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Regular self-monitoring of blood glucose did not improve HbA1c
DiGEM unconvincing with regard to benefit for noninsulin-treated patients with type 2 diabetes.
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CHICAGO – After one year, patients who regularly self-monitored their blood glucose did not have better glycemic control compared with patients who did not.
Although patients with type 1 diabetes and insulin-treated type 2 diabetes benefit from self-monitoring of blood glucose, the Diabetes Glycemic Education and Monitoring (DiGEM) study did not demonstrate convincing evidence of this same benefit in patients with noninsulin-treated type 2 diabetes.
At this time, “our results do not support the recommendation of routine self-monitoring of blood glucose for reasonably well-controlled patients with type 2 diabetes,” Andrew J. Farmer, FPCGP, DM, University Lecturer, University of Oxford, said at the American Diabetes Association 67th Annual Scientific Sessions.
“No self-monitoring was compared to two different intensities of self-monitoring, and no clinically significant different reductions were seen in results on HbA1c tests,” Farmer said in a statement. “Further, no additional effect of a more intensive self-monitoring regimen was observed.”
It is possible benefits were derived from physical activity, changes in eating habits or motivational therapy, Farmer said in the late-breaking session.
The DiGEM results do not apply to diabetes patients who take insulin, as previous data demonstrate the beneficial effect of self-monitoring in these patients.
Self-monitoring vs. standard care
The trial compared the self-monitoring of blood glucose, alone or with additional instruction in incorporating test results into self-care, with standard medical care in improving glycemic control in patients with non-insulin-treated type 2 diabetes.
Patients (n=453; mean age, 65.7 years; 57% male) were randomized into one of three groups. The control group received standardized medical care with HbA1c tests once every three months and no self-monitoring of blood glucose (n=152). Patients in the less intensive intervention group used a blood glucose meter to record levels at least six times a week and shared results with a nurse every three months for interpretation. The more intensive group used a blood glucose meter to self-monitor blood glucose six times a week, received individual training to interpret results and were encouraged to apply the results to enhance motivation, goal-setting, dietary maintenance, physical activity and medication regimens.
No changes in HbA1c
After one year, 66% of patients randomly assigned to the less intensive intervention group and 52% assigned to the more intensive intervention group had persisted in self-monitoring more than two times a week.
HbA1c levels were relatively unchanged. The baseline and year-end mean HbA1c across all three groups was around 7.5%. When comparing the control and intensive self-monitoring groups, the mean HbA1c difference was 0.14% lower (95% CI, -0.35% to -0.07%) vs. the control and more intensive self-monitoring groups: mean difference, -0.17% (95% CI, -0.35% to -0.03%).
For patients whose only received a HbA1c test every three months, levels were similar compared to those in patients assigned to a self-monitoring intervention. Of note, the results were no better for patients in the more intensive group compared with the less intensive group.
The researchers discovered differences in cholesterol levels between the groups. The mean change between the control and less intensive intervention groups was -0.06 mmol/L and the control and more intensive intervention groups was -0.23 mmol/L.
“Patients, clinicians and policy-makers will need to look at the results to reach decisions about appropriate use of SMBG technology. The results of this trial will add to the evidence available to make decisions,” Farmer said. “A difference of -0.5% or more would generally be needed for a therapy to be considered clinically effective, and we powered the study to be able to see a difference that large if it existed, but we did not get it.” – by Katie Kalvaitis
For more information:
- Farmer AJ, et al. The DiGEM Trial: An open-label parallel group randomized trial of blood glucose self-monitoring in patients with non-insulin treated diabetes. Presented at: American Diabetes Association 67th Annual Scientific Sessions. June 22-26, 2007. Chicago.