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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Sheffield Teaching Hospitals NHS Foundation Trust.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
University Hospitals, Leicester
Cambridge University Hospitals NHS Foundation Trust
University College London Hospitals
Northumbria Healthcare NHS Foundation Trust
NHS Greater Glasgow and Clyde
Norfolk and Norwich University Hospitals NHS Foundation Trust
East Lancashire Hospitals NHS Trust
Information provided by:
Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01069393
First received: February 10, 2010
Last updated: July 25, 2011
Last verified: July 2011

February 10, 2010
July 25, 2011
June 2010
June 2012   (final data collection date for primary outcome measure)
Improvement in HbA1c (glycosylated haemoglobin) [ Time Frame: 6 & 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01069393 on ClinicalTrials.gov Archive Site
  • Number of severe hypoglycaemic episodes [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Psychosocial measures, such as quality of life, emotional well-being, self-efficacy,will be assessed via questionnaires [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Qualitative evaluation via in-depth interviews to assess patients' experiences of the intervention [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Alternative Delivery of Dose Adjustment For Normal Eating (DAFNE) Trial in Patients With Type 1 Diabetes
Improving Management of Type 1 Diabetes in the UK: The DAFNE Programme as a Research Test-bed - 5 x 1 Day RCT

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 1 Diabetes Mellitus
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.
  • Active Comparator: Standard DAFNE
    Usual DAFNE course taught over 5 consecutive days in one week
    Intervention: Other: DAFNE course (Timing of delivery of education)
  • Experimental: DAFNE 5x1 day
    DAFNE course taught 1 day a week for 5 consecutive weeks
    Intervention: Other: DAFNE course (Timing of delivery of education)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
170
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01069393
STH15581
No
Professor Simon Heller, Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield Teaching Hospitals NHS Foundation Trust
  • University Hospitals, Leicester
  • Cambridge University Hospitals NHS Foundation Trust
  • University College London Hospitals
  • Northumbria Healthcare NHS Foundation Trust
  • NHS Greater Glasgow and Clyde
  • Norfolk and Norwich University Hospitals NHS Foundation Trust
  • East Lancashire Hospitals NHS Trust
Principal Investigator: Simon Heller, MD Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield Teaching Hospitals NHS Foundation Trust
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP