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ISRCTN
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ISRCTN47464659
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ClinicalTrials.gov identifier
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Public title
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A randomised controlled trial to determine the effect of blood glucose self-monitoring in people with type two diabetes
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Scientific title
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Acronym
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DiGEM
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Serial number at source
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HTA 01/38/05
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Study hypothesis
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Tight blood glucose control is recommended for many people with type two diabetes to delay and prevent the occurrence of complications. Glycaemic monitoring is required to attain this objective and current guidelines suggest that HbA1c levels below 7% should be achieved where possible. Although many people find that checking-blood glucose levels at home is a helpful way to undertake glycaemic monitoring, there is a need for more evidence to support its systematic use among people with type two diabetes. Previous trials have been small and have not incorporated a consistent approach to applying the results of tests to lifestyle. The aim of this open randomised controlled trial is to compare the use of blood glucose self monitoring to the standard practice of intermittent HbA1c checks in people managing their type two diabetes with diet or oral hypoglycaemic tablets. All patients will receive additional information about managing their diabetes. Patients randomised to blood glucose testing will be trained in the use of the blood glucose meters and given additional support to help them interpret the results in relation to the measures they are undertaking to improve HbA1c.
The main outcome is HbA1c levels in the different groups, with additional measurement of other risk factors for cardiovascular disease, satisfaction with care, quality of life and costs of care. In addition to a direct comparison of the different groups, the study will inform routine clinical practice by an exploratory study of those people who might gain particular benefit from using different techniques to check glycaemic control and a series of in-depth interviews with study participants.
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Lay summary
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Ethics approval
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The study protocol was approved by the Oxfordshire B Research Ethics Committee.
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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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Type two diabetes
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Participants - inclusion criteria
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1. Aged 25 or above
2. With type two diabetes
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Participants - exclusion criteria
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1. Use of blood glucose monitor twice a week or more often over the previous three months
2. Current use of insulin
3. Co-morbidity or limited life expectancy that would make intensive glycaemic control inappropriate
4. Last clinic HbA1c or HbA1c at the assessment visit less than 6.2%
5. Unable to follow trial procedures
6. Not independent for activities of daily living
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Anticipated start date
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01/10/2002
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Anticipated end date
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31/03/2007
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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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48 general practices in Oxfordshire and South Yorkshire; 453 patients
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Interventions
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Please note that, as of 15 January 2008, the end date of this trial has been updated from 30 June 2005 to 31 March 2007.
Interventions:
1. Control arm: three-monthly HbA1c measurement
2. Monitoring arm: use of blood glucose monitor and clinician interpretation of results
3. Intensive arm: use of blood glucose monitor, patient interpretation of results and application to lifestyle
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Primary outcome measure(s)
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The primary outcome measure is HbA1c, while additional outcome measures include blood pressure, cholesterol, self-reported smoking status, frequency of hypoglycaemia, symptom severity, changes in oral hypoglycaemic medication, addition of insulin to medication regimens and changes in Diabetes Treatment Satisfaction, Diabetes Self Care Activities and Well-being Questionnaire scales at one year.
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Secondary outcome measure(s)
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1. Change in systolic and diastolic blood pressure
2. Weight
3. Serum cholesterol and High Density Lipoprotein (HDL)
4. Self-reported smoking status
5. Dietary intake and physical activity (the Diabetes Self Care Activities Questionnaire)
6. Medication adherence (the Medication Adherence Rating Scale)
7. Scores in the Diabetes Treatment Satisfaction Questionnaire and the Well-being Questionnaire (12 item)
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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http://www.herc.ox.ac.uk/research/trials/digem.shtml
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Publications
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1. 2009 HTA monograph: http://www.ncbi.nlm.nih.gov/pubmed/19254484
2. 2008 economic evaluation in http://www.ncbi.nlm.nih.gov/pubmed/18420663
3. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17591623
4. 2005 protocol in http://www.ncbi.nlm.nih.gov/pubmed/15960852
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Contact name
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Dr
Andrew
Farmer
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Address
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Institute of Health Sciences
Roosevelt Drive
Headington
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City/town
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Oxford
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Zip/Postcode
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OX3 7LF
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Country
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United Kingdom
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Tel
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+44 (0)1865 226 768
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Fax
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+44 (0)1865 227 036
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Email
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andrew.farmer@dphpc.ox.ac.uk
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Sponsor
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Department of Health (UK)
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Address
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Quarry House
Quarry Hill
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City/town
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Leeds
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Zip/Postcode
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LS2 7UE
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Country
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United Kingdom
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Tel
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+44 (0)23 8059 5586
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Fax
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+44 (0)23 8059 5639
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Email
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Sheila.Greener@doh.gsi.gov.uk
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Sponsor website:
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http://www.dh.gov.uk/en/index.htm
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Date applied
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13/01/2004
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Last edited
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07/05/2009
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Date ISRCTN assigned
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13/01/2004
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