Phase 4 Type 1 Diabetes Trial, Recruiting (NCT06452654)

Phase 4 Type 1 Diabetes Trial, Recruiting NCT06452654 Sponsor: Technical University of Munich Condition: Type 1 Diabetes

Printed from Voxsanity (voxsanity.com.au) — NCT06452654 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Type 1 Diabetes

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

Babies who are between 3 and 4 months old at the time of joining the trial
Babies who have a high genetic risk (greater than 10%) of developing signs of type 1 diabetes by age 6, based on specific gene markers, a genetic risk score, and whether a close family member (parent or sibling) has type 1 diabetes
A parent or legal guardian has signed a written consent form on behalf of the baby

Who may not be able to join:

Babies who have previously had an allergic reaction to any of the inactive ingredients in the vaccine being studied
Babies who have a medical condition, ongoing illness, or are receiving a treatment that could affect the study results or make participation unsafe — including conditions or treatments that affect the immune system or cause immune suppression
Babies whose family is expected to move away, which may make it difficult to stay involved in the trial
Babies who have already been diagnosed with diabetes before joining the trial
Babies who are currently taking part in another drug trial or using another investigational medicine

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.

Last synced 27 July 2026

Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Anette-G. Ziegler, Klinikum r.d.Isar of Technical University Munich and Institute for Diabetes Research, Helmholtz Munich, Heidemannstr.1, 80939 Munich, Germany

Phone: +49-89-3187

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial which may be relevant to my care:

Trial: NCT06452654

Sponsor: Technical University of Munich

Phase: Phase 4

Status: Recruiting

Condition: Type 1 Diabetes

Trial contact: +49-89-3187

More information: https://clinicaltrials.gov/study/NCT06452654

Eligibility summary (AI generated)

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Babies who are between 3 and 4 months old at the time of joining the trial
Babies who have a high genetic risk (greater than 10%) of developing signs of type 1 diabetes by age 6, based on specific gene markers, a genetic risk score, and whether a close family member (parent or sibling) has type 1 diabetes
A parent or legal guardian has signed a written consent form on behalf of the baby

Who may not be able to join:

Babies who have previously had an allergic reaction to any of the inactive ingredients in the vaccine being studied
Babies who have a medical condition, ongoing illness, or are receiving a treatment that could affect the study results or make participation unsafe — including conditions or treatments that affect the immune system or cause immune suppression
Babies whose family is expected to move away, which may make it difficult to stay involved in the trial
Babies who have already been diagnosed with diabetes before joining the trial
Babies who are currently taking part in another drug trial or using another investigational medicine

Important: Always verify eligibility with the trial site directly before applying.

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 27 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Recruiting

Phase

Phase 4

Sponsor

Technical University of Munich

Registry

ClinicalTrials.gov

Start date

8 May 2024

Est. completion

1 October 2027

Where this trial is recruiting

🇦🇹 Austria 🇧🇪 Belgium 🇩🇪 Germany 🇸🇪 Sweden 🇬🇧 United Kingdom

Primary endpoints

Persistent confirmed islet autoantibodies or type 1 diabetes

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov