Sustained Impact of Intermittently Scanned Continuous Glucose Monitoring on Treatment Satisfaction and Severe Hypoglycemia in Adults with Type 1 Diabetes (FUTURE): An Analysis in People with Normal and Impaired Awareness of Hypoglycemia

Abstract
Objective: Nationwide reimbursement of intermittently-scanned continuous glucose monitoring (isCGM) was introduced in Belgium (2016). This real-world observational study investigates the impact of isCGM over 24 months on adults with type 1 diabetes with impaired or normal awareness of hypoglycemia (IAH or NAH). Methods: We included 1905 people who started first-generation 14-day FreeStyle Libre (without alerts). Sixteen percent had IAH. Primary endpoint was evolution of quality of life (QOL); secondary endpoints were evolution of severe hypoglycemia, work absenteeism, HbA1c, and sensor-measured outcomes. Results: At baseline, people with IAH (n=308) had significantly worse QOL than people with NAH (n=1594). Only people with IAH improved on the hypoglycemia fear survey-worry subscale after 24 months (22.8 [95%CI 21.4-24.2] baseline; 20.6 [19.0-22.1] 24 months, p=0.002). For both groups, Diabetes Treatment Satisfaction Scale improved over 24 months (IAH: +3.1 [2.1-4.1],p<0.001; NAH: +2.3 [1.9-2.7], p<0.001), while general QOL, diabetes distress, and HbA1c remained stable. People with IAH showed the strongest decline in work absenteeism and severe hypoglycemia (36.4% having an event six months prior to isCGM-initiation; 16.0% having an event during last six months of follow-up, p<0.001), with similar observations for hypoglycemia hospitalization, and hypoglycemia coma. Over 24 months, people with IAH spent more time in hypoglycemia, but less time in hyperglycemia than people with NAH. Conclusion: This data show sustained improvement of severe hypoglycemia, work absenteeism and hypoglycemia fear after isCGM-reimbursement, mostly driven by people with IAH. Together with improved treatment satisfaction, irrespective of hypoglycemia awareness level, isCGM without alerts is a valuable tool under long-term real-world conditions.