The Sheffield one-stop enhanced diabetes care process screening for people with type 2 diabetes and intensified care for those with early nerve damage
| ISRCTN | ISRCTN14584801 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14584801 |
| IRAS number | 325956 |
| Secondary identifying numbers | CPMS 57408, IRAS 325956 |
- Submission date
- 15/11/2023
- Registration date
- 11/01/2024
- Last edited
- 11/03/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
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.
Who can participate?
Patients with type 2 diabetes aged 18-75 years with an HbA1c of more than 8.5% (69 mmol/mol).
What does the study involve?
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.
What are the possible benefits and risks of participating?
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.
Where is the study run from?
Royal Hallamshire Hospital (UK)
When is the study starting and how long is it expected to run for?
May 2022 to July 2027
Who is funding the study?
Viatris UK Healthcare Ltd (UK)
Who is the main contact?
Dr M. Shaan Goonoo, m.goonoo@nhs.net
Contact information
Public
Sheffield Teaching Hospitals NHS Foundation Trust
Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
United Kingdom
| Phone | +44(0) 114 2265976 |
|---|---|
| sharon.caunt@nhs.net |
Scientific
Sheffield Teaching Hospitals NHS Foundation Trust
Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
United Kingdom
| Phone | +44 (0)114 271 2204 |
|---|---|
| Solomon.Tesfaye@nhs.net |
Study information
| Study design | Randomized; Interventional; Design type: Treatment, Drug, Education or Self-Management, Dietary, Physical |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | One-stop sCrEening ANd Intensified Care (OCEANIC): a proof of principle randomised, controlled trial of intensive multifactorial intervention in early diabetic peripheral neuropathy |
| Study acronym | OCEANIC |
| Study hypothesis | Treatment with multifactorial risk factor intervention will slow/reverse/stop subclinical diabetic peripheral neuropathy (DPN) in people with type 2 diabetes. |
| Ethics approval(s) | Approved 13/10/2023, North West - Greater Manchester Central Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, UK; +44 (0)207 104 8244; gmcentral.rec@hra.nhs.uk), ref: 23/NW/0301 |
| Condition | Diabetic peripheral neuropathy |
| Intervention | Screening Visit: People with type 2 diabetes attending the Sheffield One-Stop Screening Service in both community and hospital settings will be invited and consented to participate in the screening phase of this study. The study screening process will take place within their routine annual diabetes screening appointment and the visit will take approximately 1 hour. As per usual diabetes care, the screener will review the patient's previous clinical evaluation and perform a brief physical examination including a foot check, height, weight and blood pressure measurements, and ask about smoking status. Blood and urine samples will be collected to measure average blood glucose, kidney function and cholesterol. Additional research components of the visit included enhanced nerve checks using two non-invasive point-of-care devices called DPN-Check and SUDOSCAN will also be performed. DPN-Check measures the speed at which nerves transmit impulses. SudoScan measures sweat levels in one's hands and feet by placing hands and feet on metal plates which measure conductance. If one or both of these tests are abnormal, they will be asked further questions about their medical history and that of their relatives to check if they are eligible for the treatment part of the study. The blood sample will also be used to exclude other possible causes of nerve damage. Additional hip and waist circumference and body composition measurements will also be taken. From the screening cohort, the research team will identify 167 people with type 2 diabetes and poor glucose control (HbA1c>8.5% or 69mmol/l) and abnormal nerve check results indicating early (sub-clinical) neuropathy, and invite them to take part in the treatment phase of the trial. Baseline Visit: At the baseline visit, which will take about 2 hours, a member of the study team will answer any questions the participants may have, will confirm eligibility for the treatment phase of the trial, and will ask the participant to sign an informed consent form before undergoing further assessments. These assessments will include taking blood pressure, weight, and height measurements, determining readiness and ability to perform physical activity, and completing some health and nerve-related questionnaires. We will also carry out some tests to examine the nerves of the feet, including standard clinical tests to 1) check one's ability to feel different sensations, 2) measure cardiac autonomic nerve function, and 3) measure the speed of nerve impulses. 1. Quantitative sensory testing is used to measure how one's nerve endings work in your feet. There are two types of tests, thermal threshold testing to measure responses to changes in temperature and vibration testing to measure responses to vibrations. We will also check one's ability to detect light touch and sharpness; this may be uncomfortable but will not puncture the skin. 2. Cardiac autonomic function tests monitor one's heart rate and rhythm (an ECG) and blood pressure while he/she undertakes some simple breathing exercises both lying down and standing up. It will assess whether the nerves that serve the heart and control the blood pressure are working correctly. 3. Nerve conduction studies will be performed by a board-certified consultant neurophysiologist at the hospital; this may take place at a separate visit. This will measure how the nerves are conducting the information from the periphery to the brain and from the brain to the muscles, we will use neurophysiologic tests. Attachment of some electrodes and a small electrical current will be applied to assess the ability of the nerves to transmit electrical impulses. A blood sample will be taken at the baseline visit and final study visits to measure markers of inflammation as predictors of cardiovascular disease events. These samples will be stored for future analysis. An optional skin biopsy will also be performed at the first visit and last study visit to measure nerve density, the gold standard assessment of small fibre nerve damage. This would involve taking 3 mm (~1/10 inch) circular piece of skin (skin biopsy) from the participant's lower leg after numbing with a local anaesthetic. This procedure is routine practice in dermatology clinics and is deemed to be safe and has a low risk of infection and scarring. Healing usually occurs in 7-10 days. At or following the baseline visit, a computer program will randomly decide which treatment group of the trial the participant will be in. At the moment, we do not know if early signs of nerve damage in people with type 2 diabetes can be reversed/halted by managing risk factors more intensively. Randomly allocating the participants to intensified care and routine care from their GP will help to compare the different treatments in an equal way. Due to the nature of the interventions in this trial, participants and investigators will know which treatment group participants have been allocated to. However, every attempt will be made to keep the neurophysiologist performing the Nerve Conduction Studies blinded to the treatment allocation. As this assessment does not depend on treatment allocation, it will not be necessary to unblind the neurophysiologist. A letter will be sent to participants' GPs notifying them of their participation in the study and confirming treatment group allocation. Treatment group: 1. Routine care: People in this group will 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, participants will be asked to wear a continuous glucose monitoring sensor for 2 weeks at baseline, 12 months, and 24 months, but participants will not be able to view the data (it will be blinded). 2. Intensified care: Participants in this group will have intensive, holistic, individualised, target-driven, multifactorial intervention delivered by Diabetes Specialist Nurses, Diabetes Dietitians and Diabetes Doctors. The research team will support participants in this group to achieve individual blood glucose levels (HbA1c) and manage cardiovascular factors (blood pressure and cholesterol). The participants will be asked to wear a continuous glucose monitoring sensor throughout the study, attend type 2 diabetes face-to-face and/or online educational programmes and an NHS-recommended exercise programme. Endpoint Visit: All participants will be seen by the research team at 24 months to repeat the baseline visit assessments. The 24-month visit will therefore take about 2 hours as all questionnaires, blood samples, (optional) skin biopsy and nerve check assessments performed during the baseline visit will be repeated by the research team. Diabetes blood and urine results will be obtained from their routine annual diabetes screening appointment if performed within 6 weeks of this visit or collected during this visit. |
| Intervention type | Mixed |
| Primary outcome measure | Nerve damage is measured using sural nerve action potential (SNAP; obtained by conventional electrophysiology) at baseline and 24 months |
| Secondary outcome measures | 1. Small- and large-fibre dysfunction measured using skin intraepidermal nerve density, peripheral neurological examination, and quantitative sensory testing at baseline and 24 months 2. The diagnostic accuracy of the point-of-care devices (DPN-Check and Sudoscan) of diabetic peripheral neuropathy will be measured against the gold standard SNAP at baseline and 24 months 3. Cardiometabolic risk factors and quality of life are measured using patient-related outcomes, biomedical markers, and anthropometric parameters at baseline and 24 months |
| Overall study start date | 25/05/2022 |
| Overall study end date | 31/07/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 600; UK Sample Size: 600 |
| Participant inclusion criteria | For screening: 1. People with T2D 2. Age 18-75 years 3. HbA1c >8.0% (64 mmol/mol) For the trial: 1. People with T2D 2. Age 18-75 years 3. HbA1c >8.5% (69 mmol/mol) 4. Normal/mildly abnormal mTCNS 5. Have detectable DPNCheck SA (>1 mV) 6. Abnormal DPN-Check SNCV or amplitude for age (based on age-related normative values) 7. Willing and able to comply with the study schedule and be available for the treatment duration 8. Able to give written informed consent |
| Participant exclusion criteria | 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. Housebound 3. Serious illness or event with life-expectancy <1 year or other significant illness which, in the opinion of a study clinician, precludes involvement 4. Active psychotic illness 5. Current pregnancy, or actively trying to conceive 6. Other causes of sensorimotor or autonomic neuropathy (e.g., autoimmune disease) 7. Requirement for renal replacement therapy 8. Planned major surgery over the duration of the trial 9. Alcohol/substance abuse 10. Patients taking part in any other clinical trials or observational research that will interfere with the delivery of this trial protocol or overburden the patient 11. Unwilling or unable to give informed consent to participate in the study 12. 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 |
| Recruitment start date | 15/01/2024 |
| Recruitment end date | 31/07/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Sheffield
S10 2JF
United Kingdom
Sheffield
S5 7AU
United Kingdom
Sheffield
S2 1SL
United Kingdom
Sponsor information
Hospital/treatment centre
Clinical Research and Innovation Office, D Floor
Sheffield
S10 2JF
England
United Kingdom
| Phone | +44 (0)1142265941 |
|---|---|
| STH.ResearchAdministration@nhs.net | |
| Website | http://www.sth.nhs.uk/ |
"ROR" |
https://ror.org/018hjpz25 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/03/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The findings of this study will be widely disseminated through scientific meetings (communications and posters) and the publication of articles in high-impact peer-reviewed journals. Accessible, plain-language summaries of the key findings will also be disseminated using pre-existing connections with the diabetes community. |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be available upon reasonable request submitted in writing to the study Chief Investigator: Prof Solomon Tesfaye (Solomon.Tesfaye@nhs.net). |
Editorial Notes
11/03/2025: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/03/2025 to 31/07/2025.
2. The overall end date was changed from 31/03/2027 to 31/07/2027.
3. The plain English summary was updated to reflect these changes.
17/01/2025: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2024 to 31/03/2025.
2. The overall end date was changed from 31/12/2026 to 31/03/2027.
3. The intention to publish date was changed from 31/12/2027 to 31/03/2028.
4. The plain English summary was updated to reflect these changes.
21/06/2024: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2024 to 31/12/2024.
2. The overall end date was changed from 30/06/2026 to 31/12/2026.
3. The intention to publish date was changed from 30/06/2027 to 31/12/2027.
4. The plain English summary was updated to reflect these changes.
5. The participant level data sharing statement was added.
15/11/2023: Study's existence confirmed by the NIHR.
