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Delivering early care in diabetes evaluation (DECIDE): a protocol for a randomised controlled trial to assess hospital versus home management at diagnosis in childhood diabetes

Record type: Article

Background: There is increased incidence of new cases of type 1 diabetes in children younger than 15 years. The debate concerning where best to manage newly diagnosed children continues. Some units routinely admit children to hospital whilst others routinely manage children at home. A Cochrane review identified the need for a large well-designed randomised controlled trial to investigate any significant differences in comprehensive short and long-term outcomes between the two approaches. The DECIDE study will address these knowledge gaps, providing high quality evidence to inform national and international policy and practice.

Methods/Design: This is a multi-centre randomised controlled trial across eight UK paediatric diabetes centres. The study aims to recruit 240 children newly diagnosed with type 1 diabetes and their parents/carers. Eligible patients (aged 0-17 years) will be remotely randomised to either 'hospital' or 'home' management. Parents/carers of patients will also be recruited. Nursing management of participants and data collection will be co-ordinated by a project nurse at each centre. Data will be collected for 24 months after diagnosis; at follow up appointments at 3, 12 and 24 months and every 3-4 months at routine clinic visits.

The primary outcome measure is patients' glycosylated haemoglobin (HbA1c) at 24 months after diagnosis. Additional measurements of HbA1c will be made at diagnosis and 3 and 12 months later. HbA1c concentrations will be analysed at a central laboratory.

Secondary outcome measures include length of stay at diagnosis, growth, adverse events, quality of life, anxiety, coping with diabetes, diabetes knowledge, home/clinic visits, self-care activity, satisfaction and time off school/work. Questionnaires will be sent to participants at 1, 12 and 24 months and will include a questionnaire, developed and validated to measure impact of the diagnosis on social activity and independence. Additional qualitative outcome measures include the experience of both approaches by a subgroup of participants (n = 30) and health professionals. Total health service costs will be evaluated. A cost effectiveness analysis will assess direct and indirect health service costs against the primary outcome (HbA1c).

Discussion: This will be the first randomised controlled trial to evaluate hospital and home management of children newly diagnosed with type 1 diabetes and the findings should provide important evidence to inform practice and national guidelines.

Trial registration number
ISRCTN: ISRCTN78114042

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Citation

Townson, Julia K., Gregory, John W., Cohen, David, Channon, Sue, Harman, Nicola, Davies, Justin H., Warner, Justin, Trevelyan, Nicola, Playle, Rebecca, Robling, Michael, Hood, Kerenza and Lowes, Lesley (2011) Delivering early care in diabetes evaluation (DECIDE): a protocol for a randomised controlled trial to assess hospital versus home management at diagnosis in childhood diabetes BMC Pediatrics, 11, (1), p. 7. (doi:10.1186/1471-2431-11-7). (PMID:21247461).

More information

Published date: 19 January 2011

Identifiers

Local EPrints ID: 179403
URI: http://eprints.soton.ac.uk/id/eprint/179403
ISSN: 1471-2431
PURE UUID: f6913634-5d43-491a-bb03-f2f59ce0c96d

Catalogue record

Date deposited: 01 Apr 2011 10:16
Last modified: 18 Jul 2017 12:03

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Contributors

Author: Julia K. Townson
Author: John W. Gregory
Author: David Cohen
Author: Sue Channon
Author: Nicola Harman
Author: Justin Warner
Author: Nicola Trevelyan
Author: Rebecca Playle
Author: Michael Robling
Author: Kerenza Hood
Author: Lesley Lowes

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