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Completed

NCT Number: NCT01069393

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

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DAFNE course (Timing of delivery of education)

Other

Education delivered over one day a week for 5 consecutive weeks, as opposed to 5 consecutive days over 1 week.

Primary outcomes

  1. Improvement in HbA1c (glycosylated haemoglobin)

    Time frame: 6 & 12 months

Secondary outcomes

  1. Number of severe hypoglycaemic episodes

    Time frame: 12 months

  2. Psychosocial measures, such as quality of life, emotional well-being, self-efficacy,will be assessed via questionnaires

    Time frame: 12 months

  3. Qualitative evaluation via in-depth interviews to assess patients' experiences of the intervention

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Other

Collaborators

  • 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

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 17, 2010
Registry last updated
Nov 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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