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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

BMJ 2002; 325 doi: (Published 05 October 2002) Cite this as: BMJ 2002;325:746

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  1. DAFNE Study Group
  1. Correspondence to: S Heller, Clinical Sciences Centre, Northern General Hospital, Herries Road, Sheffield S5 7AUs.heller{at}
  • Accepted 29 July 2002


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<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.


  • Members of study group: Stephanie Amiel, Sue Beveridge, Clare Bradley, Carla Gianfrancesco, Simon Heller, Peter James, Natalie McKeown, Douglas Newton, Lynn Newton, Lindsay Oliver, Helen Reid, Sue Roberts, Susan Robson, Jackie Rollingson, Val Scott, Jane Speight, Carolin Taylor, Gillian Thompson, Eileen Turner, Frances Wright

  • Funding The DAFNE trial was supported by diabetes development project grants from Diabetes UK to SH, S Roberts, SA (recruitment pilot study: grant no RD99/0001871; feasibility study: grant no RD99/0002057), JS, and CB (grant no RD99/0002058).

  • Competing interests None declared.

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