Diabetes currently affects over 425 million people worldwide. Hypoglycaemia is a common and serious complication of diabetes, particularly affecting people with diabetes on insulin treatment. It is characterised by abnormally low blood sugar levels, which can lead to cognitive impairment and in some severe cases, seizures, loss of consciousness, coma and even death.
Hypoglycaemia can be caused by too much insulin in the body, a low intake of carbohydrate, unplanned exercise and activities, and missed or delayed meals/snacks.
Typical symptoms include:
For people with diabetes, the generally accepted cut-off point to define hypoglycaemia is a blood glucose level below 3.9mmol/L (70 mg/dl), although people may experience symptoms associated with hypoglycaemia at a higher level or have no symptoms at that level.
Hypoglycaemia can have a profound effect on the everyday lives of people with diabetes and their carers. Research has found that 70% of people with type 1 diabetes feel tired the day after a night-time hypoglycaemic event and that over 60% of family members of people with diabetes are worried about the risk of hypoglycaemia to their loved one.
As much about hypoglycaemia remains unknown, the International Diabetes Federation (IDF) has joined the HypoResolve(Hypoglycaemia – Redefining SOLutions for better liVEs) consortium to help gain a better understanding of hypoglycaemia’s impact on the lives of people with diabetes and their carers and families, and ultimately improve their lives. HypoResolve comprises of 23 partners from nine European countries and the US, and includes leading academic experts, pharmaceutical and device manufacturers, as well as patient organisations.
HypoResolve aims to provide researchers and clinicians with more validated data about the condition by:
Creating a sustainable clinical database;
Conducting studies to better understand the underlying mechanisms of hypoglycaemia;
Conducting a series of statistical analyses to define predictors and consequences of hypoglycaemia;
Calculating the financial cost in European countries.
The project has an initial duration of 48 months and is divided into eight individual work packages:
Work package 1 deals with all aspects of project management to ensure all contractual commitments are met.
Work package 2 aims to identify the molecular/cellular and pathophysiological mechanisms and the consequences of hypoglycaemia through clinical and non-clinical studies.
Work package 3 will collate, harmonise and structure data from a range of clinical trial datasets for use by other work packages for statistical analysis.
Work package 4 aims to provide a classification of hypoglycaemia, beyond currently-used definitions, and to develop a standardised approach for the collection of clinical and laboratory data to be used primarily in clinical trials.
Work package 5 strives to understand the predictors and the impact of hypoglycaemia in terms of its biological and health-economic outcomes, and general outcomes for people living with diabetes.
Work package 6 aims to provide a comprehensive assessment of the impact of hypoglycaemia on the quality of life (QoL) of people with diabetes and their family members.
Work package 7 will assess the economic consequences of hypoglycaemia, the value of prevention and patient impact.
Work package 8 will engage with regulators and other stakeholders to develop a consensus guideline on agreed definitions of hypoglycaemia and data collection methods for the standardisation of clinical investigations.
HypoResolve consists of three advisory committees, including a Patient Advisory Committee (PAC), which inputs into all work packages and ensures that the insights, opinions and wishes of people with diabetes are taken into account across the multiple components of the project. The PAC is led jointly by IDF and the Juvenile Diabetes Research Foundation (JDRF), with Novo Nordisk acting as co-lead.
Current PAC Members include:
Mohammed Hamid, Morocco
Bastian Hauck, Germany
Simon O’Neil, UK
Rachel Portelli, Malta
Renza Scibilia, Australia
Phil Riley, Belgium
HypoResolve is supported with a grant of € 26.8 million from 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, IDF and the Leona M. and Harry B. Helmsley Charitable Trust.