Closed Loop and Education for Hypoglycemia Awareness Restoration (CLEAR)

Hypoglycaemia (low blood glucose) is an inevitable complication of the insulin treatment of diabetes, occurring whenever the insulin dose taken is more than the body needs. When the blood glucose drops low, the body ordinarily gives out warning signs, with symptoms such as sweating, shaking and palpitations. These symptoms alert the person to eat or drink sugar and stop the fall. If hypoglycaemia remains untreated, blood glucose can drop very low, leading to loss of consciousness or very rarely, death. Around one third of people with type 1 diabetes (T1D) lose their ability to recognise symptoms of hypoglycaemia in a timely fashion. This is known as impaired awareness of hypoglycaemia (IAH). IAH increases the risk of severe hypoglycaemia, with impaired brain function, where the person needs help from others to recover. We still need to work out what treatments are most effective. Technologies such as Hybrid Closed Loop systems (a continuous glucose monitor connected to an insulin pump which adjusts the insulin according to the glucose) have, in shorter studies, reduced hypoglycaemic episodes but have not been shown to restore awareness. Educational courses, which aim to address knowledge of insulin action and behaviours related to low blood glucose have previously been shown to restore awareness in some but not in all people with T1D. The CLEAR study (Closed Loop and Education for Hypoglycaemia Awareness Restoration) will study and compare the effectiveness of new technologies and educational courses at restoring hypoglycaemia awareness, by randomising participants to these treatments (their treatment is chosen by chance). Their awareness of hypoglycaemia will be measured at the start, after 1 year and after 2 years. Participants with T1D, aged 18-75, with impaired awareness of hypoglycaemia, will be recruited across 8 specialist diabetes centres in the USA, Aus