Abstract: Disclosed are techniques to establish initial settings for an automatic insulin delivery device. An adjusted total daily insulin (TDI) factor usable to calculate a TDI dosage may be determined. The adjusted TDI factor may be a TDI per unit of a physical characteristic of the user (e.g., weight) times a reduction factor. The adjusted TDI factor may be compared to a maximum algorithm delivery threshold. Based on the comparison result, the application or algorithm may set a TDI dosage and output a control signal. Blood glucose measurement values may be collected from a sensor over a period of time. A level of glycated hemoglobin of the blood may be determined based on the obtained blood glucose measurement values. In response to the level of glycated hemoglobin, the set TDI dosage may be modified. A subsequent control signal including the modified TDI dosage may be output to actuate delivery of insulin.

Abstract: Examples of fluid delivery drive system and/or pump system that creates a vacuum in a fluid line for drawing and expelling fluid are provided. The vacuum may be created by separating two components that are positioned within the sealed fluid line. Once the two components are separated and the fluid is contained within the volume created between the separated components, the two components may be shuttled within the sealed volume. The movement of the two components can seal off an inlet to the fluid line and then open a pathway to an outlet from the fluid line while ensuring the created volume between the two components is maintained constant. The two components can then be moved back together to expel the fluid from the created volume through the outlet for delivery, for example, to a patient. Other examples are disclosed and described.

Abstract: Exemplary embodiments may address the problem of missing blood glucose concentration readings from a glucose monitor that transmits blood glucose concentration readings over a wireless connection due to problems with the wireless connection. In the exemplary embodiments, an automated insulin delivery (AID) device uses an estimate in place of a missing blood glucose concentration reading in determining a predicted future blood glucose concentration reading for a user. Thus, the AID device is able to operate normally in generating insulin delivery settings despite not receiving a current blood glucose concentration reading for a current cycle. There is no need to suspend delivery of insulin to the user due to the missing blood glucose concentration reading.

Abstract: Disclosed herein are wearable drug delivery devices and methods for component positioning of a linear shuttle pump. In some approaches, a pump may include a pump chamber operably coupled with a piston, and a detent apparatus, wherein the detent apparatus comprises a detent body, a detent arm, and a detent engagement member. The detent engagement member may be retained in direct physical contact with first or second arrest locations of either the detent body or the detent arm. The pump may further include a piston grip coupled to the piston, the piston grip including a grip component engaged with an exterior of the piston. Movement of the piston grip may cause the piston to move axially relative to the pump chamber to control receipt and delivery of a liquid drug.

Abstract: A medical device comprising an infusion device comprising a fluid reservoir to contain a therapeutic fluid and a transcutaneous access tool fluidly coupled to the fluid reservoir, the transcutaneous access tool configured to deliver the therapeutic fluid subcutaneously to a patient; wherein the infusion device operates in a stand-by mode prior to the therapeutic fluid being introduced into the fluid reservoir; wherein the infusion device operates to deploy the transcutaneous access tool within a predetermined deployment time period upon filling the fluid reservoir to a predetermined fill level with the therapeutic fluid.

Abstract: Embodiments of the present disclosure relate to approaches for more efficiently measuring glucose levels using a wearable drug delivery device. In some embodiments, the wearable drug delivery device may include a needle deployment component including a cannula and an optical conduit deployable into a user, the cannula operable to deliver a liquid drug to the user. The wearable drug delivery device may further include a glucose monitor including an optical sensor, the optical sensor operable to measure a light output received via the optical conduit.

Abstract: Disclosed herein are systems and methods for the delivery of a co-formulation of insulin and a second drug, such as GLP-1, using an automated insulin delivery system. In a first embodiment, a dose of insulin is calculated by a medication delivery algorithm and a reduction factor is applied to account for the effect of second drug on the user's daily insulin requirement. In a second embodiment of the invention, a total amount of the second drug administered to the user during the past 24 hours is used to modify the correction factor and the insulin-to-carbohydrate ratio used by the medication delivery algorithm to cause a reduction in the insulin delivered to the user to account for the effect of the administration of the second drug portion of the co-formulation.

Abstract: Disclosed are techniques and a device operable to determine a total amount of insulin delivered to the user over a predetermined time period. The total amount of insulin includes a total basal dosage delivered in basal dosages and a total bolus dosage delivered in bolus dosages over the predetermined time period. A proportion of the total amount of insulin delivered to the user provided via the total basal dosage amount over the predetermined time period is calculated. In response determining the proportion of the total amount of insulin attributed to the total basal dosage amount of insulin exceeds a threshold, an average basal dosage to be delivered within a subsequent time period that is approximately equal to the threshold may be determined. An instruction may be generated and output to deliver a modified basal dosage that substantially maintains the average basal dosage over the subsequent time period.

Abstract: The exemplary embodiments may provide a secure framework for devices in a drug delivery system to wirelessly communicate. The secure framework may use encrypted keys to carry credentials and to specify the rights of the devices presenting the credentials. The devices in the drug delivery system present the keys at the time that they wish to wirelessly communicate with other devices in the drug delivery system. The devices receiving such keys, decrypt the keys and verify if the credentials are valid. If the credentials are valid, a wireless communication session between devices may be established.

Abstract: Methods, devices, and systems of delivering infusion fluid (e.g., medication such as insulin) can detect, at multiple times during a dispensation period of time, a pressure level of the infusion fluid in an infusion fluid pathway, either directly or indirectly. Based on the detected pressure levels, one or more actual dispensation times that are after an intended dispensation time can be determined. In some cases, methods, devices, and systems provided herein can use variable occlusion alarm thresholds, which can depend on variables such as an age of an infusion set and/or a current analyte level. In some cases, methods, devices, and systems provided herein can automate medication delivery and use the actual dispensation times in a control algorithm determining medication deliveries.

Abstract: The exemplary embodiments may provide a drug delivery device that receives glucose level values for a user (e.g., a diabetic patient) and based on the glucose level values, determines when the user has consumed a meal. In some embodiments, the drug delivery device may calculate an appropriate bolus dose and automatically deliver the drug bolus to the user. In some embodiments, instead of detecting the meal, the user may announce the meal, such as by activating an element on the drug delivery device or on a management device for the drug delivery device. Responsive to the meal announcement, the drug delivery device may calculate the drug bolus dose and deliver the drug bolus. In conjunction with the delivery of the drug bolus, the drug delivery device may relax one or more safety constraints for a relaxation period following the drug bolus delivery so that additional basal drug may be delivered, if needed, under relaxed constraints.

Abstract: The disclosed embodiments are directed to a wearable automatic drug delivery device configured to provide basal-only dosing of insulin. In a primary embodiment, the wearable drug delivery device is configured to provide automatic operation and provides audible alerts and visual status indicators to the patient. In other embodiments, the patient may have some degree of control over the operation of the device by providing tapping gestures on housing of the device. In yet another embodiment, the patient may provide input and receive status from the device via an application executing on a portable computing device in wireless communication with the wearable drug delivery device.

Abstract: Disclosed herein are various embodiments of a pump mechanism comprising a rigid structure having an open end and a closed end, a plunger disposed in the open end of the rigid structure, and a flexible, fluid-proof sheet of material attached to an inner wall of the rigid structure and bonded to the head of the plunger such as to form a fluid barrier between the interior of the rigid structure and the plunger. Movement of the plunger toward the closed end of the rigid structure causes a rolling corner to be formed between the head of the plunger and the rigid structure and a fluid contained within the pump chamber to be forced out of the pump chamber via a fluid port defined in the closed end of the rigid structure.

Abstract: Disclosed are a system, methods and computer-readable medium products that provide safety constraints for an insulin-delivery management program. Various examples provide safety constraints for a control algorithm-based drug delivery system that provides automatic delivery of a drug based on sensor input. Glucose measurement values may be received at regular time intervals from a sensor. A processor may predict future glucose values based on prior glucose measurement values. The safety constraints assist in safe operation of the drug delivery system during various operational scenarios. In some examples, predicted future glucose values may be used to implement safety constraints that mitigate under-delivery or over-delivery of the drug while not overly burdening the user of the drug delivery system and without sacrificing performance of the drug delivery system. Other safety constraints are also disclosed.

Abstract: Systems, methods, and devices provide alarms and alerts in an on-body networked diabetes management system. Methods may include receiving glucose sensor data from a continuous glucose monitor and determining a dosage of insulin delivery based at least in part on the glucose sensor data. The method may include detecting an alarm or alert condition, and sending a wireless communication regarding the alarm or alert condition to a remote user-interface device. The method may include triggering an audible, visual, or haptic alarm or alert on the insulin delivery device unless an acknowledgement of the alarm or alert condition is received within a predetermined period of time.

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: The embodiments described herein may relate to methods and systems for adjusting insulin delivery. Some methods and systems may be configured to adjust insulin delivery to personalize automated insulin delivery for a person with diabetes. Such personalization may include adjusting user specific dosage parameters in response to a user provided insulin delivery amount, including a user provided insulin delivery amount that varies from a recommended insulin delivery amount.

Abstract: Exemplary embodiments provide an approach to predicting meal and/or exercise events for an insulin delivery system that otherwise does not otherwise identify such events. The insulin delivery system may use a model of glucose insulin interactions that projects estimated future glucose values based on a history of glucose values and insulin deliveries for a user. The predictions of meal events and/or exercise events may be based on residuals between actual glucose values and predicted glucose values. The exemplary embodiments may calculate a rate of change of the residuals over a period of time and compare the rate of change to thresholds to determine whether there likely has been a meal event or an exercise event. The insulin delivery system may then take measures to account for the meal event or the exercise event by the user.

Abstract: Disclosed are examples for a system for drug delivery and components thereof. The system may include an on-body pump device and a secondary unit. The on-body pump device may include a reservoir and a fluid pathway. The reservoir may be configured to hold a liquid drug. The secondary unit may be removably coupled to the on-body pump device. The secondary unit may be configured to receive a prefilled cartridge containing a liquid drug, expel the liquid drug from the prefilled cartridge, and deliver the liquid drug to the reservoir of the on-body pump device via the fluid pathway. Examples of variations to the secondary unit are also disclosed.