RecruitingOBSERVATIONAL

EXtremely Early-onset Type 1 Diabetes EXtremely Early-onset Type 1 Diabetes (A Musketeers' Memorandum Study)

This study focuses on children who developed Type 1 diabetes extremely early, before they were two years old. This is very unusual, and researchers believe these children can provide important clues about why the condition happens and how it affects the body. They will study the children's immune systems, genes, and other factors to understand why diabetes started so young. The study has expanded to also look at healthy babies and children without diabetes to compare their immune system development. By understanding these earliest cases, the aim is to discover new ways to prevent or treat Type 1 diabetes, potentially helping people of all ages.

At a glance

Status

Recruiting

Sponsor

University of Exeter

Enrolment target

300

Start

19 Sep 2017

Estimated completion

30 Nov 2028

Type1 Diabetes Mellitus

What is this study about?

Type 1 diabetes happens when the body's own defense system, called the immune system, mistakenly attacks and destroys the cells in the pancreas that make insulin. Insulin is a hormone that helps your body use sugar for energy. When these cells are destroyed, the body can't make enough insulin, leading to high blood sugar levels.

This study is unique because it focuses on children who developed Type 1 diabetes unusually early – before their second birthday. Normally, Type 1 diabetes is diagnosed a bit later in childhood, often around 13 years old. The researchers think that for diabetes to appear so early, something special or extreme must have happened with their immune system. By carefully studying these very rare cases, they hope to learn important lessons about what goes wrong at the very beginning of the disease. This could help us understand Type 1 diabetes better, no matter when it starts.

The researchers will look at many things, including the children's genes, how their immune cells behave, and even possible influences from their mothers during pregnancy. They will collect blood samples to see if the children still make any insulin and if their immune system is making specific "attack" cells against their own pancreas. Over time, the study has grown to also include healthy babies and children who don't have diabetes. This allows researchers to compare what they find in children with early-onset diabetes to how a healthy immune system develops. Ultimately, the goal is to find new ways to stop or slow down Type 1 diabetes from developing, which could help many people in the future.

Key takeaways

Researchers are studying Type 1 diabetes that starts very early in life (before age 2).
The goal is to understand why the immune system attacks insulin-making cells so young.
The study includes babies and children with early Type 1 diabetes, other diabetes types, and healthy babies.
Blood samples will be used to look at genes and immune system function.
Findings could lead to new ways to prevent or treat Type 1 diabetes for everyone.
Taking part involves providing medical information and blood samples.

Who may be eligible?

This study is looking for different groups of people. One main group is children who were diagnosed with Type 1 diabetes before their second birthday. It's important that their diabetes isn't caused by known genetic problems that lead to related types of diabetes.

The study also includes children who have Type 1 diabetes but were diagnosed when they were a bit older (between 1 and 20 years), and another group of babies diagnosed with a different type of diabetes caused by specific genetic changes. Finally, they're looking for healthy babies and young children (up to 6 years old) who are having routine surgery for other reasons.

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.

Was your child diagnosed with Type 1 diabetes before their second birthday?
Does your child not have a specific genetic cause for their diabetes (if diagnosed before 12 months)?
Does your child have a higher genetic risk score for Type 1 diabetes?
Could your child be a healthy baby aged 0-6 undergoing routine surgery?

Answer every question to see your result.

What does participation involve?

If you or your child are eligible and agree to take part, the medical team will contact your doctor to get more information about your or your child's diabetes and family health history. Samples like blood will be collected to check for markers of Type 1 diabetes and to study the immune system in detail. Some steps might involve developing new ways to test samples, especially for young children who live far away. The study has been extended and will continue until November 2028. The exact number of visits or the total length of your or your child's involvement isn't specified, but it would be over a period of time necessary to collect these samples and observations.

Potential risks and benefits

Taking part in this study could help scientists better understand Type 1 diabetes, especially what causes it to start so early in life. This knowledge might lead to new ways of preventing or treating the condition in the future, which could benefit many patients. As with any medical study, there are some potential risks, mainly from blood sample collection, such as temporary discomfort or bruising. You or your child always have the right to withdraw from the study at any time without giving a reason, and this will not affect your or your child's medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Benaroya Research Institute
Verified postcode
Seattle, United States· Not yet recruiting
Leiden University Medical Center
Verified postcode
Leiden, Netherlands· Not yet recruiting
Royal Devon & Exeter NHS Foundation Trust
Verified postcode
Exeter, United Kingdom· Recruiting
King's College London
Verified postcode
London, United Kingdom· Active not recruiting

Common questions

What is Type 1 diabetes?

Type 1 diabetes is when the body's immune system mistakenly attacks and destroys the cells in the pancreas that make insulin, a hormone needed to turn food into energy.

Why are you focusing on babies with Type 1 diabetes?

By studying babies who get Type 1 diabetes extremely young, researchers hope to find important clues about what causes the condition and how it develops. These early cases might show crucial differences.

What will happen if my child takes part?

Your child's doctor will share information, and blood samples will be taken to study their immune system and other factors. Some of these tests are very advanced and might be new for young children.

Will my child get new treatment in this study?

No, this study is about understanding Type 1 diabetes, not testing new treatments. Any results from the samples will not affect your child's current medical care.

How long will the study last?

The study itself is planned to continue until November 2028. Your individual or your child's participation would involve a specific period for collecting samples and information, which your doctor can explain.

How to find out more

Richard Oram

r.oram@exeter.ac.uk +44 (0) 1392 408538 Official trial record

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