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

Not Applicable

Not yet recruiting

• Conditions: Graves Disease
• Interventions: Procedure: Usual care; Device: Semi-automated computer-aided treatment (Digital Thyroid, DigiThy)

• Registration Number: NCT06327828
• Lead Sponsor: Medical University of Graz

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-18
• Study First Submitted QC: 2024-03-18
• Study First Posted: 2024-03-25
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-16
• Study Start: 2024-09-01
• Primary Completion: 2026-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Active Graves' hyperthyroidism [Thyroid-stimulating hormone <0.1 mU/L, elevated free thyroxine levels (fT4) above the upper limit of normal and positive Thyrotropin receptor antibody (TRAb) according to local laboratory results], measured within the last month prior to the inclusion date
• Patients not yet receiving antithyroid treatment, or having received antithyroid treatment continuously for less than 4 weeks, or relapse or recurrence of Graves' hyperthyroidism defined as patients previously having received and discontinued treatment with antithyroid drugs for at least 4 weeks)
• Age 18 years or older
• Provision of written informed consent

Exclusion Criteria

• Previous treatment with radioactive iodine
• Ongoing antithyroid treatment for more than one month
• Pregnancy
• Treatment with propylthiouracil

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care	Usual care	Treatment based on the dosing suggestions by the treating physician
Semi-automated computer-aided treatment	Semi-automated computer-aided treatment (Digital Thyroid, DigiThy)	Treatment based on the dosing suggestions by a mathematical algorithm and cross-checked by the treating physician

Primary Outcome Measures

Name	Time	Method
The primary aim is to compare semi-automated computer-guided treatment with usual care in terms of their performance indices	18 months	The performance index is the deviation from the desired free thyroxine (fT4) value

Secondary Outcome Measures

Name	Time	Method
Comparison in terms of cumulative methimazole dosing	18 months	Comparison in terms of cumulative methimazole dosing
Comparison based on free thyroxine (fT4) target range	18 months	Comparison based on free thyroxine (fT4) target range

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Austria