Computer-determined dosage of insulin in the management of neonatal hyperglycaemia (HINT2): protocol of a randomised controlled trial

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dc.contributor.author Alsweiler, J en
dc.contributor.author Williamson, K en
dc.contributor.author Bloomfield, Francis en
dc.contributor.author Chase, G en
dc.contributor.author Harding, Jane en
dc.date.accessioned 2017-06-25T21:34:46Z en
dc.date.issued 2017-03-06 en
dc.identifier.citation BMJ open 7(3):e012982 06 Mar 2017 en
dc.identifier.issn 2044-6055 en
dc.identifier.uri http://hdl.handle.net/2292/33729 en
dc.description.abstract Neonatal hyperglycaemia is frequently treated with insulin, which may increase the risk of hypoglycaemia. Computer-determined dosage of insulin (CDD) with the STAR-GRYPHON program uses a computer model to predict an effective dose of insulin to treat hyperglycaemia while minimising the risk of hypoglycaemia. However, CDD models can require more frequent blood glucose testing than common clinical protocols. The aim of this trial is to determine if CDD using STAR-GRYPHON reduces hypoglycaemia in hyperglycaemic preterm babies treated with insulin independent of the frequency of blood glucose testing.Design: Multicentre, non-blinded, randomised controlled trial.Neonatal intensive care units in New Zealand and Australia.138 preterm babies ≤30 weeks' gestation or ≤1500 g at birth who develop hyperglycaemia (two consecutive blood glucose concentrations ≥10 mmol/L, at least 4 hours apart) will be randomised to one of three groups: (1) CDD using the STAR-GRYPHON model-based decision support system: insulin dose and frequency of blood glucose testing advised by STAR-GRYPHON, with a maximum testing interval of 4 hours; (2) bedside titration: insulin dose determined by medical staff, maximum blood glucose testing interval of 4 hours; (3) standard care: insulin dose and frequency of blood glucose testing determined by medical staff. The target range for blood glucose concentrations is 5-8 mmol/L in all groups. A subset of babies will have masked continuous glucose monitoring.is the number of babies with one or more episodes of hypoglycaemia (blood glucose concentration <2.6 mmol/L), during treatment with insulin.This protocol has been approved by New Zealand's Health and Disability Ethics Committee: 14/STH/26. A data safety monitoring committee has been appointed to oversee the trial. Findings will be disseminated to participants and carers, peer-reviewed journals, guideline developers and the public.12614000492651. en
dc.format.medium Electronic en
dc.language eng en
dc.publisher BMJ Journals en
dc.relation.ispartofseries BMJ Open en
dc.rights Items in ResearchSpace are protected by copyright, with all rights reserved, unless otherwise indicated. Previously published items are made available in accordance with the copyright policy of the publisher. Details obtained from http://www.sherpa.ac.uk/romeo/issn/2044-6055/ en
dc.rights.uri https://researchspace.auckland.ac.nz/docs/uoa-docs/rights.htm en
dc.rights.uri https://creativecommons.org/licenses/by-nc/4.0/ en
dc.title Computer-determined dosage of insulin in the management of neonatal hyperglycaemia (HINT2): protocol of a randomised controlled trial en
dc.type Journal Article en
dc.identifier.doi 10.1136/bmjopen-2016-012982 en
pubs.issue 3 en
pubs.volume 7 en
dc.description.version VoR - Version of Record en
dc.rights.holder Copyright: The authors en
dc.identifier.pmid 28264826 en
dc.rights.accessrights http://purl.org/eprint/accessRights/OpenAccess en
pubs.subtype Article en
pubs.elements-id 616921 en
pubs.org-id Liggins Institute en
pubs.org-id LiFePATH en
pubs.org-id Medical and Health Sciences en
pubs.org-id School of Medicine en
pubs.org-id Paediatrics Child & Youth Hlth en
dc.identifier.eissn 2044-6055 en
pubs.number e012982 en
pubs.record-created-at-source-date 2017-06-26 en
pubs.dimensions-id 28264826 en


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