Groundbreaking study aims to tackle “hypo” unawareness
New research will trial treatments with aim to prevent hypoglycaemia, or low blood glucose.
Researchers will test out new treatments aimed at restoring warning signs of low blood glucose in people with type 1 diabetes when their blood glucose levels dip dangerously low, a condition known as hypoglycaemia, or hypo, as part of a new study.
Researchers from Sheffield Teaching Hospitals NHS Foundation Trust, in collaboration with the Universities of Sheffield and Leicester and University Hospitals of Leicester NHS Trust, will compare three innovative treatments.
The study team hope to find the most effective way to restore the body’s natural warning signs for people living with type 1 diabetes as part of a multinational National Institutes of Health-funded trial called CLEAR (Closed Loop and Education for Hypoglycaemia Awareness).
Researchers will examine the effectiveness of using an “artificial pancreas” pump system, which continually monitors blood glucose levels and automatically adjusts the amount of insulin administered via a pump and compare this with bespoke psychoeducational programmes named MyHypoCOMPaSS and HARPdoc. These programmes are designed to help people 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. Even though many rely on continuous glucose monitors, symptoms such as shaking or sweating that alert them to dropping blood glucose levels are important in protecting them from more severe episodes that can lead to loss of consciousness, seizures or even death.
A quarter of people with type 1 diabetes at risk of hypo unawareness
For around 1 in 4 people with type 1 diabetes, these warning symptoms are impaired, as their crucial alarm system fades or disappears over time. Previous studies suggest that despite using glucose monitors with alarms, people with the condition remain at increased risk of severe hypo episodes. Restoring awareness is therefore crucial to ensure patients can intervene safely before a crisis hits.
Researchers plan to check how well each intervention has restored awareness in patients after a 12-month period – with participants given the option of adding in one of the other interventions in the second year.
The trial will take place in research locations spread across the US, Australia and UK and is being led by Professor Simon Heller from the Sheffield Diabetes Centre and Professor Pratik Choudhary from Leicester Diabetes Centre.
Sheffield will coordinate treatments and recruit participants for participants north of Leicester, while Leicester will do so for volunteers south of the city. Newcastle and King’s College Hospital will deliver the MyHypoCOMPaSS and HARPdoc programmes.
Professor Heller, who is International Consortium Co-lead of the CLEAR study and Honorary Consultant Physician at Sheffield Teaching Hospitals NHS Foundation Trust, 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.”
Photo: Professor Simon Heller (centre) and Dr Ahmed Iqbal (3rd from right) are leading the trial for the benefit of patients in the north of England.
Professor 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 MyHypoCOMPaSS and HARPdoc programmes 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.”
Using artificial pancreas to prevent 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 said this helped enormously to reduce severe hypos she was previously experiencing on a weekly basis.
Sue 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, said: “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 visit the CLEAR (Closed Loop and Education for Hypoglycaemia Awareness) trial website
To participate email (Sheffield) or call 0116 258 8575 (Leicester)
Read more about type 1 diabetes
NOTE: DRWF will from time-to-time advise readers of ‘calls to participate’ in diabetes and related health research studies. It should not necessarily be considered that the charity is in any way connected to the study or the group issuing the call for participants. If we are involved in any way, we will make this known. We will only share external calls where we have confirmed that the study holds ethics committee approval, and the study is specific to diabetes and related health. Taking part in a medical research study is a big step and further helpful information can be found via the National Institute for Health and Care Research Clinical Trials Guide.
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