Wearable Metabolic Sensor for Monitoring of Lactate and Glucose for People with Diabetes

Wearable Metabolic Sensor for Monitoring of Lactate and Glucose for People with Diabetes ABSTRACT Diabetes technology has made enormous progress over the last decade with the advent of Automated Insulin Delivery (AID) systems and Continuous Glucose Monitoring (CGM) systems, bringing sophisticated computerized management systems to the continuous delivery of insulin. However, due to limited contextual information on the external influences to glucose, nutrition ingestion and exercise, the systems have increased the level of user burden with requirements to manually enter this guidance into the AID. Missing entries could result in unintended consequences, such as hypoglycemia due to missing an exercise input and hyperglycemia due to missing a nutrition input. A continuous sensor that measures exercise through an accelerometer and lactate production as well as glucose could minimize both hypoglycemia and user burden and achieve better time in target range. The Phase I and Phase II funding from NIDDK has helped us establish benchtop feasibility of the technology and a self-funded First in Human clinical research study has shown promise to further progress toward broader clinical research studies and verifying of commercial potential. This Phase IIb submission requests funding for final technology optimization, pilot process, confirming final regulatory requirements with the FDA, and initial commercial planning activities.