Automated artificial pancreas insulin onboarding and total daily insulin delivery adaptivity based on insulin history

Inventors

Lee, Joon Bok • Zheng, Yibin • O'Connor, Jason • LY, Trang • Benjamin, Eric

Assignees

Insulet Corp

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Publication Number

US-12763189-B2

Patent

Publication Date

2026-10-13

Expiration Date


Abstract

Disclosed are a device, a computer-readable medium, and techniques that provide an onboarding process and an adaptivity process for a drug delivery device. A processor executing an onboarding process determines whether a history of delivered insulin to a user meets certain sufficiency requirements. The onboarding process enables a processor to cause the drug delivery device to administer doses of insulin to a user according to an initial total daily insulin dose calculation that is determined based on the sufficiency of the insulin delivery history. The initial total daily insulin may be adapted according to the adaptivity process as new insulin delivery is collected. The insulin delivery history, when sufficient, may be used to set total daily insulin dosages that enable automated insulin delivery upon replacement of a drug delivery device. The adaptivity process may be implemented to modify an initial insulin delivery doses to provide adapted insulin delivery doses.

Core Innovation

The invention describes an artificial-pancreas onboarding and adaptivity process that uses insulin delivery history to set an initial total daily insulin value for a wearable drug delivery device and to update that value when the device is replaced. The processor evaluates whether the available history meets sufficiency requirements and uses updated delivery history to determine a replacement value. The background section is not explicitly available in the provided text.

When history is insufficient, the system uses a basal insulin profile to establish a starting value and applies safety boundaries, optionally accounting for a delivery gap through an insulin-on-board setting. When history is sufficient, the system utilizes history-based values, and replacement updates combine a previously set value with recent delivery information. This process supports earlier closed-loop delivery while adapting to changing user needs and managing delivery risk.

Claims Coverage

The relevant claims include two independent claims directed to a device and a system, providing three inventive features.

History-based initial insulin value

Claim 1 recites a processor that retrieves insulin delivery history, determines whether it meets insulin history sufficiency requirements, sets an initial total daily insulin value when the requirements are met, and transmits that value to a wearable drug delivery device.

Device replacement and updated insulin value

Claim 1 recites receiving an indication that the wearable drug delivery device is being replaced, obtaining updated insulin delivery history collected during its operation, and setting a new total daily insulin value based on the initial value and insulin delivered during the replaced device's lifecycle.

Weighted dosage update for a replacement device

Claim 10 recites obtaining updated insulin delivery history after a wearable drug delivery device is replaced and setting a total daily insulin dosage as a weighted sum of a previously set dosage and a daily average of insulin doses based on the updated history, then transmitting the dosage to the replacement device.

The independent claims cover a processor-based device and a processor-based system that use insulin delivery history to establish an initial total daily insulin value and update dosage when a wearable drug delivery device is replaced.

Stated Advantages

The approach is stated to enable earlier closed-loop delivery.

The approach is stated to adapt total daily insulin to changing user needs while managing delivery risk.

Documented Applications

The process is described for an artificial pancreas application that works with a wearable drug delivery device and uses insulin delivery history to set and update total daily insulin values.

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