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
  Purpose

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.


Condition Intervention
Type 1 Diabetes Mellitus
Other: DAFNE course (Timing of delivery of education)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Improving Management of Type 1 Diabetes in the UK: The DAFNE Programme as a Research Test-bed - 5 x 1 Day RCT

Resource links provided by NLM:


Further study details as provided by Sheffield Teaching Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • Improvement in HbA1c (glycosylated haemoglobin) [ Time Frame: 6 & 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 170
Study Start Date: June 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard DAFNE
Usual DAFNE course taught over 5 consecutive days in one week
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.
Experimental: DAFNE 5x1 day
DAFNE course taught 1 day a week for 5 consecutive weeks
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.

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01069393

Locations
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, United Kingdom
Sponsors and Collaborators
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
Investigators
Principal Investigator: Simon Heller, MD Sheffield Teaching Hospitals NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Professor Simon Heller, Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01069393     History of Changes
Other Study ID Numbers: STH15581
Study First Received: February 10, 2010
Last Updated: July 25, 2011
Health Authority: United Kingdom: National Health Service

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 25, 2014