Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Andrew Farmer
ORCID ID
Contact details
Institute of Health Sciences
Roosevelt Drive
Headington
Oxford
OX3 7LF
United Kingdom
+44 (0)1865 226 768
andrew.farmer@dphpc.ox.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 01/38/05
Study information
Scientific title
Acronym
DiGEM
Study hypothesis
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.
Ethics approval
The study protocol was approved by the Oxfordshire B Research Ethics Committee.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Condition
Type two diabetes
Intervention
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
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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.
Secondary outcome measures
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)
Overall trial start date
01/10/2002
Overall trial end date
31/03/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 25 or above
2. With type two diabetes
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
48 general practices in Oxfordshire and South Yorkshire; 453 patients
Participant exclusion criteria
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
Recruitment start date
01/10/2002
Recruitment end date
31/03/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Institute of Health Sciences
Oxford
OX3 7LF
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)23 8059 5586
Sheila.Greener@doh.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
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
Publication citations
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Protocol
Farmer A, Wade A, French DP, Goyder E, Kinmonth AL, Neil A, The DiGEM trial protocol--a randomised controlled trial to determine the effect on glycaemic control of different strategies of blood glucose self-monitoring in people with type 2 diabetes [ISRCTN47464659]., BMC Fam Pract, 2005, 6, 25, doi: 10.1186/1471-2296-6-25.
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Farmer AJ, Wade AN, French DP, Simon J, Yudkin P, Gray A, Craven A, Goyder L, Holman RR, Mant D, Kinmonth AL, Neil HA, , Blood glucose self-monitoring in type 2 diabetes: a randomised controlled trial., Health Technol Assess, 2009, 13, 15, iii-iv, ix-xi, 1-50, doi: 10.3310/hta13150.
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Simon J, Gray A, Clarke P, Wade A, Neil A, Farmer A, , Cost effectiveness of self monitoring of blood glucose in patients with non-insulin treated type 2 diabetes: economic evaluation of data from the DiGEM trial., BMJ, 2008, 336, 7654, 1177-1180, doi: 10.1136/bmj.39526.674873.BE.
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Farmer A, Wade A, Goyder E, Yudkin P, French D, Craven A, Holman R, Kinmonth AL, Neil A, Impact of self monitoring of blood glucose in the management of patients with non-insulin treated diabetes: open parallel group randomised trial., BMJ, 2007, 335, 7611, 132, doi: 10.1136/bmj.39247.447431.BE.