.png){kind=spacer}
A trial testing new treatments aimed at restoring warning signs of low blood glucose in people with type 1 diabetes when their blood sugars dip dangerously low is underway.
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 to find the most effective way to restore the body's natural warning signs for those with type 1 diabetes as part of a multinational NIH-funded trial called CLEAR (Closed Loop and Education for Hypoglycaemia Awareness).
They will look at the effectiveness of using an 'artificial pancreas' pump system which continually monitors blood glucose and automatically adjusts 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.
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.
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.
