Clinical trial NCT01069393: Alternative Delivery of Dose Adjustment For Normal Eating (DAFNE) Trial in Patients With Type 1 Diabetes
Official title: Improving Management of Type 1 Diabetes in the UK: The DAFNE Programme as a Research Test-bed - 5 x 1 Day RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University Hospitals, Leicester
name: Cambridge University Hospitals NHS Foundation Trust
name: University College London Hospitals
name: Northumbria Healthcare NHS Foundation Trust
name: NHS Greater Glasgow and Clyde
name: Norfolk and Norwich University Hospitals NHS Foundation Trust
name: East Lancashire Hospitals NHS Trust
First posted: 2010-02-17
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The best format for the delivery of structured education for adults with Type 1 diabetes is unclear. Currently some hospitals invite their patients to attend a 5 day outpatient course run over one week (Dose Adjustment For Normal Eating (DAFNE)). Other centres offer 1 day a week for 3 to 5 weeks. We aim to find out whether or not the benefit of benefits are the same then it would mean that the course could routinely be offered to patients in either format, thus allowing more patient choice and flexibility.

Detailed description: The DAFNE (Dose Adjustment for Normal Eating) course is a 1-week structured education course teaching skills in insulin use and dietary freedom to individuals with Type 1 diabetes. At the moment, we do not understand enough about why some people get more out of the DAFNE programmes than others. Currently DAFNE is always taught over 1 week. We aim to find out whether or not the benefit of DAFNE is the same whether it is delivered over 5 consecutive days, or one day a week for 5 consecutive weeks. If the benefits are the same then it would mean that the course could routinely be offered to patients in either format, thus allowing more patient choice and flexibility. At present there have been no RCTs to address

Approximately 170 people will take part in this study over the next 2 years. Half the people who participate will be allocated to attend a DAFNE course over 5 consecutive days, and the other halfwill attend one day a week for 5 consecutive weeks. We will perform routine biomedical assessments as part of the DAFNE programme and normal diabetes care (e.g. HbA1c (a measure of long-term blood glucose control), weight, blood pressure, blood biochemistry), and ask patients to recall hypoglycaemic (low blood sugar) events. We will also ask participants to fill in some research questionnaires, they will take 45-60 minutes to fill in each time. They will include questions about their diabetes, quality of life, well-being and diabetes knowledge. These assessments will be made at 3 time points; baseline, 6 and 12 months.

The main outcome measure is change in HbA1c, with the other biomedical and psychosocial parameters being of secondary importance. These evaluations will help us develop the DAFNE programme further and inform us how best to deliver the course in the future.

Eligibility criteria: Inclusion Criteria:

* adults with Type 1 diabetes for at least 6 months
* HbA1c \<12%
* willing to undertake intensive insulin therapy

Exclusion Criteria:

* severe diabetic complications (making group education difficult)
* inability to communicate in English
* strong preference for on attending a one week course or one day a week for 5 consecutive weeks
* inability to give informed consent

Primary outcomes:
measure: Improvement in HbA1c (glycosylated haemoglobin)
timeFrame: 6 & 12 months
Secondary outcomes:
measure: Number of severe hypoglycaemic episodes
timeFrame: 12 months
measure: Psychosocial measures, such as quality of life, emotional well-being, self-efficacy,will be assessed via questionnaires
timeFrame: 12 months
measure: Qualitative evaluation via in-depth interviews to assess patients' experiences of the intervention
timeFrame: 12 months
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow & Clyde
city: Lancashire
country: United Kingdom
facility: East Lancashire Hospitals NHS Trust
city: Leicester
country: United Kingdom
facility: University Hospitals, Leicester
city: London
country: United Kingdom
facility: University College London
city: Norfolk
country: United Kingdom
facility: Norfolk and Norwich University Hospitals NHS Foundation Trust
city: Northumbria
country: United Kingdom
facility: Northumbria Healthcare NHS Foundation Trust
Study officials:
affiliation: Sheffield Teaching Hospitals NHS Foundation Trust
name: Simon Heller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elliott J, Lawton J, Rankin D, Emery C, Campbell M, Dixon S, Heller S; NIHR DAFNE Research Study Group. The 5x1 DAFNE study protocol: a cluster randomised trial comparing a standard 5 day DAFNE course delivered over 1 week against DAFNE training delivered over 1 day a week for 5 consecutive weeks. BMC Endocr Disord. 2012 Nov 8;12:28. doi: 10.1186/1472-6823-12-28.