Diabetes trial aims to bring back crucial warning signs for patients
24 March 2026
A major international clinical trial is underway to help people with type 1 diabetes regain crucial warning signs of dangerously low blood sugar levels.
The study, led in the UK by Sheffield Teaching Hospitals NHS Foundation Trust in collaboration with the University of Sheffield, University of Leicester and University Hospitals of Leicester NHS Trust, is part of a multinational programme funded by the US National Institutes of Health.
Known as the CLEAR (Closed Loop and Education for Hypoglycaemia Awareness) trial, the research will compare three cutting-edge approaches to restoring the body’s natural ability to detect low blood glucose levels.
These include:
- An ‘artificial pancreas’ system that continuously monitors glucose and automatically adjusts insulin delivery
- Two specialist education programmes – MyHypoCOMPaSS and HARPdoc – designed to help patients recognise subtle symptoms and better manage their condition
Type 1 diabetes requires people to balance the amount of insulin they are using with their food and activity, and even though many rely on continuous glucose monitors, symptoms such as shaking or sweating that alert them to dropping blood sugar levels are important in protecting them from more severe episodes that can lead to loss of consciousness, seizures or even death.
Restoring critical warning systems
However, for about 1 in 4 people with type 1 diabetes, these warning symptoms are impaired - their crucial alarm system fades or disappears over time – and the data suggests that despite using glucose monitors with alarms, they remain at increased risk of severe episodes. Restoring awareness is therefore crucial to ensure patients can intervene safely before a crisis hits.
After a year the research team will check how well each intervention restores awareness in patients - with participants given the option of adding in one of the other interventions in the second year.
Professor Heller (left) and Professor Choudhary (right) are at the helm of the UK-wide trial
The trial – which is running in research sites spread across the US, Australia and UK – is being led by Professor Simon Heller from the Sheffield Diabetes Centre and Professor Pratik Choudhary from Leicester Diabetes Centre.
Sheffield leading trial in north
Sheffield will coordinate treatments and recruit participants for those north of Leicester, while Leicester will do so for those south of the city. Newcastle and King’s College Hospital will deliver the MyHypoCOMPaSS and HARPdoc programmes.
Professor Simon Heller who is International Consortium Co-lead of the CLEAR Study and Honorary Consultant Physician at Sheffield Teaching Hospitals NHS Foundation Trust, explained: “A quarter of people living with type 1 diabetes experience a delay or inability to perceive the initial warning signs of hypoglycaemia. This has huge consequences, both on patients and the wider community, with patients describing imposed changes to their lives such as leaving employment, stopping hobbies they enjoy and spending more time at home or being supervised by others. Rates of anxiety, depression and distress from diabetes are higher. Fear of having a hypo can also lead to people running their glucose levels higher leading to higher chances of having other diabetes-related complications.”
Professor Pratik Choudhary, said: “Being part of this international trial is really important and we are really pleased to be working with colleagues from Sheffield to use treatments like artificial pancreas, and HARPdoc and HYPOCOMPASS that are not easily available on the NHS to help this group of patients through this trial.
“The trial will also help us understand a lot about how to support patients for whom hypoglycaemia remains a problem despite technology. We would be happy for patients and colleagues to get in touch if they think they may be eligible.”
'Anything to help my diabetes'
Sue says the trial has helped enormously in reducing her severe hypos
Sue Deas, 66, was diagnosed with type 1 diabetes at the age of 44 when she began experiencing symptoms of fatigue, extreme thirst and weight loss.
Sue had struggled to keep her glucose levels under control through insulin injections. However, since October she has been using the artificial pump as part of the trial and says this has helped enormously to reduce severe hypos which had been occurring weekly.
She said: “The pump helps to monitor my glucose levels 24/7, ensuring I have the right amount. I’ve always found it extremely difficult to tell when I might be about to experience a severe hypo so I’m extremely happy to be on this trial and would encourage others to take part too. Anything which can help to manage my diabetes – whether through a pump or education – has got to be good.”
Dr Ahmed Iqbal, Honorary Consultant Physician in Diabetes at Sheffield Teaching Hospitals NHS Foundation Trust and Senior Clinical Lecturer at the University of Sheffield, added: “Hypoglycaemia has been designated by UK patient and professional groups as one of the top research priorities in diabetes for the next decade. This landmark trial brings together the world-class expertise of leading diabetes centres from three continents, delivering innovative treatments for problematic hypoglycaemia to patients.”
For more information about the CLEAR (Closed Loop and Education for Hypoglycaemia Awareness) trial and to take part visit the CLEAR website or email sth.clearstudy@nhs.net (Sheffield) or call 0116 258 8575 (Leicester).
The National Institutes of Health (NIH) is the primary agency of the United States government responsible for biomedical and public health research, operating under the Department of Health and Human Services.
In Sheffield the trial is also being supported by the National Institute for Health and Care Research (NIHR) Sheffield Clinical Research Facility.
ENDS
