Alternative Delivery of Dose Adjustment For Normal Eating (DAFNE) Trial in Patients With Type 1 Diabetes

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Improving Management of Type 1 Diabetes in the UK: The DAFNE Programme as a Research Test-bed - 5 x 1 Day RCT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01069393
• Other study ID #: STH15581
• Status: Completed
• Phase: N/A
• First received: February 10, 2010
• Last updated: November 18, 2014
• Start date: June 2010
• Est. completion date: June 2012

Study information

• Verified date: November 2014
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Other:
• DAFNE course (Timing of delivery of education)
Education delivered over one day a week for 5 consecutive weeks, as opposed to 5 consecutive days over 1 week.

Locations

Country	Name	City	State
United Kingdom	Cambridge University Hospitals NHS Foundation Trust	Cambridge
United Kingdom	NHS Greater Glasgow & Clyde	Glasgow
United Kingdom	East Lancashire Hospitals NHS Trust	Lancashire
United Kingdom	University Hospitals, Leicester	Leicester
United Kingdom	University College London	London
United Kingdom	Norfolk and Norwich University Hospitals NHS Foundation Trust	Norfolk
United Kingdom	Northumbria Healthcare NHS Foundation Trust	Northumbria

Sponsors (8)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust	Cambridge University Hospitals NHS Foundation Trust, East Lancashire Hospitals NHS Trust, NHS Greater Glasgow and Clyde, Norfolk and Norwich University Hospitals NHS Foundation Trust, Northumbria Healthcare NHS Foundation Trust, University College London Hospitals, University Hospitals, Leicester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in HbA1c (glycosylated haemoglobin)		6 & 12 months	No
Secondary	Number of severe hypoglycaemic episodes		12 months	Yes
Secondary	Psychosocial measures, such as quality of life, emotional well-being, self-efficacy,will be assessed via questionnaires		12 months	No
Secondary	Qualitative evaluation via in-depth interviews to assess patients' experiences of the intervention		12 months	No