RecruitingOBSERVATIONAL

Fr1da Early Diagnosis and Care of Type 1 Diabetes

The Fr1da study is finding out if checking children for early signs of type 1 diabetes can make a real difference. It focuses on children aged 2 to 10 in Germany, offering simple checks as part of their regular health appointments. The main goals are to stop serious health issues like ketoacidosis (a dangerous build-up of acids in the blood) before they happen, and to give families support and less stress if their child is found to be at risk. The study also checks relatives of people with type 1 diabetes, as they have a higher chance of developing it themselves. By finding type 1 diabetes early, the study hopes to improve lives and explore ways to prevent the condition from getting worse.

At a glance

Status

Recruiting

Sponsor

Helmholtz Zentrum München

Enrolment target

285,000

Start

01 Feb 2015

Estimated completion

01 Dec 2028

Type 1 Diabetes Mellitus

What is this study about?

Type 1 diabetes is a serious condition where your body stops making a hormone called insulin, which is needed to turn sugar into energy. This study, called Fr1da, is looking into finding type 1 diabetes much earlier in children than it's usually found.

The study offers a simple, early check for children aged 2 to 10 years old. In much of Germany, this check is done during their usual child health appointments. Finding type 1 diabetes early is really important because it can prevent a very dangerous health emergency called ketoacidosis, which can be life-threatening if the condition isn't diagnosed promptly. This means children can get the right care sooner, which can make a big difference to their health.

Besides preventing serious health problems, finding type 1 diabetes early also means families can receive support and information sooner. This can help reduce any worry or stress they might feel and help them understand how to manage the condition. The study is also looking at whether screening can be offered across different areas and how many children show early signs. They also want to understand if there are certain things in our environment that might affect who develops type 1 diabetes. In the future, this early detection might even lead to ways to slow down or stop the condition from getting worse.

Key takeaways

The Fr1da study screens for early signs of type 1 diabetes in children.
Early detection aims to prevent serious health issues and provide timely support.
It involves a simple blood test, often during routine check-ups.
Relatives of people with type 1 diabetes may also be eligible for screening.
Finding the condition early can help families prepare and manage care better.

Who may be eligible?

The Fr1da study is generally for children aged 2 to 10 years old. These checks are often offered during their routine check-ups with a paediatrician (a children's doctor).

Additionally, if you have a close family member (like a parent, brother, or sister) who has type 1 diabetes, other relatives between the ages of 1 and 21 can also be considered for screening. This is because having a close relative with type 1 diabetes means you have a higher chance of developing it yourself.

For a child to take part, one of their parents or guardians needs to give their written permission for them to be screened.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child aged between 2 and 10 years?
Does your child live in Bavaria, Germany, or another participating German state?
Do you, as their parent or guardian, agree to give written permission for screening?
Alternatively, do you have a close family member (aged 1-21) with type 1 diabetes who lives in the area?

Answer every question to see your result.

What does participation involve?

If your child takes part in the Fr1da study, it involves a simple blood test. This test looks for specific markers in the blood that can show if your child is developing or is at high risk of developing type 1 diabetes.

For most children, this screening happens alongside their routine well-child check-ups (like the 'U' check-ups in Germany) or during a visit to their paediatrician. For relatives of people with type 1 diabetes, the screening might be repeated every 3 to 5 years.

There is no mention of specific appointments, medication, or follow-up duration for the main screening beyond the initial test. The study's focus is on early detection, so once screened, you would be informed of the results. If early signs are found, further medical advice and support would be provided outside of the screening itself.

Potential risks and benefits

Participating in the Fr1da study offers the potential benefit of finding early signs of type 1 diabetes. This early detection can help prevent serious complications like diabetic ketoacidosis and allow families to get support and education sooner, which can reduce stress. The main risk involved is a simple blood test, which can cause minor discomfort or a small bruise. There's also the potential for worry if early markers are found, even if full-blown diabetes hasn't developed yet. You are always free to decide not to participate or to withdraw your child from the study at any time without giving a reason, and this will not affect their medical care.

Locations (1)

Institut für Diabetesforschung, Helmholtz Zentrum München
Verified postcode
Munich, Germany· Recruiting

Common questions

What is type 1 diabetes?

Type 1 diabetes is a condition where the body stops making insulin, a hormone needed to turn sugar from food into energy. People with type 1 diabetes need to take insulin every day.

Why is early detection important for type 1 diabetes?

Finding type 1 diabetes early can help prevent serious health emergencies like ketoacidosis and allows families to get support and learn how to manage the condition sooner, reducing stress.

How is the screening done?

The screening usually involves a simple blood test, often done during a child's routine health check-up.

Is the study only for children in Germany?

Yes, its primary focus is on children in Germany, specifically Bavaria and expanding to other federal states from 2024.

Does taking part guarantee my child won't get type 1 diabetes?

No, taking part in the screening doesn't prevent type 1 diabetes. It aims to find early signs so that if your child is at risk, you can be prepared and get the right care sooner.

How to find out more

Anette-Gabriele Ziegler, Prof.Dr.med.

diabetes.frueherkennung@helmholtz-muenchen.de +49 800-4648835 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.