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

Plain English Summary

Not provided at time of registration

Study website

Type

Scientific

Contact name

Dr Celia Emery

ORCID ID

Contact details

Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
United Kingdom
-
dafne.project@sth.nhs.uk

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

Protocol/serial number

7480

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(s)

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

Study setting(s)

Hospital

Study 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

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

Overall study end date

15/03/2010

Reason abandoned (if study stopped)

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(s)

Patient

Age group

Adult

Lower age limit

18 Years

Sex

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

Countries of recruitment

England, United Kingdom

Study participating centre

Royal Hallamshire Hospital
Sheffield
S10 2JF
United Kingdom

Organisation

Sheffield Teaching Hospitals NHS Foundation Trust (UK)

Sponsor details

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

Sponsor type

University/education

Website

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

ROR

https://ror.org/018hjpz25

Funder type

Government

Funder name

National Institute for Health Research

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

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Individual participant data (IPD) sharing plan

IPD sharing plan summary

Not provided at time of registration

Study outputs