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Clinical Trial
. 2002 Oct 5;325(7367):746.
doi: 10.1136/bmj.325.7367.746.

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

DAFNE Study Group
Clinical Trial

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

DAFNE Study Group. BMJ. .

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 (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.

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Figures

Figure 1
Figure 1
Flow of participants through study (L=London; S=Sheffield; N=Northumbria)
Figure 2
Figure 2
Glycaemic control as measured by glycated haemoglobin (HbA1c)
Figure 3
Figure 3
Reported impact of diabetes on “freedom to eat as I wish” (top; n=123), average weighted impact of diabetes on quality of life (middle; n=125), and present quality of life (bottom; n=122)
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References

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