Hypoglycemia Probability Tracking via Blood Glucose Scale Symmetrization

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Solution Overview

Problem

Current methods for predicting hypoglycemia in diabetes patients are imperfect, particularly due to the asymmetry of the blood glucose measurement scale, leading to biased predictions towards hyperglycemia and poor accuracy in detecting severe hypoglycemic events.

Innovation Solution

A method and system that uses a bivariate probability distribution based on the Low Blood Glucose Index (LBGI) and Average Daily Risk Range (ADRR) from self-monitoring blood glucose data to track the probability of hypoglycemia, employing a mathematical transformation to symmetrize the blood glucose scale and a quadratic risk function to weight deviations, enabling early warning of impending hypoglycemic events.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If traditional standard deviation and variability measures are used to predict hypoglycemia, then the calculation is simple and straightforward, but the prediction accuracy is poor and biased towards hyperglycemia

Engineering Contradiction:
Improvecalculation simplicityVSAvoidhypoglycemia prediction accuracy
Core Design Contradiction:
Ease of manufactureVSMeasurement precision

Solution Approach 1:

The patent transforms the blood glucose measurement scale using a mathematical function f(BG) that maps the asymmetric glucose range to a symmetric transformed scale. This parameter transformation allows the use of simple statistical measures like standard deviation on the transformed scale, which then accurately reflects hypoglycemia risk while maintaining calculation simplicity.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent explicitly addresses the asymmetry of the blood glucose scale by applying a transformation function that creates symmetry in the transformed values. The function is designed such that deviations below and above the target glucose level are weighted equally in the transformed space, eliminating the bias towardshyperglycemia while preserving the asymmetric nature of clinical significance.

Inventive Principle:
Principle #4Asymmetry

2Ease of operation

If the blood glucose measurement scale is used directly without transformation, then the clinical interpretation is straightforward, but the statistical analysis is biased towardshyperglycemia

Engineering Contradiction:
Improveclinical interpretabilityVSAvoidprediction reliability
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent introduces a transformed glucose scale as an intermediary representation between the original clinical measurements and the statistical analysis. The transformation function serves as a mediator that preserves clinical meaning while enabling unbiased statistical evaluation, allowing results to be interpreted in both transformed and original glucose units.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Measurement precision

If intensive diabetes treatment is applied to improve glycemic control, then HbA1c levels decrease, but the risk of severe hypoglycemia increases

Engineering Contradiction:
Improveglycemic control qualityVSAvoidsevere hypoglycemia risk
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent calculates the Low BG Index and risk metrics from historical glucose data before severe hypoglycemic events occur. This preliminary assessment allows clinicians to identify patients at high risk and adjust treatment intensity before dangerous hypoglycemia occurs, enabling preventive action rather than reactive management.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent provides feedback about hypoglycemia risk based on analyzed glucose patterns. This feedback loop allows clinicians to monitor not just average glucose control but also the variability and risk of extreme low values, enabling balanced treatment decisions that maintain control while minimizing severe hypoglycemia risk.

Inventive Principle:
Principle #23Feedback

Data Source

PatentUS10431342B2Tracking the probability for imminent hypoglycemia in diabetes from self-monitoring blood glucose (SMBG) data
Publication Date: 2019.10.01 UNIV OF VIRGINIA PATENT FOUND
  • US10431342B2 patent drawing
  • US10431342B2 patent drawing
  • US10431342B2 patent drawing

AI summary

A method, system and related computer program product for tracking the probability of hypoglycemia from routine self-monitoring of blood glucose (SMBG) data in patients with diabetes. A specific bivariate probability distribution of low BG events based jointly on the Low BG Index (LBGI) and the Average Daily Risk Range (ADRR) is used to predict hypoglycemia probability of occurrence from inputted SMBG data. The SMBG data is retrieved from a series of SMBG data of a patient available from the patient's glucose meter and allows tracking of the probability for future hypoglycemia over a predetermined duration, e.g., a 24 or 48 hour period. The tracking includes presentation of visual and/or numerical output, as we construction of hypoglycemia risk trajectories that would enable warning messages for crossing of predefined thresholds, such as 50% likelihood for upcoming hypoglycemia below 50 mg/dl.