Non‐adjunctive flash glucose monitoring system use during summer‐camp in children with type 1 diabetes: The free‐summer study.

Background: A factory‐calibrated sensor for intermittently scanned continuous glucose monitoring (isCGM) is accurate and safe in children with type 1 diabetes (T1D). Data on isCGM effectiveness as a replacement for self‐monitoring of blood glucose (SMBG) in this population is scarce. Objective: The aim of this study was to evaluate the non‐adjunctive use of isCGM in children with T1D during 2 weeks in a challenging summer‐camp setting. Methods: In this two‐arm, parallel, randomized, outpatient clinical trial we enrolled 46 children (25 females, mean ± SD: age 11.1 ± 2.6 years, glycated hemoglobin (HbA1c) 7.4% ± 0.7%): 26 in the isCGM group were blinded for the SMBG and insulin dosing was isCGM‐based, whereas 20 in the control group were blinded for isCGM and performed SMBG‐based insulin dosing. The primary outcome of intention‐to‐treat analysis was between‐group difference in the proportion of time within range 3.9 to 10 mmol/L (TIR). Results: There was no significant difference in TIR (3.9‐10 mmol/L) between the two groups. In participants with suboptimal metabolic control (HbA1c > 7%) we observed a significant reduction in time spent above 10 mmol/L (P < 0.05) and an improvement in TIR (P = 0.05) in the isCGM group. No severe hypoglycemic events or serious adverse events occurred. Overall mean absolute relative difference (MARD) between isCGM and SMBG was 18.3%, with median absolute relative difference (ARD) of 8%. Consensus error grid analysis demonstrated 82.2% and 95.2% of results in zone A, and zone A + B, respectively. Conclusion: The non‐adjunctive use of isCGM was as safe and effective as SMBG, and reduced time spent in hyperglycemia in a sub‐population of children with T1D with suboptimal glycemic control. Trial registration: NCT03182842. [ABSTRACT FROM AUTHOR]