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

November 18, 2014 updated by: Sheffield Teaching Hospitals NHS Foundation Trust

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in HbA1c (glycosylated haemoglobin)
Time Frame: 6 & 12 months
6 & 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of severe hypoglycaemic episodes
Time Frame: 12 months
12 months
Psychosocial measures, such as quality of life, emotional well-being, self-efficacy,will be assessed via questionnaires
Time Frame: 12 months
12 months
Qualitative evaluation via in-depth interviews to assess patients' experiences of the intervention
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Collaborators

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

Investigators

  • Principal Investigator: Simon Heller, MD, Sheffield Teaching Hospitals NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

February 10, 2010

First Submitted That Met QC Criteria

February 15, 2010

First Posted (Estimate)

February 17, 2010

Study Record Updates

Last Update Posted (Estimate)

November 19, 2014

Last Update Submitted That Met QC Criteria

November 18, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STH15581

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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