Closed Loop and Education for Hypoglycemia Awareness Restoration (CLEAR)

Around a quarter of adults with type 1 diabetes lose the ability to feel when their blood sugar drops dangerously low—a condition called impaired awareness of hypoglycemia (IAH). This matters because these individuals cannot sense or self-treat hypoglycemia, putting them at risk of severe episodes that can cause confusion, seizures, or unconsciousness. Current technologies like continuous glucose monitors and hybrid closed-loop insulin pumps can reduce severe hypoglycemia, but it remains unknown whether they can actually restore the body’s natural counter-regulatory response—the hormonal and nervous system alarm that normally triggers symptoms like sweating or shakiness. The CLEAR trial will test different behavioural change interventions in adults with type 1 diabetes and IAH, using a sequential trial design where people who do not respond after 12 months receive a second treatment for another 12 months. If successful, this research could shift clinical practice from simply managing hypoglycemia risk to actively reversing the underlying loss of awareness, potentially allowing more people with type 1 diabetes to safely maintain tighter blood sugar control without constant fear of severe lows.