Rapid screening tool to detect early-stage diabetes

New device with potential to improve diabetes care and management for millions of patients

Problem

The CDC estimates that approximately 7 million people in US have diabetes and don't know it.1 Delayed diagnosis increases the risk of serious complications such as premature heart disease, stroke, and kidney failure.2 Accurate screening tools that fit into clinical workflows are needed to help more patients detect diabetes at an early stage and start treatment. The standard tool for screening for diabetes is the hemoglobin A1c test. This widely used test is preferred by patients and clinicians because it does not require fasting. However, the A1c test has serious limitations. A recent study with 9,000 patients showed that the A1c test failed to catch 73 percent of diabetes cases that were detected by the oral glucose test.3 The oral glucose test is accurate, but is not practical for screening. The oral glucose test requires the patient to fast for 24 hours, get blood drawn, ingest a sugary drink, and get blood drawn again two hours later. A convenient and accurate tool is needed to screen at-risk patients for diabetes.

Solution

Clinicians recently observed a shift in chirality of metabolites in the human body with diabetes.4,5 Like our left and right hands, chiral molecules are identical in geometry except they exist as mirror images of each other. In a laboratory setting, the chirality of a biomolecule can be distinguished by fast and reliable optical methods. However, these techniques have not been translated into clinical tools. The limiting factor has been the challenge with accurately measuring the small amount of chiral metabolites that exist with many interfering molecules in saliva, blood, or urine.

Professor Yuebing Zheng, Ph.D., has published widely in the space of plasmonic detection of chiral molecules. Recently, the Zheng Lab has teamed up with a clinical team led by Kumar Sharma, M.D., Chief of the Division of Nephrology and Vice Chair for Research in the Department of Medicine at UT Health San Antonio. This group has built a system that can rapidly detect the chirality of metabolic molecules in urine via accumulation-assisted plasmonic chiral sensing. This approach does not require preparation of the sample and is currently undergoing clinical validation. This system can be developed as a point-of-care device for first-line non-invasive screening of diabetes.

References

1. CDC National Diabetes Statistics Report, 2020. https://www.diabetes.org/resources/statistics/statistics-about-diabetes
2. U.S. Department of Health and Human Services (DHHS). Diabetes detection initiative: Finding the undiagnosed. Available at: http://www.ndep.nih.gov/ddi/about/index.htm.
3. Chang Vilacreses, MM. et al., J Endocr Soc. 2019 Apr 15; 3(Suppl 1): SAT-125. Published online 2019 Apr 30. doi: 10.1210/js.2019-SAT-125
4. Furusho, A. et al., Anal. Chem. 2019, 91(18), 11569-11575. doi: 10.1021/acs.analchem.9b01615
5. Takayama, T. et al., Anal. Bioanal. Chem. 2015, 407(3),1003-14. doi: 10.1007/s00216-014-8275-9.