RecruitingOBSERVATIONAL

Benefits of Retained Insulin for Good Health

This study is exploring how having your body produce some of its own insulin (called 'retained insulin') might benefit people with diabetes, especially those who rely on insulin injections. Researchers want to understand if this natural insulin improves overall health, mental wellbeing, and daily life over many years. Currently, it's hard to measure natural insulin accurately and easily, so this study also aims to find simpler ways to do this, potentially using home tests. Understanding these benefits is important because new treatments are being developed to help people with Type 1 diabetes keep or restart making their own insulin. If we know the full, long-term advantages, it can help decide if these treatments should be widely available through healthcare services like the NHS.

At a glance

Status

Recruiting

Sponsor

Royal Devon and Exeter NHS Foundation Trust

Enrolment target

700

Start

31 Oct 2025

Estimated completion

30 Jun 2027

Diabetes (Insulin-requiring, Type 1 or Type 2)Diabetes Diabetes (DM)Type 1 Diabetes (T1D)

What is this study about?

This research is all about understanding the benefits of your body making some of its own insulin, even if you have diabetes and need extra insulin through injections. For people with Type 1 diabetes, the body usually stops making insulin completely, which makes managing blood sugar very challenging. However, some people with Type 1 diabetes actually continue to produce a small amount of their own insulin. This study wants to find out if this natural insulin helps with more than just blood sugar control – does it improve overall quality of life, mood, and general health?

It's really important to know the full picture of these benefits because new treatments are being developed that aim to protect or restore the body's ability to make its own insulin, especially in Type 1 diabetes. These treatments can be expensive and might have side effects, and so far, they've only been tested in small groups for short periods. This study will help us understand the long-term advantages. This knowledge will be vital for healthcare providers like the NHS to decide whether these new treatments are worthwhile funding and offering widely.

The study also aims to make it easier to measure how much insulin a person's body is still making. Currently, testing this often requires long hospital visits. The researchers hope to find simpler ways to do these tests, maybe even at home with a finger-prick sample. This would make it much easier for people to take part in future research into new diabetes treatments, and potentially make managing diabetes a little simpler too.

Key takeaways

This study explores how natural insulin production benefits people with diabetes.
It aims to understand long-term effects on quality of life and mental health.
Researchers want to find easier ways to measure natural insulin, potentially at home.
Findings could help decide if new insulin-preserving treatments should be widely available.
It's an observational study, meaning it won't change your current diabetes treatment.

Who may be eligible?

There are two main parts to this study, and you might be eligible for one of them.

For the first part, you would need to have already taken part in a study called 'StartRight' and previously given permission to be contacted for future research. You must also have diabetes that is treated with insulin, and be aged 18 or over. This part of the study mainly involves following up with people who are already known to the researchers.

For the second part, you need to have Type 1 diabetes and be aged 18 or over. The researchers are particularly interested in people who have had their natural insulin levels checked before, either as part of a previous study or through routine diabetes care. If your natural insulin levels haven't been checked, you might still be able to join if you've been diagnosed with Type 1 diabetes within the last 7 years and have had a specific antibody test (which shows your immune system has been active against your insulin-producing cells). You cannot take part if you have severe kidney problems.

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 18 years old or older?
Do you have diabetes?
Do you currently use insulin for your diabetes (for Part 1)?
Have you been diagnosed with Type 1 diabetes (for Part 2)?
Have you participated in the 'StartRight' study before (for Part 1)?
Do you NOT have severe kidney problems?

Answer every question to see your result.

What does participation involve?

If you take part in this study, what you do will depend on which part you are in. If you are in the first part, you might be asked to have a research visit, which could be done remotely (from your home) or in person. During this visit, researchers will look at information already collected over several years about your health, mental wellbeing, and how often you've needed healthcare. They may also ask you some new questions or collect additional information.

If you are in the second part of the study, you would be invited to take part in a more detailed assessment. This would involve checking your body's insulin production in various ways, potentially including home tests. They will also look at your blood sugar levels, possibly using information from devices that continuously monitor your glucose. The overall duration of your participation would depend on the specific assessments, but it is focused on understanding your current health and how it relates to your body's natural insulin production.

Potential risks and benefits

Taking part in this study may not directly benefit your personal health, as it is mainly about understanding more about diabetes in general. However, the information gathered will be very important for helping people with diabetes in the future, by guiding the development and funding of new treatments that could improve lives. The risks of taking part are expected to be very low, as the study mainly involves looking at existing information, questionnaires, or simple tests. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

Diabetes and Endocrine Centre
Verified postcode
Truro, United Kingdom· Recruiting
NIHR Exeter Clinical Research Facility
Verified postcode
Exeter, United Kingdom· Recruiting
D1 Wolfson Centre Research and Development
Verified postcode
Bath, United Kingdom· Recruiting
Clinical Research Centre
Verified postcode
Bristol, United Kingdom· Recruiting

Common questions

What is 'retained endogenous insulin'?

This means your body is still making some of its own insulin, even after you've been diagnosed with diabetes.

What is C-peptide?

C-peptide is a substance your body makes at the same time as insulin. Measuring C-peptide is a good way to tell how much insulin your body is producing on its own.

Why is it important to measure insulin production?

Knowing how much natural insulin your body makes helps researchers understand how it affects your health and how new diabetes treatments could work.

Will taking part change my diabetes treatment?

No, this is a research study to gather information; it will not change the treatment you receive from your doctor.

Is this study safe?

Yes, the study is designed to be very safe, mainly involving questionnaires and possibly simple tests, with minimal risks.

How to find out more

BRIGHT Study Research Team

rduh.brightstudy@nhs.net +44 1392408181 Official trial record

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