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ISRCTN
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ISRCTN71877586
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ClinicalTrials.gov identifier
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Public title
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A multi-centre randomised trial of insulin detemir in pre-diabetes associated with cystic fibrosis
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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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SCH-05-015
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Study hypothesis
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To establish a better methodology for identifying patients with Cystic Fibrosis Related Diabetes mellitus (CFRD) and to show that early treatment produces clinical benefits.
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Ethics approval
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Approved by West Midlands Research Ethics Committee on 17 October 2005.
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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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Cystic Fibrosis Related Diabetes mellitus (CFRD)
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Participants - inclusion criteria
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Any child over ten years of age with either fasting plasma glucose more than 6.1 mmol/l but less than 7.0 mmol/l and/or a two hour glucose of more than 7.8 mmol/l but less than 11.1 mmol/l.
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Participants - exclusion criteria
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1. Failure to provide informed consent
2. Pre-existing insulin or oral hypoglycaemic agent treatment
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Anticipated start date
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01/10/2006
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Anticipated end date
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01/11/2009
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Status of trial
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Ongoing
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Patient information material
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Target number of participants
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240
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Interventions
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Children will be randomised to receive Insulin detemir 0.2 units per kg body weight by once daily subcutanous injection daily for one year. The control group will receive no intervention. There is no placebo or sham treatment (it was not felt appropriate given that it would require a daily injection).
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Primary outcome measure(s)
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Measurements of beta-cell function
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Secondary outcome measure(s)
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1. Height, weight, Body Mass Index (BMI), triceps and biceps skin fold thickness
2. Respiratory function testing
3. Three monthly glycosylated haemoglobin
4. Adverse event monitoring
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Sources of funding
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1. British Society of Paediatric Endocrinology and Diabetes (UK) - Initial funding of £10,000 in November 2004
2. Sheffield Children's Appeal Charity (UK) - £32,000 in early 2005
3. Novo Nordisk (UK) - the makers of Detemir; £72,000 (post MREC approval) in summer 2005
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Trial website
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Publications
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Contact name
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Dr
Neil
Wright
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Address
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Sheffield Children's NHS Foundation Trust
Academic Unit of Child Health
C Floor Stephenson Wing
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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Sponsor
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Sheffield Children's NHS Foundation Trust (UK)
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Address
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Clinical Research Support Unit
D41 Stephenson Wing
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 2260507
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Fax
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+44 (0)114 2717417
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Email
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vee.mapunde@sch.nhs.uk
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Sponsor website:
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http://www.sheffieldchildrens.nhs.uk/
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Date applied
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19/09/2006
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Last edited
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27/06/2007
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Date ISRCTN assigned
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27/06/2007
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