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


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


METHODS
Hospital diabetes clinics.


METHODS
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.


METHODS
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.


METHODS
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.


BACKGROUND
ISRCTN 49814766.
O'Kane
Maurice J
MJ
Department of Clinical Chemistry, Altnagelvin Hospital, Western Health and Social Care Trust, Londonderry, Northern Ireland. Maurice.OKane@westerntrust.hscni.net
Bunting
Brendan
B
Copeland
Margaret
M
Coates
Vivien E
VE
D000328:Adult; D000368:Aged; D001007:Anxiety / Q000209:etiology; D015190:Blood Glucose Self-Monitoring / Q000592:standards; D015992:Body Mass Index; D003866:Depressive Disorder / Q000209:etiology; D003924:Diabetes Mellitus, Type 2 / Q000097:blood* / Q000523:psychology; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007003:Hypoglycemia / Q000209:etiology / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D011446:Prospective Studies
D006442:Glycated Hemoglobin