The Efficacy of Self-MONitoring of blood glucose in patients with type two diabetes mellitus
ISRCTN | ISRCTN49814766 |
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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
Scientific
School of Nursing
University of Ulster
Coleraine campus
Coleraine
BT52 1SA
United Kingdom
ve.coates@ulster.ac.uk |
Study information
Study design | Prospective randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Screening |
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 | 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 study start date | 01/12/2000 |
Completion date | 01/01/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 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 |
Locations
Countries of recruitment
- Northern Ireland
- United Kingdom
Study participating centre
School of Nursing
Coleraine
BT52 1SA
United Kingdom
BT52 1SA
United Kingdom
Sponsor information
University of Ulster (UK)
University/education
University/education
c/o Prof Vivien Coates
School of Nursing
Coleraine campus
Coleraine
BT52 1SA
Northern Ireland
United Kingdom
ve.coates@ulster.ac.uk | |
Website | http://www.ulster.ac.uk |
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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 |