The objective of this project is to develop a noninvasive device for the measurement of glucose in saliva to monitor diabetic control. Availability of a noninvasive method will expand the frequency of testing and the number of individuals willing to monitor glucose, recommended by results of the DCCT. Glucose in saliva ultrafiltrate collected in our current product, the SalivaSac(TM), accurately predicts blood glucose and is less variable than whole saliva. Current glucose monitors cannot detect the lowest saliva concentrations. Therefore, two methods for glucose detection, enhanced colorimetry and a new method using chemiluminescence, will be compared. The latter is proposed to increase sensitivity to low concentrations of saliva glucose in hypoglycemia. The approaches will be compared for sensitivity, speed of response, effects of sample matrix, and the simplicity, cost and durability of instrumentation. Factors that may influence the quality of the sample, such as food residue, blood in the mouth, and rinsing will be investigated. Feasibility will be demonstrated if saliva predicts blood glucose levels in diabetic and hypoglycemic patients recruited in an IRB-approved study. Phase II will be used to construct a prototype instrument for home use and test the device in a diverse diabetic population.Proposed commercial application:The new device will provide a noninvasive means of routine glucose monitoring for diabetics, a market estimated at greater than $500 million per annum. The proposed method is superior to blood sampling by its noninvasive nature, and will also enlarge the market by expanding the practice of monitoring to large groups whose failure to maintain diabetic control is the source of costly and debilitating late complications.National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
