1. A Novel Approach to Lactate Sensing Christine Zhang, Stephanie Wu, Joseph Sun, Wern Ong, Toby Li

2.  Problem  Market Potential  Background  Requirements  Design  Verification and Validation  Current Status  Questions Objectives

3.  Fill the market void for a Type II Diabetes prescreening tool  Elevated lactate levels are highly correlated with type 2 diabetes onset Problem Statement

4.  Chronic illness characterized by high blood sugar  Insulin is a hormone produced by the pancreas to control blood sugar  Type II diabetes is caused by insufficient insulin levels, most often because the body has become resistant to insulin Diabetes

5.  Death  Coronary artery disease  Diabetic retinopathy  Erection problems  Hypertension  Infections of the skin, female urinary tract, and urinary tract  Peripheral vascular disease resulting in gangrene, amputations  Stroke Symptoms

6.  Diabetes causes decreased lactate threshold  LT is a point during exhaustive, all-out exercise at which lactic acid builds up in the blood stream faster than the body can remove it Diabetes & Lactate

7.  Type II Diabetes  170 million worldwide, 20.8 million US  300 million by 2025 – WHO prediction  Diabetes is a $15 billion dollar industry Market Potential

8.  Fasting Blood Glucose Test  Fast overnight  Go into clinic  Take blood glucose measurement  Drink a 75g sugar beverage  Take blood glucose measurement 2 hours later  Common Complaints  Nausea  Pain  Long wait time Current Testing Methods

9. Background Information

10.  What is lactate?  Byproduct of anaerobic metabolism - little O 2 in environment Lactate

11. Saliva and Blood Lactate Levels  Saliva and blood lactate levels show high correlation

12. Hydrogel Mechanism

13.  pH sensitive hydrogels coupled with lactate oxidase  2-hydroxyethyl methacrylate (HEMA)  N,N,dimethylaminoethylmethacrylate (DMAEMA)  Tetraethylene glycol dimethacrylate (TEGDMA)  Crosslinking agent Hydrogel

14. Design

15.  According to the CDC and WHO, there is a need for a:  Cheap  Uniform  Reliable  Accurate  Easy-to-use …predictor for prediabetics Performance Criteria

16.  Hygienic  Non-invasive  Inexpensive  Easy to use  Accurate  Disposable Design Goals

17.  Directional swelling  Thermometer-like device  Physical Change  Colorimetric Assay  Color change  pH sensitive indicator  Internal Control Lactate Sensor

18.  Lactate sensing  0.1 mmol resolution – if digital  Range 0.15 – 0.3mmol  0.2mmol indicator level Performance Metrics

19.  How much Saliva?  Interaction Time?  Exact specification of Hydrogel Preparation Testing & Verification

20.  Hydrogel filled capillary detects lactate levels in saliva  Directional Swelling/Colorimetric Assay indicates lactate concentrations  Indicate probability of type II diabetes Solution Overview

21.  Initial Hydrogel Preparation Testing  Hydrogel Preparation Specifications  Lactate Oxidase Concentration Current Status

22.  Testing  Colorimetric Assay coupled to specific lactate levels  Establishment of Testing Standards/Protocols  Testing varying lactate concentrations under different situations  Fabrication  Calibration of Sensor In the Future…

23. http://www.bme.vanderbilt.edu/srdesign/2010/group11/ Website

24. Questions?