HyperthyroidismNCT07857421
AI-Based Wearable Monitoring (Glandy HYPER) for Antithyroid Drug Dose Adjustment in Graves' Disease
A study testing Glandy HYPER (AI-based monitoring software) and Methimazole in people with Hyperthyroidism and Graves Disease, run by THYROSCOPE INC. at 2 sites in Germany.
Trial summary
Graves' disease is the most common cause of hyperthyroidism and is usually treated with antithyroid drugs such as methimazole (MMI). The MMI dose is adjusted according to periodic blood tests, but individual responses vary, so some patients remain hyperthyroid longer than necessary while others become hypothyroid from… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Hyperthyroidism, Graves Disease, Thyrotoxicosis
- What is being tested?
- Glandy HYPER (AI-based monitoring software) and Methimazole
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesGermany
- Study dates
- 20 Oct 2026to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (>= 22 years) newly diagnosed with Graves' disease or currently in a thyrotoxic state despite ongoing treatment
- Diagnosis of Graves' disease based on: primary hyperthyroidism confirmed by thyroid function test (TFT); positive TSH-receptor antibody (TRAb); and clinical presentation consistent with Graves' disease
- At screening (Visit 1), individuals who have received an explanation of and are able to use Glandy HYPER
- Individuals who voluntarily decide to participate in the clinical study and have signed the informed consent form
Who cannot join
- Patients who are taking or require propylthiouracil (PTU) due to intolerance to methimazole (MMI), pregnancy, or other reasons
- Patients currently on MMI therapy if MMI cannot be discontinued from Visit 1 (screening) until Visit 2
- Individuals with cardiac disorders such as arrhythmia, heart failure, etc.
- Individuals currently taking medications that affect heart rate, including all types of antiarrhythmic drugs, antihistamines, etc. (intermittent use of short-acting beta-blockers to relieve hyperthyroid symptoms is permitted)
- Pregnant or breastfeeding women
- Patients who plan to become pregnant or do not agree to use appropriate contraceptive methods (pregnancy testing is required for women of childbearing potential)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites
University Hospital Frankfurt, Centre for Internal Medicine, Medical Department 1
Frankfurt am Main, Hesse, 60590
Jörg Bojunga, Prof. Dr. med.
Endokrinologikum Frankfurt am Main
Frankfurt am Main, Hesse, 60596
Alexander Mann, Prof. Dr. med.
About this study
Official title: Prospective Study Evaluating Antithyroid Drug Dose Adjustment Based on AI-Powered Monitoring of Thyrotoxicosis Using Glandy HYPER in Patients With Graves' Disease
Graves' disease is the most common cause of hyperthyroidism and is usually treated with antithyroid drugs such as methimazole (MMI). The MMI dose is adjusted according to periodic blood tests, but individual responses vary, so some patients remain hyperthyroid longer than necessary while others become hypothyroid from overtreatment. Glandy HYPER is a CE-marked, AI-based software medical device that analyzes sleep heart rate data collected by a smartwatch, together with thyroid function test results, to provide daily information on thyrotoxicosis status. This exploratory, post-market, two-center, randomized, open-label study in Germany evaluates whether MMI dose adjustment supported by Glandy HYPER shortens the time to normalization of free T4 compared with standard care, and also assesses overtreatment, thyroid-related quality of life, and safety.
Read the detailed description
This is an exploratory, post-market, prospective, randomized, open-label, two-arm clinical study conducted at two sites in Frankfurt, Germany (protocol 01-01-DE-001). It evaluates the clinical utility, performance and safety of Glandy HYPER, a CE-marked (MDR Class IIa) AI-based software medical device, in supporting methimazole (MMI) dose adjustment in adults with newly diagnosed or persistent thyrotoxic Graves' disease.
After written informed consent at Visit 1 (screening, Day -14 to 0), participants are randomized 2:1 (intervention:control) using a computer-generated procedure in the secuTrial EDC system. All participants receive a smartwatch with a CE-certified ECG function (Apple Watch for iOS users, Samsung Galaxy Watch for Android users) and are trained in its use; they wear it during sleep (at least 3 hours) and record an ECG before bedtime. Patients already taking MMI must be able to stop it between Visit 1 and Visit 2. At Visit 2 (baseline, Day 0), participants with confirmed thyrotoxicosis (free T4) and available sleep heart rate data are registered and MMI is started. Follow-up visits take place at Weeks 4, 8 and 12 (Visits 3-5, each +/- 1 week) with routine blood tests (free T4, TSH, liver parameters, blood count); the ThyPRO-39 quality-of-life questionnaire is completed at Visits 2-5. Participation lasts approximately 14 weeks.
Intervention arm (n=20): The MMI starting dose is determined by a predefined algorithm based on the Visit 1 free T4 level relative to the upper limit of normal. Glandy HYPER provides a once-daily thyrotoxicosis status result. If a "non-hyperthyroid" result occurs on three or more occasions between scheduled visits, the treating physician decides on MMI dose adjustment based on the clinical and laboratory situation, taking the Glandy HYPER data into account, and may schedule an unscheduled visit for laboratory confirmation; an unscheduled visit replaces the next scheduled visit. At each visit, if free T4 is above the normal range, the dose follows the predefined dose criteria; if free T4 is within the normal range, the dose is determined by the physician.
Control arm (n=10): MMI is started and adjusted by the physician according to routine care. Wearable data are collected, but Glandy HYPER results are not disclosed to participants or physicians and are not used for clinical decisions.
Glandy HYPER provides decision support only, and all dose decisions are made by the treating physician. After completion of the study schedule, the performance of Glandy HYPER in detecting thyrotoxicosis is evaluated against the laboratory free T4-based thyroid status.
- Conditions
- Hyperthyroidism, Graves Disease, Thyrotoxicosis
- Being tested
- Glandy HYPER (AI-based monitoring software), Methimazole
- Keywords
- Glandy HYPER, Wearable device, Artificial intelligence, Methimazole, Antithyroid drug, Software as a medical device, Thyroid function
- Medical subject headings
- Hyperthyroidism, Graves Disease, Thyrotoxicosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glandy HYPER (AI-based monitoring software)Device
CE-marked (MDR Class IIa) software as a medical device (mobile app) that analyzes sleep heart rate data collected by a smartwatch, together with thyroid function test results (free T4, TSH), to provide information on thyrotoxicosis status. In the intervention arm, the once-daily results are available to the treating physician to support methimazole dose adjustment.
MethimazoleDrug
Oral antithyroid drug for the treatment of hyperthyroidism. Intervention arm: starting dose per a predefined free T4-based algorithm; subsequent adjustments are decided by the treating physician taking Glandy HYPER results into account. Control arm: starting dose and adjustments per the physician's routine clinical judgment.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm (Glandy HYPER-supported) | Experimental | Participants wear a smartwatch and use the Glandy HYPER app, which provides a once-daily thyrotoxicosis status result based on sleep heart rate data. Methimazole (MMI) is started at Visit 2 at a dose determined by a predefined algorithm based on the Visit 1 free T4 level. If a "non-hyperthyroid" result occurs on three or more occasions between scheduled visits, the treating physician decides on MMI dose adjustment based on the clinical and laboratory situation, taking the Glandy HYPER data into account, and may schedule an unscheduled visit for laboratory confirmation. All dose decisions are made by the treating physician. Receives: Device: Glandy HYPER (AI-based monitoring software); Drug: Methimazole |
| Control arm (Standard care) | Active comparator | Participants wear the same smartwatch; wearable data are collected, but Glandy HYPER results are not disclosed to participants or physicians and are not used for clinical decisions. Methimazole (MMI) is started at Visit 2 and adjusted by the physician according to routine clinical care based on blood tests at scheduled visits (every 4 weeks +/- 1 week); the visit interval may be shortened at the physician's discretion. Receives: Drug: Methimazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Normal Free T4 Level
Time (days) from initiation of antithyroid medication (methimazole) at Visit 2 to the first laboratory confirmation of a serum free T4 (fT4) level within the site-specific normal range (Site 1: 0.82-1.77 ng/dL; Site 2: 0.93-1.67 ng/dL), assessed at scheduled and unscheduled clinic visits and compared between the intervention and control arms.
Measured: From Visit 2 (Day 0) to Visit 5 (Week 12 +/- 1 week)
Secondary outcomes (3)
Number of Occurrences of Free T4 Below the Lower Limit of Normal
Number of clinic visits (scheduled or unscheduled) per participant at which serum free T4 is below the site-specific lower limit of normal (Site 1: <0.82 ng/dL; Site 2: <0.93 ng/dL), as an indicator of overtreatment (iatrogenic hypothyroidism).
Measured: From Visit 2 (Day 0) to Visit 5 (Week 12 +/- 1 week)
Change From Baseline in Thyroid-Related Quality of Life (ThyPRO-39)
Thyroid-related quality of life is assessed with the self-administered ThyPRO-39 questionnaire (Thyroid-Related Patient-Reported Outcome, 39-item short version) at each clinic visit. Scale scores, including the composite quality-of-life impact score, range from 0 to 100, with higher scores indicating worse quality of life. Scores at each visit and change from baseline (Visit 2) are reported.
Measured: Baseline (Visit 2, Day 0), Week 4 (Visit 3), Week 8 (Visit 4) and Week 12 (Visit 5); visits +/- 1 week
Number of Participants With Procedure-Related Serious Incidents
Serious incidents (as defined in Regulation (EU) 2017/745) assessed by the investigator as related to the study device or study procedures, coded using IMDRF terminology.
Measured: From informed consent (Visit 1) to Visit 5 (Week 12 +/- 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start20 Oct 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperthyroidismStudies of the same condition, open and under way.
- 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
- Model description
- Participants are randomized 2:1 to Glandy HYPER-supported methimazole dose adjustment (intervention arm) or standard care (control arm).
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- THYROSCOPE INC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jörg Bojunga, Prof. Dr. med., Principal investigator, Universitätsmedizin Frankfurt (University Hospital Frankfurt)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857421
- Sponsor's protocol ID
- 01-01-DE-001
- Status last verified
- Oct 2026
- First submitted
- 14 Aug 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared. The final clinical study report (with personal data redacted) and a lay summary will be made publicly available on ClinicalTrials.gov.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Evaluating Antithyroid Drug Dose Adjustment Based on AI-Powered Monitoring of Thyrotoxicosis Using Glandy HYPER in Patients With Graves' Disease
- ClinicalTrials.gov ID
- NCT07857421
- Acronym / sponsor ID
- 01-01-DE-001
- Conditions
- Hyperthyroidism, Graves Disease, Thyrotoxicosis
- Keywords
- Glandy HYPER, Wearable device, Artificial intelligence, Methimazole, Antithyroid drug, Software as a medical device, Thyroid function
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- THYROSCOPE INC.Industry (pharma, biotech, devices)
- Study start
- 20 Oct 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 5 Oct 2026 (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.
Graves' disease is the most common cause of hyperthyroidism and is usually treated with antithyroid drugs such as methimazole (MMI). The MMI dose is adjusted according to periodic blood tests, but individual responses vary, so some patients remain hyperthyroid longer than necessary while others become hypothyroid from overtreatment. Glandy HYPER is a CE-marked, AI-based software medical device that analyzes sleep heart rate data collected by a smartwatch, together with thyroid function test results, to provide daily information on thyrotoxicosis status. This exploratory, post-market, two-center, randomized, open-label study in Germany evaluates whether MMI dose adjustment supported by Glandy HYPER shortens the time to normalization of free T4 compared with standard care, and also assesses overtreatment, thyroid-related quality of life, and safety.
Detailed description
This is an exploratory, post-market, prospective, randomized, open-label, two-arm clinical study conducted at two sites in Frankfurt, Germany (protocol 01-01-DE-001). It evaluates the clinical utility, performance and safety of Glandy HYPER, a CE-marked (MDR Class IIa) AI-based software medical device, in supporting methimazole (MMI) dose adjustment in adults with newly diagnosed or persistent thyrotoxic Graves' disease.
After written informed consent at Visit 1 (screening, Day -14 to 0), participants are randomized 2:1 (intervention:control) using a computer-generated procedure in the secuTrial EDC system. All participants receive a smartwatch with a CE-certified ECG function (Apple Watch for iOS users, Samsung Galaxy Watch for Android users) and are trained in its use; they wear it during sleep (at least 3 hours) and record an ECG before bedtime. Patients already taking MMI must be able to stop it between Visit 1 and Visit 2. At Visit 2 (baseline, Day 0), participants with confirmed thyrotoxicosis (free T4) and available sleep heart rate data are registered and MMI is started. Follow-up visits take place at Weeks 4, 8 and 12 (Visits 3-5, each +/- 1 week) with routine blood tests (free T4, TSH, liver parameters, blood count); the ThyPRO-39 quality-of-life questionnaire is completed at Visits 2-5. Participation lasts approximately 14 weeks.
Intervention arm (n=20): The MMI starting dose is determined by a predefined algorithm based on the Visit 1 free T4 level relative to the upper limit of normal. Glandy HYPER provides a once-daily thyrotoxicosis status result. If a "non-hyperthyroid" result occurs on three or more occasions between scheduled visits, the treating physician decides on MMI dose adjustment based on the clinical and laboratory situation, taking the Glandy HYPER data into account, and may schedule an unscheduled visit for laboratory confirmation; an unscheduled visit replaces the next scheduled visit. At each visit, if free T4 is above the normal range, the dose follows the predefined dose criteria; if free T4 is within the normal range, the dose is determined by the physician.
Control arm (n=10): MMI is started and adjusted by the physician according to routine care. Wearable data are collected, but Glandy HYPER results are not disclosed to participants or physicians and are not used for clinical decisions.
Glandy HYPER provides decision support only, and all dose decisions are made by the treating physician. After completion of the study schedule, the performance of Glandy HYPER in detecting thyrotoxicosis is evaluated against the laboratory free T4-based thyroid status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized 2:1 to Glandy HYPER-supported methimazole dose adjustment (intervention arm) or standard care (control arm).
| Arm | Type | Receives |
|---|---|---|
| Intervention arm (Glandy HYPER-supported) | Experimental | Device: Glandy HYPER (AI-based monitoring software), Drug: MethimazoleParticipants wear a smartwatch and use the Glandy HYPER app, which provides a once-daily thyrotoxicosis status result based on sleep heart rate data. Methimazole (MMI) is started at Visit 2 at a dose determined by a predefined algorithm based on the Visit 1 free T4 level. If a "non-hyperthyroid" result occurs on three or more occasions between scheduled visits, the treating physician decides on MMI dose adjustment based on the clinical and laboratory situation, taking the Glandy HYPER data into account, and may schedule an unscheduled visit for laboratory confirmation. All dose decisions are made by the treating physician. |
| Control arm (Standard care) | Active comparator | Drug: MethimazoleParticipants wear the same smartwatch; wearable data are collected, but Glandy HYPER results are not disclosed to participants or physicians and are not used for clinical decisions. Methimazole (MMI) is started at Visit 2 and adjusted by the physician according to routine clinical care based on blood tests at scheduled visits (every 4 weeks +/- 1 week); the visit interval may be shortened at the physician's discretion. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (>= 22 years) newly diagnosed with Graves' disease or currently in a thyrotoxic state despite ongoing treatment
- Diagnosis of Graves' disease based on: primary hyperthyroidism confirmed by thyroid function test (TFT); positive TSH-receptor antibody (TRAb); and clinical presentation consistent with Graves' disease
- At screening (Visit 1), individuals who have received an explanation of and are able to use Glandy HYPER
- Individuals who voluntarily decide to participate in the clinical study and have signed the informed consent form
Key exclusion criteria (6 listed)
- Patients who are taking or require propylthiouracil (PTU) due to intolerance to methimazole (MMI), pregnancy, or other reasons
- Patients currently on MMI therapy if MMI cannot be discontinued from Visit 1 (screening) until Visit 2
- Individuals with cardiac disorders such as arrhythmia, heart failure, etc.
- Individuals currently taking medications that affect heart rate, including all types of antiarrhythmic drugs, antihistamines, etc. (intermittent use of short-acting beta-blockers to relieve hyperthyroid symptoms is permitted)
- Pregnant or breastfeeding women
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 |
|---|---|---|
| Glandy HYPER (AI-based monitoring software)CE-marked (MDR Class IIa) software as a medical device (mobile app) that analyzes sleep heart rate data collected by a smartwatch, together with thyroid function test results (free T4, TSH), to provide information on thyrotoxicosis status. In the intervention arm, the once-daily results are available to the treating physician to support methimazole dose adjustment. | Device | Intervention arm (Glandy HYPER-supported) |
| MethimazoleOral antithyroid drug for the treatment of hyperthyroidism. Intervention arm: starting dose per a predefined free T4-based algorithm; subsequent adjustments are decided by the treating physician taking Glandy HYPER results into account. Control arm: starting dose and adjustments per the physician's routine clinical judgment. | Drug | Control arm (Standard care), Intervention arm (Glandy HYPER-supported) |
Primary outcome
Time to First Normal Free T4 Level
Time frame: From Visit 2 (Day 0) to Visit 5 (Week 12 +/- 1 week)
Time (days) from initiation of antithyroid medication (methimazole) at Visit 2 to the first laboratory confirmation of a serum free T4 (fT4) level within the site-specific normal range (Site 1: 0.82-1.77 ng/dL; Site 2: 0.93-1.67 ng/dL), assessed at scheduled and unscheduled clinic visits and compared between the intervention and control arms.
3 secondary outcomes
Number of Occurrences of Free T4 Below the Lower Limit of Normal
Time frame: From Visit 2 (Day 0) to Visit 5 (Week 12 +/- 1 week)
Change From Baseline in Thyroid-Related Quality of Life (ThyPRO-39)
Time frame: Baseline (Visit 2, Day 0), Week 4 (Visit 3), Week 8 (Visit 4) and Week 12 (Visit 5); visits +/- 1 week
Number of Participants With Procedure-Related Serious Incidents
Time frame: From informed consent (Visit 1) to Visit 5 (Week 12 +/- 1 week)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No. No individual participant data will be shared. The final clinical study report (with personal data redacted) and a lay summary will be made publicly available on ClinicalTrials.gov.
Related trials for Hyperthyroidism
Not yet recruiting
Impact of Restrictive Diets on Inflammation and Quality of Life in Autoimmune Thyroiditis
Thyroid Autoimmune Disease, Hashimoto's Thyroiditis
RecruitingPhase 3
A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease
Graves' Disease, Graves Disease
RecruitingPhase 3
A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease.
Graves Disease
Active, not recruitingPhase 4
Hydroxychloroquine in Mild Graves' Orbitopathy
Graves Ophthalmopathy
RecruitingPhase 2
A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease
Graves' Disease
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.
Jörg Bojunga, Prof. Dr. med. principal investigator
Universitätsmedizin Frankfurt (University Hospital Frankfurt)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glandy HYPER (AI-based monitoring software) and Methimazole in people with Hyperthyroidism and Graves Disease, run by THYROSCOPE INC. at 2 sites in Germany.
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 6 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: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Research Team, THYROSCOPE INC. (+82 52 264 4154, research@thyroscope.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Normal Free T4 Level (time frame: From Visit 2 (Day 0) to Visit 5 (Week 12 +/- 1 week)). 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 5 Oct 2026.