement determined based on historical data associated with the user for different sensor site locations.

Abstract: Embodiments of the invention provide electrochemical analyte sensors having elements designed to modulate their electrochemical reactions as well as methods for making and using such sensors.