Methimazole in Graves' Disease - Comparing the Computer-aided Treatment DigiThy Versus Usual Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Semi-automated computer-aided treatment (Digital Thyroid, DigiThy), Usual care.
- Who it may be relevant to
- Registry conditions: Graves Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Guiding Methimazole Therapy in Graves' Disease - a Randomised Controlled Trial Comparing a Computer-aided Treatment (Digital Thyroid, DigiThy) Versus Usual Care
Overview
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.
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
Primary outcome measures
- The primary aim is to compare semi-automated computer-guided treatment with usual care in terms of their performance indices [Time frame: 18 months]
Secondary outcome measures (2)
- Comparison in terms of cumulative methimazole dosing [Time frame: 18 months]
- Comparison based on free thyroxine (fT4) target range [Time frame: 18 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Austria · 1 center
- Medical University of Graz — Graz
Identifiers
NCT: NCT06327828 · 32-663