NCT06327828

Methimazole in Graves' Disease - Comparing the Computer-aided Treatment DigiThy Versus Usual Care

Guiding Methimazole Therapy in Graves' Disease - a Randomised Controlled Trial Comparing a Computer-aided Treatment (Digital Thyroid, DigiThy) Versus Usual Care

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to compare two methods of guiding methimazole therapy in patients with Graves' disease: methimazole dose adjustments based on a new semi-automated computer-guided treatment (based on a mathematical model) or based on the treating physician's decision (i.e. usual care). The main question it aims to answer is whether semi-automated computer-guided treatment is not inferior to usual care in terms of safety, the time it takes to achieve euthyroidism and the methimazole dose required.

Conditions

• Graves Disease

Interventions

Type	Name	Description
DEVICE	Semi-automated computer-aided treatment (Digital Thyroid, DigiThy)	Semi-automated computer-aided treatment based on a mathematical model
PROCEDURE	Usual care	Guiding methimazole therapy based on the treating physician's decision

Timeline

• Start date: 2024-09-01
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2024-03-25
• Last updated: 2024-05-16

Locations

1 site across 1 country: Austria