Expert system for insulin pump therapy

Inventors

Blomquist, Michael L.

Assignees

Tandem Diabetes Care Inc

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Publication Number

US-12249412-B2

Patent

Publication Date

2025-03-11

Expiration Date


Abstract

An apparatus comprising a controller. The controller includes an input/output (I/O) module and a rule module. The I/O module is configured to present a question for a patient when communicatively coupled to a user interface and receive patient information in response to the question via the user interface. The rule module is configured to apply a rule to the patient information and generate a suggested insulin pump setting from application of the rule. Other devices, systems, and methods are disclosed.

Core Innovation

An insulin-therapy expert system controller is implemented as an insulin pump system that includes an input/output module and a rules module. The system prompts a patient to enter information, including body weight, via a user interface, receives patient information, and applies stored rules to generate one or more initial pump settings for an initial set up of the pump for the patient.

The generated initial pump settings are applied to cause insulin delivery by an insulin pump while the system receives glucose level data of the patient during insulin delivery based on the one or more initial pump settings. The glucose data is used to generate modified pump settings that modify one or more of the initial pump settings, and in configurations with target blood glucose levels the system compares received glucose level data to one or more target glucose levels and generates the modified pump settings based on that comparison.

The system further supports feedback-driven retuning, where ongoing glucose monitoring provides glucose data, including glucose sensors producing a blood glucose signal and optionally a rate of change. Based on this received glucose data and testing concepts such as basal rate testing, carbohydrate ratio testing, and correction factor testing, the system recommends updates to pump settings, with optional rule development/editing and tracking of effectiveness of the suggested settings.

Claims Coverage

The independent claims cover a user-wearable infusion pump system with a body-weight prompt, rule-based generation of initial pump settings, and glucose-data-driven modification of pump settings during insulin delivery, including configurations that compare glucose data to one or more target glucose levels. Across the independent claims, the inventive features center on closed-loop operation with initial rule-based setup and subsequent modification using glucose data.

Body-weight prompt with stored rules to generate initial pump settings

Prompt a patient to enter a body weight of the patient into the user interface; apply one or more stored rules to the body weight of the patient; generate one or more initial pump settings for an initial set up of the pump for the patient based on the application of the one or more stored rules to the body weight of the patient.

Glucose-level-data reception during insulin delivery and modified pump settings

Cause the pump to deliver insulin to the patient according to the one or more initial pump settings; receive glucose level data of the patient while insulin is being delivered to the patient based on the one or more initial pump settings; and generate one or more modified pump settings that modify one or more of the one or more initial pump settings based on the glucose level data.

Closed-loop modification of insulin being delivered based on glucose data

Cause the pump to deliver insulin to the patient according to the one or more initial pump settings; receive glucose level data of the patient while insulin is being delivered to the patient based on the one or more initial pump settings; and modify the insulin being delivered to the patient based on the glucose level data.

Initial basal rate pattern generated from body weight

Generate an initial basal rate pattern for the patient based on the application of the one or more stored rules to the body weight of the patient; and cause the pump to deliver insulin to the patient according to the initial basal rate pattern.

Target glucose comparison for modification based on glucose versus targets

Compare obtained glucose level data to one or more target glucose levels; and generate one or more modified pump settings or modify insulin delivery based on the comparison of glucose level data to the one or more target glucose levels in combination with initial pump settings.

Across the independent claims, the inventive coverage centers on prompting for body weight, applying one or more stored rules to generate initial pump settings, delivering insulin using the initial pump settings, and receiving glucose level data while insulin is being delivered to generate modified pump settings or to modify insulin delivery. Dependent refinements include initial basal rate patterns and comparison of glucose level data to one or more target glucose levels to drive the modifications.

Stated Advantages

Documented Applications

No documented applications found

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