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Enrolling by invitationOBSERVATIONAL

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.

At a glance

Status
Enrolling by invitation
Sponsor
Royal Devon and Exeter NHS Foundation Trust
Enrolment target
1,000
Start
03 Dec 2024
Estimated completion
01 Dec 2025

What is this study about?

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.

Key takeaways

  • 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.

Who may be eligible?

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.

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.

  1. Are you 18 years old or older?
  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?
Answer every question to see your result.

What does participation involve?

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.

Potential risks and benefits

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.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • NIHR Exeter Clinical Research Facility
    Verified postcode
    Exeter, United Kingdom

Common questions

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.

Why is this study important?

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.

How to find out more

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

Interested in taking part?

Register your interest

Share your details and the research team for "Assessing Remote Confirmation of Type 1 Diabetes…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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