NCT06187519

UR+AIMS Gout Wearable Skin Uric Acid Monitor Study

Cutaneous Uric Acid and Metabolite Monitor System (UR+AIMS) Lab Validation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

15 patients with gout \[10 patients no recent urate-lowering therapy (ULT) and 5 patients on stable urate-lowering therapy (ULT)\] will be invited to participate in a standardized meal at the UCLA Human Nutrition Center and a 7-day community follow-up for the measurement of uric acid (and other metabolites) using our Uric Acid and Metabolite Monitor System (UR+AIMS) skin patch.

Detailed description

First Visit at the UCLA Human Nutrition Center: * Patients will sign the informed consent, then answer some study questionnaires. * The Uric Acid and Metabolite Monitor System (UR+AIMS) skin patch and the study mobile device will be provided. * Study nurse will start an IV for pre and post blood draws. * Patients will be provided a standardized high-purine meal within 15 minutes. Pre-blood is drawn right before the patients eat the meal, then post-blood will be drawn every 15 minutes for the first hour after completion of the meal, then every 30 minutes for the next 3 hours (total of 4 hours). * Then patients will be sent home with the skin patch and study mobile device. Community 7-day observation period: * Patients will be asked to apply a study patch each morning before their first meal of the day. The patch should be removed at the end of the day and put under water. * The study device will monitor the patient's UA, glucose, heart rate, blood pressure, daily steps, and sleep. Patients will be asked to enter before and after meal uric acid levels and may be asked to take a picture of their meals using the study mobile device.

Conditions

• Gout

Interventions

Type	Name	Description
DEVICE	Uric Acid and Metabolite Monitor System (UR+AIMS) skin patch	The intervention tested is the system (patch and mobile device/phone for reporting) that provides patients with better knowledge (test results) about the impact of their daily dietary choices on their uric acid levels.

Timeline

• Start date: 2025-03-10
• Primary completion: 2025-06-18
• Completion: 2025-09-03
• First posted: 2024-01-02
• Last updated: 2025-11-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study