A randomised study of continuous subcutaneous insulin infusion (CSII) therapy compared to conventional bolus insulin treatment in preschool aged children with Type 1 diabetes

ISRCTN	ISRCTN77773974
DOI	https://doi.org/10.1186/ISRCTN77773974
Secondary identifying numbers	N0544116582

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 18/11/2009

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Not provided at time of registration

Contact information

Dr Carlo Acerini
Scientific

Department of Paediatrics
Box No 116
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom

Phone	+44 (0)1223 336865
Email	cla22@cam.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study hypothesis	To establish whether treatment with CSII therapy results in better blood glucose control, reduced hypoglycaemia frequency, preserved endogenous insulin secretion and in improved quality of life measures in parents and families of preschool aged children with diabetes, compared to those treated with conventional bolus subcutaneous insulin injection (CIT) regimens.
Ethics approval(s)	Not provided at time of registration
Condition	Diabetes
Intervention	Randomised Controlled trial: A. Continuous subcutaneous insulin infusion (CSII) B. Conventional bolus insulin treatment This study aims to establish whether continuous subcutaneous insulin infusion (CSII) therapy has advantages over conventional bolus insulin injection treatment (CIT) in children less than 5 years of age with Type 1 (insulin dependent) diabetes mellitus, particularly in terms of improved blood glucose control, reduced hypoglycaemia frequency and improved parental quality of life (QoL) measures. A randomised controlled study will be carried out, with newly diagnosed children with diabetes (aged <5 years) assigned to treatment with either CSII (n = 10) or CIT (n= 10). All participating children and their families will be regularly reviewed in the diabetes clinic setting and will have support from the paediatric diabetes team as per normal clinical routine. At 3 to 6 month intervals 24 h blood glucose profiles will be performed using a subcutaneous continuous glucose monitoring sensor (CGMS) device and parental QoL questionnaires will be completed.
Intervention type	Other
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	12/09/2002
Overall study end date	11/09/2005
Reason abandoned (if study stopped)	1. Lack of funding/sponsorship 2. Participant recruitment issue

Eligibility

Participant type(s)	Patient
Age group	Child
Upper age limit	5 Years
Sex	Both
Target number of participants	20
Participant inclusion criteria	20 children <5 years with type 1 diabetes
Participant exclusion criteria	Does not match inclusion criteria
Recruitment start date	12/09/2002
Recruitment end date	11/09/2005

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Paediatrics

Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Government

Cambridge Consortium - Addenbrookes (UK) (NHS R&D Support Funding + Addenbrooke's Charitable Funds)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan