Condition category
Nutritional, Metabolic, Endocrine
Date applied
08/01/2007
Date assigned
26/02/2007
Last edited
21/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.ulster.ac.uk

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

  1. 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.

Additional files

Editorial Notes