Efficacy of self monitoring of blood glucose in patients with newly diagnosed type 2 diabetes (ESMON study): randomised controlled trial

doi:10.1136/bmj.39534.571644.BE

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Maurice J O’Kane, consultant1,
Brendan Bunting, professor2,
Margaret Copeland, trial manager3,
Vivien E Coates, professor3
on behalf of the ESMON study group

¹Department of Clinical Chemistry, Altnagelvin Hospital, Western Health and Social Care Trust, Londonderry, Northern Ireland
²Psychology Research Institute, University of Ulster, Londonderry, Northern Ireland
³Institute of Nursing Research, University of Ulster, Coleraine, Northern Ireland

Correspondence to: M J O’Kane Maurice.OKane{at}westerntrust.hscni.net

Accepted 21 March 2008

Abstract

Objectives To assess the effect of self monitoring of blood glucose concentrations on glycaemic control and psychological indices in patients with newly diagnosed type 2 diabetes mellitus.

Design Prospective randomised controlled trial of self monitoring versus no monitoring (control).

Setting Hospital diabetes clinics.

Participants 184 (111 men) people aged <70 with newly diagnosed type 2 diabetes referred to the participating diabetes clinics. Major exclusion criteria were secondary diabetes, insulin treatment, previous self monitoring of blood glucose.

Interventions Participants were randomised to self monitoring or no monitoring (control) groups for one year with follow-up at three monthly intervals. Both groups underwent an identical structured core education programme. The self monitoring group received additional education on monitoring.

Main outcome measures Between group differences in HbA_1c, psychological indices, use of oral hypoglycaemic drugs, body mass index (BMI), and reported hypoglycaemia rates.

Results 96 patients (55 men) were randomised to monitoring and 88 (56 men) to control. There were no baseline differences in mean (SD) age (57.7 (11.0) in monitoring group v 60.9 (11.5) in control group) or HbA_1c (8.8 (2.1)% v 8.6 (2.3)%, respectively). Those in the monitoring group had a higher baseline BMI (34 (7) v 32 (6.2)). There were no significant differences between groups at any time point (12 months values given) in HbA_1c (6.9 (0.8)% v 6.9 (1.2)%, P=0.69; 95% confidence interval for difference −0.25% to 0.38%), BMI (33.1 (6.4) v 31.8 (6.0); adjusted for baseline BMI, P=0.32), use of oral hypoglycaemic drugs, or reported incidence of hypoglycaemia. Monitoring was associated with a 6% higher score on the depression subscale of the well-being questionnaire (P=0.01).

Conclusions In patients with newly diagnosed type 2 diabetes self monitoring of blood glucose concentration has no effect on glycaemic control but is associated with higher scores on a depression subscale.

Trial registration ISRCTN 49814766.

Footnotes

The ESMON Study Group comprises Vivien Coates, Margaret Copeland, Brendan Bunting (University of Uster); Maurice O’Kane, Sandra McConnell, Kenneth Moles, Sharon Patton (Altnagelvin Hospitals Health and Social Services Trust); Michael Ryan, Fergal Tracey, Mary Glass, Lesley Hamilton (Causeway Hospital Trust); Randal Hayes, Pooler Archbold, Sharon Martin, Margaret Devlin, Sonia Cambridge (Belfast City Hospital Trust); and Roy Harper, Moira Campbell, Lynne Thomas (Ulster Hospital and Community Trust). The executive committee comprises Vivien Coates, Brendan Bunting, Mary Glass, Sharon Martin, Roy Harper, Maurice O’Kane, and Margaret Copeland.
Contributors: MJO’K and VEC had the original idea for the study and wrote the protocol with BB in conjunction with members of the ESMON study group. BB was the study statistician. VEC and MC managed the study. MJOK, BB, MC, and VEC analysed and interpreted the study data. MJO’K wrote the first draft of the manuscript. All members of the study executive committee reviewed the final draft of the manuscript. VEC is guarantor.
Funding: Northern Ireland research and development office. MC was employed as a research associate as part of the funding allocation. The blood glucose meters were supplied free of charge by Johnson and Johnson, Milpitas, CA.
Competing interests: None declared.
Ethical approval: University of Ulster ethics committee.
Provenance and peer review: Not commissioned; externally peer reviewed.