Meal bolus subcategories in model based insulin therapy

Inventors

METZMAKER, ThomasCONTE, NicholasMcLaughlin, IanLee, Joon BokBENTE, IV, Paul FrederickZADE, AshutoshCARDINALI, Steven

Assignees

Insulet Corp

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Publication Number

US-12495994-B2

Patent

Publication Date

2025-12-16

Expiration Date


Abstract

Disclosed are examples that include receiving information related to ingestion of a meal. The information may include a coarse indication of a size of the meal, a relative time of ingestion of the meal, and a general composition indication of the meal. A blood glucose measurement value received within a predetermined time range of a relative time of ingestion of the meal may be identified. Settings for a delay and an extend parameter and a delivery constraint may be determined. A meal model may be modified using the determined settings for the delay parameter, the extend parameter, and the delivery constraint. The modified meal model may be used to determine a dose of insulin to be delivered in response to the received information. An instruction indicates a determined dose of insulin to be delivered may be output for delivery to a drug delivery device.

Core Innovation

The invention relates to an artificial pancreas application for drug delivery that receives a user’s coarse indication of meal size. The system displays a plurality of options for a coarse indication of size of a meal and receives the chosen option, categorizing the meal as a meal of a first size or a meal of a second size while leaving an amount of carbohydrates unspecified and items in the meal unknown and unspecified to the drug delivery system.

After the meal is categorized, the system updates a delivery constraint based on the category. Responsive to the meal being categorized as the first size, a first updated setting for the delivery constraint is determined to a first preset percentage above a current maximum amount of the drug permitted to be delivered as specified by the delivery constraint, and responsive to the second size, a second updated setting for the delivery constraint is determined to a second preset percentage above the current maximum amount as specified by the delivery constraint. A dose of the drug is then determined in response to the chosen coarse indication of the meal size subject to the determined delivery constraint.

The invention further includes determination and/or refinement of additional settings and parameters that support meal-model selection and dose determination using received blood glucose measurement values. The system determines a trajectory of blood glucose measurement values over a time period relative to meal ingestion and compares it to blood glucose measurement value trajectories for fast-absorbing and slow-absorbing meal categories to determine an extend parameter based on similarity values, including selecting an extend parameter based on a highest similarity value.

Additionally, the system limits a plurality of meal models using factors such as time of day, a calendar setting, a closest match to a meal profile trajectory, and user inputs, then chooses among remaining meal models based on a confidence level.

Claims Coverage

The independent claims are directed to a non-transitory computer readable medium for an artificial pancreas drug delivery system and to a drug delivery system including an artificial pancreas application. Across these independents, the main inventive features cover coarse meal-size input, category-based delivery constraint updating via preset percentages above a current maximum, constrained dose determination, and causing drug delivery from a reservoir, with dependent claim features adding glucose-trajectory-driven parameter and meal-model selection.

Coarse meal-size options for meal categorization

Display a plurality of options for a coarse indication of size of a meal, receive a chosen option, and categorize the meal as a meal of a first size or a meal of a second size while an amount of carbohydrates is unspecified and items in the meal are unknown and unspecified.

Preset-percentage delivery constraint update based on meal size category

Responsive to categorization as the first size, determine a first updated setting for a delivery constraint to a first preset percentage above a current maximum amount of the drug permitted to be delivered; responsive to categorization as the second size, determine a second updated setting to a second preset percentage above the current maximum amount.

Constrained dose determination and drug delivery from reservoir

Determine a dose of the drug to be delivered in response to the chosen coarse indication of the size of the meal subject to the determined delivery constraint, and cause the determined dose of the drug to be delivered from the reservoir.

Relative ingestion time input to delay-parameter setting

Receive an input indicating a relative time of ingestion of the meal and determine a delay parameter setting based on that indication.

Blood glucose trajectory comparison to select extend parameter via similarity

Receive blood glucose measurement values over a time period relative to meal ingestion, determine a trajectory of the received blood glucose measurement values, compare it to blood glucose measurement value trajectories for meals categorized as fast absorbing and slow absorbing by quantifying similarity values, and determine an extend parameter based on a highest similarity value.

General meal composition indication to determine extend-parameter setting

Receive an indication of a general composition of the meal and determine a setting for an extend parameter based on that general composition indication.

Meal-model limiting using multiple factors and confidence level

Determine factors usable in limiting a plurality of meal models, select meal model(s) satisfying a greatest number of factors and eliminate others, choose among remaining meal models based on a confidence level, and use the selected meal model to determine the dose of the drug to be delivered.

Numeric delivery-constraint updated setting

Set the updated setting for the delivery constraint to a numeric value when determining the first updated setting for the delivery constraint.

Transceiver communication with a blood glucose sensor at predetermined time intervals

Include a transceiver that communicates with a blood glucose sensor to receive blood glucose measurement values at predetermined time intervals and provide measured values to a processor executing the artificial pancreas application.

Across the independent claims, the invention centers on constrained drug delivery for artificial pancreas operation using coarse meal-size options that map to meal size categories, with delivery constraint settings updated using preset percentages above a current maximum before determining and delivering a constrained dose from a reservoir. Dependent claim features extend the approach by incorporating relative ingestion time, general meal composition, and blood glucose measurement trajectory comparisons to determine delay and extend parameters and by limiting and selecting meal models using multiple factors and a confidence level.

Stated Advantages

Documented Applications

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