CGM Superior to Routine Care in Non-Insulin Type 2 Diabetes: NEJM
A multi-center randomized control trial conducted at various primary care practices in the United States investigating continuous glucose monitoring (CGM) devices in people with non-insulin type 2 diabetes has been a significant contributor to wearables’ advancement as health devices. The study found that adults with non-insulin type 2 diabetes who were under treatment in primary care practices exhibited lower levels of glycated hemoglobin and were less likely to be at a risk of high blood sugar when using CGM devices compared to the group receiving conventional treatment. The study was published in The New England Journal of Medicine by Tamara K. and colleagues.
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
