Risk-Based Insulin Delivery Set Points for Glycemic Variability

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Solution Overview

Problem

Current insulin delivery systems impose a significant cognitive burden on patients and healthcare providers due to the need for frequent dosing determinations and recalibration, lacking a simple, safe, and reliable automatic control for glycemic management.

Innovation Solution

A method and system that adjusts basal insulin delivery rates based on estimated variability in blood glucose levels over a diurnal period, using a continuous glucose monitor and insulin pump to modify target blood glucose levels and deliver insulin accordingly, incorporating user-specific dosage parameters and predictive models to minimize hypoglycemic and hyperglycemic risks.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If manual insulin dosing and recalibration is used, then glycemic control can be achieved, but cognitive burden on patients and healthcare providers increases significantly

Engineering Contradiction:
Improveglycemic controlVSAvoidcognitive burden
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The system enables self-service by automatically monitoring blood glucose levels and adjusting insulin delivery rates without requiring manual intervention from patients or healthcare providers. The closed-loop system continuously makes dosing determinations based on real-time glucose data, eliminating the cognitive burden of manual recalibration while maintaining reliable glycemic control

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The system implements continuous feedback by monitoring blood glucose levels in real-time and using this information to automatically adjust insulin delivery rates. This closed-loop feedback mechanism ensures reliable glycemic control while removing the need for manual dosing decisions, thereby reducing cognitive burden on patients and providers

Inventive Principle:
Principle #23Feedback

2Reliability

If frequent dosing determinations and recalibration are required, then glycemic control can be maintained, but the complexity of the therapy increases

Engineering Contradiction:
Improveglycemic controlVSAvoidtherapy complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The system merges multiple functions into a single integrated platform that combines continuous glucose monitoring, automated insulin delivery, and predictive algorithms. This unified system maintains reliable glycemic control through frequent adjustments while reducing therapy complexity by consolidating what would otherwise require separate manual interventions into one automated device

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The automated system performs dosing determinations and recalibration operations autonomously based on glucose sensor data, eliminating the need for complex manual therapy protocols. This self-service capability maintains precise glycemic control while simplifying the overall therapy structure by removing the burden of frequent manual adjustments

Inventive Principle:
Principle #25Self-service

3Ease of operation

If automatic control systems are implemented, then cognitive burden is reduced, but the system must accurately predict and adapt to individual variability to ensure safety

Engineering Contradiction:
Improvecognitive burdenVSAvoidsafety
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The system uses continuous feedback from glucose sensors to monitor actual glycemic responses and automatically adjusts insulin delivery to account for individual variability. This real-time feedback ensures safety by detecting and responding to unexpected glucose changes, maintaining reliability while reducing cognitive burden through automation

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The system dynamically adapts to individual variability by continuously adjusting insulin delivery rates based on real-time glucose data and predictive algorithms. This dynamic control ensures safety by responding to changing physiological conditions while maintaining ease of operation through automated adaptation to individual patient characteristics

Inventive Principle:
Principle #15Dynamics

Data Source

PatentUS12383166B2Insulin delivery system and methods with risk-based set points
Publication Date: 2025.08.12 INSULET CORP
  • US12383166B2 patent drawing
  • US12383166B2 patent drawing
  • US12383166B2 patent drawing

AI summary

A method may include obtaining blood glucose level readings over a diurnal period for each of a plurality of days and determining an estimated variability of the blood glucose levels over the diurnal period for the plurality of days. The method may also include modifying, based on the estimated variability of the blood glucose level, a target blood glucose level to a modified target blood glucose level, and delivering insulin, using an insulin pump, during the diurnal period based on the modified target blood glucose level.