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

ABSTRACT

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.