DAFNEplus cluster randomised controlled trial

ISRCTN	ISRCTN42908016
DOI	https://doi.org/10.1186/ISRCTN42908016
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	235621
Protocol serial number	38046
Sponsor	Sheffield Teaching Hospital NHS Foundation Trust
Funder	NIHR Central Commissioning Facility (CCF); Grant Codes: RP-PG-0514-20013

Submission date: 08/05/2018
Registration date: 17/05/2018
Last edited: 06/02/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Current plain English summary as of 31/12/2019:

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 Hospital NHS Foundation Trust (UK)
3. University College London Hospitals NHS Foundation Trust (UK)
4. Worcestershire Acute Hospital 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. Guy’s and St Thomas’ NHS Foundation Trust (UK)
9. South Tees Hospitals NHS Foundation Trust (UK)
10. Hertfordshire Community NHS Trust (UK)
11. Nottingham University Hospitals NHS Trust (UK)
12. Hull University Teaching Hospitals NHS Trust (UK)
13. Birmingham Community NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
March 2016 to January 2024 (updated from July 2022)

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

Who is the main contact?
Elaine Scott (Trial manager)
dafneplus@sheffield.ac.uk

_____
Previous 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

Contact information

Mrs Elaine Scott
Public

Clinical Trials Research Unit
School of Health & Related Research
University of Sheffield
Regent Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom

Phone	+44 (0)114 2225158
Email	dafneplus@sheffield.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised; Both; Design type: Treatment, Prevention, Education or Self-Management, Psychological & Behavioural, Complex Intervention, Qualitative
Secondary study design	Cluster randomised trial
Study type	Participant information sheet
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
Study acronym	DAFNEplus
Study objectives	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(s)	South West - Exeter Research Ethics Committee, 14/05/2018, ref: 18/SW/0100
Health condition(s) or problem(s) studied	Type 1 diabetes
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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Current secondary outcome measures as of 31/12/2019: 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 7. Albumin/ creatinine, measured at baseline and 12 months after the course Psychological outcomes, measured at baseline, course completion, 3, 6 and 12 months: 1. Dawn Impact of Diabetes Profile (DIDP) 2. Problem Areas in Diabetes Scale (PAID-11) 3. Diabetes-specific positive well-being (W-BQ-28) 4. Hypoglycaemia Fear Survey (HFS-11) Process measures: 5. Diabetes Management Experiences Questionnaire (DMEQ) 6. Self-Regulation/Behavioural Regulation Questionnaire (SRQ-T1D) 7. Diabetes Strengths & Resilience Questionnaire (DSRQ) 8. Confidence in Diabetes Scale (CIDS) assesses beliefs about capabilities (self-efficacy). 9. Diabetes Self-Care Behaviours – SCB-T1D 10. Hypoglycaemia Confidence Scale (HCS) 11. Beliefs about consequences of engaging in DAFNE behaviours and weaving diabetes management into everyday routines. 12. The System Usability Score 13. Use and dose received of the DANFEplus programme assessed via logs of attendance at group and individual sessions, and use of the DANFEplus website Hypoglycaemia Awareness 14. Hypoglycaemia awareness assessed via Gold score Health economic measures assessed at baseline, course completion, 6 and 12 months using: 1. Health status – EQ-5D-5L 2. Health and Self-Management in Diabetes HASMID 3. Healthcare utilisation using a bespoke questionnaire 4. Contact between professionals and course participants will also be recorded at each site using questionnaires and data from the DANFEplus website (in the intervention arm) _____ Previous 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
Completion date	31/01/2024

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	662
Total final enrolment	471
Key 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
Key exclusion criteria	Current exclusion criteria as of 31/12/2019: 1. Current use of continuous subcutaneous insulin infusion (CSII) pump therapy 2. HbA1c > 12%/108 mmol/mol (Investigators can use their judgement, informed by standard DAFNE guidelines and in agreement with the trial team, to include participants with HbA1c >12%/108 mmol/mol) 3. Serious diabetic complications (e.g. blindness, renal dialysis). (Investigators can use their clinical judgement, informed by standard DAFNE guidelines and in agreement with the trial team). 4. Other serious co-morbidities e.g. psychosis, diagnosed eating disorder (Investigators can use their clinical judgement, informed by standard DAFNE guidelines and in agreement with the trial team). 5. Previous participation in standard DAFNE course less than 5 years before proposed study enrolment date 6. Unable to hear/speak/understand/read/write in English 7. Unable to give written informed consent _____ Previous 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
Date of first enrolment	01/09/2018
Date of final enrolment	31/10/2022

Locations

Countries of recruitment

United Kingdom
England
Scotland

Study participating centres

Harrogate and District NHS Foundation Trust

HG2 7SX
United Kingdom

Cambridge University Hospitals NHS Foundation Trust

CB2 0QQ
United Kingdom

University College London Hospitals NHS Foundation Trust

NW1 2PG
United Kingdom

Worcestershire Acute Hospitals NHS Foundation Trust

B97 4BD
United Kingdom

NHS Dumfries and Galloway

DG1 4TG
United Kingdom

Derby Teaching Hospitals NHS Foundation Trust

DE22 3NE
United Kingdom

Greater Glasgow and Clyde Health Board

G42 9LF
United Kingdom

South Tees Hospitals NHS Foundation Trust

TS4 3BW
United Kingdom

Guy's and St Thomas' NHS Foundation Trust

SE1 9RT
United Kingdom

Birmingham Community NHS Foundation Trust

B21 0SY
United Kingdom

Hertfordshire Community NHS Trust

SG1 4AB
United Kingdom

Nottingham University Hospitals NHS Trust

NG7 2UH
United Kingdom

Hull University Teaching Hospitals NHS Trust

HU3 2JZ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	The data sharing plans for the current study are unknown and will be made available at a later date. Previous 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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	18/01/2021	02/02/2021	Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

06/02/2025: The following changes were made to the trial record:
1. The IRAS number was added.
2. The intention to publish date was changed from 31/10/2024 to 01/06/2025.
05/07/2023: The following changes were made to the study record and the plain English summary was updated to reflect these changes:
1. The intention to publish date was changed from 31/07/2023 to 31/10/2024.
2. The recruitment end date was changed from 28/02/2021 to 31/10/2022.
3. The total final enrolment number was added.
06/09/2021: The overall end date was changed from 31/08/2023 to 31/01/2024.
02/02/2021: Publication reference added.
12/05/2020: The publication and dissemination plan has been updated.
24/04/2020: Due to current public health guidance, recruitment for this study has been paused.
31/12/2019: The following changes were made to the trial record:
1. The overall end date was changed from 31/07/2022 to 31/08/2023.
2. The recruitment end date was changed from 30/11/2019 to 28/02/2021.
3. The secondary outcome measures were changed.
4. The exclusion criteria were changed.
5. The trial participating centres "Northumbria Healthcare NHS Foundation Trust and Essex Partnership University NHS Foundation Trust" were removed and "Guy's and St Thomas' NHS Foundation Trust and Birmingham Community NHS Foundation Trust" were added.
6. The public contact was changed from Patrick Phillips to Elaine Scott.
7. The plain English summary was updated to reflect these changes.
22/03/2019: The condition was updated from "Specialty: Diabetes, Primary sub-specialty: Type 1; UKCRC code/ Disease: Metabolic and Endocrine/ Diabetes mellitus" to "Type 1 diabetes".