Electrochemical Home Monitoring System for Lithium Blood Level Lithium in the form of lithium carbonate is an important pharmacological treatment option in bipolar disorder and other conditions. However, lithium has a narrow therapeutic treatment range and its use requires careful monitoring of a patient's lithium blood level, particularly during the initiation of treatment. Current monitoring techniques are inconvenient and costly, requiring a clinical analytical laboratory. There is no commercially- available system for home measurement of blood lithium. This program will develop an advanced, rapid, and convenient home system which could make a significant impact in the health of those individuals being treated with lithium and encourage full therapeutic use of lithium when the medical condition merits. The innovation in the proposed work is to develop an electrochemical sensor comprised of a high performance microelectrode combined with a sensitive and selective electroanalytical technique in a predominantly nonaqueous electrochemical environment to measure lithium concentration in the clinically important range (0.2 - 3.0 millimoles per liter) from (aqueous) blood samples. Giner, Inc. will expand on its preliminary data on lithium detection and utilize its experience with the proposed electrochemical techniques and electrode materials. A major advantage of the proposed technology is that electrochemical techniques can be packaged into instruments for automated operation in the home which makes them very inexpensive and convenient compared to other laboratory-based analytical techniques. The final product will have the ease-of-use of a home glucose monitor and provide the clinician with real-time lithium measurements needed for optimal and cost-effective treatment of the patient. While there are multiple pharmacotherapy treatments for bipolar disorder, approximately 20% of the 5.7 million diagnosed patients in the U.S. use lithium as part of their treatment. The proposed product could be used in the home by the patient and also by the clinician during office visits.
The overall goal of this SBIR research and development program is the development of a home-based monitoring system for blood lithium for patient's use. The lithium blood level is very critical;therefore, bipolar disorder patients are now required to have frequent laboratory blood tests. A home-based system would provide convenience for patients while improving treatment and decreasing health care costs.
