Developing a Dose Adjustment For Normal Eating (DAFNE) structured education course for adults with Type 1 diabetes incorporating insulin infusion pump start

ISRCTN	ISRCTN04179596
DOI	https://doi.org/10.1186/ISRCTN04179596
Secondary identifying numbers	7480

Submission date: 21/05/2010
Registration date: 21/05/2010
Last edited: 12/09/2016

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Celia Emery
Scientific

Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
United Kingdom

Email	dafne.project@sth.nhs.uk

Study information

Study design	Multicentre randomised interventional process of care and treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Developing a Dose Adjustment For Normal Eating (DAFNE) structured education course for adults with Type 1 diabetes delivering the skills to undertake both DAFNE insulin adjustment and continuous subcutaneous insulin infusion: pilot study
Study acronym	DRN 385 (DAFNE Pump Pilot study)
Study objectives	1. To establish that both the skills of DAFNE insulin dose adjustment, and use of an insulin infusion pump can be taught during a 5-day outpatient course 2. To ensure that the proposed outcome measures (biomedical, psychosocial, additional measures for a health economic analysis) can be collected during the 5 day course 3. To establish the proportion of patients on established DAFNE waiting lists who would be prepared to be randomised to either a standard course or one in which pump training is given 4. To obtain data on change in the primary outcome measure (HbA1c) to confirm power calculations for the main randomised controlled trial (RCT) 5. To validate the algorithms in the DAFNE programme which have been modified to exploit the facilities of continuous subcutaneous insulin infusion
Ethics approval(s)	Sheffield REC, 24/04/2009, ref: 09/H1398/39
Health condition(s) or problem(s) studied	Topic: Diabetes Research Network; Subtopic: Type 1; Disease: Diabetic Control, Education
Intervention	Intervention: a DAFNE educational course, 5 day, outpatient, skills training course, incorporating the additional training necessary to teach participants to use an insulin infusion pump (CSII) as therapy for diabetes. Comparator: standard DAFNE education course (DAFNE course plus multiple injections of insulin as therapy for diabetes). The standard DAFNE educational course is held over 5 consecutive days (full day) with a 2 hour visit at 6 weeks for a recap of course core details. Both arms: Follow-up length: 6 months post-course Study entry: single randomisation only
Intervention type	Mixed
Primary outcome measure	Change in HbA1c %, measured at baseline and 6 months post-course
Secondary outcome measures	1. Change in psychological outcome, specifically reduction in anxiety and depression scores on Hospital Anxiety and Depression Scale (HADS), measured at baseline and 6 months 2. Changes in weight, measured at baseline and 6 months 3. Diet related behaviours, measured at baseline and 6 months 4. Number and severity of hypoglycaemic episodes, measured at baseline, 6 weeks post-course and 6 months post-course
Overall study start date	16/09/2009
Completion date	15/03/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned sample size: 64; UK sample size: 64
Key inclusion criteria	1. T1DM of at least 1 year's duration 2. Waiting to attend a standard DAFNE skills 5 day course 3. Aged 18 - 80 years, either sex 4. Not been treated by continuous subcutaneous insulin infusion pump for the last four years
Key exclusion criteria	1. Factors which will impair participation in group education, i.e., non-English speaking 2. Evidence of an eating disorder 3. Previous significant experience of pump therapy (greater than 6 months in the last 4 years)
Date of first enrolment	16/09/2009
Date of final enrolment	15/03/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Royal Hallamshire Hospital

Sheffield
S10 2JF
United Kingdom

Sponsor information

Sheffield Teaching Hospitals NHS Foundation Trust (UK)
University/education

Research Department
1st Floor
11 Broomfield Road
Sheffield
S10 2SE
England
United Kingdom

Website	http://www.sth.nhs.uk/
"ROR"	https://ror.org/018hjpz25

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2014		Yes	No

Editorial Notes

12/09/2016: Publication reference added.