CompletedObservational

Performance evaluation of type 1 diabetes genetic risk test

This study is testing a new genetic test designed to help doctors tell the difference between Type 1 Diabetes and other types of diabetes, like Type 2. Knowing the exact type of diabetes someone has is very important because the treatments and care needed can be quite different. The study is evaluating how well this new test works by looking at DNA from old blood samples that are already stored. These samples come from people with Type 1 Diabetes, Type 2 Diabetes, or no diabetes. The study hopes that genetic tests like this could help identify people at higher risk for Type 1 Diabetes even before they show symptoms, leading to better and faster care.

At a glance

Status

Completed

Sponsor

Randox Laboratories Limited

Enrolment target

500

Start

07 Apr 2025

Estimated completion

09 Jun 2025

Discrimination of Type 1 Diabetes from other non-autoimmune diabetes such as type 2 diabetes, monogenic diabetes or secondary diabetes.

What is this study about?

Imagine there are different kinds of diabetes, and sometimes it's tricky for doctors to figure out exactly which type someone has. This study is all about a new genetic test that could make this much clearer, especially for Type 1 Diabetes. Why does it matter? Because getting the right diagnosis quickly means you get the right treatment and support from the start, and that can make a big difference to your health and well-being.

Type 1 Diabetes has a strong genetic link, meaning it can run in families. This genetic information stays the same throughout a person's life. The new test looks at these genetic markers to create a 'risk profile' – basically, it helps to show if someone has a low, medium, or high genetic risk for Type 1 Diabetes. The hope is that by using this test, doctors might be able to identify Type 1 Diabetes earlier, sometimes even before symptoms appear.

This early identification could lead to better overall care, more targeted treatment plans, and potentially better health outcomes for people with Type 1 Diabetes. This particular study is evaluating the test by looking at DNA from existing, stored samples, rather than asking new people to join.

Key takeaways

Tests a new genetic tool for Type 1 Diabetes.
Aims to improve accurate and early diagnosis.
Uses existing, stored blood and DNA samples (no new participants).
No direct risks to individuals.
Could lead to better treatment and care for Type 1 Diabetes patients in the future.
Funded by Randox Laboratories Limited.

Who may be eligible?

This study is a bit different because new people are not being asked to join. Instead, the researchers are using leftover blood or DNA samples that have already been collected for other research projects. These samples come from people who have given their permission for their samples to be used for future research.

The samples being used are from people who have either been diagnosed with Type 1 Diabetes (both younger people, under 18, and adults), Type 2 Diabetes, or who do not have diabetes at all. These samples help the researchers see how well the genetic test works in different groups of people.

Because no new individuals are involved, there are no specific eligibility rules for you to check if you wanted to participate. The study is only using samples that have already been collected and stored.

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 interested in learning about genetic research?
Do you understand that this study does not involve new patients?
Are you aware that it uses samples already provided for research?
Do you recognise the importance of accurate diabetes diagnosis?

Answer every question to see your result.

What does participation involve?

This study is very low-key for individuals because it doesn't involve any new participants. The researchers are simply using stored leftover blood and DNA samples. They will take these existing samples and run them through the new genetic test. Each sample will then be given a 'genetic risk' for Type 1 Diabetes, which will be categorised as low, medium, or high. No one will need to attend any appointments, give new samples, or take any medication. The entire study involves only the testing of these existing samples in the lab, which is expected to be completed within 10 working days.

Potential risks and benefits

Since this study only uses existing, stored samples and doesn't involve new participants, there are no risks to anyone. The samples are already collected and have been anonymised for research purposes. The potential benefit of this research is in developing a better test for Type 1 Diabetes. If successful, this test could help doctors diagnose Type 1 Diabetes more accurately and earlier in the future, which could lead to improved treatments and better health for patients. Because no one is directly participating, there's no need to consider withdrawing.

Locations (3)

Randox Clinical Laboratory Services
City only
Antrim, United Kingdom
NIHR Exeter Clinical Research Facility
Approximate
Exeter, United Kingdom
Exeter 10,000 & Peninsula Research Bank (EXTEND/PRB)
City only
Exeter, United Kingdom

Common questions

What is Type 1 Diabetes?

Type 1 Diabetes is a serious condition where your body's immune system attacks and destroys the cells that produce insulin, a hormone vital for using sugar for energy.

How is this different from Type 2 Diabetes?

Type 2 Diabetes is where your body doesn't make enough insulin or the insulin it makes doesn't work properly. They are different conditions requiring different treatments.

Will this test tell me if I have Type 1 Diabetes?

This study is evaluating a test that could help doctors identify genetic risk for Type 1 Diabetes. While this particular study isn't testing new people, it aims to develop better tools for future diagnosis.

Are my personal details or samples being used without my permission?

No. All the samples used in this study were originally collected with full informed consent, meaning the donors agreed to their samples being used for research purposes.

Who is paying for this research?

The study is funded by Randox Laboratories Limited, a company in Northern Ireland.

How to find out more

Helena Murray

helena.murray@randox.com +44 2894422413 Official trial record

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