Assessment of Patient-reported Satisfaction and Metabolic Outcomes Following Initiation of the Second Generation of Flash Glucose Monitoring in Patients with Type 1 Diabetes.

Abstract

This study aims to assess patient-reported satisfaction and metabolic outcomes following the initiation of the second generation of the Freestyle Libre 2 (FSL2) system in patients with type 1 diabetes (T1D). This non-randomized single-arm observation study was conducted on 86 patients with T1D living in Saudi Arabia, who were asked to wear the FSL2 for 12 weeks. The demographic data were collected at baseline, while the continuous glucose monitoring (CGM) metrics were gathered, i.e., Glucose Variability (GV) (%), mean Time in Range (TIR), Time Above Range (TAR), Time Below Range (TBR), and average duration of hypoglycemic events were collected at baseline, 6th week and 12 weeks. Further, the Continuous Glucose Monitoring Satisfaction (CGM-SAT) was collected at the end of the follow-up. Compared to the 6th week, significant differences were observed in the low glucose events (p = 0.037), % TIR (p = 0.045), and % below 70 mg/dL (p = 0.047) at 12 weeks. Improvement was seen in the other glucometric variables, but no significant changes were evident (p > 0.05). On completion of the study period, the ambulatory glucose profile (AGP) metrics showed a 74.3 ± 5.01 (mg/dL) FSL2 hypoglycemia alarm threshold and a 213 ± 38.1 (mg/dL) hyperglycemia alarm threshold. A majority of the patients stated that CGM-SAT had benefits (mean score > 3.58), although they felt FSL2 had 'additional benefits. With regard to the problems with the use of FSL2 majority of the patients stated that FSL2 has minimal discomfort. Using second-generation FSL2 in patients with T1D is positively associated with patient- reported satisfaction and metabolic outcomes.