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Effectiveness of home or hospital initiation of treatment at diagnosis for children with type 1 diabetes (DECIDE trial): a multicentre individually randomised controlled trial

Gregory, John W. ORCID:, Townson, Julia ORCID:, Channon, Sue ORCID:, Cohen, David, Longo, Mirella ORCID:, Davies, Justin, Nicola, Harman, Hood, Kerenza ORCID:, Pickles, Timothy ORCID:, Playle, Rebecca ORCID:, Tabitha, Randell, Robling, Michael ORCID:, Morro, Touray, Trevelyan, Nicola, Warner, Justin and Lowes, Lesley ORCID: 2019. Effectiveness of home or hospital initiation of treatment at diagnosis for children with type 1 diabetes (DECIDE trial): a multicentre individually randomised controlled trial. BMJ Open 9 , e032317. 10.1136/bmjopen-2019-032317

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Objective: To determine whether, in children with newly diagnosed type 1 diabetes who were not acutely unwell, management at home for initiation of insulin treatment and education of the child and family, would result in improved clinical and psychological outcomes at 2 years postdiagnosis. Design: A multicentre randomised controlled trial (January 2008/October 2013). Setting: Eight paediatric diabetes centres in England, Wales and Northern Ireland. Participants: 203 clinically well children aged under 17 years, with newly diagnosed type 1 diabetes and their carers. Intervention: Management of the initiation period from diagnosis at home, for a minimum of 3 days, to include at least six supervised injections and delivery of pragmatic educational care. Main outcome measures: Primary outcome was glycosylated haemoglobin (HbA1c) concentration at 24 months postdiagnosis. Secondary outcomes included coping, anxiety, quality of life and use of NHS resources. Results: 203 children, newly diagnosed, were randomised to commence management at home (n=101) or in hospital (n=102). At the 24 month primary end point, there was one withdrawal and a follow-up rate of 194/202 (96%). Mean HbA1c in the home treatment arm was 72.1 mmol/mol and in the hospital treated arm 72.6 mmol/mol. There was a negligible difference between the mean HbA1c levels in the two arms adjusted for baseline (1.01, 95% CI 0.93 to 1.09). There were mostly no differences in secondary outcomes at 24 months, apart from better child self-esteem in the home-arm. No home-arm children were admitted to hospital during initiation and there were no adverse events at that time. The number of investigations was higher in hospital patients during the follow-up period. There were no differences in insulin regimens between the two arms. Conclusions: There is no evidence of a difference between home-based and hospital-based initiation of care in children newly diagnosed with type 1 diabetes across relevant outcomes.

Item Type: Article
Date Type: Publication
Status: Published
Schools: Medicine
Centre for Trials Research (CNTRR)
Additional Information: This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial.
Publisher: BMJ Publishing Group
ISSN: 2044-6055
Date of First Compliant Deposit: 4 November 2019
Date of Acceptance: 4 November 2019
Last Modified: 23 Feb 2024 03:44

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