CGM Superior to Routine Care in Non-Insulin Type 2 Diabetes: NEJM

For assessment of the clinical effectiveness of CGM relative to control group receiving the current standard of care, a prospective 26-week randomized controlled trial was carried out across 22 primary care practices in the United States. In all, 283 adults suffering from type 2 diabetes and not under any form of insulin treatment were randomly assigned into two groups, group under the regimen of CGM (n = 145) and group receiving routine care through fingerstick self-measurement (n = 138). Participants were from varied age groups of 21 to 84 years.

The primary efficacy end-point was determined as the difference in HbA1c between the treatment arms after 26 weeks of randomization. The following secondary end-points were assessed via CGM using the hierarchical testing approach in order to minimize type I error rate: glucose levels in the range of 70–180 mg/dL, as well as hypoglycemic parameters (70 and 54 mg/dL) during nighttime and daytime periods.

Key findings:

• Detailed statistical analysis among the 283 randomized subjects revealed superior efficacy of continuous glucose monitoring over the standard routine treatment regarding glycemic management.
• The CGM group witnessed a statistically significant reduction in the levels of glycated hemoglobin from 8.8 ± 1.3% at baseline to 7.2 ± 1.1% at 26 weeks compared to a slight reduction in patients with the routine treatment from 8.7 ± 1.2% to 8.0 ± 1.4% (adjusted mean difference −0.9 percentage points; 95% CI, −1.1 to −0.6; P < 0.001).
• Mean percentage time the glucose stayed in a desired range between 70 to 180 mg/dL was 21 percentage points higher in CGM group than in the routine group (95% CI, 16 to 26, P < 0.001).
• Percentage difference of the time the glucose stayed below 54 mg/dL was −0.17 percentage points (95% CI, −0.27 to −0.11; P < 0.001 for noninferiority).
• Difference in time staying below 70 mg/dL was −0.20 percentage points (95% CI, −0.43 to −0.09; P < 0.001 for noninferiority; P = 0.004 for superiority).
• There were no severe hypoglycemia incidents in either of the treatment groups.

In summary, from the 26-week multicenter study, it is evident that continuous glucose monitoring offers improved glycemic control relative to standard of care using finger stick measurements in type 2 diabetics not on insulin therapy. The major conclusions drawn from this study are that continuous monitoring decreases HbA1c and reduces hyperglycemia exposure.

Reference:

Oser, T. K., Martens, T., Ruedy, K. J., Bergford, S., Calhoun, P., Chang, K.-L., Kramer, E. S., Klug, B. A., Anderson, R. L., Cook, B. R., Pickering, D., Ortega, M., Peterson, B., Davidson, L., Schmid, R., Desai, N. D., Burkett, E., Haynes, J. L., Herman, A., … Beck, R. W. (2026). Continuous glucose monitoring in non–insulin-treated type 2 diabetes. New England Journal of Medicine. https://doi.org/10.1056/nejmoa2608571