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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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17 October 2016 |
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Main ID: |
ISRCTN04179596 |
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Date of registration:
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21/05/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Developing a Dose Adjustment For Normal Eating (DAFNE) structured education course for adults with Type 1 diabetes incorporating insulin infusion pump start
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Scientific title:
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Developing a Dose Adjustment For Normal Eating (DAFNE) structured education course for adults with Type 1 diabetes delivering the skills to undertake both DAFNE insulin adjustment and continuous subcutaneous insulin infusion: pilot study |
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Date of first enrolment:
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16/09/2009 |
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Target sample size:
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64 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN04179596 |
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Study type:
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Interventional |
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Study design:
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Multicentre randomised interventional process of care and treatment trial (Treatment)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Celia
Emery |
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Address:
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Royal Hallamshire Hospital
Glossop Road
S10 2JF
Sheffield
United Kingdom |
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Telephone:
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- |
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Email:
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dafne.project@sth.nhs.uk |
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Affiliation:
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Name:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. T1DM of at least 1 year's duration
2. Waiting to attend a standard DAFNE skills 5 day course
3. Aged 18 - 80 years, either sex
4. Not been treated by continuous subcutaneous insulin infusion pump for the last four years
Exclusion criteria: 1. Factors which will impair participation in group education, i.e., non-English speaking
2. Evidence of an eating disorder
3. Previous significant experience of pump therapy (greater than 6 months in the last 4 years)
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Topic: Diabetes Research Network; Subtopic: Type 1; Disease: Diabetic Control, Education
Nutritional, Metabolic, Endocrine
Type 1 diabetes
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Intervention(s)
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Intervention: a DAFNE educational course, 5 day, outpatient, skills training course, incorporating the additional training necessary to teach participants to use an insulin infusion pump (CSII) as therapy for diabetes.
Comparator: standard DAFNE education course (DAFNE course plus multiple injections of insulin as therapy for diabetes).
The standard DAFNE educational course is held over 5 consecutive days (full day) with a 2 hour visit at 6 weeks for a recap of course core details.
Both arms:
Follow-up length: 6 months post-course
Study entry: single randomisation only
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Primary Outcome(s)
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Change in HbA1c %, measured at baseline and 6 months post-course
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Secondary Outcome(s)
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1. Change in psychological outcome, specifically reduction in anxiety and depression scores on Hospital Anxiety and Depression Scale (HADS), measured at baseline and 6 months
2. Changes in weight, measured at baseline and 6 months
3. Diet related behaviours, measured at baseline and 6 months
4. Number and severity of hypoglycaemic episodes, measured at baseline, 6 weeks post-course and 6 months post-course
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Source(s) of Monetary Support
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National Institute for Health Research
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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