An interventional study of Semi-automated computer-aided treatment (Digital Thyroid, DigiThy) and Usual care in Graves Disease, sponsored by Medical University of Graz. Not yet recruiting at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-16.
Sponsored by Medical University of Graz · Not applicable, Interventional, and Treatment
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.
150 studies on the registry are indexed under Graves Disease; 53 are open to participants now.
This study's planned enrollment of 52 is below the median of 60 across 92 interventional studies indexed under Graves Disease.
Browse Graves Disease studies →Medical University of Graz is the lead sponsor of 459 studies on the registry; 98 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment based on the dosing suggestions by a mathematical algorithm and cross-checked by the treating physician
Device: Semi-automated computer-aided treatment (Digital Thyroid, DigiThy)
Treatment based on the dosing suggestions by the treating physician
Procedure: Usual care
Semi-automated computer-aided treatment based on a mathematical model
Guiding methimazole therapy based on the treating physician's decision
The primary aim is to compare semi-automated computer-guided treatment with usual care in terms of their performance indices
The performance index is the deviation from the desired free thyroxine (fT4) value
Time frame: 18 months
Comparison in terms of cumulative methimazole dosing
Comparison in terms of cumulative methimazole dosing
Time frame: 18 months
Comparison based on free thyroxine (fT4) target range
Comparison based on free thyroxine (fT4) target range
Time frame: 18 months
Plan to share: No
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This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Medical University of Graz