Continuous Steroid Monitoring in Interstitial Fluid With Wearable and Nanoparticle-enhanced Biosensors for Improved Management of Adrenal Disorders

The goal of this project is to provide novel technology that will pave the way from the present single-point (analogue) endocrinology towards continuous cortisol and aldosterone monitoring with full time resolution. Current endocrine practice relies on occasional and often random determination of hormone level or functional tests that require a clinical setting. These measurements include sample extraction and analysis in a clinical laboratory rendering such tests laborious and expensive. Most importantly, through the individual variations of hormone oscillation and spatiotemporal distribution of hormones, infrequent hormone measurements have limited diagnostic and prognostic value as the dynamic changes are not captured and relevant intra-individual variability occurs. A requirement for this vision are sensing solutions capable to track hormone dynamics over prolonged periods at high patient comfort (e.g., at home), as targeted by this research proposal. This project has the overarching goals of (1) establishing dynamic interstitial aldosterone and cortisol monitoring as reliable diagnostic tool for cortisol and aldosterone excess or deficiency, and (2) develop a wearable molecular sensing device to detect them accurately.

NCT Number	NCT06980753
Lead Sponsor	University of Sao Paulo General Hospital Collaborators: Swiss Federal Institute of Technology in Zurich (ETH Zurich), Fundação de Amparo à Pesquisa do Estado de São Paulo
Conditions	Cushing Syndrome, Primary Aldosteronism, Adrenal Insufficiency
Enrollment	246 participants
Start Date	2025-06-01
Primary Completion	2025-11-01 (estimated)
Study Completion	2025-12-01 (estimated)
Updated on ClinicalTrials.gov	2025-05-20