Abstract: Infusion devices, systems, and methods can detect a presence or absence of an infusion cartridge in an infusion pump. Embodiments may include a loading sequence, recording loading pulse width modulation (PWM) commands applied to an infusion pump motor during the loading sequence, setting a value of threshold PWM commands based on the commands applied during the loading sequence and comparing values of operational PWM commands applied during pumping operations to the value of the threshold PWM commands. If the value of the operational PWM commands drops below the threshold by a predetermined amount, a missing infusion cartridge warning may be generated.

Abstract: Disclosed herein are apparatuses and methods incorporating an infusion pump and a CGM that can include software that automatically populates a blood glucose section of a bolus calculator with a most recent valid CGM value. The software can additionally be programmed to automatically populate the bolus calculator with a single CGM reading only when one or more predefined conditions are met that aid in mitigating the risk of inaccurate and/or invalid single CGM readings.

Abstract: Methods and systems are disclosed wherein temperature in a device such as an ambulatory infusion pump is monitored during inductive charging of the device such that temperature-sensitive contents or components, such as, for example, insulin, particular circuitry and/or other components are not damaged. Temperature can be monitored in the device at one or more locations during inductive charging. If the temperature breaches one or more predetermined thresholds and/or is rising at a rate greater than one or more predetermined thresholds, charging can be suspended or provided at reduced power to prevent the temperature from further rising and damaging the contents and/or components of the device. One or more alerts associated with these events may also be triggered so that the user is aware of the situation and may take corrective action.

Abstract: Disclosed herein are systems and methods for remotely monitoring and/or controlling medical therapy of a patient. Embodiments of the current disclosure provide a remote monitoring and/or control architecture that can establish a predetermined set of permissions for real time monitoring of patient data and/or notifications and/or control of medical device therapy. The system can include permissions to determine who, how and when information and/or control is shared that can consider factors such as time, location and relationship with the patient.

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: A battery-powered infusion pump for delivery of insulin or other medicament may collect and store data related to the pump. The infusion pump can communicate some or all of the stored data to another device, and control the timing and amount of data communicated in order to conserve battery life.

Abstract: Infusion devices, systems, and methods can for detecting a presence or an absence of an infusion cartridge in an infusion pump. Embodiments may include a loading sequence, recording loading pulse width modulation (PWM) commands applied to an infusion pump motor during the loading sequence, setting a value of threshold PWM commands based on the loading PWM commands applied during the loading sequence and comparing values of operational PWM commands applied during pumping operations to the value of the threshold PWM commands. If the values of the operational PWM commands drops below the value of the threshold PWM commands by a predetermined amount, a missing infusion cartridge warning may be generated.

Abstract: Methods and systems are disclosed wherein temperature in a device such as an ambulatory infusion pump is monitored during inductive charging of the device such that temperature-sensitive contents or components, such as, for example, insulin, particular circuitry and/or other components are not damaged. Temperature can be monitored in the device at one or more locations during inductive charging. If the temperature breaches one or more predetermined thresholds and/or is rising at a rate greater than one or more predetermined thresholds, charging can be suspended or provided at reduced power to prevent the temperature from further rising and damaging the contents and/or components of the device. One or more alerts associated with these events may also be triggered so that the user is aware of the situation and may take corrective action.

Abstract: Disclosed herein are systems and methods for remotely monitoring and/or controlling medical therapy of a patient. Embodiments of the current disclosure provide a remote monitoring and/or control architecture that can establish a predetermined set of permissions for real time monitoring of patient data and/or notifications and/or control of medical device therapy. The system can include permissions to determine who, how and when information and/or control is shared that can consider factors such as time, location and relationship with the patient.

Abstract: A battery-powered infusion pump for delivery of insulin or other medicament may collect and store data related to the pump. The infusion pump can communicate some or all of the stored data to another device, and control the timing and amount of data communicated in order to conserve battery life.

Abstract: Apparatuses and methods for training users of ambulatory medical devices. The methods relate to improving user interactions with the touchscreens of devices. In one embodiment there is an operating mode that records all user interactions along with various device parameters and allows the clinician to review the patient’s performance for the initial use period. Automated analysis software may be employed to analyze the data generated by the device. The results of the analysis may be used by the clinician to improve the patient and device interaction.

Abstract: Apparatuses and methods for training users of ambulatory medical devices. The methods relate to improving user interactions with the touchscreens of devices. In one embodiment there is an operating mode that records all user interactions along with various device parameters and allows the clinician to review the patient's performance for the initial use period. Automated analysis software may be employed to analyze the data generated by the device. The results of the analysis may be used by the clinician to improve the patient and device interaction.

Abstract: Disclosed herein are systems and methods for mitigating the risk of insulin stacking in automated insulin delivery systems. In AID systems configured to both automatically calculate insulin delivery based on glucose levels and receive manual programming of meal boluses configured to counteract carbohydrates in a meal, insulin stacking can result if the system automatically increases insulin delivery based on a rise in glucose levels in response to consumption of a meal and the user later programs a meal bolus for the meal. The risk of such double dosing is mitigated by the systems and methods disclosed herein by enabling the system to account for recent automated insulin increases when a meal bolus is programmed.

Abstract: Disclosed herein are apparatuses and methods that can provide a delayed bolus calculator for use in closed loop diabetes therapy that can account for additional factors not taken into account in regular meal bolus calculations when a user wants to deliver a meal bolus a period of time after a meal was consumed. A delayed bolus calculator can enable the user to enter a period of time since the meal was consumed in addition to the number of carbohydrates consumed in a meal. This enables the system to account for the amount of increased insulin from the closed loop algorithm in response to the meal and/or the time since the meal to ensure that the risk of hypoglycemia is mitigated while still reducing hyperglycemia.

Abstract: An alternate mode for addressing meals in closed loop insulin delivery systems is disclosed. An Eating Soon Mode may be a user-selectable feature that can be activated when a user anticipates eating a meal in the near future. Once activated, Eating Soon Mode preemptively modifies the closed loop algorithm in preparation for the expected rise in glucose levels from consumption of the meal. This can result in a greater amount of time in range for the user, a lower coefficient of variation of the user's glucose levels and/or a lower maximum BG level for the user. According to embodiments disclosed herein, activation of Eating Soon Mode modifies the algorithm to deliver a correction bolus to lower the user's glucose level and to provide a modified, lower target range at which to maintain the user's glucose levels in anticipation of the glucose rise that will result from the meal.

Abstract: Disclosed herein are systems and methods for automated insulin delivery that provide an Alternate Normal Activity Mode that has a lower and narrower target range than the standard range employed in Normal Mode. The Alternative Normal Mode can be a user-selectable feature that provides more aggressive glucose level control that is designed to decrease hyperglycemia without significantly increasing the risk of hypoglycemia. For example, Normal Mode may employ a standard glucose range between which the closed loop algorithm attempts to maintain the user's glucose levels such as 112.5 mg/dL to 160 mg/dL and Alternative Normal Mode may employ a lower and narrower range such as 90 mg/dL to 130 mg/dL. Alternative Normal Mode can also employ a lockout feature that is activated when glucose is high, but is falling rapidly.

Abstract: Embodiments of the present disclosure enable a user-wearable infusion pump that may have a limited user interface including no display to be paired with a remote control device that can include a remote consumer electronic device such as a smartphone and/or a dedicated remote controller.

Abstract: Disclosed herein are systems and methods for monitoring performance of an ambulatory infusion pump. An ambulatory infusion pump can include a reservoir configured to contain a medicament including a plunger at a proximal end of the reservoir and an outlet port at a distal end of the reservoir. A motor can be configured to cause linear motion of a pushrod to contact and move the plunger to cause medicament to flow from the reservoir out of the outlet port to a patient. An optical encoder can be employed to monitor a linear position of the pushrod. In addition, the optical encoder can be employed to monitor additional system conditions and/or a secondary encoder can be employed to monitor the performance of the optical encoder.

Abstract: Disclosed herein are apparatuses and methods for improved use of infusion sites for infusion pumps. Apparatuses and methods for delivery of medicaments such as insulin disclosed herein can increase the effectiveness of therapy by more accurately determining when an infusion site is no longer absorbing insulin at an acceptable rate as well as determining the effectiveness of different infusion sites on the body with respect to each other and over time.

Abstract: Disclosed herein are apparatuses and methods for improved use of infusion sites for infusion pumps. Apparatuses and methods for delivery of medicaments such as insulin disclosed herein can increase the effectiveness of therapy by more accurately determining when an infusion site is no longer absorbing insulin at an acceptable rate as well as determining the effectiveness of different infusion sites on the body with respect to each other and over time.