Contact information
Type
Scientific
Primary contact
Prof Vivien Coates
ORCID ID
Contact details
School of Nursing
University of Ulster
Coleraine campus
Coleraine
BT52 1SA
United Kingdom
ve.coates@ulster.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RRG5.7
Study information
Scientific title
Acronym
ESMON
Study hypothesis
Self blood glucose monitoring is not associated with benefit in terms of improved glycaemic control or psychological indices.
Ethics approval
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
Study design
Prospective randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Condition
Type two diabetes mellitus
Intervention
Self monitoring of blood glucose versus non-monitoring.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Between-group differences in glycaemic control (HbA1c)
2. Between-group differences in psychological indices
3. Between-group differences in reported hypoglycaemia
Secondary outcome measures
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
Overall trial start date
01/12/2000
Overall trial end date
01/01/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients with newly diagnosed type two diabetes
2. Aged less than 70 years old
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant exclusion criteria
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
Recruitment start date
01/12/2000
Recruitment end date
01/01/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Nursing
Coleraine
BT52 1SA
United Kingdom
Sponsor information
Organisation
University of Ulster (UK)
Sponsor details
c/o Prof Vivien Coates
School of Nursing
Coleraine campus
Coleraine
BT52 1SA
United Kingdom
ve.coates@ulster.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Northern Ireland Department of Health, Research and Development Office (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
Results - basic reporting
Publication summary
Results in http://www.ncbi.nlm.nih.gov/pubmed/18420662
Publication citations
-
Results
O'Kane MJ, Bunting B, Copeland M, Coates VE, , Efficacy of self monitoring of blood glucose in patients with newly diagnosed type 2 diabetes (ESMON study): randomised controlled trial., BMJ, 2008, 336, 7654, 1174-1177, doi: 10.1136/bmj.39534.571644.BE.