Contact information
Type
Scientific
Primary contact
Dr Celia Emery
ORCID ID
Contact details
Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
United Kingdom
-
dafne.project@sth.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
7480
Study information
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
Acronym
DRN 385 (DAFNE Pump Pilot study)
Study hypothesis
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
Sheffield REC, 24/04/2009, ref: 09/H1398/39
Study design
Multicentre randomised interventional process of care and treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
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
Phase
Drug names
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 trial start date
16/09/2009
Overall trial end date
15/03/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 64; UK sample size: 64
Participant 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)
Recruitment start date
16/09/2009
Recruitment end date
15/03/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Hallamshire Hospital
Sheffield
S10 2JF
United Kingdom
Sponsor information
Organisation
Sheffield Teaching Hospitals NHS Foundation Trust (UK)
Sponsor details
Research Department
1st Floor
11 Broomfield Road
Sheffield
S10 2SE
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25642502