Safety and user experience with off-label use of a flash glucose monitor (FreeStyle Libre (R) 1) among very young children with type 1 diabetes mellitus

Objectives: FreeStyle Libre 1 (FGM) has been approved by the FDA for children older than 4 years. It enables noninvasive glucose monitoring without the need for finger pricking. Parents of very young children often use the device off-label. Thus, we aimed to evaluate the safety of and user experience with FreeStyle Libre (R) 1 and determine its impact on sleep and glycemic control. Methods: This was an ambi-directional cohort study. We recruited parents of very young children with type 1 diabetes mellitus (T1DM) who were less than 5 years old when they started using FGM at the King Saud University Diabetes Center. The parents filled out a survey evaluating their experience with the system. In addition, the glucose metrics of the children were also obtained from the Libre View system. Results: We included 31 children with mean age of the children when they started using FGM was 3.88 +/- 1.10 years (range, 1.46-5.4 years), and the mean sensor use was 2.3 +/- 1.3 years. During the use of the device, the parents had increased sleep duration of 0.71 h (p-value=0.04), had earlier bedtime by 2.8 h (p-value=0.04), and were able to sleep in a separate room from their children. In addition, the time in range improved by 9.9%, the time above range decreased by 8.8%, and the HbA1c level reduced by 1.56%. Conclusions: The safety profile of FGM used for very young children with T1DM is the same for older children, which leads to improved metabolic control and sleep quality of both the parent and the child.