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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 |
| Source of record | UK Trials |
| ISRCTN | ISRCTN78114042 |
| Date ISRCTN assigned | 09/11/2007 |
| Local reference number(s) | N/A |
| 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 |
| Disease/condition/study domain | Type 1 Diabetes |
| 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. |
| Design/methodology | A multi-centre randomised controlled trial |
| Research ethics review | To be submitted to MREC for Wales on 30th August 2007. |
| Countries of trial | United Kingdom |
| 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 |
| Patient information material | |
| Anticipated start date | 01/01/2008 |
| Anticipated end date | 01/01/2012 |
| Status of trial | Ongoing |
| Target number of participants | 240 |
| Interventions | Patients will be randomised to either: 1. Home Management Hospital Managment 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 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 two 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) |
| Sponsor name | Cardiff University (UK) |
| Sponsor details | 30 - 36 Newport Road Cardiff United Kingdom CF24 0DE |
| Sponsor website | http://www.cf.ac.uk |
| Contact name | Dr Lesley Lowes |
| Contact details | Department Of Child Health University Hospital Of Wales Heath Park Cardiff United Kingdom CF14 4XW |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN78114042 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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