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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
ISRCTN ISRCTN78114042
DOI 10.1186/ISRCTN78114042
ClinicalTrials.gov identifier
EudraCT number
Public 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
Scientific title
Acronym DECIDE
Serial number at source N/A
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.
Lay summary Not provided at time of registration
Ethics approval Multi-centre Research Ethics Committee for Wales, 26/10/2007, ref: 07/MRE09/59
Study design Multi-centre randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Type 1 diabetes
Participants - 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)
Participants - 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
Anticipated start date 01/01/2008
Anticipated end date 01/01/2012
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 240
Interventions 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.
Primary outcome measure(s) Glycaemic control (HbA1c) over the 2 years post diagnosis.

Measurements will be taken at 0, 1, 12 and 24 months.
Secondary outcome measure(s) 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.
Sources of funding Diabetes UK (UK), ref: BDA:RD06/0003353
Trial website
Publications 2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21247461
Contact name Dr  Lesley  Lowes
  Address Department Of Child Health
University Hospital Of Wales
Heath Park
  City/town Cardiff
  Zip/Postcode CF14 4XW
  Country United Kingdom
Sponsor Cardiff University (UK)
  Address 30 - 36 Newport Road
  City/town Cardiff
  Zip/Postcode CF24 0DE
  Country United Kingdom
  Sponsor website: http://www.cf.ac.uk
Date applied 03/08/2007
Last edited 21/07/2014
Date ISRCTN assigned 09/11/2007
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