There is limited literature regarding flash glucose monitoring (FGM) associated cutaneous adverse events (AE). This study aimed to evaluate participant reported cutaneous AEs and sensor use associated with the Freestyle Libre FGM compared to usual care with SMBG as part of a six-month multisite randomised controlled trial (RCT) among adolescents with T1D.
Patients aged 13-20 years with type 1 diabetes ( [pre-enrolment mean HbA1c ≥75mmol/mol (≥9%)] were randomised to intervention (FGM and usual care), or control (self-monitoring blood glucose and usual care). Participants self-reported AEs every 14 days for six months. Reports were analysed to determine frequency, type, and severity and cause, as well as premature sensor loss.
64 participants were recruited, 33 randomised to FGM and 31 controls. In total, 80 cutaneous AEs were reported, 40 in each group, however the proportion of participants experiencing AEs was greater in the FGM group compared to control (58% and 23% respectively, p = 0.004). FGM participants most frequently reported erythema (50%) while controls most commonly reported skin hardening (60%). For both groups the majority of AEs were rated as mild. One participant ceased using FGM due to reoccurring cutaneous AEs. 27/33 (82%) FGM participants experienced at least one premature sensor loss, largely unrelated to an AE.
Frequency of cutaneous AEs were similar for FGM compared to SMBG, with most AEs rated as mild. For FGM, the majority of users continued use despite AEs. Awareness of cutaneous complications and efforts to mitigate them may reduce cutaneous AEs associated with FGM use.