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Self-monitoring does not improve glycaemic control and affects quality of life

The studies found that self-monitoring in type 2 diabetes does not improve glycaemic control, lowers quality of life, and is not a cost-effective intervention.

The studies found that self-monitoring in type 2 diabetes does not improve glycaemic control, lowers quality of life, and is not a cost-effective intervention.

Two papers, in the BMJ, challenge the assumption that self-monitoring in patients with type 2 diabetes who do not use insulin leads to improved glycaemic control and empowers patients. The studies found that self-monitoring does not improve glycaemic control, lowers quality of life, and is not a cost-effective intervention.

The ESMON study was a randomised controlled trial based in hospital diabetes clinics in Northern Ireland. It recruited 184 patients newly diagnosed with type 2 diabetes, of whom 111 were men. All participants were < 70 years, had never performed a blood test or used insulin, and had no other major illness.

Ninety-six participants were randomised to self-monitoring of blood glucose (four fasting and four post-prandial tests per week, with advice on appropriate responses to high or low readings) and 88 to a control group with no self-monitoring. Both patient groups were given an identical structured education programme and a standard treatment regimen was followed.

Follow-up was for one year, with reviews every three months. At each review, HbA1c was measured and patients were asked to complete a modified version of the diabetes attitude scale and a wellbeing questionnaire, which included a subscale for depression.

The results showed no significant difference between the groups at any stage during follow-up for HbA1c, BMI (after baseline correction), reported hypoglycaemia or the use of oral hypoglycaemics. However, self-monitoring was associated with a significantly higher score on the depression subscale (mean 6% higher, P=0.01) at one year.

The authors conclude that self-monitoring of glucose in patients with newly diagnosed type 2 diabetes does not improve glycaemic control, but may be associated with higher depression scores.

These findings are consistent with the DiGEM study,1 which was based in general practices across the UK. The study recruited 453 patients with type 2 diabetes aged at least 25 years at diagnosis, who were randomised to one of three arms: standardised usual care; use of a blood glucose meter with advice to contact their doctor for interpretation of results; and use of a blood glucose meter with training in self-interpretation and application of the results to lifestyle and treatment.

After one year of follow-up, it found no significant differences in HbA1c, blood pressure or weight between the three groups, although there was an increased incidence of hypoglycaemic episodes in the intensively managed patient group.

A further analysis of data from the DiGEM study has recently been published in the BMJ. The authors performed a cost effectiveness evaluation and calculated QALYs. Data were collected for one year before the study baseline, on recruitment to the study, and at three month intervals during the study. Information included drugs taken, frequency and duration of visits to a nurse, frequency of self-monitoring and the use of secondary care. Strictly trial-related activity was excluded and only direct costs to the NHS were included in the analysis.

The results showed that the average cost of standardised usual care was around half that of both self-monitoring groups, suggesting that self-monitoring is not a cost-effective strategy.

In addition, patients on standardised usual care showed no significant change in mean quality of life during the trial. By contrast, an initial negative impact of self-monitoring on quality of life occurred, averaging -0.027 per patient for the less intensively managed group, and -0.075 per patient for the more intensively managed self-monitoring group, which was statistically significant compared with the control group (P=<0.05).

These are clearly important papers, producing consistent results. They demonstrate that in patients with type 2 diabetes managed by diet or oral hypoglycaemics self-monitoring of glucose does not improve outcomes over one year. Patients do not seem to be empowered and score higher on depression scales.

Another study, from Australia, found no correlation between blood glucose testing and improved control in a large population of patients with diabetes on all types of treatment.2

I am not aware of any large trials that have confirmed an improvement in outcome associated with self-monitoring of blood glucose.

The increasing burden of type 2 diabetes has significant implications. This research does not apply to patients who use insulin, but suggests that patients with newly diagnosed type 2 diabetes can be managed confidently without the need to teach self-monitoring of blood glucose.

As always in primary care, decisions should be taken on a case-by-case basis; some patients with type 2 diabetes will benefit from monitoring. However, this evidence suggests that routine use of self-monitoring will not improve outcomes.

O'Kane MJ, Bunting B, Copeland M et al. Efficacy of self monitoring of blood glucose in patients with newly diagnosed type 2 diabetes (ESMON study): randomised controlled trial. BMJ 2008 doi:10.1136/bmj.39534.571644.BE

Simon J, Gray A, Clarke P et al. Cost effectiveness of self monitoring of blood glucose in patients with non-insulin treated type 2 diabetes: economic evaluation of data from the DiGEM trial. BMJ 2008 doi: 10.1136/bmj.39526.674873.BE

Reviewer

Dr Matthew Lockyer
GP, Suffolk and hospital practitioner in diabetic medicine

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