Hypoglycaemia Awareness Restoration Programme - the RCT v1.0
Research type
Research Study
Full title
Beyond education: A Hypoglycaemia Awareness Restoration Programme for people with type 1 diabetes and problematic hypoglycaemia persisting despite optimised self-care (HARPdoc)
IRAS ID
216381
Contact name
Stephanie A Amiel
Contact email
Sponsor organisation
King's College London
Duration of Study in the UK
3 years, 11 months, 31 days
Research summary
Research Summary
Insulin treatment for type 1 diabetes inevitably carries risk of hypoglycaemia (low blood sugar) which can be severe enough to cause coma, seizure, even death. Being unable to feel when blood glucose is falling, a condition called impaired awareness of hypoglycaemia, IAH, increases risk of severe hypoglycaemia 6-fold. IAH can be reversed and risk of severe hypoglycaemia (SH) reduced when people are taught how to adjust their insulin around their life-styles through structured education but problematic hypoglycaemia may persist. Many people with apparently intractable IAH and recurrent SH hold underlying beliefs about hypoglycaemia that form barriers to their taking timely steps to avoid hypoglycaemia. They cannot benefit from conventional treatments to reduce hypoglycaemia. We developed the Hypoglycaemia Awareness Restoration Programme for people with type 1 diabetes and problematic hypoglycaemia despite otherwise optimised self-care (HARPdoc), a novel intervention that combines revision of knowledge about hypoglycaemia avoidance with psychological theories and techniques that address unhelpful health beliefs about hypoglycaemia. HARPdoc is delivered over six weeks, by diabetes educators to groups of 6 people. In a pilot study, SH was greatly reduced in 23 people with very longstanding IAH and recurrent severe hypoglycaemia.We propose a group-randomised controlled trial of HARPdoc, comparing it to an established educational intervention (Blood Glucose Awareness Training, BGAT) which has also been shown to reduce SH. 96 people with type 1 diabetes and problematic hypoglycaemia persisting despite otherwise optimised insulin self-management will be recruited into groups which will be randomised to receive either HARPdoc or BGAT, in 4 centres. We will measure SH over two years following courses; hypoglycaemia risk and experience; overall diabetes control and quality of life. If HARPdoc is superior to BGAT in reducing and sustaining reduced SH, it can be rolled out across healthcare systems and adapted to treat other recurrent asymptomatic diseases.
Summary of Results
Hypoglycaemia (low blood sugar) occurs as a complication of the insulin treatment of type 1 diabetes mellitus - a condition of extreme insulin deficiency. An episode is called "severe" when the person experiencing it becomes too confused (through lack of sugar supply to the brain) to self-treat and rescue therapy has to be given by someone else. Losing the ability to feel early falls in blood sugar is called impaired awareness of hypoglycaemia and greatly increases risk of severe episodes. Our study compared two interventions to help improve hypoglycaemia awareness and reduce severe hypoglycaemia in adults with type 1 diabetes whose problems with hypoglycaemia had persisted despite using their using recommended treatment strategies for minimising hypoglycaemia risk. The new intervention was HARPdoc, Hypoglycaemia Awareness Restoration Programme for adults with type 1 diabetes and persistent problematic hypoglycaemia despite otherwise optimised self-care, which uniquely addresses how people think about their hypoglycaemia and its avoidance. We compared it with another programme, Blood Glucose Awareness Training, BGAT, which does not address these thoughts but has been shown in the past to improve hypoglycaemia awareness and reduce severe hypoglycaemia. Both interventions are delivered by diabetes educators to small groups of participants over six weeks. IN HARPdoc the educators receive additional training and supervision from a clinical psychologist. 99 people with type 1 diabetes who were experiencing hypoglycaemia despite having undertaken training in how best to use their insulin and, in many cases, also been offered the latest technologies for blood sugar monitoring and insulin delivery, were offered either HARPdoc or BGAT and followed up for 2 years. Overall, the rate of severe hypoglycaemia fell - from a median of 5 episodes per person year to 0 by 2 years. HARPdoc was not better than BGAT in reducing severe hypoglycaemia, or in improving awareness of hypoglycaemia, and neither programme caused rise in measures of high blood sugar. HARPdoc was associated with change in how people thought about their hypoglycaemia and also with lower scores on questionnaires for diabetes distress and for anxiety and for depression, which had been high for both groups before their intervention. We concluded that both courses can help reduce their hypoglycaemia risk in people who have already experienced other educational interventions to minimise hypoglycaemia and that HARPdoc may have additional benefits in improving mental health.REC name
London - Dulwich Research Ethics Committee
REC reference
16/LO/1992
Date of REC Opinion
9 Dec 2016
REC opinion
Further Information Favourable Opinion