Urine Test Strip for Diabetic Ketoacidosis Detection

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Solution Overview

Problem

Current monitoring tools for diabetic ketoacidosis in patients taking sodium-glucose cotransporter 2 (SGLT2) inhibitors are either inaccurate or invasive, making it difficult to detect the onset of diabetic ketoacidosis, particularly in patients with Euglycemic Diabetic Ketoacidosis (EuDKA), which can lead to delayed treatment and serious complications.

Innovation Solution

A noninvasive urine test using test strips that change color upon detection of β-hydroxybutyrate (BHB) in urine, allowing patients to self-monitor for the presence of BHB and discontinue SGLT2 inhibitor administration if detected, thereby preventing the onset of diabetic ketoacidosis.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If urinary acetoacetate strips are used to monitor for DKA, then the monitoring can be performed at home, but the results are inaccurate and potentially dangerous due to false positives or false negatives

Engineering Contradiction:

Improvehome monitoring capabilityVSAvoidDKA status detection accuracy

Core Design Contradiction:

Ease of operationVSMeasurement precision

Solution Approach 1:

The patent changes the monitored parameter from acetoacetate to beta-hydroxybutyrate (BHB), which is the predominant ketone body in DKA. This parameter change provides accurate detection of actual DKA status while maintaining home monitoring capability through simple urine dipstick testing.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent replaces the need for complex blood sampling and laboratory analysis with a simple urine-based chemical test. The BHB-detecting dipstick uses chemical reaction (nitroprusside reagent) to detect BHB in urine, providing accurate results without invasive procedures or complex equipment.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Measurement precision

If capillary finger-prick BHB testing is used, then early monitoring of DKA is accurate, but the method is invasive and costly, deterring patient use

Engineering Contradiction:

Improveearly DKA monitoring accuracyVSAvoidpatient acceptance and compliance

Core Design Contradiction:

Measurement precisionVSEase of operation

Solution Approach 1:

The patent employs disposable urine dipsticks that are inexpensive and single-use. Each dipstick is discarded after one test, eliminating the need for cleaning, calibration, or maintenance. This makes the testing method economically accessible and highly convenient for daily home use by patients.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The patent enables patients to perform their own DKA monitoring independently without requiring healthcare providers, laboratory facilities, or complex equipment. The simple dipstick test can be performed at home by the patient themselves, providing continuous self-monitoring capability.

Inventive Principle:

Principle #25Self-service

3Reliability

If SGLT2 inhibitors are administered to diabetic patients, then blood glucose control is improved, but the risk of diabetic ketoacidosis increases

Engineering Contradiction:

Improveblood glucose controlVSAvoiddiabetic ketoacidosis risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent implements a feedback mechanism where patients regularly test their urine for BHB and report results to their healthcare provider. This feedback loop allows for early detection of ketosis and timely adjustment of SGLT2 inhibitor dosage or discontinuation, preventing progression to full DKA while maintaining glucose control benefits.

Inventive Principle:

Principle #23Feedback

Solution Approach 2:

The patent enables preliminary detection of ketone production before full DKA develops. By monitoring BHB levels in urine, the system provides early warning signals that allow preventive action (dose reduction or discontinuation of SGLT2 inhibitor) before the harmful condition of DKA ensues.

Inventive Principle:

Principle #10Preliminary action

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 urine test provides a simple, accurate method for early detection of diabetic ketoacidosis risk, enabling timely intervention and reducing the incidence of severe complications associated with SGLT2 inhibitor use.

Implementation Method 1

A noninvasive urine test using test strips that change color upon detection of β-hydroxybutyrate (BHB) in urine

Methodology Applied

Scientific EffectColor change: Chemiluminescence

Data Source

PatentUS11808708B2Method for maintaining the health of a diabetic patient by preventing the occurrence of diabetic ketoacidosis

Publication Date: 2023.11.07 F A T STATS LLC

AI summary

A method for maintaining the health of a diabetic patient by preventing onset of diabetic ketoacidosis in said patient, the method comprising: prescribing an SGLT2 inhibitor for administration to a patient in need thereof; providing at least one test strip for identifying the presence of β-hydroxybutyrate in the patient's urine; and upon indication of the presence of β-hydroxybutyrate in the patient's urine, discontinuing the administration of the SGLT2 inhibitor. Also disclosed is a kit useful in the monitoring of risk of onset of diabetic ketoacidosis in patients taking an SGLT2 inhibitor, the kit comprising: the SGLT2 inhibitor and at least one test strip to identify the presence of β-hydroxybutyrate in the patient's urine, wherein the at least one test strip undergoes a change in color upon detection of β-hydroxybutyrate in the patient's urine.