Chicago, IL - While the self-monitoring of blood glucose levels for people with non-insulin-treated diabetes is often recommended, a new study presented and published this week suggests that the cost and time required is not worth the effort [1]. The study showed that an intensive treatment program that included self-monitoring of blood glucose levels, with and without learning how to interpret the results, did not improve glycemic control when compared with usual care in type 2 diabetic patients.

Presenting the results of the Diabetes Glycemic Education and Monitoring (DIGEM) study here at the American Diabetes Association 2007 Scientific Sessions, a study also published online June 25, 2007 in BMJ, lead investigator Dr Andrew Farmer (University of Oxford, UK) said the effect of self-monitoring on HbA1_c levels was marginal. "The DIGEM trial does not provide convincing evidence of benefit in non-insulin-treated type 2 diabetes," said Farmer, "and the results do not support recommendations for the routine self-monitoring of blood glucose in reasonably well-controlled patients with type 2 diabetes."

Self-monitoring costly, time consuming, and with no proven benefits

Presenting the findings during a late-breaking clinical trials session, Farmer explained that the existing evidence suggesting improved glycemic control among non-insulin-treated diabetic patients who monitor their blood glucose levels is inconclusive. These patients, he said, may derive benefits from physical activity, changing eating habits, and motivational therapy, but the data on the efficacy of self-monitoring are mixed. Despite the inconclusive results and the cost of self-monitoring, Farmer said many physicians believe self-monitoring helps and recommend its use.

The aim of the DIGEM investigators, then, was to test the efficacy of increasing intensity of treatment on blood glucose levels in non-insulin-treated diabetics 25 years of age and older. To test whether self-monitoring, alone or with instruction in incorporating the results into self-care, is more effective than usual care in improving glycemic control, investigators randomized 453 non-insulin-treated diabetic patients from 48 treatment centers in the UK to one of three treatment arms:

• Standardized usual care with measurements of HbA1_c every three months (n=152).
• Blood glucose self-monitoring with advice for patients to contact their physician for interpretation of results (n=150).
• Blood glucose self-monitoring with additional education to train patients to interpret and apply the results, with the intention of enhancing motivation and adherence to a healthy lifestyle (n=151).

Despite the increasing intensity of treatment, investigators observed no changes in HbA1_c levels at 12 months. No subgroups benefited from the intensive or less intensive self-monitoring treatment program. In addition, there were no changes in other variables, including systolic blood pressure, LDL cholesterol, or weight, but total cholesterol levels did improve, decreasing most in patients who self-monitored and were instructed to incorporate the measurements into their dietary choices and behaviors.

DIGEM: Change in HbA1_c levels from baseline

HbA1c (%)	Control group (n=152)	Less intensive self-monitoring (n=150)	Most intensive self-monitoring (n=151)	p for difference between groups
Baseline	7.49	7.41	7.53	0.12
Follow-up	7.49	7.28	7.36	0.12
Change	0.00	-0.14	-0.17	0.12

Farmer said there were significantly more reported incidents of hypoglycemia in the self-monitoring patient population, a finding that may be attributed to increased awareness. He noted that previous studies have shown that patients become frustrated when results do not fall into line or results stop being of interest to the patient when they are predictable. While there was an improvement in total cholesterol levels, this finding needs to be studied further, although Farmer said the increased awareness of dietary habits and lifestyle modification, including the importance of taking lipid-lowering medications, could be the reasons for such a change. Based on the overall findings, Farmer said self-monitoring of blood glucose levels should not be considered in the treatment of type 2 diabetics not taking insulin.