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

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 &ldquo;delayed DAFNE&rdquo; 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&lt;0.0001). The impact of diabetes on dietary freedom was significantly improved in immediate DAFNE patients compared with delayed DAFNE patients (t=&minus;5.4, P&lt;0.0001), as was the impact of diabetes on overall quality of life (t=2.9, P&lt;0.01). General wellbeing and treatment satisfaction were also significantly improved, but severe hypoglycaemia, weight, and lipids remained unchanged. Improvements in &ldquo;present quality of life&rdquo; did not reach significance at 6 months but were significant by 1 year.Conclusion: Skills training promoting dietary freedom improved quality of life and glycaemic control in people with type 1 diabetes without worsening severe hypoglycaemia or cardiovascular risk. This approach has the potential to enable more people to adopt intensive insulin treatment and is worthy of further investigation.<br /