Training in flexible, intensive insulin management to enable dietary freedom in people with type 1 diabetes: dose adjustment for normal eating (DAFNE) randomised controlled trial

Abstract Objectives: To evaluate whether a course teaching flexible intensive insulin treatment combining dietary freedom and insulin adjustment can improve both glycaemic control and quality of life in type 1 diabetes. Design: Randomised design with participants either attending training immediately (immediate DAFNE) or acting as waiting list controls and attending “delayed DAFNE” training 6 months later. Setting: Secondary care diabetes clinics in three English health districts. Participants: 169 adults with type 1 diabetes and moderate or poor glycaemic control. Main outcome measures: Glycated haemoglobin (HbA1c), severe hypoglycaemia, impact of diabetes on quality of life (ADDQoL). Results: At 6 months, HbA1c was significantly better in immediate DAFNE patients (mean 8.4%) than in delayed DAFNE patients (9.4%) (t=6.1, P