Basal Insulin Rate Testing For Over- and Under-Delivery

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Solution Overview

Problem

Conventional insulin therapy methods, including insulin pumps and multiple daily injections, often result in large variations in insulin levels, making it difficult for diabetic patients to maintain optimal blood glucose levels, leading to complications such as heart disease, blindness, and kidney damage.

Innovation Solution

A basal rate testing system for insulin management devices that includes a user interface, input for receiving blood glucose data, and a controller to determine the amount of basal insulin over-delivered or under-delivered, using a specified basal insulin rate pattern to adjust the basal rate accordingly, with features like lag time compensation and correction factor adjustments.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If conventional insulin therapy with one or two injections a day is used, then the treatment is simple and convenient, but large variations in insulin levels occur making it difficult to maintain optimal blood glucose levels

Engineering Contradiction:

Improveconvenience of insulin therapyVSAvoidstability of insulin levels

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The patent implements dynamic basal rate adjustment by allowing the insulin pump to automatically modify basal insulin delivery rates based on continuous blood glucose monitoring data. The system transitions from static pre-programmed basal rates to dynamic rates that adapt in real-time to the patient's physiological needs, resolving the contradiction between operational simplicity and insulin level stability.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The system employs closed-loop feedback control where continuous blood glucose measurements are fed back to the pump controller, which then adjusts basal insulin delivery accordingly. This feedback mechanism enables automatic fine-tuning of insulin rates without requiring manual intervention, maintaining stable glucose levels while keeping the system easy to operate.

Inventive Principle:

Principle #23Feedback

2Reliability

If multiple daily injections (MDI) with more than three injections a day are used, then better control of blood glucose is achieved, but the treatment becomes inconvenient and requires tracking of multiple parameters

Engineering Contradiction:

Improvecontrol of blood glucose levelsVSAvoidconvenience of insulin therapy

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The insulin pump system performs self-adjustment of basal insulin rates based on continuous glucose monitoring data without requiring the patient to manually track or calculate multiple parameters. The automated algorithm processes glucose readings and modifies insulin delivery autonomously, eliminating the burden of manual tracking while maintaining precise glucose control.

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

The patent replaces the mechanical manual injection and tracking system with an automated electronic pump system. The pump automatically delivers insulin at precise rates and adjusts these rates based on glucose levels, substituting manual mechanical operations with automated electronic control, thereby improving convenience while maintaining control reliability.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Measurement precision

If frequent blood glucose testing is performed to improve control accuracy, then better insulin dosing decisions can be made, but the time and effort required increases significantly

Engineering Contradiction:

Improveaccuracy of blood glucose monitoringVSAvoidtime for blood glucose testing

Core Design Contradiction:

Measurement precisionVSLoss of time

Solution Approach 1:

The system implements continuous blood glucose monitoring that provides uninterrupted glucose level data without requiring intermittent manual testing. The continuous sensor delivers a steady stream of glucose measurements, eliminating the need for repeated finger-stick tests and significantly reducing the time and effort required for monitoring while maintaining high measurement precision.

Inventive Principle:

Principle #20Continuity of useful action

Solution Approach 2:

The patent replaces manual finger-stick blood glucose testing with an automated continuous glucose sensor. The sensor continuously measures glucose levels in interstitial fluid without requiring patient intervention, substituting the mechanical testing process with an automated sensing system that provides continuous data with minimal time investment from the patient.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Data Source

PatentUS12458754B2Basal rate testing using frequent blood glucose input

Publication Date: 2025.11.04 TANDEM DIABETES CARE INC

AI summary

An apparatus comprising a user interface configured to generate an electrical signal to start a basal insulin rate test when prompted by a user, an input configured to receive sampled blood glucose data of a patient that is obtained during a specified time duration, including a time duration during delivery of insulin according to a specified basal insulin rate pattern, and a controller communicatively coupled to the input and the user interface. The controller includes an insulin calculation module configured for determining at least one of an amount of basal insulin over-delivered and an amount of basal insulin under-delivered during the basal insulin rate test in trying to meet a target blood glucose baseline. Other devices and methods are disclosed.