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Non‐adjunctive flash glucose monitoring system use during summer‐camp in children with type 1 diabetes: The free‐summer study
Author(s) -
Piona Claudia,
Dovc Klemen,
Mutlu Gül Y.,
Grad Klara,
Gregorc Petra,
Battelino Tadej,
Bratitaša
Publication year - 2018
Publication title -
pediatric diabetes
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.678
H-Index - 75
eISSN - 1399-5448
pISSN - 1399-543X
DOI - 10.1111/pedi.12729
Subject(s) - medicine , dosing , type 1 diabetes , glycated hemoglobin , type 2 diabetes , adverse effect , randomized controlled trial , population , diabetes mellitus , mean difference , metabolic control analysis , pediatrics , insulin , confidence interval , endocrinology , environmental health
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.