Information about the PreTreg clinical trial

It is a way to check whether new drugs or therapies are effective and safe.

The purpose of the trial is to see if Tregs therapy is safe and effective in children aged 3–18 years who have early-stage type 1 diabetes (no symptoms of the disease).

The trial is open to children and young people aged 3–18, weighing more than 20 kg, who do not yet have symptoms of diabetes and who meet specific medical criteria.

Participation in the trial lasts up to 5 years, depending on the individual course of therapy.

The trial has been approved by an independent bioethics committee and the relevant authority. The entire process will take place under the supervision of experienced specialist physicians.

This therapy has been used before and is considered safe. As with any treatment, side effects can occur, but patients are informed about these and are under constant medical supervision.

The medical team conducting the trial, including physicians and nurses.

Treatment will be stopped and you will receive the right medical care.

First, there is an interview, followed by signing the consent form. Initial tests are then performed to see if the participant meets the criteria.

No, you do not need to undergo any tests beforehand. As part of the eligibility process, physicians will examine the patient from head to toe and perform all the necessary tests and follow-up examinations. Based on these results, a decision will be made as to whether the person is eligible to participate in the trial.

Yes, participation is voluntary, and you can withdraw at any time.

In the first year, visits are more frequent – initially every one to two weeks, then every few months. In subsequent years, visits are made once a year.

Randomisation, i.e. random assignment to a trial group, is a key element of clinical trials as it enables the effectiveness and safety of a new therapy to be reliably assessed. Regardless of their assignment, all participants will receive medical care for the entire duration of the trial.

As well as access to modern treatment and constant medical care, participation in the trial is a real contribution to the development of medicine that can help many other children in the future.

Yes, trial results contribute to medical advances.

Additional doses of the drug are not provided after the trial ends, as the therapy does not require further administration outside the established schedule.

Yes, all procedures and medications are funded by the organisers of the trial.

No, participation in a clinical trial does not involve financial gratification. However, patients may receive partial or full reimbursement for travel and accommodation costs to and from appointments, up to a limit set by the trial organisers.

It is encrypted and stored in accordance with privacy laws.

You have the right to information, voluntary participation and to opt out at any time.

Contact the trial team or trial coordinator, as detailed in the information materials provided during the informed consent process at the start of the trial.