Discussion
hypoglycemia, T1D, diabetes
HYPOGLYCEMIA, RECRUITMENT, DIABETES
This study investigated second-generation isCGM in children with elevated glycemic control who were naive to any form of CGM. This is the first RCT to be conducted in children aged <13 years worldwide and importantly was carried out independently (i.e., was not industry funded). The main findings are that despite a clear increase in glucose-checking frequency, there were no benefits over 12-weeks seen in the primary outcome HbA1c using isCGM 2.0 compared to SMBG. However, time spent in the hypoglycemic range was considerably improved, and TIR was clinically improved, but this finding did not reach clinical significance.This lack of improvement (in both the control and intervention groups) in the primary outcome (HbA1c) is consistent with the only other study conducted in pediatric and youth aged children using isCGM (1.0),Similarly, both studies were impacted by COVID effects on procedures and delays in recruitment. Clearly in those struggling with diabetes control and burden, as seen in both pediatric studies to date, sensors alone are less likely to result in substantial improvement in longer term glycemic values as measured by HBA1c.Interestingly, while HBA1c did not change, there were important glycemic findings when assessing CGM metrics. First, and of considerable clinical relevance, time in hypoglycemia was improved using isCGM 2.0, similar to published studies.In children with T1D and elevated HbA1c, these results will reinforce caution in extrapolating data from adults with T1D.Despite the increased use of glucose checking with isCGM, no psychosocial gains were seen on the traditional measures collected.