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 |
| Protocol serial number | N0544116582 |
| Sponsor | Department of Health (UK) |
| Funder | Cambridge Consortium - Addenbrookes (UK) (NHS R&D Support Funding + Addenbrooke's Charitable Funds) |
- 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 of protocol
Not provided at time of registration
Contact information
Dr Carlo Acerini
Scientific
Scientific
Department of Paediatrics
Box No 116
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom
| Phone | +44 (0)1223 336865 |
|---|---|
| cla22@cam.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion 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 | All |
| Target sample size at registration | 20 |
| Key inclusion criteria | 20 children <5 years with type 1 diabetes |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 12/09/2002 |
| Date of final enrolment | 11/09/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Paediatrics
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
