RecruitingInterventional

Capillary markers to predict type 1 diabetes

This study aims to make early type 1 diabetes tests much simpler and kinder for children and their families. Currently, these tests, like the Oral Glucose Tolerance Test (OGTT), often involve needles, hospital visits, and can be quite long. This can be upsetting and inconvenient. Researchers want to use finger-prick blood tests, potentially done at home, to check for early signs of diabetes and predict when insulin might be needed. They are also exploring whether a ready-made sugary drink could replace the current method where the drink is measured out individually. The study hopes to find new ways to monitor children that are less painful and easier to do, maybe even at home, which could help more children get tested.

At a glance

Status

Recruiting

Sponsor

University of Oxford

Enrolment target

Start

01 Dec 2025

Estimated completion

30 Apr 2027

Type 1 diabetes

What is this study about?

Imagine a world where checking for early signs of type 1 diabetes in children is much simpler, less stressful, and can even be done at home. That's what this study is all about. Currently, a common test called an Oral Glucose Tolerance Test (OGTT) helps doctors diagnose diabetes and figure out when someone might need insulin. However, this test involves several blood samples taken from a vein using a small tube (cannula), which can be painful and upsetting for children. It also means spending 2-3 hours in a hospital, which can be difficult for busy families.

This study is looking into whether we can use finger-prick blood samples instead of samples from a vein. These finger-prick tests could be used for the OGTT and for another important blood test that measures two proteins (proinsulin and C-peptide) linked to insulin production. The goal is to make these tests much easier to do, possibly even in your own home. This could remove the need for lots of hospital visits and make the whole process much more comfortable for children and their parents.

The study is split into two parts. Part A focuses on making the OGTT simpler, looking at whether finger-prick tests can replace vein samples and if a pre-made sugary drink (instead of one specially mixed each time) works just as well. Part B explores using finger-prick samples for the proinsulin and C-peptide tests. If successful, these changes could mean less pain and more convenience for families dealing with type 1 diabetes.

Key takeaways

Researchers are seeking less painful ways to test children for early type 1 diabetes.
The study aims to replace vein blood samples with finger-prick tests.
The goal is to make tests easier to do, potentially even at home, reducing hospital visits.
A new kit is being tested for measuring blood sugar levels from a finger-prick.
Results from this study could help improve future diabetes testing for children.
Children under 18 with specific early signs (autoantibodies) are invited to participate.

Who may be eligible?

This study is looking for children and young people who might be in the early stages of type 1 diabetes. To join, a child needs to be under 18 years old.

They must also have had tests that show at least two specific signs in their blood called 'diabetes autoantibodies.' These autoantibodies are markers that their body's immune system is starting to attack the cells that make insulin. The child also needs to be able to drink the special sugary drink used in the tests within 10 minutes.

Children who are already taking insulin for diabetes or are on certain medications that might affect their blood sugar levels, like steroids, won't be able to take part in this study.

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 under 18 years old?
Has your child had tests showing two or more 'diabetes autoantibodies'?
Is your child able to drink a sugary drink within 10 minutes?
Is your child NOT currently taking insulin for diabetes?
Is your child NOT on any medicines that might affect their blood sugar (like steroids)?

Answer every question to see your result.

What does participation involve?

If your child takes part, they will have two visits to the hospital, no more than three weeks apart. Each visit will last about three hours. The first study visit will happen at the same time as an OGTT your child is already scheduled to have, to avoid extra trips to the hospital.

During the first visit (Parts A and B), a small tube called a cannula will be placed in a vein. This is to collect a few small blood samples at the beginning and end of the test. At the same time, finger-prick blood samples will also be taken using a special kit. Your child will then drink a sugary drink, measured out by the study team. Two hours later, more blood samples will be taken (from the cannula and by finger-prick). One of the finger-prick samples will be collected using a device that absorbs blood like a sponge, for later analysis.

For the second visit (Part A only), there will be no cannula. Your child will have finger-prick blood samples taken at the start and end of the visit, and will drink a pre-made sugary drink. This drink is designed to be suitable for many different weights without needing to be specially mixed. The total study will involve these two visits within about three weeks.

Potential risks and benefits

While there might not be an immediate personal benefit for your child, taking part could help many other children and families in the future. The study aims to make diabetes tests less painful and easier, possibly allowing them to be done at home. This could lead to a better experience for everyone. Some small discomfort is possible. Finger-prick tests might feel a bit unpleasant and cause slight soreness or redness, but this usually passes quickly. Having blood taken from a vein, or having a cannula inserted, can cause brief discomfort. We can offer numbing cream to help with this. Occasionally, some people might feel a little lightheaded when blood is taken, or get a small bruise or swelling. Remember, you can choose to withdraw your child from the study at any time.

Locations (2)

University of Oxford
Approximate
Oxford, England
Oxford University Hospitals NHS Foundation Trust
City only
Oxford, England

Common questions

What is type 1 diabetes?

Type 1 diabetes is a condition where the body's immune system mistakenly attacks and destroys the cells in the pancreas that produce insulin. Insulin is a hormone that helps sugar (glucose) from food get into your cells to be used for energy. Without insulin, sugar builds up in the blood.

What is an Oral Glucose Tolerance Test (OGTT)?

An OGTT is a test used to check how your body handles sugar. You drink a sugary drink, and then blood samples are taken over a couple of hours to see how your blood sugar levels change. It helps doctors diagnose diabetes or see if someone is at risk.

Why are you looking for 'easier ways' to test?

Current tests often involve needles, multiple blood samples from a vein, and hospital visits, which can be upsetting for children and inconvenient for families. This study wants to find less painful, simpler methods, like finger-prick tests, that could potentially be done at home.

What are 'diabetes autoantibodies'?

These are special proteins made by the body's immune system. If a child has certain autoantibodies, it can be an early sign that their immune system is starting to attack the cells that make insulin, even before they have symptoms of diabetes.

What happens to the information collected from the study?

The information, especially glucose results, from the finger-prick kit will be sent instantly and securely to a database. All blood samples will be analysed later. This data will be compared to standard lab results to see if the new, simpler methods work just as well.

How to find out more

Claire Scudder

edent1fi_wp3@ndm.ox.ac.uk +44 1865 287664 Official trial record

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