Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lesley Lowes

ORCID ID

Contact details

Department Of Child Health
University Hospital Of Wales
Heath Park
Cardiff
CF14 4XW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

DECIDE

Study hypothesis

To determine whether, in children with newly diagnosed diabetes who are not acutely unwell, it is better to admit to hospital for initiation of insulin treatment and education of child and family, or whether results would be better if initial management was provided at home.

Ethics approval

Multi-centre Research Ethics Committee for Wales, 26/10/2007, ref: 07/MRE09/59

Study design

Multi-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Type 1 diabetes

Intervention

Patients will be randomised to either:
1. Home management
2. Hospital managment

Patients and their parents will be randomised on the day of diagnosis to receive their diabetes treatment from home or from hospital. Patients in the Hospital Management Group will be admitted for a minimum of three nights (receiving at least six supervised injections while hospitalised). Patients in the Home Management Group will be discharged home on day of diagnosis and treatment and support will be delivered at home for a minimum of three days (at least six supervised injections). All patients will receive the same care and at their 1, 12 and 24 month clinic visits follow-up data will be collected and when the patients HbA1c is being tested, extra blood will be taken to be sent off for HbA1c analysis at a central laboratory. At 1, 12 and 24 months post diagnosis patients aged greater than or equal to 8 years old and all parents will be asked to complete a questionnaire to assess psychological, social, physical or economic outcomes of home or hospital management. Children with type 1 diabetes have traditionally been hospitalised at diagnosis but are increasingly starting treatment at home. There is no high-quality evidence regarding psychological, social, physical or economic outcomes of home or hospital management.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Glycaemic control (HbA1c) over the 2 years post diagnosis.

Measurements will be taken at 0, 1, 12 and 24 months.

Secondary outcome measures

1. Clinical: growth (height, weight, body mass index [BMI]) and adverse events (e.g. severe hypoglycaemia)
2. Patient: quality of life, coping with diabetes, diabetes knowledge, satisfaction and time off school
3. Parent: anxiety, coping with diabetes, diabetes knowledge, satisfaction and time off work
4. Health professionals: experience of both approaches to care
5. Health resource usage: hospitalisation, home and clinic visits

Measurements will be taken at 0, 1, 12 and 24 months.

Overall trial start date

01/01/2008

Overall trial end date

01/01/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children aged 0 - 17 years old
2. Newly diagnosed type 1 diabetes (using recognised standard diagnostic criteria) who are clinically well (pH greater than 7.29) at presentation
3. Written informed consent given by parent(s)/carer/child and assent from child
4. Able to fill out study material (all parents and children aged greater than or equal to 8 years old)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

240

Participant exclusion criteria

1. Children with a coexisting chronic disorder (e.g., cystic fibrosis) which will impact significantly on blood glucose control
2. Children with type 2 diabetes
3. Children with Maturity Onset Diabetes of the Young (MODY)
4. Children with an uncertain diagnosis
5. Children who are under the care of the local authority
6. Children whose home circumstances are assessed as being unsuitable for home management
7. Children who require hospitalisation for reasons other than their diagnosis

Recruitment start date

01/01/2008

Recruitment end date

01/01/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department Of Child Health
Cardiff
CF14 4XW
United Kingdom

Sponsor information

Organisation

Cardiff University (UK)

Sponsor details

30 - 36 Newport Road
Cardiff
CF24 0DE
United Kingdom

Sponsor type

University/education

Website

http://www.cf.ac.uk

Funders

Funder type

Charity

Funder name

Diabetes UK (UK), ref: BDA:RD06/0003353

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21247461

Publication citations

  1. Protocol

    Townson JK, Gregory JW, Cohen D, Channon S, Harman N, Davies JH, Warner J, Trevelyan N, Playle R, Robling M, Hood K, Lowes L, Delivering early care in diabetes evaluation (DECIDE): a protocol for a randomised controlled trial to assess hospital versus home management at diagnosis in childhood diabetes., BMC Pediatr, 2011, 11, 7, doi: 10.1186/1471-2431-11-7.

Editorial Notes