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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Prof Solomon Tesfaye
+44 (0)114 271 2204
Solomon.Tesfaye@nhs.net


Dr Sharon Caunt
+44(0) 114 2265976
sharon.caunt@nhs.net


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Be Part of Research - Trial Details - The Sheffield one-stop enhanced diabetes care process screening for people with type 2 diabetes and intensified care for those with early nerve damage
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The Sheffield one-stop enhanced diabetes care process screening for people with type 2 diabetes and intensified care for those with early nerve damage

Recruiting

Open to: All Genders

Age: Adult

Sheffield Sheffield Sheffield

Medical Conditions

Diabetic peripheral neuropathy

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The aim of this study is to find out if nerve damage in people with type 2 diabetes can be reversed by managing risk factors more intensively. About half of people with type 2 diabetes develop nerve damage resulting in loss of sensation in the feet and legs. This increases the risk of injury leading to foot ulceration. Unfortunately, if foot ulcers get worse this can result in toe or leg amputation. One in four people with nerve damage can also suffer from distressing pain in the feet which responds poorly to treatment. Studies have shown that poor sugar control, high blood pressure, high cholesterol and increasing weight contribute to nerve damage in diabetes.
Nerve damage can be prevented or stopped in people with type 1 diabetes with good blood sugar control. However, similar evidence is lacking in type 2 diabetes. There is therefore a clear need to examine if a more intensive multi-factorial risk reduction approach aiming to support patients to achieve satisfactory individual target risk factor levels, will reverse or halt early nerve damage in people suffering from type 2 diabetes.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

15 Jan 2024 31 Jul 2025

The study is split into two parts, Screening and Treatment.
Firstly, people identified by their usual care team as having sub-optimally controlled type 2 diabetes will undergo a screening visit on or following their usual annual diabetes review visit. In addition to performing the usual annual diabetes review visit care processes (foot check, blood pressure, weight and height (to calculate body mass index (BMI), smoking status, a blood sample to measure average blood glucose, kidney function and cholesterol, and a urine sample to check for signs of kidney damages).
Following informed consent, two non-invasive point-of-care tests will be conducted using the DPNCheck and SudoScan devices to check for nerve damage in the patient’s feet and hands. If one or both tests are abnormal, further questions about their medical history and that of their relatives will be asked to check if they are eligible for the treatment part of the study. If nerve damage is detected, the blood sample will also be used to exclude other possible causes of nerve damage. Hip and waist circumference and body composition will also be measured. This will be the end of the involvement in the study for people without early nerve damage.
People identified as having early nerve damage will be invited to a baseline visit to confirm their eligibility for the treatment phase of the trial. Baseline assessments will include a more detailed nerve examination; blood pressure, weight, height, hip, and waist measurements, and body composition will also be repeated to determine their readiness and ability to perform physical activity and they will be supported to complete some health, quality of life and nerve-related questionnaires. Blood and urine samples will be repeated if the baseline visit is performed more than 6 weeks after the screening visit, and an optional skin biopsy sample will also be performed to measure nerve density, the gold standard assessment of small fibre nerve damage.
Eligible participants will be randomly allocated to receive either intensified or usual diabetes care.
Usual care: People in this group will continue to receive usual diabetes care normally given by their GP or practice nurse. This will include regular blood tests and time with the GP and/or practice nurse. As part of the study, they will be asked to wear a continuous glucose monitoring sensor for 2 weeks at baseline, 12 and 24 months, but they will not be able to view the data (it will be blinded).
At the end of the study, people in this group will be notified of their individual risk factors (if any) and referred to their GP for further support to manage their blood glucose levels (HbA1c), blood pressure and cholesterol. They will also be signposted to other relevant services and resources, for example, those relating to Type 2 diabetes structured education (DESMOND), smoking cessation, and exercise, if they have not already accessed these.
Intensified care: People in this group will have frequent in-person and/or telephone contact with diabetes specialist nurses, diabetes dietitians and diabetes doctors to support them to achieve individual blood glucose levels (HbA1c) and manage cardiovascular factors (blood pressure and cholesterol). They will be asked to wear a continuous glucose monitoring sensor throughout the study and be able to view this data, be referred for smoking cessation (if applicable), and attend type 2 diabetes face-to-face and/or online educational programmes and an NHS-recommended exercise programme (light-to-moderate exercise for at least 30 minutes three to five times weekly will be recommended where it is safe to do so. Where this is not possible tailored exercise according to ability will be recommended). Where necessary additional emails/text alerts will be used to support people in this group.
The final visit will take place at 24 months when all study assessments performed at the baseline visit (including the optional skin biopsy) will be repeated in both the standard care and intensive care group. Diabetes blood and urine results will be obtained from their routine annual diabetes screening appointment if performed within 6 weeks of this visit.


Patients with type 2 diabetes aged 18-75 years with an HbA1c of more than 8.5% (69 mmol/mol).

You can take part if:



You may not be able to take part if:


For the trial:1. Diagnosis with other forms of diabetes (e.g., type 1 diabetes, monogenic diabetes (MODY), gestational diabetes or latent autoimmune diabetes in adults (LADA)2. Housebound3. Serious illness or event with life-expectancy <1 year or other significant illness which, in the opinion of a study clinician, precludes involvement4. Active psychotic illness5. Current pregnancy, or actively trying to conceive6. Other causes of sensorimotor or autonomic neuropathy (e.g., autoimmune disease)7. Requirement for renal replacement therapy8. Planned major surgery over the duration of the trial9. Alcohol/substance abuse10. Patients taking part in any other clinical trials or observational research that will interfere with the delivery of this trial protocol or overburden the patient11. Unwilling or unable to give informed consent to participate in the study12. Any other conditions, which, in the opinion of the Investigator would make the patient unsuitable for inclusion, or could interfere with the patient participating in or completing the study


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Royal Hallamshire Hospital
    Glossop Road
    Sheffield
    S10 2JF
  • Northern General Hospital
    Herries Road
    Sheffield
    S5 7AU
  • The White House Surgery
    1 Fairfax Rise
    Sheffield
    S2 1SL

There may be no direct benefit to participating in this trial, but we hope it will demonstrate that improved diabetes control is possible with an intensified care approach and that this will halt/reverse early diabetic peripheral neuropathy. People in the routine care group will continue to receive usual diabetes care provided by their GP or practice nurse.
This is a low-risk study. The intensified treatment uses technologies that are proven safe to use in people with diabetes, and glucose control and exercise recommendations will be tailored to the individual. Taking part in this research will require additional visits to the hospital compared to the number of appointments normally attended, particularly for people allocated to the intensive treatment group.

Prof Solomon Tesfaye
+44 (0)114 271 2204
Solomon.Tesfaye@nhs.net


Dr Sharon Caunt
+44(0) 114 2265976
sharon.caunt@nhs.net



The study is sponsored by Sheffield Teaching Hospitals NHS Foundation Trust and funded by Viatris.




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Read full details for Trial ID: ISRCTN14584801

Or CPMS 57408

Last updated 11 March 2025

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