- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01069393
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
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Cambridge, United Kingdom
- Cambridge University Hospitals NHS Foundation Trust
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Glasgow, United Kingdom
- NHS Greater Glasgow & Clyde
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Lancashire, United Kingdom
- East Lancashire Hospitals NHS Trust
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Leicester, United Kingdom
- University Hospitals, Leicester
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London, United Kingdom
- University College London
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Norfolk, United Kingdom
- Norfolk and Norwich University Hospitals NHS Foundation Trust
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Northumbria, United Kingdom
- Northumbria Healthcare NHS Foundation Trust
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
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
|
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
Collaborators
Investigators
- Principal Investigator: Simon Heller, MD, Sheffield Teaching Hospitals NHS Foundation Trust
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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