Graves DiseaseNCT06327828
Methimazole in Graves' Disease - Comparing the Computer-aided Treatment DigiThy Versus Usual Care
A study testing Semi-automated computer-aided treatment (Digital Thyroid, DigiThy) in people with Graves Disease, run by Medical University of Graz at 1 site in Austria.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graves Disease
- What is being tested?
- Semi-automated computer-aided treatment (Digital Thyroid, DigiThy)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteAustria
- Study dates
- 1 Sep 2024to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previous treatment with radioactive iodine
- Ongoing antithyroid treatment for more than one month
- Pregnancy
- Treatment with propylthiouracil
Trial locations and contacts
1 site in 1 country.
Stefan Pilz, MD, PhD contact
Austria1 site
Medical University of Graz
Graz, 8044
Verena Theiler-Schwetz, MD, PhD
About this study
Official title: Guiding Methimazole Therapy in Graves' Disease - a Randomised Controlled Trial Comparing a Computer-aided Treatment (Digital Thyroid, DigiThy) Versus Usual Care
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.
- Conditions
- Graves Disease
- Being tested
- Semi-automated computer-aided treatment (Digital Thyroid, DigiThy), Usual care
- Medical subject headings
- Graves Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-automated computer-aided treatment (Digital Thyroid, DigiThy)Device
Semi-automated computer-aided treatment based on a mathematical model
Usual careProcedure or surgery
Guiding methimazole therapy based on the treating physician's decision
| Study group | Role | What they receive |
|---|---|---|
| Semi-automated computer-aided treatment | Experimental | Treatment based on the dosing suggestions by a mathematical algorithm and cross-checked by the treating physician Receives: Device: Semi-automated computer-aided treatment (Digital Thyroid, DigiThy) |
| Usual care | Active comparator | Treatment based on the dosing suggestions by the treating physician Receives: Procedure: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 months
Secondary outcomes (2)
Comparison in terms of cumulative methimazole dosing
Comparison in terms of cumulative methimazole dosing
Measured: 18 months
Comparison based on free thyroxine (fT4) target range
Comparison based on free thyroxine (fT4) target range
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Graz University of Technology
- Responsible party
- Sponsor
- Investigators
- Stefan Pilz, MD, PhD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06327828
- Sponsor's protocol ID
- 32-663
- Status last verified
- May 2024
- First submitted
- 18 Mar 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guiding Methimazole Therapy in Graves' Disease - a Randomised Controlled Trial Comparing a Computer-aided Treatment (Digital Thyroid, DigiThy) Versus Usual Care
- ClinicalTrials.gov ID
- NCT06327828
- Acronym / sponsor ID
- 32-663
- Conditions
- Graves Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- Graz University of Technology
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 25 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semi-automated computer-aided treatment | Experimental | Device: 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 |
| Usual care | Active comparator | Procedure: Usual careTreatment based on the dosing suggestions by the treating physician |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Previous treatment with radioactive iodine
- Ongoing antithyroid treatment for more than one month
- Pregnancy
- Treatment with propylthiouracil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semi-automated computer-aided treatment (Digital Thyroid, DigiThy)Semi-automated computer-aided treatment based on a mathematical model | Device | Semi-automated computer-aided treatment |
| Usual careGuiding methimazole therapy based on the treating physician's decision | Procedure or surgery | Usual care |
Primary outcome
The primary aim is to compare semi-automated computer-guided treatment with usual care in terms of their performance indices
Time frame: 18 months
The performance index is the deviation from the desired free thyroxine (fT4) value
2 secondary outcomes
Comparison in terms of cumulative methimazole dosing
Time frame: 18 months
Comparison based on free thyroxine (fT4) target range
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Pilz, MD, PhD contact
Stefan Pilz, MD, PhD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semi-automated computer-aided treatment (Digital Thyroid, DigiThy) in people with Graves Disease, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Verena Theiler-Schwetz, MD, PhD (++4331638582383, verena.schwetz@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.