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

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 Overview

• Status: Not yet recruiting
• Conditions: Graves Disease
• Intervention / Treatment: Device: Semi-automated computer-aided treatment (Digital Thyroid, DigiThy); Procedure: Usual care

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Verena Theiler-Schwetz, MD, PhD; Phone Number: ++4331638582383; Email: verena.schwetz@medunigraz.at
• Study Contact Backup: Name: Stefan Pilz, MD, PhD

Study Locations

• Austria
  • Graz, Austria, 8044
    • Medical University of Graz
    • Contact: Verena Theiler-Schwetz, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Semi-automated computer-aided treatment; 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); Semi-automated computer-aided treatment based on a mathematical model
Active Comparator: Usual care; Treatment based on the dosing suggestions by the treating physician	Procedure: Usual care; Guiding methimazole therapy based on the treating physician's decision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison based on free thyroxine (fT4) target range	Comparison based on free thyroxine (fT4) target range	18 months
Comparison in terms of cumulative methimazole dosing	Comparison in terms of cumulative methimazole dosing	18 months

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Collaborators: Graz University of Technology
• Investigators: Principal Investigator: Stefan Pilz, MD, PhD, Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: March 18, 2024
• First Submitted That Met QC Criteria: March 18, 2024
• First Posted (Actual): March 25, 2024

Study Record Updates

• Last Update Posted (Estimated): May 15, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Eye Diseases; Endocrine System Diseases; Thyroid Diseases; Exophthalmos; Orbital Diseases; Goiter; Hyperthyroidism; Graves Disease
• Other Study ID Numbers: 32-663

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No