Novel Approach to Lactate Sensing Diabetes Pre-screening Tool
description
Transcript of Novel Approach to Lactate Sensing Diabetes Pre-screening Tool
Novel Approach to Lactate Sensing
Diabetes Pre-screening ToolChristine Zhang, Stephanie Wu, Joseph Sun,
Wern Ong, Toby Li
No Type II Diabetes Pre-screening device exists in the market
To address this need, we will create a hydrogel based lactate sensor where lactate level predicts probability of Diabetes II onset
Problem Statement
Chronic illness characterized by high blood sugar
Type II diabetes is caused by insufficient insulin levels, most often because the body has become resistant to insulin
Insulin is a hormone produced by the pancreas to control blood sugar
Diabetes
Indicators/Complications
Heart Disease/Stroke High Blood Pressure Blindness Kidney Disease Nervous System
Disease (Neuropathy) Amputation
Age Ethnicity Weight Family History Other Symptoms
Infections Vision Slow to heal
3 pre-diabetes tests A1C test Fasting plasma glucose test Oral glucose tolerance test
Lactate Sensor Simple More accessible
Current Testing Methods
Diabetes
Testing
A1C
Fasting Plasma Glucose (FPG)
Oral Glucose Tolerance (OGTT)
Prevalence 25.8 million people (8.3%) U.S. population
18.8 million people diagnosed 7.0 million people undiagnosed
170 million people worldwide 79 million Pre-diabetes (U.S.) 1.9 million cases of diabetes diagnosed in 2010
(U.S.) 300 million people by year 2025
Diabetes (I & II)
174 Billion: Total Costs of Diagnosed Diabetes (2007) 116 Billion: Direct Medical Costs 58 Billion: Indirect Costs
Medical expenditure of diabetics 2.3X higher than non-diabetics
Market Potential
Performance Criteria
Sense over a large range of lactate levels 0.15 – 0.3 mmol
Work in a timely manner <24 hrs. FPG 32 hrs OGTT 10 hrs
Low cost < $1 dollar Glucose Monitors
$10 Roche diagnostics
$190 Accuracy
60%
Develop lactate sensitive screening device for pre-diabetes screening
Using lactate sensitive hydrogels Measure volumetric change (directional
swelling) Correlate volume change to saliva lactate
Levels Predict probability of developing type II
diabetes
Primary Objective
Tube filled with lactate sensitive hydrogel polymer
Exposure to saliva lactate causes directional swelling of hydrogel polymer
Volumetric change to saliva lactate concentration correlated to blood lactate levels
Correlation of lactate concentration to development of type-2 diabetes
Solution Description
Hydrogel
Volume Change
Supporting Figures
0 2 4 6 8 10 120
2
4
6
8
10
12
f(x) = 0.850823832103762 x + 0.409893044982292R² = 0.957238587803571
Blood and Saliva Lactate Correlation
[Blood Lactate]
[Sal
iva
Lact
ate]
Probability curve
Hygienic Non-Invasive Disposable Uniform Cheap < $10 Easy To Use Accurate
Goals
Polymer Ratio (More DMAEMA = more pH sensitive)
Number of Tubes per batch Concentration of Lactate Oxidase [Lactate] Capillary diameter
Factors
System and Environment
Lactate Sensor
Saliva Sample
Lactate Conc.Water
pHProteins
Diabetes Predictio
n
Volumetric Change
Temperature
Lifestyle ChangeBlood TestSee
Physician
Self Testing
Clinical Setting
Literature Research
Hydrogel Synthesis
Lactate Sensitive Prototype
Testing Sensitivity to
Lactate
Calculation of Calibration
CurveStatistics/Analysis
Establishment of real world
protocolsApplication
Testing
Experiment Block Diagram
Performance
1 222232425262728293031
pH
Batch 1 (Normal)Batch 2 (DMAEMA)
Sample
Volu
me
(mm
^3)
Performance (Cont.)
0 0.2 0.3 0.4 0.5 1 50
0.20.40.60.8
11.21.41.61.8
2
Batch 7
Lactate Conc. [mmol]
Hei
ght
Chan
ge (
mm
)
Hygienic Non-Invasive Disposable Uniform Cheap $0.23/tube
Conclusion
Hard to measure volume change Hard to control directional swelling Hydrogel polymer not very sensitive to small
lactate concentrations Gradual volumetric change not immediate
(hrs) Air bubbles Un-uniform distribution of lactate oxidase
Informal Observations
Colorimetric Assay – Gradient of color change for more specific lactate readings
Digital Readout – More accurate saliva lactate readings
Testing in a public health application – test viability in large clinical settings (ie. Schools, businesses, clinics)
Recommendations
http://www.who.int/diabetes/publications/en/screening_mnc03.pdf
References