Subcutaneous Insulin: Pumps or Injections (SCIPI) Version Number 3.0
Research type
Research Study
Full title
A randomised controlled trial of continuous subcutaneous insulin infusion(CSII) compared to multiple daily injection(MDI) regimens on insulin in children and young people at diagnosis of type I diabetes mellitus (TIDM).
IRAS ID
64773
Contact name
Joanne Blair
Contact email
Sponsor organisation
Alder Hey Children's NHS Foundation Trust
Eudract number
2010-023792-25
ISRCTN Number
ISRCTN29255275
Duration of Study in the UK
3 years, 8 months, 0 days
Research summary
Subcutaneous Insulin: Pumps or Injections(SCIPI) trial is an open labelled randomized controlled trial to compare continuous subcutaneous insulin infusion (CSII) with multiple daily injections (MDI) of insulin in children and young people aged 7 months to 15 years who have been newly diagnosed with type I diabetes mellitus(TIDM).
Type I diabetes mellitus (TIDM) is a common disease of childhood. The daily management of TIDM is burdensome requiring two or more daily injections of insulin, blood glucose monitoring and dietary manipulation. However it is the long term vascular complications of the disease like heart and renal failure, minor and major amputation which increases the rate of disease, affect well being and leads to death.
The risk of acquiring these complications of TIDM is directly related to blood glucose control, duration of diabetes, insulin sensitivity and weight. So the aim of this study is to compare two methods of insulin delivery during childhood and adolescence to identify which facilitates superior blood glucose control, and to examine the impact of the treatments on other predictors of vascular complications of TIDM, safety (adverse events) and quality of life. We hope to recruit 316 newly diagnosed type 1 diabetes mellitus patients aged 7 months- 15 years at 10 paediatric outpatient clinics in the UK over 2 years. We hope that this study will provide an evidence base to inform future NHS investment in health care services for children and young people with TIDM.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
10/H1002/80
Date of REC Opinion
10 Feb 2011
REC opinion
Further Information Favourable Opinion