Tandem Diabetes Care, Inc.

Paul Harris

Geoffrey A Kruse

Michael Michaud

Thomas R Ulrich

Garrett Marin

Jacob Kearns

Scott Leas

Betsy Dokken

Nicholas Sherer

Michael J Rosinko

Alexandra Elena Constantin

Mike Rosinko

David Berger

Virginia S Lu

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.

Systems and methods for automated insulin delivery for diabetes therapy

Disclosed herein are apparatuses and methods that account for exercise in closed loop insulin delivery systems. Rather than increasing a target insulin on board (IOB) as glucose levels rise, which would increase insulin delivery to address the raised glucose levels, when a user indicates that the user will be exercising raised glucose levels are addressed by reducing the target IOB within the closed loop algorithm. By reducing the target IOB, the algorithm responds less aggressively to pre-exercise food, and does not build up the IOB that can cause dangerously low glucose levels once the exercise also begins lowering glucose levels.

System and method for incorporating exercise into closed-loop diabetes therapy

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.

Transitioning to other modes in automated insulin delivery

Missed meal bolus reminders or alerts require a user to access the user's pump and/or remote control to clear the reminder/alert even when the user skipped a meal such that no meal bolus was needed. CGM data can be leveraged such that the missed meal bolus alert is only triggered when glucose levels rise in response to consuming the meal within the programmed time window. Therefore, the alert is only provided when a meal is actually consumed and no bolus has been delivered. This further allows the user to be alerted sooner, i.e., as soon as glucose levels rise a predetermined amount or passed a predetermined threshold indicating consumption of a meal as opposed to only at the end of the programmed window.

Automatic detection of un-bolused meals

Occlusions in a delivery line of an infusion pump can be detected by measuring pressure differentials in the pump over short periods of time in order to minimize the effects of long term systematic sensor changes. In a delivery mode such as basal insulin delivery where a small portion of a volume of fluid is delivered, pressure readings can be obtained before and after the motor move to deliver each portion and compared. The differentials after one or more motor moves can be compared to determine whether an occlusion is present. In a delivery mode such as bolus insulin delivery in which an entire volume of fluid is delivered, pressure differentials can be obtained for consecutive deliveries at a common point in the delivery cycle of each delivery. Comparison of these pressure values can be used to determine whether an occlusion is present.

System and method for detecting occlusions in an infusion pump

A portable infusion pump can communicate with continuous glucose monitor (CGM) to receive continuous feedback relating to a user's blood glucose level during insulin or other medicament therapy and can automatically deliver insulin to a user when the CGM data indicates a need for additional insulin. Because patient behavior can interfere with the accuracy and efficacy of such closed loop or semi-closed loop therapy, a system can employ various mechanisms for manual temporary suspension of closed-loop therapy when a patient is aware that current or future behavior may inhibit therapy.

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San Diego, CA, United States of America

Paul Harris