Alternative Delivery of Dose Adjustment For Normal Eating (DAFNE) Trial in Patients With Type 1 Diabetes
NCT ID: NCT01069393
Last Updated: 2014-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
170 participants
INTERVENTIONAL
2010-06-30
2012-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard DAFNE
Usual DAFNE course taught over 5 consecutive days in one week
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.
DAFNE 5x1 day
DAFNE course taught 1 day a week for 5 consecutive weeks
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* HbA1c \<12%
* willing to undertake intensive insulin therapy
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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University Hospitals, Leicester
OTHER
Cambridge University Hospitals NHS Foundation Trust
OTHER
University College London Hospitals
OTHER
Northumbria Healthcare NHS Foundation Trust
OTHER
NHS Greater Glasgow and Clyde
OTHER
Norfolk and Norwich University Hospitals NHS Foundation Trust
OTHER
East Lancashire Hospitals NHS Trust
OTHER
Sheffield Teaching Hospitals NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Simon Heller, MD
Role: PRINCIPAL_INVESTIGATOR
Sheffield Teaching Hospitals NHS Foundation Trust
Locations
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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
Countries
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References
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Elliott J, Lawton J, Rankin D, Emery C, Campbell M, Dixon S, Heller S; NIHR DAFNE Research Study Group. The 5x1 DAFNE study protocol: a cluster randomised trial comparing a standard 5 day DAFNE course delivered over 1 week against DAFNE training delivered over 1 day a week for 5 consecutive weeks. BMC Endocr Disord. 2012 Nov 8;12:28. doi: 10.1186/1472-6823-12-28.
Other Identifiers
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STH15581
Identifier Type: -
Identifier Source: org_study_id