Piecewise Glucose Cost Control in Insulin Delivery Devices

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Solution Overview

Problem

Conventional insulin delivery devices struggle with persistent positive glucose excursions due to conservative cost functions that fail to aggressively address low-level glucose deviations from the target level, leading to negative health effects.

Innovation Solution

The implementation of a piecewise cost function that dynamically adjusts based on glucose excursion persistence and magnitude, combining linear and quadratic functions to more aggressively penalize low-level deviations, using weights derived from historical data to enhance the control loop's responsiveness.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a conservative cost function is used to balance penalties for insulin delivery and glucose excursions, then the system delivers smaller insulin doses more frequently, but persistent positive glucose excursions occur at low levels

Engineering Contradiction:
Improveglucose level controlVSAvoidpersistent positive glucose excursions
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent changes the parameter of the cost function by introducing a piecewise definition with different penalty weights for different glucose excursion ranges. Specifically, it applies a higher penalty weight (e.g., 4.0) for excursions within a low-level range (e.g., 70-180 mg/dL) compared to standard excursions, thereby altering the system's response characteristics to address persistent low-level hyperglycemia while maintaining overall glucose control reliability

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The cost function is segmented into multiple ranges with different penalty applications. The patent divides the glucose excursion problem into segments: a first range for low-level excursions (70-180 mg/dL) with enhanced penalties, and a second range for higher excursions with standard penalties. This segmentation allows the system to address different aspects of glucose control with appropriate specificity, preventing persistent low-level excursions without over-correcting for higher excursions

Inventive Principle:
Principle #1Segmentation

2Object-affected harmful factors

If the cost function aggressively penalizes glucose excursions, then persistent positive glucose excursions are reduced, but larger insulin deliveries may be required more frequently

Engineering Contradiction:
Improvepersistent positive glucose excursionsVSAvoidinsulin delivery amount
Core Design Contradiction:
Object-affected harmful factorsVSQuantity of substance

Solution Approach 1:

The patent modifies the penalty parameter selectively by applying different weightings to different excursion ranges. The enhanced penalty weight (e.g., 4.0) is applied only to low-level excursions (70-180 mg/dL), while standard weighting is applied to higher excursions. This selective parameter change allows aggressive correction of persistent low-level excursions without proportionally increasing overall insulin delivery requirements

Inventive Principle:
Principle #35Parameter changes

3Productivity

If a piecewise cost function with enhanced penalties is applied to low-level glucose excursions, then the control loop becomes more responsive to maintain target levels, but the device complexity increases

Engineering Contradiction:
Improvecontrol loop responsivenessVSAvoidcost function structure
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The patent segments the cost function into manageable ranges with distinct penalty applications. By dividing the glucose excursion space into a first range (70-180 mg/dL) with enhanced penalties and a second range with standard penalties, the system achieves enhanced responsiveness for the critical low-level excursions while keeping the overall function structure organized and computationally manageable through clear range-based segmentation

Inventive Principle:
Principle #1Segmentation

Data Source

PatentUS12431229B2Medicament delivery device with an adjustable and piecewise analyte level cost component to address persistent positive analyte level excursions
Publication Date: 2025.09.30 INSULET CORP
  • US12431229B2 patent drawing
  • US12431229B2 patent drawing
  • US12431229B2 patent drawing

AI summary

The exemplary embodiments may modify a glucose cost component of the cost function of the control loop of an insulin delivery device to compensate for persistent positive low level glucose excursions relative to a target glucose level. The exemplary embodiments may enable use of different glucose cost component functions for different glucose levels of the user. These glucose cost component functions may be employed in piecewise fashion with a different piece being applied for each respective range of glucose level values for the user. The final glucose cost function for calculating the glucose cost component may be a weighted combination of a piecewise glucose cost function and a weighted standard cost function (such as a quadratic function). The weights may reflect the magnitude and/or persistence of glucose excursions relative to a target glucose level.