Systems and methods for automated insulin delivery response to inaccurate or missed glucose values
Inventors
Kearns, Jacob • Michaud, Michael • Kruse, Geoffrey A. • Marin, Garrett • Harris, Paul • Ulrich, Thomas R. • Nichols, Brendan
Assignees
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Publication Number
US-12564677-B2
Publication Date
2026-03-03
Expiration Date
Abstract
Disclosed herein are systems and methods incorporating an ambulatory infusion pump and a CGM. These systems that can include software and related methods to provide improved automated insulin delivery algorithms that enable the algorithms to safely continue delivering insulin for some time periods of missing or known inaccurate glucose values.
Core Innovation
The disclosure describes an ambulatory infusion pump system that facilitates delivery of insulin to a user using closed-loop delivery. The system includes a pump mechanism, a user interface, and a communication element adapted to receive glucose levels from a continuous glucose monitor. A processor executes a closed-loop delivery algorithm to automatically calculate insulin doses based on glucose levels received from the continuous glucose monitor and to automatically deliver the calculated insulin doses to the user via the pump mechanism.
When glucose levels are not being received from the continuous glucose monitor, the processor enables the closed-loop delivery algorithm to continue automatically calculating insulin doses for automatic delivery with the pump mechanism for a predetermined period of time, based on execution of a safety mechanism associated with the closed-loop delivery algorithm. The safety mechanism determines a current glucose value noise based on recent glucose levels received from the continuous glucose monitor and a variance between the glucose levels and predicted glucose levels.
The safety mechanism reduces an amount of one or more insulin doses or delays delivery of one or more insulin doses if the current glucose value noise is above a threshold. The system terminates the automatic delivery to the user with the pump mechanism when it determines that the glucose levels have not been received for a time longer than the predetermined period of time. A corresponding method is also disclosed for delivering insulin by receiving glucose levels, calculating and delivering insulin doses with a closed-loop delivery algorithm, continuing for the predetermined period when glucose levels are not received, and terminating after the time without received glucose exceeds the predetermined period.
Claims Coverage
The partial content identifies two independent claims: a system claim and a method claim. Each claim includes closed-loop insulin calculation and delivery, detection of missing continuous glucose monitor glucose reception, and a safety mechanism that uses glucose value noise with a threshold to reduce or delay insulin dosing for a predetermined period before termination.
Closed-loop insulin delivery with CGM-based calculation
A system or method automatically calculates insulin doses with a closed-loop delivery algorithm based on glucose levels received from a continuous glucose monitor and automatically delivers the insulin doses to the user with the pump mechanism.
Predetermined continuation when CGM glucose levels are not received
The processor or method determines that glucose levels are not being received from the continuous glucose monitor and enables the closed-loop delivery algorithm to continue automatically calculating insulin doses for automatic delivery for a predetermined period of time based on execution of a safety mechanism associated with the closed-loop delivery algorithm.
Glucose value noise assessment and threshold-based dose reduction or delay
The safety mechanism determines a current glucose value noise based on recent glucose levels received from the continuous glucose monitor and a variance between the glucose levels and predicted glucose levels, and reduces an amount of one or more insulin doses or delays delivery of one or more insulin doses if the current glucose value noise is above a threshold.
Termination after exceeding the predetermined period without received glucose
The processor or method terminates automatic delivery when the glucose levels have not been received for a time longer than the predetermined period of time.
Across both independent claims, the coverage centers on maintaining closed-loop insulin dosing calculation and delivery during missing continuous glucose monitor reception for a predetermined period, using a safety mechanism that computes glucose value noise from recent glucose levels and variance versus predicted glucose, and reduces or delays dosing when noise exceeds a threshold, followed by termination if missing reception persists longer than the predetermined period.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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