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

NCT06327828 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2024-05-16

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Graz University of Technology

    collaborator OTHER

  • Medical University of Graz

    lead OTHER

Principal Investigators

  • Stefan Pilz, MD, PhD · Medical University of Graz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2026-10-01
Completion
2026-10-01

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06327828 on ClinicalTrials.gov