Dettagli per singolo studio

DEC-NET Serial number GB264

Published online	30/06/2004 11.27.00
Last updated	06/03/2006 9.55.27

Other protocol ID number	N0544116582
This trial has been approved by an ethics committee
Current trial status	Open (actively recruiting new participants)
First subject enrolment Target N. of subjects	10/2003 20
Major Disease (ICD9 class)	DIABETES MELLITUS WITHOUT MENTION OF COMPLICATION, TYPE I
Experimental drug
Insulin Treatment regimen (dosage and duration) Continuous Subcutaneous Insulin Infusion (CSII)
Gender	Both
Age (range)	at diagnosis <3 years
Eligibility criteria
Inclusion criteria
Newly diagnosed children with Type 1 diabetes melitus(aged < 3 years)
Exclusion criteria
Other chronic illness
Trial design/methodology
Phase	3
Kind of study	Efficacy Safety
Design	Controlled Randomised
Purpose of study
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
Primary outcomes
1. Better blood glucose control
Secondary outcomes
1. Reduced hypoglycaemia frequency 2. Preserved endogenous insulin secretion 3. Improved quality of life measures
Summary of study design, objectives, and ongoing research findings
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 hour blood glucose profiles will be performed using a subcutaneous continuous glucose monitoring sensor (CGMS) device and parental QoL questionnaires will be completed.