A novel glucose beta‐hydroxybutyrate combination improves hypoglycaemia recovery and patient‐reported outcomes in type 1 diabetes
Authors' conclusion
FLO23011 provides superior hypoglycaemia management through improved glycaemic stability, reduced recurrence, and enhanced patient experience compared to current glucose-only treatments.
Study context
- Population
- Study A: healthy adults; Study B: adults with T1DStudy A 6
- Comparison
- FLO23011 vs standard glucose treatment
Methodological detailspharmacokinetic study and clinical trial, open-label (Study B), Study A: randomised crossover PK study in healthy adults over 180 min, Study B: 12-week randomised, open-label, crossover trial in adults with T1D
- Pharmacokinetic study and clinical trial
- Open-label (Study B)
- Study A: randomised crossover PK study in healthy adults over 180 min
- Study B: 12-week randomised, open-label, crossover trial in adults with T1D
Primary result
As reported in the abstract
Post-hypoglycaemia time in range (Study B, CGM)
P = 0.019
Further findings
Glucose Cmax (Study A) · over 180 min
P = 0.122
| Outcome | Reduction | P value |
|---|---|---|
| Recurrent hypoglycaemic episodes (Study B)Reduced with FLO23011 | 27% | P = 0.031 |
Beta-hydroxybutyrate Cmax with FLO23011 (Study A)
- Sustained beta-hydroxybutyrate elevation with FLO23011, Cmax
- 0.6-1.2 mmol/L
Hypoglycaemic episodes recorded by CGM (Study B)
- Total hypoglycaemic episodes
- 1032
Patient-reported outcomes (Study B)
- Domains favouring FLO23011
- 13 of 14
Original publication
A novel glucose beta‐hydroxybutyrate combination improves hypoglycaemia recovery and patient‐reported outcomes in type 1 diabetes. Diabetes Obes Metab. Published 8 December 2025. doi:10.
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