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
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Many of the early rapid responses to the DAFNE trial paper (1) [see
bmj.com] claimed that improved quality of life (QoL) resulting from
flexible intensified insulin treatment was well established prior to the
DAFNE trial (Ullman, 5th Oct; Black, 6th Oct; Chaufan, 12th Oct). However,
the only evidence cited was anecdotal.
Early German studies did not measure QoL, patient satisfaction or
well-being and the authors gave only passing mention to possible lifestyle
benefits in the small print of the methods section: "they should gain a
certain ‘liberalisation’ of lifestyle with respect to exercise and eating
schedules" (2, p471). In contrast, Kinga Howorka who, in Vienna, developed
Functional Insulin Treatment (3) (similar to the Düsseldorf-derived DAFNE
approach) not only acknowledged that this approach enables dietary freedom
but also that this "represents the most important factor in the long-term
motivation of patients" (4, p23). Unfortunately, both in Düsseldorf and in
Vienna, psychological outcomes were measured only after many patients had
already adopted the approach and it was routine practice in the clinics
concerned. Thus, it was not possible to measure the QoL benefits in those
settings. Further, the names used for the two treatment approaches
("structured teaching and treatment programme" and "functional insulin
treatment") did not imply any lifestyle benefits. "Dose Adjustment For
Normal Eating" indicates short-term benefits to be gained from
intensifying treatment and the motto "like what you eat, eat what you
like" makes explicit the potential for DAFNE training to improve dietary
freedom.
DAFNE clinicians were far-sighted in their desire to evaluate a
flexible, intensive approach to insulin treatment in the UK, and in
choosing the DAFNE name and motto, but even they were concerned that
increased injections and blood glucose monitoring might be too big a price
to pay for increased dietary freedom. Many observers of the DAFNE trial
have also taken this view. However, our work in developing the ADDQoL (a
measure of the impact of diabetes on quality of life) had shown that
dietary freedom is the aspect of life which, of all the 18 aspects of life
included in the questionnaire, is most negatively impacted by diabetes and
its treatment (5,6). Such evidence made us confident that the increased
dietary freedom afforded by DAFNE would have major benefits for QoL,
despite the need for more injections and blood glucose monitoring. After
observing a Düsseldorf training course, DAFNE clinicians were more
prepared to accept that DAFNE would not further damage QoL but few
expected QoL benefits. In addition, despite Diabetes UK's interest and
support, such was their doubt about the acceptability of this approach to
UK patients that only the recruitment phase of the DAFNE trial was funded
initially. Funding of the main trial was approved only after we had
demonstrated that sufficient numbers of participants could be recruited.
Now that DAFNE has been shown to provide significant QoL benefits for
adults with type 1 diabetes, it is likely that many more people will be
interested in adopting this form of intensive diabetes management.
However, these benefits had not been demonstrated empirically prior to the
DAFNE trial and were counter-intuitive to many clinicians specialising in
diabetes care.
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. Howorka K. Functional insulin treatment. 3rd English ed. Berlin:
Springer, 2003 in press.
4. Howorka K. Functional Insulin Treatment. 2nd English ed. Berlin,
Heidelberg, New York: Springer-Verlag, 1996.
5. Bradley C, Todd C, Gorton T, Symonds E, Martin A, Plowright R. The
development of an individualised questionnaire measure of perceived impact
of diabetes on quality of life: the ADDQoL. Quality of Life Research
1999;8:79-91.
6. Bradley C, Speight J. Patient perceptions of diabetes and diabetes
therapy: assessing quality of life. Diabetes/Metabolism Research and
Reviews 2002;18:S64-S69.
Competing interests:
None declared
Competing interests: No competing interests
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
The DAFNE study (1) was not a fair clinical trial, because there was
no control intervention in the control (waiting) group. I wonder what
would have happened to the HbA1c level of the control patients if they,
too, had enjoyed a five- day teaching and treatment course to improve
their current insulin regime, liberalize their diet, reinforce their
knowledge and strengthen their motivation. Simply being recruited for a
waiting cohort may include patients who were sent to jail while on the
list (which happened during one of the former Düsseldorf-Bucharest studies
in former communist Roumania as I was told). Reinforcemend of a given
diabetic treatment improves HbA1c, as does lifestyle intervention (2).
Dietary freedom, i.e. freedom from unfounded outmoded dietary
prescriptions (3) may also be provided with more conventional insulin
regiments. Thus, DAFNE may be good for some people, but other approaches
may be good as well for other people. There are many ways leading to Rome.
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) randomized controlled trial. Br.Med.J.2002;
325:746-9
2) Perry TL, Mann JI, Lewis-Barned NJ et al. Lifestyle intervention in
people with insulin dependent diabetes mellitus (IDDM). Eur J Clin Nutr
1997; 51:757-63
3) Diabetes and Nutrition Study Group (DNSG) of the European Association
for the Study of Diabetes (EASD) 2000: Recommendations for the nutritional
management of patients with diabetes mellitus. Eur J Clin Nutr 2000; 54:
353 - 55
Competing interests: No competing interests
Adjusting insulin doses in anticipation of expected food intake is hardly a new strategy in the management of diabetes. Flexible timing and doses of insulin are an integral part of intensive insulin management. I believe that many diabetes specialists and educators have been teaching variations of this strategy, under various names, for several years.
I recall an article entitled "How to Cheat Sensibly" (I think in Diabetes Forecast at least 10 years ago.) My own publication "Think Like a Pancreas" now in its 2nd edition, was 1st published in 1998, and uses a similar approach.
Nevertheless, congratulations are in order to the authors for finding a new name, DAFNE, for this strategy. Its publication has captured the imagination of the media and the public world-wide. Successful marketing of this "new" approach can only be of benefit to people with diabetes as they strive to balance the need for better blood glucose control against the impact on their lifestyle.
Competing interests: No competing interests
I was disheartend to read Dr Jenkins and Dr Nagi's comments about use
of resources and patients with greater need than a young population with a
chronic, life altering and potentially debilitating disease
I would be hard pressed to find a more needy group of patients, with
the exception of course of this same group in 10 to 20 years time when
they suffer visual impairment, renal dysfunction and all the other
mischief that can arise from poor glycaemic control. A tragic group too if
these had arisen from failure to afford them the basic education and tools
to live better with their diabetes both in terms of metabollic control and
quality of life
How many more patients have to feel guilty or suffer from needless
fluctuations in blood glucose because they want a quality of life that
most people take for granted.
How many more patients will be judged becasue they work irregular hours
and eat at irregular times
Would many of you involved in diabetes care be prepared to put up with the
restrcitions, frustrations and poor long term outlook imposed by this
disease and lack of modern approaches to it's management?
How many more people who attend clinic appointments disheartened by lack
of control will be either judged and accused of having an inappropriate
lifestyle becaues they do not adhere to the same routine each day, or told
to go away and not measure their blood glucose as frequently because this
is deemed too costly or too much work for the health care professional to
deal with, or results in the patient asking for better, more expensive
analogues or pumps
When I was diagnosed in 1986 the education I recieved was superior to the
education many people are given now. We were taught to use the tools that
we had effectively
What has happened to the paragraph in the NSF regarding patient
empowerment?
Are we really looking towards reducing the long term morbidity and
mortality of this disease or is this an empty promise and is the cycle of
poor management, early complications and even greater need,to be
perpetuated?
Competing interests: No competing interests
We welcome the recent report of the DAFNE study (1) and are pleased
to see research demonstrating evidence of improvements in glycaemic
control and quality of life with alternative educational and empowerment
models of care in patients with type 1 diabetes. The DAFNE programme has
been extended to more diabetes centres prior to the formal peer-reviewed
publication of its results and an assessment and appraisal of its
implications. We have recently considered becoming a DAFNE centre but
decided to defer taking part in such a programme for a number of reasons.
We believe that the implementation of the DAFNE programme will be very
demanding on the already overstretched resources of the typical Diabetes
Centre. For example, the programme documentation states that it requires
30 weeks time of a Diabetes Specialist Nurse, at least 10 weeks time for a
dietitian and the costings calculated by the DAFNE co-ordinators are
prohibitive. Unless new staff are taken on to deliver DAFNE then their
time is taken away from other patients whose needs may be greater. In
addition, whilst a course is being run there is a risk that the Diabetes
Centre space is monopolised by the course, again to the potential
detriment of other educational activities and those with type 2 diabetes.
Secondly, no funding is allocated to DAFNE so this resource either needs
to be found from within existing funds or needs to be attracted from
primary care. At present there are competing priorities which include the
forthcoming implementation of the diabetes National Service Framework,
establishing proper IT structures to co-ordinate care, digital retinal
screening, the epidemic of type 2 diabetes, the expanding evidence base
for treatment and ever more stringent treatment goals. It is likely that
even diabetes centres which consider themselves well-established and
resourced may find themselves in a similar situation to ourselves.
We therefore believe strongly that more data are needed to justify
this large resource allocation. Specifically it needs to be shown that the
improvements in glycaemic control are maintained and that the improvements
in patient autonomy are translated into decreased utilization of diabetes
services; this should include a full cost effectiveness analysis,
estimating downstream benefits over a longer period of time.
Whilst we believe that DAFNE is an exciting new model of patient
education and empowerment for the UK, it is important that its impact is
analysed in the context of the overall delivery of diabetes services.
Without new resources to deliver the DAFNE model we are concerned that
whilst its use may improve the care of a subset of patients with type 1
diabetes, the diversion of resources from the majority of other diabetic
patients may compromise their care. We are aware that DAFNE is currently
under review by NICE but these issues should be addressed before it is
adopted as a standard model of care. For diabetes care teams to roll out
this care model without new monies would seem an unachievable task. The
potential adoption of DAFNE by a few larger centres will potentially widen
the gap in quality of diabetes care that the forthcoming NSF is trying to
address.
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. BMJ
2002;325:746-9
Competing interests: No competing interests
As mother of a 12 year old son with type 1, we were lucky enough to
have received a basic training from the hospital in diabetes, but found
out so much more ourselves; as he is my youngest child and I had the time
and access to the internet, and bought books.When he went on a recent
holiday with other children, he was amazed that they knew so little about
adjusting their dose depending on what their BG was and what they were
going to eat. In fact he was the only one to do this, possibly because he
is on a pump and had training to go with this.
However, not everyone has, and it should be aright for all diagnosed to be
infromed of the truth about this condition and the fact that looking after
all aspects of it, especially matching food intake to insulin,matters
greatly on your health as time goes on.Dafne type training should be
compulsory, and available as a course or update, at intervals as required
for existing diabetics. How can you possibly get good control, when you do
not know what you are controlling ?
Children especially must be taught this, as they will live with the
condition for longer, and may be more responsive to learning at an earlier
age than they are given credit for.
Competing interests: No competing interests
It this treatment new? Should we be suprised that patients achieve
better control and experience improved quality of life? I've been
professionally involved with diabetes for at least 15 years and I am
completely puzzled that what American research has already proved beyond
reasonable doubt, and what many American doctors (indeed nurse diabetes
educators) have known, practiced and preached (oftentimes unsuccessfully)
about diabetes type 1 is being announced as novel. I've even found the
"news" in the American Diabetes Association webpage...Am I missing
something?
Competing interests: No competing interests
The DCCT clearly demonstrated for the first time the benefits of
intensive insulin therapy to improve glycaemic control and reduce the risk
of diabetic microvascular complications (1).The DAFNE study group are to
be congratulated on their efforts to improve glycaemic control in their
patients, albeit this did not achieve the target set by the DCCT (HbA1c
7%) (2). Many factors influence glycaemic control and it is therefore
difficult to dissect out the impact of any one factor in isolation. It is
possible that the beneficial effect seen in the DAFNE study was simply
related to an increased frequency of insulin administration, for example
switching from twice daily to five times daily insulin injection in some
patients, which is well established. Furthermore poor compliance is well
recognized to be a major contributing factor to glycaemic control
especially in young patients (3). The baseline HbA1c of 9.4 % may
indicate irregular compliance which would be likely to improve in the
setting of a research trial particularly where this involved extensive
diabetic education.
If indeed as the authors claim the improvement in the DAFNE study
related to a novel specific dietary intervention combined with education
about insulin self-adjustment, which is already widely practiced, then it
is suprising that the details of what this involved are absent from the
methods section. If these results are to be replicated widely then this
information will be crucial. We also need this information to respond to
enqiries from patients some of whom have already interpreted the recent
press coverage to suggest that a healthy eating plan is no longer a
requirement of intensive diabetes management and that they may eat
whatever and whenever they like.
References
1.The Diabetes Control and Complications Trial Research Group. The effect
of intensive treatment of diabetes on the development and progression of
long-term complications in insulin-dependent diabetes mellitus. N Engl J
Med 1993;329:683-9.
2.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. BMJ 2002;325:746-
9.
3.Morris AD, Boyle DIR, McMahon AD, Greene SA, MacDonald TM, Newton RW et
al. Adherence to insulin treatment, glycaemic control, and ketoacidosis
in insulin-dependent diabetes mellitus. Lancet 1997;350:1505-10.
Competing interests: No competing interests
Longer follow up is required before advocating DAFNE to all
DAFNE 1 certainly seems to be a sensible approach to an old problem.
However following up these patients for one year is probably not adequate.
The dose of insulin went up by a small but significant amount and the
increase in weight gain was not significant. However if we look at the
DCCT trial 2 the baseline doses of insulin used in the primary prevention
group, (which is probably comparable to the DAFNE group) were lower than
the doses of insulin used in this trial (0.62 U/kg/day vs 0.71U/kg). The
DCCT group documented a weight gain of 4.6 kg in the intensive group over
5 years despite dietary restriction and hence it is perhaps not surprising
that the weight gain was not significant during the period of the DAFNE
trial. Weight gain worsens insulin resistance and can further increase
insulin requirements. The EURODIAB 3 study provided compelling evidence
that diabetic retinopathy was related to markers of insulin resistance.
Longer follow up is required before this regime can be advocated to
an unselected group of people with diabetes seen in the Diabetes Clinic.
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. BMJ
2002;325:746- 9.
2.The Diabetes Control and Complications Trial Research Group. The
effect of intensive treatment of diabetes on the development and
progression of long-term complications in insulin-dependent diabetes
mellitus. N Engl J Med 1993;329:683-9.
3. Chaturvedi N, Sjoelie AK, Porta M, Aldington SJ, Fuller JH,
Songini M, Kohner EM; The EURODIAB Prospective Complications Study.
Markers of insulin resistance are strong risk factors for retinopathy
incidence in type 1 diabetes. Diabetes Care 2001 Feb;24(2):284-9
Competing interests:
None declared
Competing interests: No competing interests