CompletedInterventional

The Sheffield one-stop enhanced diabetes care process screening for people with type 2 diabetes and intensified care for those with early nerve damage

About half of people with type 2 diabetes develop nerve damage in their feet and legs. This can cause pain or loss of feeling, leading to foot sores. While good blood sugar control can protect nerves in type 1 diabetes, less is known about reversing early nerve damage in type 2 diabetes. Researchers in Sheffield want to find out if intensive, personalised care can help. Adults aged 18 to 75 with type 2 diabetes and higher blood sugar levels will first have quick, painless nerve checks. Those showing early nerve changes can join a two-year study. Half will continue with their usual GP care, while the other half will receive extra support from diabetes specialists, dietitians, and exercise programmes, along with continuous glucose monitors. The aim is to see if targeted lifestyle and medical support can protect long-term nerve health.

At a glance

Status

Completed

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Enrolment target

600

Start

02 Feb 2024

Estimated completion

02 May 2026

Diabetic peripheral neuropathy

What is this study about?

Type 2 diabetes affects how the body manages blood sugar. Over time, high blood sugar, high blood pressure, and cholesterol can harm the small blood vessels that supply our nerves. This condition, called diabetic nerve damage or peripheral neuropathy, often starts in the feet and legs. It can cause numbness, tingling, or severe pain. When you lose feeling in your feet, small cuts or blisters can easily go unnoticed and turn into serious ulcers that are hard to heal.

Doctors know that keeping blood sugar in a safe range helps prevent nerve damage in type 1 diabetes. However, we do not yet have clear evidence about whether early nerve damage can be slowed, stopped, or even reversed in type 2 diabetes by tackling multiple health factors at the same time. This trial aims to answer that important question.

The study will first screen people during their routine diabetes check-ups using quick, gentle skin and nerve tests. Participants who show early signs of nerve damage will then be invited to take part in a 24-month study. Researchers want to compare whether intensive, joined-up care—focusing on diet, physical activity, blood pressure, cholesterol, and blood sugar—works better than standard GP care to protect nerve health.

Key takeaways

Tests whether intensive lifestyle and medical support can stop or reverse early diabetic nerve damage.
Open to adults aged 18 to 75 with type 2 diabetes and higher blood sugar levels.
Begins with simple, painless nerve tests during or after your routine review in Sheffield.
Participants with early nerve changes are randomly split into usual GP care or intensive specialist care.
The main study lasts for two years and includes regular monitoring and wearable glucose sensors.

Who may be eligible?

This study is open to adults aged 18 to 75 who have been diagnosed with type 2 diabetes. To take part in the initial screening, your recent blood sugar check (known as an HbA1c test) should be higher than 7.6% (or 60 mmol/mol), showing that your diabetes could be managed more closely.

To move on to the main two-year study, the simple screening tests must detect early, mild signs of nerve damage in your feet or hands. You also need to be able to attend visits at the hospital in Sheffield and follow the study guidance over the two years.

If the screening checks show your nerves are working completely normally, or if you have severe, long-standing nerve damage that cannot be reversed, you will not be eligible for the main treatment trial. The research team will explain your results and your participation will simply end after the screening visit.

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.

I have been diagnosed with type 2 diabetes.
I am between 18 and 75 years old.
My recent blood sugar (HbA1c) level is 7.6% (60 mmol/mol) or higher.
I am able and willing to attend appointments at the Royal Hallamshire Hospital in Sheffield.
I can commit to taking part in a two-year study.

Answer every question to see your result.

What does participation involve?

Taking part begins with a screening appointment, often arranged around your normal annual diabetes review. You will have your usual checks, such as blood pressure, weight, and blood and urine samples. The researchers will also carry out two quick, painless, non-invasive nerve tests on your feet and hands.

If early nerve changes are found, you will be invited to a baseline visit for a more detailed nerve check and health questionnaires. You may also be offered an optional, tiny skin sample (biopsy) to examine your small nerve fibres under a microscope.

You will then be placed into one of two groups by chance (randomly):

• Usual Care Group: You will carry on receiving your normal care from your GP surgery. You will wear a small sensor on your arm (continuous glucose monitor) for two weeks at three different points in the study to track your blood sugar, but the screen will be blank so it does not alter your usual routine.

• Intensified Care Group: You will receive frequent one-to-one support from hospital diabetes specialists, dietitians, and doctors. You will wear a continuous glucose monitor that you can view anytime, receive help with quitting smoking (if needed), join an NHS-backed exercise plan suited to your fitness, and get tailored advice to improve your blood pressure, cholesterol, and blood sugar.

Both groups will return for a final review at 24 months to see how their nerve health has changed. The total study duration is two years.

Potential risks and benefits

You may not benefit directly from taking part, but you will receive detailed nerve assessments that are not usually part of routine NHS checks. If you are placed in the intensive group, you will get extra professional support to help improve your overall health and diabetes control. The study involves very low physical risk. The nerve tests and glucose monitors are safe, standard medical devices. If you choose to have the optional skin biopsy, you might feel a brief pinch and experience minor bruising. Taking part requires several extra hospital trips to Sheffield. Joining is entirely your choice, and you are free to leave the trial at any time without your regular NHS care being affected.

Locations (3)

Royal Hallamshire Hospital
Approximate
Sheffield, England
Northern General Hospital
Approximate
Sheffield, England
The White House Surgery
Approximate
Sheffield, England

Common questions

What is diabetic nerve damage?

Diabetic nerve damage happens when persistent high blood sugar and other health factors injure the nerves, most commonly in the feet and legs. It can cause tingling, burning pain, or a complete loss of sensation.

Do the screening nerve tests hurt?

No. The screening tests use small, non-invasive devices placed gently against the skin of your feet and hands. They are quick, painless, and do not use needles.

Can I choose which treatment group I join?

No. A computer randomly decides whether you receive usual GP care or the intensified specialist care. This ensures the results are completely fair and scientifically reliable.

Do I have to agree to the skin biopsy?

No. The skin biopsy is entirely optional. You can still take part in the main study even if you decide not to have the skin sample taken.

What happens if my screening shows my nerves are healthy?

If no early nerve damage is detected, your participation in the study ends immediately. The team will share the results with you, and you will simply continue your usual diabetes care with your GP.

How to find out more

Sharon Caunt

sharon.caunt@nhs.net +44(0) 114 2265976 Official trial record

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