390-P: Improving Quality of Life and Self-Efficacy through a Hypoglycemia Management Program—The HARPdoc Randomised Controlled Trial

Abstract

Background: A significant minority (15-18%) of adults with type 1 diabetes (T1D) continue to experience problematic hypoglycemia despite access to structured education in flexible insulin therapy and advanced technologies. Many have impaired awareness of hypoglycemia, now recognised to be associated with significant mental health burden. The HARPdoc trial (Hypoglycemia Awareness Restoration Program for people with problematic hypoglycemia Despite Optimised Care) showed that a group programme focused on cognitions and motivation improved scores for diabetes distress, anxiety and depression compared to BGAT (blood glucose awareness training, which addresses education and behaviours), with similarly reduced rates of severe hypoglycaemia. Methods: This exploratory study addresses the further impact of these programmes on quality of life and mental health. Quality of life was measured at baseline with EQ-5D-5L and it and service use (Adult Service Utilisation Schedule) were measured at 12 and 24 months after randomised participation to either HARPdoc or BGAT. Results: Mean EQ-5D scores rose by 14%, +0.1 HRQoL utility score (HUS), over 24 months in HARPdoc and fell by 1%, -0.007 HUS in BGAT. Use of mental health services after HARPdoc or BGAT was 26 vs 56 contacts with a psychiatrist, psychologist or counsellor in months 0-12 and 1 vs 17 contacts in months 13 - 24 respectively. Conclusions: We conclude that HARPdoc reduces previously treatment-resistant severe hypoglycaemia in adults with type 1 diabetes but also enhances quality of life, whilst reducing use of mental health services. We hypothesise that the psychosocial aspects of HARPdoc increase self-efficacy and coping skills, thereby reducing disease burden and the need to access general and mental healthcare provision. Disclosure S.A.Amiel: Advisory Panel; Medtronic, Other Relationship; Sanofi, Novo Nordisk. E.Toschi: Advisory Panel; Eli Lilly and Company. S.R.Heller: Advisory Panel; Zealand Pharma A/S, Zucara Therapeutics, Other Relationship; Eli Lilly and Company, Research Support; Dexcom, Inc., Speaker's Bureau; Novo Nordisk, Medtronic. M.A.Stadler: None. P.Choudhary: Advisory Panel; Medtronic, Novo Nordisk, Dexcom, Inc., MannKind Corporation, Insulet Corporation, Research Support; Abbott Diabetes, Speaker's Bureau; Sanofi, Lilly. N.De zoysa: None. Funding JDRF (4-SRA-2017-266-M-N); National Institute of Health Research UK