Systems and methods for automated insulin delivery for diabetes therapy
Inventors
Kearns, Jacob • Michaud, Michael • Kruse, Geoffrey A. • Ulrich, Thomas R. • Harris, Paul • Leas, Scott • Dokken, Betsy • Marin, Garrett • Sherer, Nicholas
Assignees
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Publication Number
US-12383673-B2
Publication Date
2025-08-12
Expiration Date
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.
Core Innovation
The invention relates to an ambulatory infusion pump system that facilitates delivery of insulin to a user and includes at least one processor functionally linked to the pump. The processor automatically calculates insulin doses with a closed loop delivery algorithm based on glucose levels of the user, and determines that a meal bolus configured to deliver insulin to counteract carbohydrates consumed in a meal should be delivered to the user.
To mitigate insulin stacking, the processor determines whether delivery of the meal bolus is within a predetermined time of one or more automatically calculated insulin doses that increased an amount of insulin delivered to the user. If the determination is within the predetermined time, the processor automatically modifies the meal bolus by accounting for recently delivered automatically calculated insulin dose increases.
A related embodiment determines that a meal bolus should be delivered and then determines whether a closed loop delivery algorithm calculated an increase in insulin based on glucose levels of the user that was delivered within a predetermined time prior to determining that the meal bolus should be delivered. The system automatically modifies the meal bolus if that increase in insulin was delivered within the predetermined time, and the closed loop delivery algorithm is based on glucose levels received from a continuous glucose monitor.
Claims Coverage
The independent claims are clm-00001 and clm-00013. Both cover a processor-controlled ambulatory infusion pump that decides to deliver a meal bolus for consumed carbohydrates and automatically modifies the meal bolus based on whether a prior closed-loop-calculated insulin increase was delivered within a predetermined time window; this introduces two core inventive features in the independent claims.
Timing-based insulin increase accounting for meal bolus delivery
Automatically calculating insulin doses with a closed loop delivery algorithm based on glucose levels of the user, determining that a meal bolus configured to deliver insulin to counteract carbohydrates consumed in a meal should be delivered to the user, determining whether the meal bolus delivery is within a predetermined time of one or more automatically calculated insulin doses that increased an amount of insulin delivered to the user, and automatically modifying the meal bolus if the determination is within the predetermined time.
Predetermined time prior to meal bolus decision for closed-loop insulin increase
Determining that a meal bolus configured to deliver insulin to counteract carbohydrates consumed in a meal should be delivered to the user, determining whether a closed loop delivery algorithm calculated an increase in insulin based on glucose levels of the user that was delivered within a predetermined time prior to determining that the meal bolus should be delivered, and automatically modifying the meal bolus if the increase in insulin based on glucose levels received from the continuous glucose monitor was delivered within the predetermined time.
Across clm-00001 and clm-00013, the claim coverage centers on automatically modifying a meal bolus when a recently delivered closed-loop insulin increase falls within a predetermined time window relative to the meal bolus decision to mitigate insulin stacking.
Stated Advantages
Mitigating insulin stacking in automated insulin delivery by accounting for recent closed-loop automatically delivered insulin increases when programming a meal bolus.
Documented Applications
Automated insulin delivery (AID) / closed-loop insulin delivery in an ambulatory infusion pump system, including adjustment of a meal bolus when the user later programs a meal bolus after recent automatically calculated insulin increases.
Using continuous glucose monitor (CGM) glucose levels to modify a meal bolus based on whether a prior closed-loop-calculated insulin increase was delivered within a predetermined time prior to the meal bolus decision.
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