A trial testing new treatments aimed at restoring warning signs of low blood glucose in people with type 1 diabetes who can no longer perceive when their blood sugars dip dangerously low is underway.
Researchers from The University of Leicester, in collaboration with University Hospitals of Leicester NHS Trust, the University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust are part of a multinational NIH-funded trial called CLEAR (Closed Loop and Education for Hypoglycemia Awareness) which will compare three innovative treatments to find the most effective way to restore the body’s natural warning signs for those with type 1 diabetes.
They will look at the effectiveness of using an ‘artificial pancreas’ pump system which continually monitors blood glucose, automatically adjusting the amount of insulin administered via a pump and compare this with bespoke psychoeducational programmes named MyHypoCOMPaSS and HARPdoc - aimed at helping individuals re-tune their body and mind to recognise subtle hypo symptoms and equip them with strategies to identify and manage low blood sugar promptly.
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.
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.
The trial – which is running in research sites spread across the US, Australia and UK – is being led by Professor Simon Heller, Professor of Clinical Diabetes at the University of Sheffield and Professor Pratik Choudhary from Leicester Diabetes Centre .
Leicester Diabetes Centre will coordinate treatments and recruit participants for those south of Leicester, while Sheffield will do so for those north 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, said: “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.”
Sue Deas, 66, from Market Harborough is participating in the CLEAR trial.
She 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 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.”
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.
For more information about the trial visit the Clear webpage .