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Randomized trial evaluates effectiveness of FLO23011 for hypoglycaemia management in adults with Type 1 Diabetes, indicating improved patient-reported outcomes.
Introduction and Objective: Hypoglycaemia management significantly impacts quality of life in Type 1 Diabetes. FLO23011 is a Multi Energy Substrate Hypoglycaemia (MESH) oral rescue treatment providing glucose, lactate, and beta-hydroxybutyrate, which targets multiple metabolic pathways. Superiority over standard of care glucose gel (SoC) has been previously shown in a randomized cross-over study. This is an evaluation of comparative patient-reported outcomes from the study. Methods: Twelve adults with Type 1 Diabetes (8 M/4 F; mean age 49) completed a randomized cross-over study using FLO23011 or SoC for hypoglycaemia self-care. Participants rated comparative preferences (0-10 Likert; 14 domains; scores >5 indicating FLO23011 preference) and completed structured interviews. Results: FLO23011 showed preference in 13 of 14 domains (median scores 6-8). For effectiveness, 64-82% preferred FLO23011 for hypoglycaemia reversal, headache relief, and speed. After-effects were optimized: 70% reported less severe fatigue/weakness; 80% returned to activities faster. Rebound hypoglycaemia management favored FLO23011 (58%). Packaging: 75% preferred ease-of-use; 33% for portability. Psychological domains showed benefits: 82% felt increased control; 73% reported greater dosing confidence; 55% experienced reduced worry. Overall management preference: 64%. Interviews reinforced findings: 92% rated FLO23011 “Very/Extremely” effective versus 50% for SoC; 92% reported “Never/Rarely” experiencing ‘hangover’ symptoms versus 33%. Over half described rapid cognitive restoration, while 75% reported reduced glucose spikes, attributed to precise dosing and reduced over-treating. Conclusion: FLO23011's superior patient-reported outcome profile demonstrates that MESH preparations may address unmet needs beyond glucose normalization in type 1 diabetes. FLO23011 represents a meaningful advance in hypoglycaemia self-care. Disclosure D. Russell-Jones: Research Support; Current; Abbott Diabetes, Dexcom, Inc., Novo Nordisk A/S. Research Support; Ended; Insulet Corporation, Ypsomed AG, Medtronic. Research Support; Current; Applied strategic. T. Young: None. D.B. Bartlett: None. G. Myers: Employee; Current; Flow Science Holdings Ltd. R. Littlewood: Stock/Shareholder; Current; Flow Science Holdings Ltd.
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RUSSELL-JONES et al. (2026) studied this question.
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