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ISRCTN
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ISRCTN49814766
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ClinicalTrials.gov identifier
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Public title
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The Efficacy of Self-MONitoring of blood glucose in patients with type two diabetes mellitus
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Scientific title
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Acronym
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ESMON
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Serial number at source
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RRG5.7
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Study hypothesis
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Self blood glucose monitoring is not associated with benefit in terms of improved glycaemic control or psychological indices.
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Ethics approval
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Ethics approval received from:
1. University of Ulster Ethics Committee on the 17th August 2001 (ref: 01/29)
2. Altnagelvin Hospitals Health and Social Services Trust on the 14th June 2000
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Study design
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Prospective 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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Type two diabetes mellitus
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Participants - inclusion criteria
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1. Patients with newly diagnosed type two diabetes
2. Aged less than 70 years old
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Participants - exclusion criteria
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1. Secondary diabetes
2. Insulin use
3. Previous monitoring
4. Pregnancy
5. Previous malignancy
6. Major illness within 6 months (including major surgery, myocardial infarction (MI), acute coronary syndrome, stroke, acute limb ischaemia)
7. Liver disease
8. Creatinine > 150 µmol/L
9. Proteinuria > 0.5 g/ 24 h
10. Chronic use of oral steroids
11. Alcohol abuse
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Anticipated start date
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01/12/2000
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Anticipated end date
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01/01/2006
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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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200
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Interventions
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Self monitoring of blood glucose versus non-monitoring.
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Primary outcome measure(s)
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1. Between-group differences in glycaemic control (HbA1c)
2. Between-group differences in psychological indices
3. Between-group differences in reported hypoglycaemia
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Secondary outcome measure(s)
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1. Between-group differences in body mass index (BMI)
2. Between-group differences in oral hypoglycaemic drug usage
3. Longitudinal within-group changes in HbA1c, BMI and psychological indices
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Sources of funding
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Northern Ireland Department of Health, Research and Development Office (UK)
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/18420662
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Contact name
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Prof
Vivien
Coates
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Address
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School of Nursing
University of Ulster
Coleraine campus
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City/town
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Coleraine
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Zip/Postcode
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BT52 1SA
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Country
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United Kingdom
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Email
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ve.coates@ulster.ac.uk
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Sponsor
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University of Ulster (UK)
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Address
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c/o Prof Vivien Coates
School of Nursing
Coleraine campus
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City/town
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Coleraine
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Zip/Postcode
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BT52 1SA
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Country
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United Kingdom
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Email
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ve.coates@ulster.ac.uk
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Sponsor website:
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http://www.ulster.ac.uk
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Date applied
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08/01/2007
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Last edited
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21/04/2008
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Date ISRCTN assigned
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26/02/2007
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