Not yet recruitingPhase IIIInterventional

Semaglutide as an add-on treatment to optimise glycaemic control in children and young people with type 1 diabetes (Smile T1D)

The SMILE T1D study aims to see if adding semaglutide, a medicine used for Type 2 diabetes in adults, can help children and young people (10-24 years old) with Type 1 diabetes. Semaglutide is a weekly injection that helps people feel fuller and can lower blood sugar. We want to find out if it can make managing Type 1 diabetes easier when given alongside current treatments. Participants will be split into two groups: one continues standard care, and the other receives standard care plus semaglutide. Researchers will compare blood sugar readings from continuous monitors. The study runs from March 2025 to August 2028 and is funded by Breakthrough T1D.

At a glance

Status

Not yet recruiting

Phase

Phase III

Sponsor

University of Birmingham

Enrolment target

240

Start

01 Jul 2026

Estimated completion

31 Mar 2027

Type 1 diabetes

What is this study about?

The SMILE T1D study is exploring a new way to help children and young people aged 10 to 24 who have Type 1 diabetes. We know that managing Type 1 diabetes can be challenging, and researchers are always looking for new treatments to make it easier to keep blood sugar levels stable. This study focuses on a medicine called semaglutide, which you might know as Ozempic. This medicine is already used for adults with Type 2 diabetes and works by helping them feel full, eat less, and generally helps improve blood sugar control.

The main goal of this study is to see if adding semaglutide to the usual diabetes care can help bring down blood sugar levels in children and young people with Type 1 diabetes. By doing this, we hope it could make managing their diabetes simpler and lead to better health outcomes. It's about finding out if this existing treatment can offer new benefits for those with Type 1 diabetes.

Participants will be divided into two groups. One group will continue with their regular diabetes treatment as normal. The other group will receive semaglutide as an additional treatment, alongside their usual care. Researchers will then carefully compare the blood sugar information collected from continuous glucose monitors in both groups to understand if semaglutide makes a positive difference. We will also check if semaglutide affects how well the pancreas is working in some participants.

Key takeaways

The study explores if semaglutide (Ozempic) can help young people aged 10-24 with Type 1 diabetes.
It aims to improve blood sugar control and make diabetes management easier.
Participants will continue their usual diabetes care, with some adding a weekly semaglutide injection for 26 weeks.
Extra hospital visits for tests and safety monitoring will be required.
The study runs from March 2025 to August 2028.

Who may be eligible?

This study is looking for children and young people aged between 10 and 24 years old who have Type 1 diabetes. You must have been diagnosed with Type 1 diabetes at least a year ago and be receiving your care from an NHS hospital. You should also be using insulin daily (either by injection or pump) and have been keeping your insulin doses fairly stable for the past three months. You also need to already be using a continuous glucose monitor (CGM) regularly.

There are also some reasons why you might not be able to join. For example, if you have Type 2 diabetes or a different rare type of diabetes, or if you're using certain specific diabetes devices like self-made closed-loop systems. Your weight will also be considered as part of the criteria. If you've had more than two very serious low blood sugar episodes in the last year, this study might not be suitable for you.

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.

Are you between 10 and 24 years old?
Have you had Type 1 diabetes for at least one year?
Are you currently seeing an NHS hospital for your diabetes care?
Do you use insulin daily (injections or pump) and have your doses been stable recently?
Are you already using a continuous glucose monitor (CGM)?
Have you had no more than two very severe low blood sugar episodes in the past year?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will involve several things. We'll try to arrange your study visits to fit in with your regular clinic appointments as much as possible, but there will be some extra hospital visits. Some of these extra visits will include a special blood test called a Mixed Meal Tolerance Test, which checks how your body handles sugar after a meal. This test takes about 2.5 hours.

If you are in the group that receives semaglutide, you'll have an extra injection once a week for the first 26 weeks. You're already used to injections with your diabetes care, so this shouldn't be too different. For safety, female participants who could become pregnant will also need to attend extra hospital visits for pregnancy tests during the study. Throughout the study, we'll keep in touch by phone or video calls to regularly check how you’re feeling, review your blood sugar levels, and look out for any side effects. The study is expected to run for about 3.5 years in total, from early 2025 to mid-2028.

Potential risks and benefits

Taking part in the study could offer potential benefits, such as potentially better control of your blood sugar levels if semaglutide proves effective. This could make managing your diabetes easier. However, there are also some potential risks. Semaglutide can sometimes cause low blood sugar (hypoglycaemia), but the study team will monitor you closely and adjust your medication if needed to reduce this risk. Some visits will require fasting, which can also lower blood sugar, so precautions are in place like checking your blood sugar before tests and offering snacks afterwards. You'll also need to attend extra appointments and have blood samples taken. It's really important to remember that joining a study is always your choice, and you are free to stop participating at any time without giving a reason, and this won't affect your regular medical care.

Locations (7)

Addenbrookes
Approximate
Cambridge, England
Birmingham Children's Hospital
Approximate
Birmingham, England
Heartlands Hospital
Approximate
Birmingham, England
Leicester Royal Infirmary
Approximate
Leicester, England
Royal Hallamshire Hospital
Approximate
Sheffield, England
Sheffield Children's Hospital
Approximate
Sheffield, England
Queen Elizabeth Hospital
Approximate
Birmingham, England

Common questions

What is semaglutide?

Semaglutide is a medicine (also known as Ozempic) that's currently used for adults with Type 2 diabetes to help manage blood sugar, feel fuller, and sometimes lose weight. This study is exploring if it can help those with Type 1 diabetes.

Will I still take my regular insulin if I'm in the study?

Yes, all participants in the study will continue with their usual insulin treatment and diabetes care, regardless of which group they are in.

How long will I be in the study if I join?

The study itself runs from March 2025 to August 2028. Your individual participation would involve regular visits over a period, likely around 6 months with follow-up.

What is a Mixed Meal Tolerance Test?

It's a blood test where you drink a special liquid, and then blood samples are taken over about 2.5 hours to see how your body processes sugar. You’ll need to fast overnight before this test.

Who is paying for this study?

The study is being funded by an organisation called Breakthrough T1D, which is based in the USA.

How to find out more

Timothy Barrett

t.g.barrett@bham.ac.uk +44 (0)7917 638 161 Official trial record

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