Following some discussions on the DCUK forum relating to DAFNE, I thought it would be an interesting topic to look into. Before I go on, I must state that I have never undertaken the DAFNE course, although I completed the Bournemouth BDEC course on-line, some ten years ago, and when diagnosed 27 years ago, carb counting was the normal way to manage diabetes, so this focuses on results of RCT trials and perceptions.
The DAFNE course is a widely used structured education course for Type 1 diabetics. DAFNE stands, of course, for Dose Adjustment for Normal Eating and was derived from work that grew, under Michael Berger, out of Dusseldorf University. It has shown successful patient outcomes in reducing Hba1C levels and done so under RCTs so can be considered to be an effective tool for patients in dealing with T1.
By the 2nd November 2015, 36,699 people had “graduated” from the DAFNE course, which is delivered in approximately 145 localities. Statistics for other DAFNE-like courses are not widely available and are done on a CCG by CCG basis. It’s fair to estimate that the number of people with some form of structured education under their belts is therefore significantly greater than the number that has completed DAFNE, but with the recent NICE and global guidelines recommending an Hba1C of less than 6.5%, is “normal eating” really that manageable for most T1s, or is the name DAFNE and the idea behind it setting us up for failure on the 48mmol/mol target?
The question here is with regard to the description – “Normal Eating”. Every long term Type 1 has experienced the myriad ups and downs that come with the condition. Non-repeated highs, sudden accidental lows, and an Hba1C that seems less reliably indicated by blood glucose recording than one might expect. I’ve somehow, in the last 27 years, managed to stay mostly around the 7% level, and in the last couple, drop that down to the 40mmol/mol level (5.8% in the old money).
DAFNE’s efficacy is not in doubt, and the statistics speak for themselves. But the published data leads to some interesting questions. So lets start there, with the UK RCT that was undertaken.
Key points about the UK DAFNE RCT:
- Starting Hba1C of participants was 7.5% to 12% – not what is considered well controlled by most in the medical world
- The initial “average” Hba1C of the participants was 9.4% (which roughly equates to an average blood glucose level of 12.4%)
- The 6 month post-RCT average Hba1C was 8.4% (which roughly equates to a blood glucose level of 10.8%)
- The average Hba1C reduction observed amongst participants was 1%, which is considered clinically significant
- Wellbeing measures had increased – patients felt more able to deal with food presented to them and felt they had a better quality of life
- Weight, had on average, increased by 1.2% and Cholesterol level changes were statistically insignificant
- Perceived incidence of hyperglycaemia had dropped by about 19% while perceived incindence of hypoglycaemia had increased by 6%
The full details of this are available in many of the DCCT/EDIC documents, an example of which is the 30th Anniversary Booklet.
Should the DAFNE course be renamed to reflect that it is really about Managing Diabetes Everyday (MADIE) rather than really about “Normal Eating”? Should all of these courses make it clearer that the average glucose levels really matter a lot from a very early stage? Should they introduce the idea of eating fewer carbs to manage the spikes more safely and show, via CGM, how timing is critical in insulin dosing? Should the impact of protein and fat on bs management be given a higher level of awareness in the discussions?
One thing I am certain about, after 27 years, is that if I was to undertake “Normal Eating” all the time, there is no way I would achieve the 48mmol/mol Hba1C target without a huge number of hypoglycaemic episodes. The NHS definition of normal eating is between 33% and 66% carbs, or 165g-330g of carbs per day. I used to undertake normal eating and that gave me an Hba1C of around 7%, still too high. As it stands, on a diet which is much lower in carbs than normal, I achieve an Hba1C of 40 mmol/mol and a standard deviation of 2.0 on an average glucose level of 6.6, so <30% of my average, which is where it needs to be.
Taking a look back at the evidence presented, we see that the NDA shows that 93% of T1s exceed the new best practice Hba1C and are therefore at risk of complications. We know that there has been little long term follow-up (more than 12 months) following the RCT on DAFNE interventions. We can see that DAFNE in the near to mid-term has a positive effect.
Does it allow the DAFNE graduate to live a normal life? Maybe. Can they eat a normal diet? If they choose. How long will their normal life remain so? No that long, given the NDA data. Fundamentally, alongside the structured education about managing their condition, a clear and concise message is needed about the risks of high blood glucose and where they lie. Without this, I believe any diabetic education is only doing half its job.