Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
18/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Carlo Acerini

ORCID ID

Contact details

Department of Paediatrics
Box No 116
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom
+44 (0)1223 336865
cla22@cam.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0544116582

Study information

Scientific title

Acronym

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

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

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

12/09/2002

Overall trial end date

11/09/2005

Reason abandoned

1. Lack of funding/sponsorship
2. Participant recruitment issue

Eligibility

Participant inclusion criteria

20 children <5 years with type 1 diabetes

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

20

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

12/09/2002

Recruitment end date

11/09/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Paediatrics
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes