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Dr Simon Heller
DM FRCP
Reader in Medicine
University of Sheffield
Honorary Consultant
Physician
Sheffield Teaching Hospitals
Sheffield, UK
On behalf of the DAFNE study group
The management of type 1 diabetes requires patients to adjust their insulin dose to the food they eat, to maintain blood glucose close to normal levels, throughout their lives. Despite receiving fairly intensive education, few patients sustain this successfully, and many throughout Europe have poor levels of glucose control, high rates of diabetic complications and hence an impaired quality of life.
However, there are approaches that appear to engage patients with type 1 diabetes with considerable success. Over the last 22 years, the diabetes team at the Diabetes Centre in Düsseldorf, led by the late Michael Berger, has developed a five-day structured training programme in intensive insulin therapy and self-management.(1–3) The educational approach is based on the Assal model of “therapeutic education”, (4) allowing patients to lead a flexible lifestyle while maintaining healthy glycaemic control without an increased risk of severe hypoglycaemia and with minimal support from healthcare professionals. It is noteworthy that the Düsseldorf course does not specifically address the emotional issues associated with living with diabetes, but is purely skills based.
Their group has demonstrated a fall in haemoglobin A(1c) (HbA(1c)) of 1.5% in a randomised controlled trial compared with knowledge transfer alone in a group setting.(2) In other studies, similar improvements in glycaemic control were sustained for up to six years with no increase in severe hypoglycaemia.(5) These benefits have been achieved whether the course is delivered in outpatient(6) or inpatient settings, both in district general hospitals across Germany(7) and in countries with limited healthcare resources, including Romania(2) and Russia.(8) This approach has also been adapted in other European centres.(9)
Following a visit to Düsseldorf we undertook the DAFNE (Dose Adjustment For Normal Eating) trial,(10) in which we examined the feasibility of delivering a course in three UK clinical centres (Sheffield, King’s College Hospital, London and Northumbria), based on the Düsseldorf model but with individuals attending as outpatients.
We randomised 169 patients with poorly controlled type 1 diabetes (HbA(1c)>8.5%) either to attend DAFNE training immediately or to act as controls for six months before undergoing training themselves. Those who underwent training experienced a fall in HbA(1c) from 9.5% to 8.5% at six months, while the HbA(1c) of the controls remained unchanged. The HbA(1c) of the delayed DAFNE group also fell after training by a mean of 0.7%, and although the HbA(1c) of the immediate group tended to drift up it remained significantly lower than baseline at one year (by 0.5%, p=0.02). 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 six months but were significant by one year.
We concluded that skills training promoting dietary freedom was feasible in a UK setting, improved quality of life and glycaemic control in people with type 1 diabetes without worsening severe hypoglycaemia or cardiovascular risk, and had the potential to enable more people to adopt intensive insulin treatment.
The main principles of the approach are:
- Skills-based training to teach flexible insulin adjustment to match carbohydrate in a free diet on a meal-by-meal basis.
- Emphasis on self-management and independence from the diabetes care team.
- The use of adult education principles to facilitate new learning in a group setting.
Participants attend the course for the full five days in groups of between six and eight. In theory, those using twice-daily insulin regimens might benefit, but in practice, participants switch to a multiple injection regimen on the first day of the course to maximise the opportunities for dose adjustment.
Insulin dose adjustment
The skills of dose adjustment are based on a basal/bolus regimen with basal insulin supplied by two injections of isophane insulin, given at bedtime and before breakfast, with food covered by premeal soluble insulin. Those participants who are already taking a fast-acting insulin analogue usually continue to do so, and it may also be useful for those people whoeat meals containing large amounts of carbohydrate. Blood glucose monitoring is performed before each main meal. This value, the results of previous blood glucose measurements and the quantity of the proposed intake of carbohydrate are all taken into
account when calculating the dose of insulin, using standard algorithms as a starting point.
We believe that the structured training courses in intensive insulin management are likely to spread throughout the UK. Following the publication of our paper in the BMJ,(10) an economic evaluation by the York Health Economic Consortium has been submitted for publication to the UK National Institute for Clinical Excellence (NICE), which was due to report in March 2003. Their preliminary evaluation, in light of the cost profile (£580 per attendee), was that DAFNE and similar programmes should be supported. The potential of the approach has also been recognised by the UK Department of Health, which, as part of the national Expert Patient Programme, asked the three original centres to pilot a roll-out of the programme to another seven centres and provided funding until March 2003. The National DAFNE Collaborative Project runs the training course (DAFNE Educator Programme – DEP) for diabetes specialist nurses and dieticians to become DAFNE “educators”, coordinates audit and quality assurance programmes to maintain standards, and brings participating centres together to share good practice and develop the programme. It is based on an extensive quality assurance programme that now runs in many centres throughout Germany.
Current research will eventually let us know how many people can benefit from DAFNE-type programmes and whether certain patient characteristics can predict success or failure. It is offered to many adults with type 1 diabetes in Germany and Austria and is probably followed by about 60% of those who attend. Until we know more, it seems appropriate for it to be offered to every adult with type 1 diabetes. The aim is to give individuals the information they need to make properly informed choices about their own management.
Practical issues
A centre with trained educators can deliver 10–15 courses a year (training 80–120 people). Although each DAFNE course requires only 1.5 educators to be present, the work is intensive, involves preparatory work recruiting and preparing participants, follow-up work and keeping records for quality assurance. Clinical skills would suffer if educators were involved only in DAFNE training. Therefore, to build in flexibility and security (for sickness, staff movements, etc) each centre needs at least four DAFNE-experienced educators and two DAFNE-aware doctors. This allows two pairs of educators to run courses every two to four weeks, alternating with each other.
In the long term, it is expected that the need for traditional care will lessen as the majority of patients become DAFNE-trained. After a course most patients find the conventional clinics no longer suitable for their needs, and we are already planning to reorganise our service and provide support for people with diabetes in a different way. We also expect the need for additional support for DAFNE educators to diminish as nurses and dieticians are freed from supporting conventional diabetic clinics.
References
- Mühlhauser I, 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.
- Mühlhauser I, et al. Evaluation of an intensified insulin treatment and teaching programme as routine management of type 1 (insulin-dependent) diabetes. The Bucharest–Düsseldorf Study. Diabetologia 1987;30:681-90.
- Bott S, et al. Intensified insulin therapy and the risk of severe hypoglycaemia. Diabetologia 1997;40:926-32.
- Assal JP, et al. Patient education as the basis for diabetes care in clinical practice and research. Diabetologia 1985;28:602-13.
- Bott S, et al. Intensified insulin therapy and the risk of severe hypoglycaemia. Diabetologia 1985;40:926-32.
- Pieber TR, et al. Evaluation of a structured outpatient group education program for intensive insulin therapy. Diabetes Care 1995;18:625-30.
- Jörgens V, et al. Effective and safe translation of intensified insulin therapy to general internal medicine departments. Diabetologia 1993;36:99-105.
- Starostina EG, et al. Effectiveness and cost-benefit analysis of intensive treatment and teaching programmes for type 1 (insulin dependent) diabetes mellitus in Moscow-blood glucose monitoring versus urine glucose monitoring. Diabetologia 1994;37:170-6.
- Howorka K. Functional insulin treatment. Berlin: Springer; 1996.
- The DAFNE Group. Training in flexible, intensive insulin management to enable dietary freedom in people with type 1 diabetes: the Dose Adjustment For Normal Eating (DAFNE) randomised controlled trial. BMJ 2002;325:746-9.
DAFNE clinical centres in the UK
Addenbrooke’s Hospital Trust,
Cambridge
Central Middlesex
Hospital Trust,
London
Derby Hospitals Trust
King’s College Hospital Trust,
London
Northampton Hospital Trust,
London
Northumbria Healthcare Trust
Scarborough Hospital Trust
Sheffield Teaching Hospitals Trust
University Hospitals
Leicester Healthcare Trust
University Hospital Nottingham Trust
For further information contact:
Gillian Thompson
Project Manager
T:+44 (0)191 293 4115
