The Efficacy of Self-MONitoring of blood glucose in patients with type two diabetes mellitus

ISRCTN ISRCTN49814766
DOI https://doi.org/10.1186/ISRCTN49814766
Secondary identifying numbers RRG5.7
Submission date
08/01/2007
Registration date
26/02/2007
Last edited
21/04/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Vivien Coates
Scientific

School of Nursing
University of Ulster
Coleraine campus
Coleraine
BT52 1SA
United Kingdom

Email ve.coates@ulster.ac.uk

Study information

Study designProspective randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeScreening
Scientific title
Study acronymESMON
Study objectivesSelf blood glucose monitoring is not associated with benefit in terms of improved glycaemic control or psychological indices.
Ethics approval(s)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
Health condition(s) or problem(s) studiedType two diabetes mellitus
InterventionSelf monitoring of blood glucose versus non-monitoring.
Intervention typeOther
Primary outcome measure1. Between-group differences in glycaemic control (HbA1c)
2. Between-group differences in psychological indices
3. Between-group differences in reported hypoglycaemia
Secondary outcome measures1. 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 study start date01/12/2000
Completion date01/01/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants200
Key inclusion criteria1. Patients with newly diagnosed type two diabetes
2. Aged less than 70 years old
Key exclusion criteria1. 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
Date of first enrolment01/12/2000
Date of final enrolment01/01/2006

Locations

Countries of recruitment

  • Northern Ireland
  • United Kingdom

Study participating centre

School of Nursing
Coleraine
BT52 1SA
United Kingdom

Sponsor information

University of Ulster (UK)
University/education

c/o Prof Vivien Coates
School of Nursing
Coleraine campus
Coleraine
BT52 1SA
Northern Ireland
United Kingdom

Email ve.coates@ulster.ac.uk
Website http://www.ulster.ac.uk
ROR logo "ROR" https://ror.org/01yp9g959

Funders

Funder type

Government

Northern Ireland Department of Health, Research and Development Office (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 24/05/2008 Yes No