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
Scientific
Department Of Child Health
University Hospital Of Wales
Heath Park
Cardiff
CF14 4XW
United Kingdom
Study information
| Study design | Multi-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/01/2008 |
| Completion date | 01/01/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 17 Years |
| Sex | Both |
| Target number of participants | 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
CF14 4XW
United Kingdom
Sponsor information
Cardiff University (UK)
University/education
University/education
30 - 36 Newport Road
Cardiff
CF24 0DE
Wales
United Kingdom
| Website | http://www.cf.ac.uk |
|---|---|
"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)
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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.
