SGLT Inhibitor and Insulin Dosing for Type 1 Glycemic Control

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Solution Overview

Problem

Existing insulin delivery systems, particularly Automated Insulin Delivery (AID) systems, struggle to effectively manage daytime glucose variability and postprandial hyperglycemia due to the slow action of subcutaneously administered insulin, leading to limitations in glycemic control and increased risk of cardiovascular complications in Type 1 diabetes.

Innovation Solution

Combining low-dose sodium-glucose cotransporter inhibitors (SGLTis) with automated insulin delivery systems, utilizing an adaptive advisory module (AAM) and automated supervisory module (ASM) to adjust insulin delivery and SGLTi dosing based on continuous glucose monitoring (CGM) data, thereby optimizing glycemic control and reducing the risk of diabetic ketoacidosis (DKA).

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Extent of automation

If subcutaneously administered insulin is used in automated insulin delivery systems, then insulin delivery can be automated and overnight control can be improved, but daytime glucose control remains suboptimal due to the slow action of insulin relative to meal glucose rate of appearance

Engineering Contradiction:

Improveautomated insulin deliveryVSAvoidaction speed of insulin

Core Design Contradiction:

Extent of automationVSSpeed

Solution Approach 1:

The patent combines SGLT2 inhibitors with automated insulin delivery systems to create a hybrid therapy that merges the slow-acting insulin mechanism with the rapid glucose-lowering effect of SGLT2 inhibitors, thereby addressing both overnight and daytime glucose control needs

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

SGLT2 inhibitors act as an intermediary mechanism that rapidly reduces glucose levels in the bloodstream through renal excretion, bridging the gap between meal intake and insulin action during daytime periods

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If SGLT2 inhibitors are added to improve glycemic control and cardiorenal benefits, then time-in-range increases and glucose variability reduces, but the risk of diabetic ketoacidosis increases

Engineering Contradiction:

Improveglycemic controlVSAvoidrisk of diabetic ketoacidosis

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent employs low doses of SGLT2 inhibitors (below the standard therapeutic dose) to achieve sufficient glycemic control and cardiorenal benefits while minimizing the metabolic stress that leads to diabetic ketoacidosis

Inventive Principle:

Principle #16Partial or excessive action

Solution Approach 2:

The system incorporates continuous glucose monitoring with automated supervisory modules that provide real-time feedback to adjust insulin delivery and detect early signs of ketosis, enabling proactive prevention of diabetic ketoacidosis

Inventive Principle:

Principle #23Feedback

3Reliability

If standard doses of SGLT2 inhibitors are used, then significant cardiorenal benefits are achieved, but the complexity of dosing optimization increases and DKA risk rises

Engineering Contradiction:

Improvecardiorenal benefitsVSAvoiddosing optimization complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent changes the dosage parameter of SGLT2 inhibitors from standard high doses to low doses, fundamentally altering the risk-benefit profile to achieve cardiorenal protection with reduced DKA risk and simplified integration into automated insulin delivery systems

Inventive Principle:

Principle #35Parameter changes

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The combination of low-dose SGLTis with insulin delivery systems improves glycemic control by increasing time-in-range (TIR), reducing glucose variability, and minimizing DKA risk, while providing cardiovascular benefits, outperforming standalone insulin therapies.

Implementation Method 1

sodium-glucose cotransporter-2 inhibitors are a newer class of agents that act in an insulin-independent manner to improve glucose control

Methodology Applied

Scientific EffectSodium-glucose cotransport inhibition:

Data Source

PatentUS20250345512A1Combination sodium-glucose cotransporter inhibitor (SGLTI) insulin therapy for glycemic control in type 1 diabetes

Publication Date: 2025.11.13 UNIV OF VIRGINIA PATENT FOUND

AI summary

Provided are a method, system, and computer-readable medium for optimizing glycemic control of a diabetic subject having Type 1 diabetes through co-administration of sodium-glucose cotransporter inhibitors (SGLTi) and insulin. Such co-administration can be effected by, for example, regulating one or more administration reactions in view of analyses of continuous glucose monitoring (CGM) data that can be indicative of at least the potential for one or more glycemic events including hypoglycemia and hyperglycemia. The aforementioned regulation can occur according to a balancing of insulin infusion and provisioning of SGLTi so as to avoid the occurrence of either of such events while, at the same time, not promoting an instance of diabetic ketoacidosis (DKA).