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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Other: DAFNE course (Timing of delivery of education)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard DAFNE<br>Usual DAFNE course taught over 5 consecutive days in one week | Other: DAFNE course (Timing of delivery of education)<br>* Education delivered over one day a week for 5 consecutive weeks, as opposed to 5 consecutive days over 1 week.<br>|
| Experimental: DAFNE 5x1 day<br>DAFNE course taught 1 day a week for 5 consecutive weeks | Other: DAFNE course (Timing of delivery of education)<br>* Education delivered over one day a week for 5 consecutive weeks, as opposed to 5 consecutive days over 1 week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in HbA1c (glycosylated haemoglobin) |  | 6 & 12 months | 

Secondary Outcome Measures

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