CGM Provides No Significant Glycemic Improvement in Glulisine-Treated Patients
Hypoglycemic events were not statistically significant between both groups throughout the duration of the study.
Using a continuous glucose monitor (CGM) sensor for the identification of a high-glycemic meal and to subsequently facilitate adjustment of prandial glulisine insulin timing is not associated with a substantial improvement in glycemic control, according to findings from an open-label, multicenter, randomized controlled trial published in Diabetes, Obesity and Metabolism.
After an 8-week run-in period, patients with poorly controlled type 2 diabetes (HbA1c ≥8%) were randomly assigned (1:1) to receive a 16-week intensified prandial glulisine treatment with either a CGM sensor (n=60) or no CGM sensor (n=61). Participants completing treatment without a sensor received glulisine before breakfast vs glulisine before the meal with the highest glucose level based on CGM sensor data. Investigators sought to determine differences between the 2 groups in regard to the average HbA1c at 24 weeks of treatment. In addition, researchers compared safety outcomes (ie, hypoglycemic events) as well as differences in insulin dosage.
At 24 weeks of treatment, the investigators observed no differences between the group receiving a CGM sensor vs those not receiving a sensor (8.4%±1.0% vs 8.5%±1.2%, respectively; P =.66). Group A (no sensor) and group B (sensor) required prandial insulin glulisine treatment of 9.3 and 10.1 units, respectively (P =.39). Although HbA1c levels significantly decreased from the run-in phase to week 24 in both grous (P <.0001), there was no difference between the 2 groups in regard to these changes (P =.75).
In addition, fasting plasma glucose (FPG) levels significantly increased in groups A and B by week 24 (P =.021 and P =.004, respectively). Similar to HbA1c, there were no differences between the 2 groups in regard to FPG changes from baseline (P =.51). Although there was a trend toward more hypoglycemic events among those receiving a CGM sensor, the differences between the 2 groups were not considered significant (36.1% vs 51.7%; P =.08).
Because the investigators did not use a control group receiving basal insulin only in the randomized phase, the findings are limited to that of glulisine. Despite this limitation, a greater improvement in glycemic control was observed with glulisine during the randomized portion of the study compared with basal insulin in the run-in phase, demonstrating the potential advantage of glulisine insulin.
Although using a CGM sensor is not associated with greater improvement in blood glucose levels compared with no sensor, the findings suggest that CGM technology "may be considered in patients in whom a specific meal is suspected to considerably contribute to the HbA1c level."
Ilany J, Bhandari H, Nabriski D, et al. Effect of prandial treatment timing adjustment, based on continuous glucose monitoring, in patients with type 2 diabetes uncontrolled on once daily basal insulin: a randomized, phase IV study [published online January 8, 2018]. Diabetes Obes Metab. doi:10.1111/dom.13214