ISRCTN37042683
Completed
Phase 3
A multicentre, randomised controlled trial comparing intensive structured education with standard education in 11 - 16 year olds on intensive insulin therapy
Sheffield Children's NHS Foundation Trust (UK)0 sites576 target enrollmentJuly 7, 2010
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Sheffield Children's NHS Foundation Trust (UK)
- Enrollment
- 576
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23355675 2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26248789 2016 cost-effectiveness results in: http://www.ncbi.nlm.nih.gov/pubmed/27719689
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. T1DM of at least 1 year's duration
- •2\. Already on or willing to use multiple dose insulin (MDI)
- •3\. Aged 11 \- 16 years (in Secondary School years 7 \- 12\), either sex
Exclusion Criteria
- •1\. Factors which will impair group participation
- •2\. Non\-English speaking
- •3\. Learning disability \- additional help in school
- •4\. Major behavioural problems
- •5\. Evidence of an eating disorder
- •6\. Associated illness that may influence control
Outcomes
Primary Outcomes
Not specified
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