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

Sponsor
Medical University of Graz
Study ID
NCT06327828
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 1, 2024
Status verified
May 2024
Primary completion
Oct 1, 2026
Completion
Oct 1, 2026

Study Design

Enrollment
52 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Semi-automated computer-aided treatment
    Treatment based on the dosing suggestions by a mathematical algorithm and cross-checked by the treating physician
  • Active Comparator: Usual care
    Treatment based on the dosing suggestions by the treating physician

Primary Outcome Measure

The primary aim is to compare semi-automated computer-guided treatment with usual care in terms of their performance indices [ Time Frame: 18 months ]

Central Contacts

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