Reducing the Burden of Hypoglycemia in Type 1 Diabetes: The Impact of FLO23011 on Patient-Reported Outcomes and Glycemic Correlates of Treatment Response

Abstract Objective To compare patient-reported outcomes (PROs) for hypoglycemia recovery with FLO23011, a glucose/beta-hydroxybutyrate Multi-Energy Substrate for Hypoglycemia (MESH) treatment, versus standard glucose gel in type 1 diabetes, contextualized by continuous glucose monitoring (CGM) analyses. Research Design and Methods In a randomized, open-label, crossover study, 12 adults with type 1 diabetes used FLO23011 or glucose gel to treat hypoglycemia during two 6-week CGM-monitored periods. PROs were assessed using 14-domain questionnaires and exit interviews. CGM analyses from a broader discovery analysis examined patient-relevant recovery signals: glucose-band exposure versus psychological PRO scores, and baseline glycemic variability versus time-in-range response. Results FLO23011 was rated more favorably than glucose gel in 13/14 domains, with 10 significant. Differences included speed of action (8.0 vs. 7.3; P = 0.025), after-effects reduction (8.0 vs. 6.2; P = 0.014), ease-of-use (8.9 vs. 4.9; P = 0.002), and overall management ability (8.5 vs. 7.4; P = 0.019). Interviews described faster cognitive recovery, reduced disruption, and greater confidence. Reduced Level 1 hypoglycemia exposure was associated with higher reduced-worry and management-ability ratings (ρ = 0.90; P = 0.037). Higher baseline coefficient of variation predicted greater time-in-range improvement with FLO23011 (ρ = 0.917; P = 0.0005). Conclusions FLO23011 showed more favorable patient-reported recovery than glucose gel. Initial CGM-PRO analyses findings suggest perceived benefit may align with reduced Level 1 hypoglycemia, while baseline variability may identify greater objective response. Results support integrating patient-reported and glycemic outcomes to evaluate hypoglycemia treatments, warranting confirmation in larger blinded studies.