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

Condition(s) studied

Investigational drug(s) / intervention(s)

Participants will use the biossensor for 48 h: Participants will use the biossensor for 48 h

Study summary

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.

Eligibility

Primary outcome measure(s)

• The total area under the curve (AUC) of aldosterone and cortisol levels measured over 48 hours using the biossensor — 8 weeks
  It is important to note that the units of concentration for aldosterone (ng/dl) and cortisol (mcg/dl) do not influence the calculation of the AUC

Trial sites (1)

More University of Sao Paulo General Hospital trials in Brazil