Researchers from Sheffield are to play a leading role in a major international effort aimed at devising better treatments for people living with hypoglycaemia, a common and potentially serious complication of diabetes.
The £23.6 million project, funded by the European Economic Community, which will run over four years and involves 10 countries and six UK centres, brings together world leaders from the field of diabetes, including clinicians from Sheffield Teaching Hospitals NHS Foundation Trust and internationally renowned health economists from the University of Sheffield’s School of Health and Related Research (ScHARR).
The Hypo-RESOLVE Consortium will look to find better solutions to alleviate the burden and consequences of hypoglycaemia in people living with diabetes, which can be very frightening and have a major psychological impact on people’s lives. The effects range from unpleasant symptoms such as sweating and tremor to loss of concentration and confusion. In the most severe cases people can become unconsciousness and experience epileptic seizures. Even severe episodes can be treated successfully but often require the attendance of paramedics or admission to hospital.
Hypoglycaemia is a side effect of insulin treatment and develops when blood glucose levels drop lower than the normal range. A mild hypo can be treated by eating fast-acting carbohydrate while more severe episodes may require injection of glucose solutions into a vein.
Led by Professor Simon Heller, director of research and development and honorary consultant physician at Sheffield Teaching Hospitals Foundation Trust, the Sheffield team will amass all the published evidence on hypoglycaemia from 100 to 150 recently conducted clinical trials into an evidence-based, validated mega-database. This will bring together all the published knowledge of hypoglycaemia, and determine definitive glucose-lowering interventions which will enable clinicians to compare different treatments using the same baseline information. This in turn will improve understanding of the condition and the impact it has on people’s lives.
The multi-million pound project will also involve the setting up of a large clinical trial where patients with type 1 or type 2 diabetes who use continuous glucose monitoring will be recruited to identify periods when hypoglycaemia occurs, the risks of severe episodes and what the effects are on the quality of their lives. Sheffield Teaching Hospitals NHS Foundation will be the only UK site in the north of England involved in the study, which is due to begin in around a year’s time.
Professor Simon Heller, who has been researching hypoglycaemia since 1985 and led a ground-breaking study that uncovered a direct correlation between dipping overnight blood sugar levels and prolonged abnormal heart disturbances, said: “This is a really exciting project which will bring together leading international players from academia, industry and members of the public to raise awareness of the impact of hypoglycaemia on people’s lives and to build evidence-based data that will help us to formulate answers to key questions about the mechanisms that cause it.
“Hypoglycaemia presents a huge psychological burden for people with diabetes, causing professional embarrassment and limiting people’s lifestyles through simple things we all take for granted like being able to have a driving licence or undertake a career in the armed forces. It’s also the main reason people on insulin don’t reach glucose targets and can be particularly distressing for parents of young children who witness children having seizures. Although there’s a lot we do know about the condition, there is still much to learn. We’re delighted to be one of only a handful of centres in the world to be at the cutting-edge of this ground breaking research, funded by both European Union and major pharmaceutical companies. It will be fundamental in helping clinicians to agree on a definition of the thresholds of the condition, develop new treatments and better predict the mechanisms that cause hypos to occur. This will ultimately improve people’s lives.”
Andy Broomhead, 37, of Chapeltown, who has lived with Type 1 diabetes since 2001, said: “Hypoglycaemia can be so difficult to manage. Having to stop a presentation part way through a meeting to treat because you're no longer able to think or speak clearly is frustrating at best and embarrassing at worst. It can get in the way of exercising, stop you leaving the house because your glucose levels are too low to drive, and waking in the middle of the night sweating and shaking takes a huge toll. It’s fantastic that this research will be carried out in Sheffield and led by Professor Heller as the more we understand about hypoglycaemia and how to limit its impact on people with diabetes the better.”
Professor Alan Brennan from the University of Sheffield's School of Health and Related Research (ScHARR) said, “Our research team will be leading work to develop a new measure of how hypoglycaemia affects people’s quality of life and analysis of the costs caused by hypoglycaemia to the healthcare system e.g. additional ambulance journeys, emergency room visits and hospital admissions. This is tremendously important because these things are used to help patients and clinicians understand the effectiveness of different treatments and also governments and decision makers to decided which treatments are good value for money in their healthcare systems.”
As well as involving academics, clinicians and leading industry partners, the Hypo-RESOLVE consortium will see the establishment of a Patient Advisory Committee. This will ensure that patients’ insights, opinions and wishes are taken into account across all areas of the project.
The project is being funded by the Innovative Medicines Initiative (IMI), a joint undertaking of the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA), T1D Exchange, JDRF, International Diabetes Federation (IDF), and the Leona M. and Harry B. Helmsley Charitable Trust.
Around 400,000 people in the UK are currently living with type 1 diabetes.
