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
Protocol serial number	N/A
Sponsor	Cardiff University (UK)
Funder	Diabetes UK (UK), ref: BDA:RD06/0003353

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

Primary study design	Interventional
Study design	Multi-centre randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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 acronym	DECIDE
Study objectives	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(s)	Multi-centre Research Ethics Committee for Wales, 26/10/2007, ref: 07/MRE09/59
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Glycaemic control (HbA1c) over the 2 years post diagnosis. Measurements will be taken at 0, 1, 12 and 24 months.
Key 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.
Completion date	01/01/2012

Eligibility

Participant type(s)	Patient
Age group	Child
Upper age limit	17 Years
Sex	All
Target sample size at registration	240
Total final enrolment	203
Key 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)
Key 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
Date of first enrolment	01/01/2008
Date of final enrolment	01/01/2012

Locations

Countries of recruitment

United Kingdom
Wales

Study participating centre

Department Of Child Health

Cardiff
CF14 4XW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
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
Protocol article	protocol	19/01/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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.