HypoAware-a brief and partly web-based psycho-educational group intervention for adults with type 1 and insulin-treated type 2 diabetes and problematic hypoglycaemia: design of a cost-effectiveness randomised controlled trial

摘要: Problematic hypoglycaemia is a significant problem among people with insulin-treated type 1 and 2 diabetes mellitus, which adversely affects quality of life leads to high societal costs. Blood glucose awareness training (BGAT) psycho-educational group intervention that has shown be effective but difficult implement in clinical practice, due its demanding nature. The aim this study evaluate the cost-effectiveness HypoAware roots BGAT helps patients effectively recognize, treat prevent hypoglycaemia, while also focussing on psychosocial consequences living constant risk both for their others. An economic evaluation will conducted alongside cluster-randomised controlled trial eight hospitals Netherlands. We include 154 participants who either receive or care as usual. consists three sessions combined two online modules. primary outcome severe hypoglycaemia. Secondary outcomes mild awareness, fear distress, anxiety depression, health-related life, diabetes-specific self-efficacy HbA1c. Utilities measured using EQ-5D-5 L questionnaire. Costs from perspective health utilization, medication lost productivity Measurements performed at baseline, 2, 4, 6 months compare groups, an additional 12 months only. Process gathered after every meeting via telephone/email contact professionals environment. expected significantly reduce episodes subsequent beneficial effects When proven cost-effective, incorporated guidelines Dutch care. Trial Register NTR4538