Methimazole in Graves' Disease - Comparing the Computer-aided Treatment DigiThy Versus Usual Care
Guiding Methimazole Therapy in Graves' Disease - a Randomised Controlled Trial Comparing a Computer-aided Treatment (Digital Thyroid, DigiThy) Versus Usual Care
1 other identifier
interventional
52
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2024
CompletedFirst Posted
Study publicly available on registry
March 25, 2024
CompletedStudy Start
First participant enrolled
September 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
May 16, 2024
May 1, 2024
2.1 years
March 18, 2024
May 13, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
18 months
Secondary Outcomes (2)
Comparison in terms of cumulative methimazole dosing
18 months
Comparison based on free thyroxine (fT4) target range
18 months
Study Arms (2)
Semi-automated computer-aided treatment
EXPERIMENTALTreatment based on the dosing suggestions by a mathematical algorithm and cross-checked by the treating physician
Usual care
ACTIVE COMPARATORTreatment based on the dosing suggestions by the treating physician
Interventions
Semi-automated computer-aided treatment based on a mathematical model
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Previous treatment with radioactive iodine
- Ongoing antithyroid treatment for more than one month
- Pregnancy
- Treatment with propylthiouracil
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical University of Grazlead
- Graz University of Technologycollaborator
Study Sites (1)
Medical University of Graz
Graz, 8044, Austria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stefan Pilz, MD, PhD
Medical University of Graz
Central Study Contacts
Stefan Pilz, MD, PhD
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2024
First Posted
March 25, 2024
Study Start
September 1, 2024
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
May 16, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share