Diabetes represents an increasing global healthcare challenge. Controlling blood glucose is a cornerstone in diabetes management aiming to reduce the increased morbidity and mortality associated with this disease. However, only around 50% of patients achieve accepted international glycaemic targets.
Hypoglycaemia is common, and the importance of hypoglycaemia as a major concern for both healthcare professionals and patients is reflected by its impact on intrusions into daily living as well as serious consequences including hospitalisation and mortality. Hypoglycaemia and the fear of hypoglycaemia represent a recognised and measurable contributor to the burden of disease for people afflicted by diabetes, as well as their families, friends, and other parties – also known as ‘The Greater Patient’.
Thus, hypoglycaemia is an important clinical issue for many people with diabetes, and it constitutes a major concern for patients on glucose lowering treatment regimens, who face the daily challenge of achieving accepted glucose targets safely, without increasing the risk of hypoglycaemia.
In recent years we have seen an increasing number of phase III clinical trials in type 1 and type 2 diabetes, but despite the improved accuracy of glucose measuring devices and increased patient access to continuous glucose monitoring (CGM) technology, detecting and reliably registering hypoglycaemic events in clinical trials remain a challenge. No approved guidelines or methods for how hypoglycaemia should be measured exist. Regarding hypoglycaemia, detailed monitoring of blood glucose and the recording of daily events, including physical activity and diet, are rarely carried out. Although data on severe and in most cases, symptomatic hypoglycaemia are collected during the trial period, information on other types of hypoglycaemia, particularly asymptomatic as well as episodes wherein patient outcomes are not immediately noticeable is limited. Moreover, people with a past history of severe hypoglycaemia are often excluded from clinical trials and little if any information is routinely collected on other types of pre-trial hypoglycaemia; as a consequence, this type of information is rarely included in post-trial analyses.
The current gaps and challenges in our understanding of hypoglycaemia consequently limit the management of hypoglycaemia. Furthermore, a consensus between healthcare professionals and other professional bodies including the regulatory authorities on the definitions of the clinical categories of hypoglycaemia is lacking which makes analyses of hypoglycaemic episodes difficult. Thus the overarching objective of this call topic is to reduce the risk and burden of hypoglycaemia and, as a consequence, ultimately improve glycaemic control in people with diabetes. To achieve this we will focus on a number of related specific challenges including:
The need for better insights into the underlying pathophysiology and defects in the counter-regulatory mechanisms associated with hypoglycaemia ,recurrent hypoglycaemic episodes and hypoglycaemia unawareness.
To achieve our objective of reducing the risk and burden of hypoglycaemia and ultimately improving glycaemic control in people with diabetes, we aim to gain a better understanding of hypoglycaemia through a series of integrated activities that are expected to include:
Opening a dialogue with regulatory agencies to define clinically meaningful endpoints/methods to document rates of hypoglycaemia and the potential to reduce these with pharmacological intervention.
The proposed programme will lead to:
Generation of evidence-based data to support discussions with regulatory authorities on acceptable definitions of hypoglycaemia.