A randomised controlled study of continuous subcutaneous insulin infusion (CSII) therapy compared to conventional bolus insulin treatment in preschool aged children with Type 1 diabetes. - n/a
Phase 1
- Conditions
- Type 1 Diabetes Mellitus
- Registration Number
- EUCTR2005-004526-72-GB
- Lead Sponsor
- Addenbrooke's NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
Inclusion Criteria
i. Newly diagnosed Type 1 diabetes mellitus
ii. Age at diagnosis < 3.99 years
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
i. Neurological disability / handicap e.g. Cerebral palsy
ii. Gastrointestinal disease
iii. Chronic illness other than T1DM that may affect conduct of study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method