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

ISRCTN	ISRCTN49814766
DOI	https://doi.org/10.1186/ISRCTN49814766
Protocol serial number	RRG5.7
Sponsor	University of Ulster (UK)
Funder	Northern Ireland Department of Health, Research and Development Office (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Vivien Coates
Scientific

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

Email	ve.coates@ulster.ac.uk

Primary study design	Interventional
Study design	Prospective randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	ESMON
Study objectives	Self 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) studied	Type two diabetes mellitus
Intervention	Self monitoring of blood glucose versus non-monitoring.
Intervention type	Other
Primary outcome measure(s)	1. Between-group differences in glycaemic control (HbA1c) 2. Between-group differences in psychological indices 3. Between-group differences in reported hypoglycaemia
Key secondary outcome measure(s)	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
Completion date	01/01/2006

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	200
Key inclusion criteria	1. Patients with newly diagnosed type two diabetes 2. Aged less than 70 years old
Key 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
Date of first enrolment	01/12/2000
Date of final enrolment	01/01/2006

School of Nursing

Coleraine
BT52 1SA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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