A novel glucose beta‐hydroxybutyrate combination improves hypoglycaemia recovery and patient‐reported outcomes in type 1 diabetes

Aims Hypoglycaemia remains a major barrier to optimal diabetes management. Current treatments based on simple sugars have limitations, including rapid glucose fluctuations and persistent neuroglycopenic symptoms. We investigated FLO23011, a novel multi‐substrate energy formulation containing glucose and beta‐hydroxybutyrate, as a superior hypoglycaemia treatment. Methods Two studies were conducted: Study A, a randomised, crossover pharmacokinetic investigation in six healthy adults comparing FLO23011 versus standard glucose treatment over 180 min; and Study B, a 12‐week randomised, open‐label, crossover clinical trial in 12 adults with type 1 diabetes comparing FLO23011 to standard of care. Study B evaluated glycaemic control using continuous glucose monitoring and assessed patient experience through structured questionnaires across 14 domains. Results Study A demonstrated a comparable glucose response between FLO23011 and standard of care (Cmax 7.4 ± 0.3 vs. 7.9 ± 0.2 mmol/L, p = 0.122), but FLO23011 resulted in sustained beta‐hydroxybutyrate elevation (Cmax 0.6–1.2 mmol/L). Study B participants experienced 1032 hypoglycaemic episodes, as recorded by continuous glucose monitoring. FLO23011 significantly improved post‐hypoglycaemia time in range (82.5% vs. 77.0%, p = 0.019) and reduced recurrent episodes by 27% ( p = 0.031). Patient‐reported outcomes favoured FLO23011 in 13 of 14 domains. Conclusions FLO23011 provides superior hypoglycaemia management through improved glycaemic stability, reduced recurrence, and enhanced patient experience compared to current glucose‐only treatments.