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 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
01/01/2008
Overall trial end date
01/01/2012
Reason abandoned (if study stopped)
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
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
Basic results (scientific)
Publication list
2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21247461
Publication citations
-
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.