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Assessing Remote Confirmation of Type 1 Diabetes

This research aims to see if a simple home finger-prick test can help confirm a Type 1 diabetes diagnosis. Sometimes, adults with Type 1 are wrongly thought to have Type 2, leading to unnecessary insulin treatment. We're sending kits to 1500 people treated for Type 1 diabetes in one hospital to collect a small blood sample at home. This sample is sent back for a C-peptide test, which measures natural insulin production. If this remote testing works well and people find it easy to do, it could be offered nationwide. This might help identify approximately 23,000 people in the UK who are currently on insulin but might not actually have Type 1 diabetes, potentially allowing them to explore other treatment options.

Em resumo

Status
Inscrição por convite
Patrocinador
Royal Devon and Exeter NHS Foundation Trust
Meta de inscrição
1,000
Iniciar
03 Dec 2024
Conclusão estimada
01 Dez 2025

Sobre o que é este estudo?

This study is looking into a new, easier way to check if someone truly has Type 1 diabetes. Sometimes, it can be tricky for doctors to tell the difference between Type 1 and Type 2 diabetes in adults because the symptoms can be very similar. This matters a lot because if someone with Type 2 diabetes is mistakenly diagnosed with Type 1, they might end up taking insulin injections for their whole life, even if they don't need them, and they might miss out on treatments that are better suited for Type 2 diabetes.

To help get the diagnosis right, doctors can use a test called C-peptide. This test measures how much insulin your own body is still making. It's best done if you've had diabetes for more than three years, as insulin levels can be confusing in the early stages. While it's becoming standard to check C-peptide in hospitals, our current methods mean you often need to visit the hospital for a blood test from your arm. This can be time-consuming for patients and a lot of work for hospital staff, especially when trying to test many people.

That's where this study comes in. We've found a way to do the C-peptide test using just a tiny spot of blood from a finger-prick, much like how people check their blood sugar at home. The exciting part is that you can collect this sample yourself at home and post it back to the hospital. This means fewer hospital visits for you and makes it much simpler for hospitals to test a larger number of patients. If this home testing works well and is accepted by patients, it could mean that many more people with Type 1 diabetes in the UK could have their diagnosis confirmed easily.

Pontos principais

  • This study is testing a home finger-prick test for Type 1 diabetes.
  • It aims to make C-peptide testing easier and more widespread.
  • Could help identify people who might not need insulin treatment.
  • Participation involves collecting a simple blood sample at home.
  • No hospital visits are needed for this research.
  • It has the potential to improve diabetes care across the UK.

Quem pode ser elegível?

To be part of this study, you need to be an adult (18 years or older) and currently receiving care for your diabetes at the Royal Devon University Healthcare NHS Foundation Trust.

You should have been treated for Type 1 diabetes, or have moved to insulin treatment very quickly after your diagnosis (within three years). Also, you need to have had diabetes for more than three years.

There are a few reasons why you might not be able to take part. For example, if your healthcare team feels it's not suitable for you, perhaps because of severe eyesight problems or if it would be difficult for you to understand and agree to take part.

Este estudo pode ser adequado para você?

Responda a estas perguntas rápidas para ver se você pode ser elegível. Este é apenas um guia — a decisão final é da equipe de pesquisa.

  1. Você tem 18 anos ou mais?
  2. Are you currently cared for by the diabetes team at Royal Devon University Healthcare NHS Foundation Trust?
  3. Have you been treated for Type 1 diabetes, or started insulin quickly after diagnosis (within 3 years)?
  4. Have you had diabetes for more than 3 years?
Responda a todas as perguntas para ver o seu resultado.

O que envolve a participação?

If you agree to take part, we will send you detailed information about the study, a kit to collect a small blood sample at home, and a pre-paid envelope to send it back. You'll need to read the information and agree to take part, either online or by signing a paper form. Then, you'll collect a finger-prick blood sample between 1 and 5 hours after a meal. At the same time, you'll also check and record your blood sugar level. Collecting the sample should only take about 10 minutes. Afterwards, you'll send the sample and your blood sugar reading back to the hospital laboratory using the pre-paid envelope. There are no hospital visits required specifically for this study.

Riscos e benefícios potenciais

A potential benefit of taking part is helping to improve how Type 1 diabetes is diagnosed and managed across the UK. For some people, it could even lead to them being identified as not having Type 1 diabetes, which might mean they could stop insulin treatment and explore other options better suited to their condition. Taking a finger-prick blood sample carries a very small risk of minor discomfort, bruising, or bleeding, similar to routine home blood glucose checks. Any information you provide will be kept confidential. You are free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Localizações (1)

  • NIHR Exeter Clinical Research Facility
    Código postal verificado
    Exeter, Reino Unido

Perguntas frequentes

What is C-peptide?

C-peptide is a substance your body makes when it produces insulin. Measuring its level helps doctors understand how much natural insulin your body is still making.

Por que este estudo é importante?

This study could make it much easier to check for Type 1 diabetes from home, potentially helping thousands of people get the right diagnosis and treatment.

Do I need to go to the hospital?

No, you don't need to visit the hospital for this study. All sample collection happens at home.

How long will it take to collect the sample?

Collecting the finger-prick blood sample should take no more than 10 minutes.

What if I don't want to take part?

Taking part is completely voluntary. If you choose not to, it will not affect your medical care in any way.

Como saber mais

Sempre consulte seu médico ou especialista antes de decidir participar de um estudo.

Interessado em participar?

Registre seu interesse

Compartilhe seus detalhes e a equipe de pesquisa para "Assessing Remote Confirmation of Type 1 Diabetes…" entrará em contato com você se você for elegível. Sempre fale com seu médico antes de concordar em participar.

Discussão

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