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dc.contributor.authorRuan, Yueen
dc.contributor.authorElleri, Danielaen
dc.contributor.authorAllen, Janeten
dc.contributor.authorTauschmann, Martinen
dc.contributor.authorWilinska, Malgorzataen
dc.contributor.authorDunger, Daviden
dc.contributor.authorHovorka, Romanen
dc.date.accessioned2015-02-17T15:28:02Z
dc.date.available2015-02-17T15:28:02Z
dc.date.issued2014-12-24en
dc.identifier.citationDiabetologia Volume 58, Issue 4, pp 687-690. DOI: 10.1007/s00125-014-3483-6en
dc.identifier.issn0012-186X
dc.identifier.urihttps://www.repository.cam.ac.uk/handle/1810/246832
dc.description.abstractAims/hypothesis The aim of this study was to compare the pharmacokinetics of two different concentrations of insulin aspart (B28Asp human insulin) in children aged 3–6 years with type 1 diabetes. Methods Young children with type 1 diabetes underwent an open-label, randomised, two-period crossover study in a clinical research facility, 2–6 weeks apart. In random order, diluted (1:5 dilution with saline [154 mmol/l NaCl]; 20 U/ml) or standard strength (100 U/ml) insulin aspart was administered via an insulin pump as a meal bolus and then overnight by closed-loop insulin delivery as determined by a model predictive algorithm. Plasma insulin was measured every 30–60 min from 17:00 hours on day 1 to 8:00 hours on day 2. We measured the time-to-peak insulin concentration (tmax), insulin metabolic clearance rate (MCRI) and background insulin concentration (insc) using compartmental modelling. Results Eleven children (six male; age range 3.75–6.96 years, HbA1c 7.6%±1.3% [60±14 mmol/mol], BMI standard deviation score 1.0±0.8, duration of diabetes 2.2±1.0 years, total daily dose 12.9 [10.6–16.5] U, fasting C-peptide concentration 5 [5–17.1] pmol/l; mean±SD or median [interquartile range]) participated in the study. No differences between standard and diluted insulin were observed in terms of tmax (59.2±14.4 vs 61.6±8.7) min for standard vs diluted, p=0.59; MCRI (1.98×10−2±0.99×10−2 vs 1.89×10−2±0.82×10−2 1/kg/min, p=0.47), and insc (34 [1–72] vs 23 [3–65] pmol/l, p=0.66). However, tmax showed less intersubject variability following administration of diluted aspart (SD 14.4 vs 8.7 min, p=0.047). Conclusions/interpretation Diluting insulin aspart does not change its pharmacokinetics. However, it may result in less variable absorption and could be used in young children with type 1 diabetes undergoing closed-loop insulin delivery. Trial registration: Clinicaltrials.gov NCT01557634 Funding: Funding was provided by the JDRF, 7th Framework Programme of the European Union,Wellcome Trust Strategic Award and the National Institute for Health Research Cambridge Biomedical Research Centre.
dc.description.sponsorshipFunding was provided by the JDRF (grant number 22-2011- 668), 7th Framework Programme of the European Union (Spidiman project; grant agreement number 305343), Wellcome Trust Strategic Award (100574/Z/12/Z) and the National Institute for Health Research Cambridge Biomedical Research Centre.
dc.languageEnglishen
dc.language.isoenen
dc.publisherSpringer
dc.rightsAttribution 2.0 UK: England & Wales*
dc.rights.urihttp://creativecommons.org/licenses/by/2.0/uk/*
dc.subjectAsparten
dc.subjectInsulin absorptionen
dc.subjectInsulin concentrationen
dc.subjectPharmacokineticsen
dc.subjectRapid-acting insulinen
dc.subjectType 1 diabetesen
dc.subjectYoung childrenen
dc.titlePharmacokinetics of diluted (U20) insulin aspart compared with standard (U100) in children aged 3–6 years with type 1 diabetes during closed-loop insulin delivery: a randomised clinical trialen
dc.typeArticle
dc.description.versionThis is the final published version. It first appeared at http://link.springer.com/article/10.1007%2Fs00125-014-3483-6.en
prism.endingPage690
prism.publicationDate2014en
prism.publicationNameDiabetologiaen
prism.startingPage687
prism.volume58en
dc.rioxxterms.funderEU FP7
dc.rioxxterms.funderWellcome Trust
dc.rioxxterms.funderNIHR
dc.rioxxterms.projectid22-2011-668
dc.rioxxterms.projectid305343
dc.rioxxterms.projectid100574/Z/12/Z
dcterms.dateAccepted2014-12-08en
rioxxterms.versionofrecord10.1007/s00125-014-3483-6en
rioxxterms.licenseref.urihttp://www.rioxx.net/licenses/all-rights-reserveden
rioxxterms.licenseref.startdate2014-12-24en
dc.contributor.orcidTauschmann, Martin [0000-0002-2305-2490]
dc.contributor.orcidWilinska, Malgorzata [0000-0003-2739-1753]
dc.contributor.orcidDunger, David [0000-0002-2566-9304]
dc.contributor.orcidHovorka, Roman [0000-0003-2901-461X]
dc.identifier.eissn1432-0428
rioxxterms.typeJournal Article/Reviewen
pubs.funder-project-idWellcome Trust (100574/Z/12/Z)
pubs.funder-project-idEC FP7 CP (305343)


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Attribution 2.0 UK: England & Wales
Except where otherwise noted, this item's licence is described as Attribution 2.0 UK: England & Wales