RecruitingInterventional

Balancing "bad" and "good" immune cells: testing a novel method for monitoring an immunosuppression strategy in people with Type 1 diabetes

This study aims to develop a faster way to test new treatments for Type 1 diabetes. Currently, it takes a long time to see if treatments are working because they measure changes in insulin. This research will use two existing medicines, abatacept and interleukin-2, which are known to affect the immune system. We believe combining these drugs will help balance the 'good' and 'bad' immune cells that cause Type 1 diabetes. By observing how these drugs change immune cells, we hope to create a quick test to identify promising new medicines before they go into long and expensive trials. This could lead to more effective ways to prevent the immune system from destroying insulin-producing cells sooner.

At a glance

Status

Recruiting

Sponsor

Cardiff University

Enrolment target

Start

21 Jan 2025

Estimated completion

31 Jul 2026

Type 1 diabetes

What is this study about?

Type 1 diabetes happens when your body's own defence system, called the immune system, mistakenly attacks and destroys the cells in your pancreas that make insulin. These cells are called beta-cells. Researchers are trying to find treatments that can calm down this overactive immune system, but it's often hard to tell if these new treatments are working quickly enough. We currently measure changes in how much insulin someone makes, but these changes happen very slowly, making trials long and expensive.

This study wants to find a faster and more accurate way to test new medicines. We're doing this by trying out two existing drugs, abatacept and interleukin-2, which have been used in other conditions to help control the immune system. We think that using these two drugs together will help balance the immune cells – with one drug dealing with the 'bad' cells that cause the attack, and the other protecting the 'good' cells that help keep the immune system in check. By seeing how these drugs affect your immune cells, we hope to develop a quick way to predict if a treatment is likely to work in future larger studies. This means we could find effective new treatments much faster.

Ultimately, the goal is to develop a tool that can help us quickly identify which new potential drugs are best at stopping the immune system from attacking the body’s own insulin-making cells. This could change how we approach Type 1 diabetes, moving towards preventing the damage rather than just dealing with the consequences after the insulin-producing cells are gone. This is a vital step in discovering better ways to manage and potentially even prevent Type 1 diabetes.

Key takeaways

This study aims to find a faster way to test new Type 1 diabetes treatments.
It uses two existing drugs to help balance 'good' and 'bad' immune cells.
Participation involves frequent visits, blood tests, and a small procedure called a lymph node aspiration.
You'll drink 'heavy water' at home to help researchers track cells, which is safe.
The study makes efforts to make participation easier, like offering home visits and flexible appointment times.
Your contribution helps future research, even if you don't personally see a direct treatment benefit.

Who may be eligible?

This study is looking for adults aged 18 to 50 who have been diagnosed with Type 1 diabetes. You must have been diagnosed within the last five years, but not more recently than three months ago. You'll also need to show that your body is still producing some insulin, which will be checked with a blood test.

Certain things would mean you couldn't take part. For example, if you are pregnant, breastfeeding, or planning to become pregnant soon, or if you're not using certain types of effective contraception. If you're on other medications that affect your immune system, or if you've had certain vaccinations recently, you wouldn't be able to join. They'll also check your general health, including your blood counts and if you have any active infections or conditions like tuberculosis, HIV, or hepatitis.

The study team will make sure you are in good health and don't have certain conditions that could make taking part unsafe. This includes checks for your immune system and for infections like tuberculosis or hepatitis. Your blood counts will also need to be within a healthy range.

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 18 and 50 years old?
Were you diagnosed with Type 1 diabetes within the last 5 years, but not in the last 3 months?
Are you still producing some insulin (they will test for this)?
Are you not pregnant, breastfeeding, or planning to become pregnant soon, and are you using effective contraception if required?
Are you free from certain active infections or conditions like tuberculosis or HIV?
Are you not taking other medications that significantly affect your immune system?

Answer every question to see your result.

What does participation involve?

If you join this study, it will involve frequent visits and a significant time commitment. You will receive two specific drugs, abatacept and interleukin-2. The abatacept will be given at weeks 0, 2, 4, and 8, and the interleukin-2 will be given for 16 weeks starting at week 0.

Along with the medication, you will have regular blood tests. Over 16 weeks, no more than 470ml (about the amount taken when you donate blood) will be collected, and your red blood cell count will be monitored. You will also have a procedure called a lymph node aspiration, where a small sample is taken from a gland (lymph node) using a fine needle under local anaesthetic. This is a common and quick procedure, typically lasting less than 30 minutes.

You will also be given 'heavy water' to drink at home, which helps track cells. This is not toxic or radioactive, and you'll get clear instructions on how to use and store it safely. The study aims to make participation easier by offering home visits, flexible timing for appointments (evenings, weekends, holidays), and recruiting people close to the study sites to reduce travel.

Potential risks and benefits

Participating in this study might not directly benefit your Type 1 diabetes, as the main goal is to improve future research methods. However, by taking part, you'll be helping scientists develop faster and more effective ways to find treatments for Type 1 diabetes, which could greatly benefit others down the line. The study involves two medications that are approved for other conditions and have been used in diabetes research, generally considered safe. There are some risks, such as those associated with regular blood tests, and the lymph node aspiration, which is a common procedure though it might cause a brief sting from the local anaesthetic. You will also need to commit a lot of time to the study due to frequent visits and tests. You will be closely monitored by a doctor, and your safety will be checked with regular blood tests. Remember, you can choose to leave the study at any time.

Locations (2)

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

Cardiff ECMC
City only
Cardiff, Wales
Royal Free London NHS Foundation Trust
City only
London, England

Common questions

What is 'heavy water' and is it safe?

Heavy water is a special type of water that helps researchers track your cells. It is not toxic or radioactive, and you'll receive clear instructions on how to use and dispose of it safely.

What is a lymph node aspiration?

It's a quick and safe procedure where a small sample from one of your lymph nodes (glands that are part of your immune system) is taken with a fine needle. It's done under local anaesthetic and usually takes less than 30 minutes.

Will I get better if I join this study?

The main goal of this study is to develop a better and faster way to test new treatments for Type 1 diabetes in the future. While you might not experience a direct personal benefit, your participation will greatly help in finding new treatments for Type 1 diabetes.

How much blood will be taken during the study?

Over the course of 16 weeks, no more than 470ml of blood will be taken. This is about the same amount as a single blood donation, and your blood counts will be regularly checked.

Where are the study locations?

The study will take place at NHS sites linked with Cardiff University (University Hospital of Wales) and University College London (Royal Free Hospital London) in the UK.

How to find out more

Danijela Tatovic

SMART@cardiff.ac.uk +44 (0)2920742182 Official trial record

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