UR+AIMS Gout Wearable Skin Uric Acid Monitor Study

Gout Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06187519
• Other study ID #: UR+AIMS
• Secondary ID: R21DK132666
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 30, 2024
• Est. completion date: February 1, 2028

Study information

• Verified date: April 2024
• Source: University of California, Los Angeles
• Contact: John FitzGerald, MD
• Phone: 310-825-2448
• Email: JFitzgerald[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: February 1, 2028
• Est. primary completion date: February 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age > 18 with diagnosis of gout (screening positive ACR/EULAR Gout Classification Criteria - see screening survey) and eGFR > 60 (within the last 12-months).

2. For the 10 patients with gout off urate-lowering therapy (ULT) [no Allopurinol, febuxostat, or probenecid prescription within the last 6-months] and serum urate (SU) > 7 mg/dL (within the last 12-months).

3. For the 5 patients with gout on urate-lowering therapy (ULT) [no dose change within the last 30 days].

Exclusion Criteria:

1. Contraindications to miosis, which include acute iritis, narrow-angle glaucoma

2. Known Hypersensitivity to pilocarpine hydrochloride

3. Pupillary block glaucoma (ophthalmic solution)

4. Subjects reporting any allergy to glue or latex or any allergy to food that will be provided in the study (sardines in extra virgin olive oil and Sprite).

Related Conditions & MeSH terms

• Gout

Intervention

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.

Locations

Country	Name	City	State
United States	UCLA	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate tolerability and adherence of daily recorded patch wear time.	Daily recorded patch wear time as recorded by mobile phone app.	3 years
Primary	Recording of uric acid (and oxypurinol) measurements while wearing patch.	Recording of uric acid (and other metabolites e.g., uric acid, oxypurinol, ethanol) measurements while wearing patch recorded by patch Bluetooth to mobile phone.	3 years