Groundbreaking trial launched in bid to reverse lifetime risks of devastating diabetes complication
25 July 2024
World-leading diabetes experts at Sheffield Teaching Hospitals NHS Foundation Trust have opened a groundbreaking trial aiming to reverse the lifetime risks of nerve damage in people living with type 2 diabetes.
The brand-new trial, known as OCEANIC, will build on recent evidence that shows that intensive management of blood glucose (sugar) levels can prevent the progression of nerve damage in people with type 1 diabetes.
The trial will take advantage of smart technologies that help track body fat percentage and glucose levels in real time as well as offer patients a package of intensive lifestyle support to help manage risk factors. It is being funded by an investment from global pharmaceutical company Viatris and consumer electronics company Withings. The study is being sponsored by Sheffield Teaching Hospitals NHS Foundation Trust.
Around half of people with diabetes suffer with nerve damage (also known as diabetic peripheral neuropathy) caused by high blood glucose levels injuring nerves over time. This can result in loss of sensation (numbness) while also causing severe, disabling nerve pain in the feet and legs.
The condition – which is one of the most devastating complications of diabetes – leaves sufferers with the inability to perceive sensation putting them at greater risk of inadvertent injuries, and foot ulcers that can become infected leading to amputations.
Trial will use newer technologies to manage risk factors
Now the research team want to see if intensive strategies to manage risk factors including high-blood glucose, cholesterol, blood pressure and obesity can halt or reverse diabetes-related nerve damage when identified at an early stage in people living with uncontrolled type 2 diabetes. These intensive strategies will be compared against standard care over a period of two years.
Patients aged 18 to 75 identified as having early-stage diabetes-related nerve damage will be enrolled into the trial, with half being randomly assigned into an intensified care programme.
How the trial will work
In the intensified care programme part of the trial, participants will have frequent in-person contact with diabetes specialist nurses, dietitians, and doctors to help manage blood glucose levels, blood pressure and cholesterol and be given lifestyle modifications and tailored support.
This will be supported by newer technologies including wearable sensors that detect glucose levels in real time, activity tracking watches, and smart weighing scales that record weight loss progress through key health metrics such as body fat percentage and muscle mass. Data from these devices – which they will be asked to use throughout the study – will be available for them to view to reinforce lifestyle change.
They will also be offered personalised diabetes education and exercise programmes, and smokers will be referred to a smoking cessation programme. These strategies will be delivered in one-to-one consultations, group sessions and online, and will be tailored to the needs of the individual person with diabetes.
The other group of participants (the control group) will continue to receive normal diabetes care through their GP and/or GP practice. They will also be asked to wear a continuous glucose monitoring sensor and activity tracking watch for 2 weeks at 0-, 12 and 24-months as part of the research, but they will not have access to the data.
Patients will be screened for the trial alongside their annual diabetes review, some of which will be via the Sheffield One-Stop Diabetes Screening Service.
"Important next step" - Professor Solomon Tesfaye
The clinical trial in Sheffield is being led by Professor Solomon Tesfaye, Consultant Physician/Diabetologist at Sheffield Teaching Hospitals NHS Foundation Trust and a National Institute for Health Research and Care Senior Investigator.
Professor Tesfaye said: “Diabetic peripheral neuropathy is a distressing and painful condition impacting on quality of life, independence, and livelihoods.
“Sheffield has world-leading expertise in diabetes research, and through this trial we hope to demonstrate the importance of early identification of diabetes-related nerve damage and how intensive management of risk factors can reverse the terrible consequences of this major complication of diabetes.
“Delivery of this trial is also an important next step in our bid to demonstrate the widespread benefit of giving patients kidney, eye and foot checks at the same time, to prevent dialysis, sight and limb loss, respectively. This is the model successfully used in the Sheffield Diabetes One-Stop Screening Service. As well as ensuring patients with diabetes get all their annual health checks in one visit, this has successfully improved health outcomes by early referrals and management of diabetes-related complications, transforming and saving lives.”
Hope for future diabetes patients
Tracey Smythe, 55, of Parsons Cross, whose diabetes-related nerve damage is too advanced to be reversed, said she hoped the new trial can make a difference to others like her in the future.
“Being where I am today is not the life I’d dreamt of, I’m on lots of medications, I can’t get off to sleep because the pain in my feet burns so much, I get pins and needles and cramp. It’s not only my feet and legs that are affected; I suffer in my hands as well. Last time I was between medications, I could hardly walk on my feet, and by the end of it, I was losing my balance because the pain was so intense. My quality of life is very poor and very limited, but if it can be diagnosed early and reversed people like me will be able to have the quality of life that I can't.”
Type 2 diabetes occurs when the body’s cells no longer respond to insulin produced by the pancreas. A carbohydrate-controlled diet and exercise programmes are common treatments.
The OCEANIC (One-stop sCrEening ANd Intensified Care) trial is set to run for 24 months. For further information about the study, contact Dr M. Shaan Goonoo on 0114 2712568 / 07564669525 or email m.goonoo@nhs.net.
ENDS
Photo: Professor Solomon Tesfaye (far right) and the Oceanic study team
