CompletedInterventional

DAFNEplus cluster randomised controlled trial

The DAFNE programme teaches people with type 1 diabetes how to match their insulin doses to the food they eat. While standard DAFNE helps people gain freedom and improve blood sugar control in the short term, many find it hard to keep up these habits without ongoing help. This study compares the standard DAFNE course with a new version called DAFNEplus. Both courses run one day a week for five weeks. However, the DAFNEplus programme also provides digital tools to spot blood sugar trends and includes up to five structured review appointments with healthcare professionals over the following year. The goal is to see if DAFNEplus gives adults with type 1 diabetes better lifelong control over their glucose levels, reducing hospital visits and serious health problems.

At a glance

Status

Completed

Sponsor

Sheffield Teaching Hospital NHS Foundation Trust

Enrolment target

662

Start

01 Sep 2018

Estimated completion

31 Oct 2022

Type 1 diabetes

What is this study about?

Living with type 1 diabetes means constantly balancing food, activity, and insulin to keep blood sugar levels in a safe range. For years, the NHS has offered a popular group course called DAFNE, which stands for Dose Adjustment For Normal Eating. It teaches people how to calculate insulin doses so they can eat normally without feeling restricted. While DAFNE has helped tens of thousands of people, past participants have shared that it can be tricky to keep up these skills on their own once the course finishes.

Researchers created 'DAFNEplus' to solve this issue. DAFNEplus updates the training by adding modern technology, such as apps to track blood sugar patterns and calculate insulin doses. It also adds regular follow-up check-ins with diabetes specialist teams over a full year. The aim is to turn a one-off class into lifelong support so participants feel confident managing their diabetes every day.

This study compares participating NHS centres using standard DAFNE against those using DAFNEplus. By tracking both groups, researchers hope to find out whether DAFNEplus leads to better long-term blood sugar levels, fewer diabetes-related emergencies, and an improved quality of life. The findings could shape how diabetes education is delivered across the UK in the future.

Key takeaways

Tests whether extra digital tools and regular check-ups improve the classic DAFNE diabetes course.
Open to adults with type 1 diabetes who use multiple daily insulin injections.
Both courses involve attending one session per week for five weeks.
DAFNEplus includes up to five follow-up visits over 12 months to provide ongoing support.
This is a low-risk educational study aimed at boosting confidence and long-term health.

Who may be eligible?

This trial is for adults aged 18 and over who have had a confirmed diagnosis of type 1 diabetes for at least six months. To join, you must manage your condition using multiple daily insulin injections (rather than an insulin pump) and be willing to test your blood sugar regularly. You also need to be able to attend all course sessions and understand written and spoken English.

You cannot take part if you currently use an insulin pump, or if you attended a standard DAFNE course within the past five years. People with very high average blood sugar levels (HbA1c over 12% or 108 mmol/mol) are generally excluded, although doctors can make exceptions based on individual health.

Those experiencing severe diabetes complications (such as kidney failure needing dialysis or severe vision loss) or other serious medical conditions, including active psychosis or an eating disorder, may also be advised against taking part. Your diabetes team will review your health to make sure the course is safe and suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged 18 or older.
I have been diagnosed with type 1 diabetes for at least 6 months.
I manage my diabetes with multiple daily injections, not an insulin pump.
I have not completed a DAFNE course within the last 5 years.
I can attend five weekly sessions and follow-up appointments.
I can read, write, and speak English comfortably.

Answer every question to see your result.

What does participation involve?

If you take part, your local NHS hospital or clinic will be assigned to run either the standard DAFNE course or the new DAFNEplus course. Whichever group you are in, you will attend group training sessions one day per week for five weeks in a row. You will learn practical skills for estimating carbohydrates and adjusting your mealtime insulin.

Both groups will receive a dose calculator tool to help work out insulin needs. If your clinic is allocated to DAFNEplus, you will also use digital technology to log and view blood sugar trends, and you will attend up to five structured follow-up appointments with your diabetes team over the next 12 months. Those in the standard group will receive their usual NHS clinic check-ups.

Throughout the study, researchers will check your blood sugar levels and ask you to complete questionnaires about your well-being. The study runs for about a year from the time you start your course, and your normal insulin medication continues throughout.

Potential risks and benefits

Taking part offers the chance to gain practical skills, greater food freedom, and better blood sugar control, which can lower your risk of future health problems. There are no direct medical risks from participating, as you are simply attending an educational programme alongside your regular insulin therapy. You are free to leave the study at any time without giving a reason, and choosing to withdraw will never affect your standard NHS care.

Locations (13)

Harrogate and District NHS Foundation Trust
City only
Harrogate, England
Cambridge University Hospitals NHS Foundation Trust
City only
Cambridge, England
University College London Hospitals NHS Foundation Trust
City only
London, England
Worcestershire Acute Hospitals NHS Foundation Trust
City only
-, England
NHS Dumfries and Galloway
Approximate
Dumfries, Scotland
Derby Teaching Hospitals NHS Foundation Trust
Unverified
-, England
Greater Glasgow and Clyde Health Board
Unverified
-, Scotland
South Tees Hospitals NHS Foundation Trust
Unverified
Middlesbrough, England
Guy's and St Thomas' Hospitals
Unverified
London, England
Birmingham Community NHS Foundation Trust
Unverified
-, England
Hertfordshire Community NHS Trust
Unverified
-, England
Nottingham University Hospitals NHS Trust
Unverified
Nottingham, England

Common questions

What does DAFNE stand for?

DAFNE stands for Dose Adjustment For Normal Eating. It is an educational course designed to help people with type 1 diabetes match their insulin doses to what they eat.

Can I choose whether I get standard DAFNE or DAFNEplus?

No. The participating NHS centres are randomly allocated to provide either the standard course or DAFNEplus, so your course depends on your local clinic.

Will taking part change my insulin prescription?

The study does not introduce new medicines. You will continue using your regular insulin, but you will learn how to adjust your doses more accurately.

Can I join if I use an insulin pump?

No. This study is specifically designed for people who take multiple daily insulin injections.

What happens if I cannot make all the sessions?

Because the training builds week by week, participants need to commit to attending all five weekly sessions to get the full benefit.

How to find out more

Elaine Scott

dafneplus@sheffield.ac.uk +44 (0)114 2225158 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.