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 https://doi.org/10.1186/ISRCTN78114042
Secondary identifying numbers N/A
Submission date
03/08/2007
Registration date
09/11/2007
Last edited
21/05/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Lesley Lowes
Scientific

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

Study information

Study designMulti-centre randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleDelivering 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 acronymDECIDE
Study objectivesTo 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(s)Multi-centre Research Ethics Committee for Wales, 26/10/2007, ref: 07/MRE09/59
Health condition(s) or problem(s) studiedType 1 diabetes
InterventionPatients 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 typeOther
Primary outcome measureGlycaemic control (HbA1c) over the 2 years post diagnosis.

Measurements will be taken at 0, 1, 12 and 24 months.
Secondary outcome measures1. 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 study start date01/01/2008
Completion date01/01/2012

Eligibility

Participant type(s)Patient
Age groupChild
Upper age limit17 Years
SexBoth
Target number of participants240
Total final enrolment203
Key inclusion criteria1. 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)
Key exclusion criteria1. 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
Date of first enrolment01/01/2008
Date of final enrolment01/01/2012

Locations

Countries of recruitment

  • United Kingdom
  • Wales

Study participating centre

Department Of Child Health
Cardiff
CF14 4XW
United Kingdom

Sponsor information

Cardiff University (UK)
University/education

30 - 36 Newport Road
Cardiff
CF24 0DE
Wales
United Kingdom

Website http://www.cf.ac.uk
ROR logo "ROR" https://ror.org/03kk7td41

Funders

Funder type

Charity

Diabetes UK (UK), ref: BDA:RD06/0003353
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
DIABETES UK LIMITED, British Diabetic Association
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 19/01/2011 Yes No
Results article results 01/01/2016 Yes No
Results article results 03/12/2019 05/11/2020 Yes No
Results article cost-effectiveness results 19/05/2021 21/05/2021 Yes No

Editorial Notes

21/05/2021: Publication reference added.
05/11/2020: Publication reference and total final enrolment number added.
04/10/2018: Publication reference added.