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ISRCTN
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ISRCTN22414310
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ClinicalTrials.gov identifier
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Public title
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Does oral terbutaline prevent asymptomatic nocturnal hypoglycaemia in children with insulin dependent diabetes mellitus in a clinical setting?
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0220093140
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Study hypothesis
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Does oral terbutaline prevent asymptomatic nocturnal hypoglycaemia in children with diabetes?
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Diabetes
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Participants - inclusion criteria
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Twenty-five diabetic children will be recruited from the population attending the diabetes clinic in Sheffield.
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Participants - exclusion criteria
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Does not match inclusion criteria
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Anticipated start date
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01/11/2002
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Anticipated end date
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28/02/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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25
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Interventions
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Twenty-five diabetic children will be recruited from the population attending the diabetes clinic in Sheffield. They will be visited at home on three separate occasions by a diabetes research nurse. Following either placebo or one of two doses of terbutaline at bedtime, their blood sugar will be measured every half hour overnight whilst they sleep. Blood samples will be taken from a cannula sited in a vein on the back of the hand after application of an anaesthetic cream. The day before and the day after the overnight study, each child will be asked to do several finger prick glucose measurements using both their usual glucose meter and dried blood spots on to paper. The child's routine should be only minimally disrupted.
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Primary outcome measure(s)
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The main outcome measures are:
1. Differences in the number of nights when hypoglycaemia occurs between placebo and terbutaline treatment
2. The effect on blood sugar assessed by comparing the children¿s home blood glucose measurements before/after the bedtime dose
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Sheffield Childrens Hospital NHS Trust (UK)
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Trial website
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Publications
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Contact name
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Dr
NP
Wright
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Address
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Division of Child Health
Sheffield Children's Hospital
Western Bank
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City/town
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Sheffield
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Zip/Postcode
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S10 2TH
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Country
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United Kingdom
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Tel
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+44 (0)114 222 2000
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Fax
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+44 (0)114 271 7531
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Email
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N.P.Wright@sheffield.ac.uk
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Sponsor
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Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)207 307 2622
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Fax
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+44 (0)207 307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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12/09/2003
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Last edited
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24/11/2009
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Date ISRCTN assigned
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12/09/2003
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