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Rapid response to:

Papers

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: https://doi.org/10.1136/bmj.325.7367.746 (Published 05 October 2002) Cite this as: BMJ 2002;325:746

Rapid Response:

DAFNE: authors’ response to electronic letters from 5th October to 22nd October 2002

The rapid responses received following the publication of the
DAFNE trial reflect the controversy surrounding the current
inadequate management of Type 1 diabetes. [1] While it is true
that the approach is not novel (Ullman, 5th Oct; Black, 6th Oct;
Reed 9th Oct; Chaufan, 12th Oct, Cohen, 22nd Oct), it is new to
the UK. The biomedical benefits of this intensified approach had
been known for some time in parts of Europe [2,3] but it was
unclear whether these could be transferred to a British healthcare
setting. Furthermore, the impact on quality of life was unknown, as
psychological outcomes were not measured in the early German
work.

Several rapid response letters, mostly from pump users or their
families - have suggested that this research was redundant or
wasteful because of the clear superiority of continuous
subcutaneous insulin infusion (CSII) therapy or because
carbohydrate counting is already practised to enable a free choice
of food (Ullman, 5th Oct; Black, 6th Oct; Reed, 9th Oct; King, 11th
Oct). We appreciate the benefits of CSII but, although welcome,
they are only used by a minority of people with diabetes. Expense
is certainly an issue for some (Rosu, 6th Oct) but many simply
dislike the idea of wearing a pump. [4] Consequently, there are
few data on the effects of providing all comers with the type of
education package routinely offered to would-be pump users
without the pump itself. DAFNE was not designed as a
replacement for the pump but as an option for people with type 1
diabetes, whatever their method of insulin delivery, enabling them
to be free to eat what they like when they like while maintaining
optimal blood glucose control.

Among people who have not been trained in DAFNE or related
approaches, many use carbohydrate counting to restrict their diet
to match prescribed insulin doses with few using it to make major
changes in insulin doses to accommodate real dietary freedom.
Some individuals have, over time, discovered for themselves how
to achieve dietary freedom with carbohydrate counting and insulin
adjustment but there is no published evidence that this improves
both biomedical and psychological outcomes. Furthermore, we
are unaware of evidence that this is undertaken widely. DAFNE is
an approach to managing type 1 diabetes that teaches explicitly
the skills necessary for insulin adjustment and true dietary
freedom.

We would challenge the view that DAFNE encourages people to
abandon healthy eating (Hunter, 11th October). DAFNE divorces
the decisions about healthy eating from decisions about balancing
carbohydrate and insulin. It enables people with Type1 diabetes
to have the same choices as those without diabetes, i.e. to choose
to eat regularly or to be flexible, and to choose to eat healthily or
not.

We agree that improvements in satisfaction with treatment, well-
being and quality of life need to be understood in the light of
information about the treatment previously recommended to these
patients (Ehrlich, 4th Oct). Prior to DAFNE, patients injected on
average 3.5 (sd=1.0) times per day (indicating that most followed a
basal bolus regimen) rising to 5.3 (sd=0.7) per day after training.
We also agree that the separation of basal insulin replacement
from meal-related insulin probably contributes to DAFNE’s
success in controlling blood glucose levels (Lawrence & Robinson
(9th Oct) and Hunter (11th Oct). However, it cannot completely
explain the specific improvements in dietary freedom or account
for the widespread and highly significant improvements in overall
treatment satisfaction and well-being. It is the demonstration of
improvements in psychological as well as biomedical outcomes
(without the patient having to compromise one in favour of the
other) and the potential for this to become mainstream treatment
that makes the DAFNE approach novel.

The DAFNE trial was financed by research grants from Diabetes
UK and as Jenkins and Nagi (16th Oct) suggest the initial costs of
training healthcare professionals to deliver courses may be
beyond the current budget of most diabetes centres. However, an
economic analysis based upon data from the DAFNE trial and
other studies using the Düsseldorf approach (Bagust, personal
communication) suggests major cost savings per participant (in
terms of anticipated reduction in complications of diabetes
associated with improved blood glucose control) in the longer
term. We believe that re-designing services around a DAFNE
programme would eventually be cost saving although these
services probably need to include on-going support for the
patients to maintain biomedical and psychological benefits (Hunter
11th Oct; Jenkins & Nagi, 16th Oct; Chantelau 23rd Oct). Much
current diabetes care is neither effective nor evidence based, so
there may be opportunities to redirect resources.

We appreciate the need to roll out the DAFNE approach and
acknowledge concerns about provision of an exclusive service in
a few centres in the short term (Hunter, 11th Oct; Jenkins & Nagi,
16th Oct). The Department of Health has already provided funding
for a further seven UK centres to be trained to provide and
evaluate DAFNE. A temporary quality gap could arise, but we
believe that a gradual, quality assured roll-out, which is carefully
monitored, will result in a better service for all in the longer term. It

is a sad fact that many people struggle with diabetes without
having the skills with which to treat it successfully (Hanscombe,
16th Oct; King 19th Oct) and we believe that a DAFNE or similar
approach should be available to all adults with Type 1 diabetes.
Marked benefits might also be expected in children (Hanscombe
16th Oct) and adolescents though this remains to be investigated.
For now, it seems evident that the DAFNE approach offers a step
forward in improving the quality of health and quality of life for
people with diabetes in the UK.

[1] DAFNE Study Group. 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. British Medical Journal 2002;325:746-749.

[2] Mühlhauser I, Jörgens V, Berger M, Graninger W, Gurtler W,
Hornke L, et al. Bicentric evaluation of a teaching and treatment
programme for type 1 (insulin-dependent) diabetic patients:
improvement of metabolic control and other measures of diabetes
care for up to 22 months. Diabetologia 1983;25:476.

[3] Mühlhauser I, Bruckner I, Berger M, Cheta D, Jörgens V,
Scholz V, et al. Evaluation of an intensified insulin treatmetn and
teaching programme as routine management of type 1 (insulin-
dependent) diabetes: the Bucharest-Düsseldorf study.
Diabetologia 1987;30:681-690.

[4] Bradley C, Gamsu DS, Moses JL, Knight G, Boulton AJM, Drury
J, et al. The use of diabetes-specific perceived control and health
belief measures to predict treatment choice and efficacy in a
feasibility study of continuous subcutaneous insulin infusion
pumps. Psychology and Health 1987;1:133-146.

Competing interests: No competing interests

29 October 2002
Simon R Heller
Reader in Medicine, University of Sheffield
Jane Speight, Stephanie Amiel, Clare Bradley, Peter James and Sue Roberts on behalf of the DAFNE Study Group.
Clinical Sciences Centre, Northern General Hospital, Sheffield, S5 7AU