Condition category
Nutritional, Metabolic, Endocrine
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Lesley Lowes


Contact details

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

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Delivering Early Care In Diabetes Evaluation (DECIDE): To assess hospital versus home management at diagnosis in childhood type 1 diabetes - a comparison of psychological, social, physical and economic outcomes



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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

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


Type 1 diabetes


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



Not Applicable

Drug names

Primary outcome measure

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


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Department Of Child Health
CF14 4XW
United Kingdom

Sponsor information


Cardiff University (UK)

Sponsor details

30 - 36 Newport Road
CF24 0DE
United Kingdom

Sponsor type




Funder type


Funder name

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

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit


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

Basic results (scientific)

Publication list

1. 2011 protocol in:
2. 2016 results in:

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.

Additional files

Editorial Notes

04/10/2018: Publication reference added.