Condition category
Nutritional, Metabolic, Endocrine
Date applied
08/05/2018
Date assigned
17/05/2018
Last edited
17/05/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
DAFNE stands for Dose Adjustment For Normal Eating. It is a 5-day training course for adults with type 1 diabetes (T1D), delivered in small groups. DAFNE has been delivered to over 30,000 adults in the UK. Recent research confirmed that after attending a DAFNE course, people have better quality of life, better glucose levels (in the short term), and are admitted to hospital less often for diabetes emergencies. Although participants find DAFNE training useful, some find it tough to keep up the skills needed to maintain glucose levels to prevent diabetic complications. After the course, people also find it hard to get support from health professionals. They have asked to improve the course to help others develop and keep their skills over the long term. The aim of this study is to develop and convert DAFNE into a lifelong package to help people better manage their blood glucose levels in the longer term,as high levels can cause dangerous complications. This is done by revising the course, putting together structured follow-up with health professionals after the course, and using technology to help people maintain the skills they need to manage their type 1 diabetes effectively.

Who can participate?
Patients aged 18 and over with T1D referred to DAFNE courses at participating centres

What does the study involve?
Participating centres are randomly allocated to provide either the current DAFNE course or the newly developed DAFNEplus, with seven centres providing each course. Participants who are in sites allocated to DAFNEplus attend the DAFNEplus course one day per week over five consecutive weeks, which includes the use of technology to transmit and display blood glucose data to support pattern recognition and interpretation (and provision of a bolus calculator to support insulin dose calculations) and up to five structured follow-up appointments in the 12 months after the course. Participants at the other sites receive treatment as usual and attend the current DAFNE course one day per week over five consecutive weeks. A bolus calculator is provided to support calculation of insulin dose. There is no structured follow-up appointments beyond those provided in usual care.

What are the possible benefits and risks of participating?
All those who complete a DAFNE course should feel more confident about managing their diabetes and be able to adjust their insulin dose correctly to suit their choice of food. This should mean greater freedom, improved quality of life and improved blood glucose control. It is also hoped that the information collected from people in this study will help to show whether there is any advantage to doing the new DAFNEplus programme when compared with standard DAFNE. This is a low risk study - no risks to participation have been identified.

Where is the study run from?
1. Harrogate and District NHS Foundation Trust (UK)
2. Cambridge University Hospitals NHS Foundation Trust (UK)
3. University College London Hospitals NHS Foundation Trust (UK)
4. Worcestershire Acute Hospitals NHS Foundation Trust (UK)
5. NHS Dumfries and Galloway (UK)
6. Derby Teaching Hospitals NHS Foundation Trust (UK)
7. Greater Glasgow and Clyde Health Board (UK)
8. South Tees Hospitals NHS Foundation Trust (UK)
9. Northumbria Healthcare NHS Foundation Trust (UK)
10. Essex Partnership University NHS Foundation Trust (UK)
11. Hertfordshire Community NHS Trust (UK)
12. Nottingham University Hospitals NHS Trust (UK)
13. Hull and East Yorkshire Hospitals NHS Trust (UK)

When is the study starting and how long is it expected to run for?
March 2016 to July 2022

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Mr Patrick Phillips
p.phillips@sheffield.ac.uk

Trial website

https://www.sheffield.ac.uk/scharr/sections/dts/ctru/dafneplus

Contact information

Type

Public

Primary contact

Mr Patrick Phillips

ORCID ID

http://orcid.org/0000-0003-0241-1527

Contact details

Clinical Trials Research Unit
School of Health & Related Research
University of Sheffield
Regent Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom
+44 (0)114 2225158
p.phillips@sheffield.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

38046

Study information

Scientific title

A cluster randomised controlled trial of the DAFNEplus (Dose Adjustment for Normal Eating) intervention: a lifelong approach to promote effective self-management in adults with type 1 diabetes

Acronym

Study hypothesis

DAFNE stands for Dose Adjustment For Normal Eating. It is a 5-day training course for adults with type 1 diabetes, delivered in small groups. DAFNE has been delivered to over 40,000 adults in the UK. Our recent research confirmed that after attending a DAFNE course, people have better quality of life, better glucose levels (in the short term) and are admitted to hospital less often for diabetes emergencies. Although participants find DAFNE training useful, some find it tough to keep up the skills needed to maintain glucose levels to prevent diabetic complications. After the course, people also find it hard to get support from health professionals. They have asked us to improve the course to help others develop and keep their skills over the long term.

The aim of DAFNEplus is to develop and convert DAFNE into a lifelong package to help people better manage their blood glucose levels in the longer term, as high levels can cause dangerous complications. We are doing this by revising the course, putting together structured follow-up with health professionals after the course, and using technology to help people maintain the skills they need to manage their type 1 diabetes effectively.

Following a successful pilot study which piloted and refined the prototype DAFNEplus programme in three NHS diabetes centres, we will now conduct a pragmatic cluster randomised controlled trial (RCT) to compare DAFNEplus with standard DAFNE.

A cluster RCT design is required since DAFNE educators, trained in the new programme would be ‘contaminated’ if they delivered current DAFNE, so we are randomising centres rather than individuals. The trial will take place in 14 centres across the UK, and will recruit a total of 662 participants (331 will receive DAFNEplus and 331 will receive standard DAFNE).

Ethics approval

South West - Exeter Research Ethics Committee, 14/05/2018, ref: 18/SW/0100

Study design

Randomised; Both; Design type: Treatment, Prevention, Education or Self-Management, Psychological & Behavioural, Complex Intervention, Qualitative

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Specialty: Diabetes, Primary sub-specialty: Type 1; UKCRC code/ Disease: Metabolic and Endocrine/ Diabetes mellitus

Intervention

Participating centres will be randomised on a 1:1 basis to control (standard DAFNE courses) or the intervention arm (DAFNEplus course) of the trial. As there are numerous stratification variables that have been identified as clinically important and the small number of randomising centres, a covariate constrained methodology will be employed. The centres will be matched on the number of patients within the centre, number of educators within the centre and number of previous DAFNE courses delivered (as a marker of centre experience) to balance centres between the two arms of the trial.

Intervention
Following informed consent, participants who are in sites allocated to the intervention arm will attend the DAFNEplus course one day per week, over five consecutive weeks. The intervention includes the use of technology to transmit and display blood glucose data to support pattern recognition and interpretation. A bolus calculator to support insulin dose calculations will also be provided. Five structured follow-up appointments are also scheduled in the 12 months following the course.

Control
Participants who are recruited at the control sites will receive treatment as usual and will attend the DAFNE course one day per week, over five consecutive weeks. A bolus calculator will be provided to participants in the control arm to support calculation of insulin dose. There will be no structured follow-up appointments beyond those provided in usual care.

Intervention type

Other

Phase

Drug names

Primary outcome measure

The primary biomedical outcome is glycaemic control, defined as the change in HbA1c (using a centralised assay to ensure standardisation), in those entering the trial with HbA1c >7.5% (estimated at 75% of those currently undertaking DAFNE courses based on our research database); Timepoint(s): End of the study

The primary psychological outcome is diabetes-specific quality of life, measured using the DAWN Impact of Diabetes Profile at baseline and 12 months

Secondary outcome measures

Secondary biomedical outcome:
Number of participants achieving either an HbA1c <7.5% (58 mmol/mol) or a decrease in HbA1c of ≥0.5% (≥5.5 mmol/mol) (using a centralised assay to ensure standardisation). These endpoints will be calculated using data collected at baseline and 12 months after the course.

Other secondary biomedical outcomes will include:
1. Severe hypoglycaemia, as defined by the American Diabetes Association, denotes severe cognitive impairment requiring external assistance for recovery, both rates and proportion of those affected, measured at baseline at 12 months after the course
2. Diabetic ketoacidosis, both rates and proportion of those affected, collected at baseline and 12 months after the course
3. Weight, measured at baseline and 12 months after the course
4. Body Mass Index, measured at baseline and 12 months after the course
5. Blood pressure, measured at baseline and 12 months after the course
6. Lipids, measured at baseline and 12 months after the course

Psychological outcomes, measured at baseline, course completion, 3, 6 and 12 months:
1. Diabetes self-care behaviours, measured using SCB-T1D
2. Belief about capabilities (self-efficacy): bespoke study questionnaire with 9 items mirroring the wording in the self-care behaviour scale
3. Personal Models of Diabetes Scale
4. Hyperglycaemia Avoidance Scale
5. Diabetes-specific positive well-being
6. Hypoglycaemia Fear Survey
7. Hypoglycaemia awareness assessed via Gold score
8. The System Usability Score
9. Use and dose received of the DAFNEplus programme assessed via logs of attendance at group and individual sessions, and use of the DAFNEplus website

Health economic measures assessed at baseline, course completion, 6 and 12 months using:
1. EQ5D - L
2. A bespoke healthcare use questionnaire
3. HASMID

Overall trial start date

01/03/2016

Overall trial end date

31/07/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Adults (≥18 years)
2. Diagnosis of type 1 diabetes for at least 6 months, or post-honeymoon
3. Prepared to undertake multiple daily injection (MDI) therapy and frequent self-monitoring of blood glucose
4. Confirms availability to attend all sessions as part of the intervention
5. Investigator has confidence that the patient is capable of adhering to all the trial protocol requirements

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 662; UK Sample Size: 662

Participant exclusion criteria

1. Current use of continuous subcutaneous insulin infusion (CSII) pump therapy
2. HbA1c > 12%
3. Serious diabetes-related complications (e.g. blindness, renal dialysis), or other serious co-morbidities (e.g. psychosis, diagnosed eating disorder)
4. Previous participation in standard DAFNE course less than 5 years before proposed study enrolment date
5. Unable to hear/speak/understand/read/write in English
6. Unable to give written informed consent

Recruitment start date

01/09/2018

Recruitment end date

30/11/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Harrogate and District NHS Foundation Trust
HG2 7SX

Trial participating centre

Cambridge University Hospitals NHS Foundation Trust
CB2 0QQ

Trial participating centre

University College London Hospitals NHS Foundation Trust
NW1 2PG

Trial participating centre

Worcestershire Acute Hospitals NHS Foundation Trust
B97 4BD

Trial participating centre

NHS Dumfries and Galloway
DG1 4TG

Trial participating centre

Derby Teaching Hospitals NHS Foundation Trust
DE22 3NE

Trial participating centre

Greater Glasgow and Clyde Health Board
G42 9LF

Trial participating centre

South Tees Hospitals NHS Foundation Trust
TS4 3BW

Trial participating centre

Northumbria Healthcare NHS Foundation Trust
NE29 8NH

Trial participating centre

Essex Partnership University NHS Foundation Trust
CO4 5JR

Trial participating centre

Hertfordshire Community NHS Trust
SG1 4AB

Trial participating centre

Nottingham University Hospitals NHS Trust
NG7 2UH

Trial participating centre

Hull and East Yorkshire Hospitals NHS Trust
HU3 2JZ

Sponsor information

Organisation

Sheffield Teaching Hospital NHS Foundation Trust

Sponsor details

Herries Road
Sheffield
S5 7AU
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Central Commissioning Facility (CCF); Grant Codes: RP-PG-0514-20013

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The trial protocol will be published on an open access source. A number of academic outputs will be produced as the data are analysed throughout the trial. Journals will be selected based on the highest possible impact. Other stakeholder specific outputs in relevant formats will also be produced for commissioners, third sector, and user advocacy organisations. A website has been established to promote the work of the trial.

The outputs from the work will be provided to the 70+ DAFNE centres across the UK, in a form which will enable them to be readily communicated to clinical commissioning groups (in England) and the respective funders in the devolved nations. This will facilitate decisions on establishing and sustaining funding of this enhanced support for adults with T1D in the UK. Through Diabetes UK and the DAFNE collaborative the trialists will communicate their findings to the All Parliamentary Group on Diabetes, the National Clinical Director of Diabetes and NICE.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/07/2023

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes