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

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, glycated hemoglobin (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% confidence interval: 21.4-24.2] at baseline; 20.6 [19.0-22.1] at 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), whereas 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 6 months before isCGM initiation; 16.0% having an event during last 6 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: These 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.Clinical Trial Registration number: NCT02898714.

Automated summary

This study investigates the impact of nationwide reimbursement of intermittently scanned continuous glucose monitoring (isCGM) on adults with type 1 diabetes with impaired or normal awareness of hypoglycemia over 24 months. The results show sustained improvement in severe hypoglycemia, work absenteeism, and hypoglycemia fear after isCGM reimbursement, with increased treatment satisfaction. isCGM is a valuable tool under long-term real-world conditions regardless of hypoglycemia awareness level.