Condition category
Nutritional, Metabolic, Endocrine
Date applied
21/05/2010
Date assigned
21/05/2010
Last edited
12/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.sth.nhs.uk/

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

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25642502

Publication citations

Additional files

Editorial Notes

12/09/2016: Publication reference added.