Gregory, John W, Townson, Julia, Channon, Sue, Cohen, David, Longo, Mirella, Davies, Justin, Harman, Nicola 
ORCID: 0000-0001-6958-6466, Hood, Kerenza, Pickles, Timothy, Playle, Rebecca et al (show 6 more authors)
(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 (12).
e032317-e032317.
Abstract
<jats:sec><jats:title>Objective</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Design</jats:title><jats:p>A multicentre randomised controlled trial (January 2008/October 2013).</jats:p></jats:sec><jats:sec><jats:title>Setting</jats:title><jats:p>Eight paediatric diabetes centres in England, Wales and Northern Ireland.</jats:p></jats:sec><jats:sec><jats:title>Participants</jats:title><jats:p>203 clinically well children aged under 17 years, with newly diagnosed type 1 diabetes and their carers.</jats:p></jats:sec><jats:sec><jats:title>Intervention</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Main outcome measures</jats:title><jats:p>Primary outcome was glycosylated haemoglobin (HbA1c) concentration at 24 months postdiagnosis. Secondary outcomes included coping, anxiety, quality of life and use of NHS resources.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Trial registration number</jats:title><jats:p><jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="ISRCTN78114042">ISRCTN78114042</jats:ext-link>.</jats:p></jats:sec>
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | Humans, Diabetes Mellitus, Type 1, Insulin, Hypoglycemic Agents, Hospitalization, Home Nursing, Adaptation, Psychological, Health Knowledge, Attitudes, Practice, Anxiety, Quality of Life, Adolescent, Child, Child, Preschool, Caregivers, Cost-Benefit Analysis, Disease Management, Female, Male, United Kingdom, Outcome Assessment, Health Care, Glycated Hemoglobin |
| Depositing User: | Symplectic Admin |
| Date Deposited: | 16 Dec 2019 10:35 |
| Last Modified: | 09 Feb 2023 06:07 |
| DOI: | 10.1136/bmjopen-2019-032317 |
| Open Access URL: | https://bmjopen.bmj.com/content/9/12/e032317 |
| Related URLs: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3066621 |
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