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 "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 (HbA(1c)), severe hypoglycaemia, impact of diabetes on quality of life (ADDQoL).

Results: At 6 months, HbA(1c) was significantly better in immediate DAFNE patients (mean 8.4%) than in delayed DAFNE patients (9.4%) (t=6.1, P<0.0001). The impact of diabetes on dietary freedom was significantly improved in immediate DAFNE patients compared with delayed DAFNE patients (t=-5.4, P<0.0001), as was the impact of diabetes on overall quality of life (t=2.9, P<0.01). General wellbeing and treatment satisfaction were also significantly improved, but severe hypoglycaemia, weight, and lipids remained unchanged. Improvements in "present quality of life" 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.