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

Maurice J. O'Kane, Brendan Bunting, Margaret Copeland, Vivien Coates

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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.
LanguageEnglish
Pages1174+
JournalBRITISH MEDICAL JOURNAL
Volume336
Issue number7654
DOIs
Publication statusPublished - May 2008

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Blood Glucose Self-Monitoring
Type 2 Diabetes Mellitus
Body Mass Index
Randomized Controlled Trials
Hypoglycemia
Hypoglycemic Agents
Psychology
Education
Control Groups
Outcome Assessment (Health Care)
Confidence Intervals
Insulin
Incidence

Cite this

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title = "Efficacy of self monitoring of blood glucose in patients with newly diagnosed type 2 diabetes (ESMON study): randomised controlled trial",
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.",
author = "O'Kane, {Maurice J.} and Brendan Bunting and Margaret Copeland and Vivien Coates",
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Efficacy of self monitoring of blood glucose in patients with newly diagnosed type 2 diabetes (ESMON study): randomised controlled trial. / O'Kane, Maurice J.; Bunting, Brendan; Copeland, Margaret; Coates, Vivien.

In: BRITISH MEDICAL JOURNAL, Vol. 336, No. 7654, 05.2008, p. 1174+.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Efficacy of self monitoring of blood glucose in patients with newly diagnosed type 2 diabetes (ESMON study): randomised controlled trial

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AU - Copeland, Margaret

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PY - 2008/5

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N2 - 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.

AB - 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.

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