Pivotal data showing the effectiveness of Flow Health Science’s Klario™ for people with Type 1 Diabetes published in leading therapy area journal
LONDON – [Dec, 10, 2025] – Flow Health Science today announced the publication of positive clinical trial results in the leading peer‑reviewed journal Diabetes, Obesity and Metabolism, showing that FLO23011 (Klario™) – a glucose plus beta‑hydroxybutyrate (BHB) adaptive energy drink – improves recovery from hypoglycaemia in adults with type 1 diabetes (T1D), with steadier post‑hypo glucose, less recurrence and better patient‑reported outcomes than standard glucose treatment.
This publication of the full study results follows an oral abstract presentation at the European Association for the Study of Diabetes (EASD) earlier this year.
The randomized crossover study successfully demonstrated statistically significant and clinically meaningful results for Klario™ across 1,032 evaluated episodes of hypoglycaemia. The positive outcomes included significant improvement in key measures of glycaemic control and patient experience compared to standard glucose treatment (SoC).
Notably, the study showed that using Klario™ resulted in a statistically significant 7.1% increase in Time in Range during the critical 2-hour post-hypoglycemia recovery period, alongside a 27% relative reduction in recurrent hypoglycaemic episodes. In addition to these improved glycemic outcomes, Klario™ showed statistically significant improvement over SoC in 10 of 14 assessed patient experience domains, including faster symptom resolution, reduction in post-treatment effects, and improved overall hypoglycemia management ability. Overall, 75% of participants reported a faster Return to daily activities and superior Sense of control. Addressing the after-effects (like fatigue and cognitive dysfunction) associated with current glucose-only treatments is a major benefit of Klario™.
“Hypoglycemia represents a critical therapeutic challenge in diabetes management. It can take time to recover from, leaving people feeling wiped out and disrupting daily activities, including work, sleep, social life and sport.” said Professor David Russell-Jones, Head of the CEDAR Centre in the UK and Principal Investigator of the study. “The demonstrated ability of Klario™ to reduce after-effects like fatigue or ‘brain fog’, and accelerate return to normal daily activity after hypoglycaemia is a critical advance that has potential to significantly impact the lives of many people with diabetes.”
Summary of Results
The publication is based on two clinical studies comparing Klario™ with SoC: Study A, a pharmacokinetic investigation in six healthy adults; and Study B, a 12-week randomized, open-label, crossover clinical trial in 12 adults with T1D. Study B evaluated glycemic control using continuous glucose monitoring (CGM) and assessed patient experience through structured questionnaires across 14 domains.
Key results include:
- Acute Glycemic Correction: Klario™produces sustained elevation of circulating BHB for at least 3 hours, and raises blood glucose similarly to SoC.
- Improved Time in Range: CGM data showed a statistically significant increase in time in range during the 2-hour recovery period immediately following an episode of hypoglycaemia with Klario™ compared to SoC.
- Reduced Recurrence: Treatment with Klario™ resulted in a 27% risk reduction in recurrent episodes.
- Faster Functional Recovery: Participants experienced significantly faster return to daily activities and resolution of after-effects (fatigue, cognitive dysfunction) with Klario™.
- Improved Psychological Outcomes: Participants reported enhanced confidence and overall ability to manage low blood glucose.
“Klario represents a major shift in hypoglycaemia treatment,” said Georgia Myers, CEO of Flow Health Science Inc.. “The combination of glucose with BHB and other energy sources addresses both the immediate glycaemic correction and the sustained, complete recovery of the patient. These results demonstrate that this product has the potential to significantly reduce the burden and fear of hypoglycaemia, leading to better overall diabetes management for people with type 1 diabetes.“.
About Klario™: A Novel Approach to Hypoglycaemia Management
Hypoglycemia represents a critical therapeutic challenge in diabetes management: people with T1D may experience 100–200 treatment-related episodes annually. Current recommended therapeutic interventions using glucose-only treatments frequently result in suboptimal outcomes, including rapid glucose fluctuations, persistent neuroglycopenic symptoms, and fear-driven non-adherence to medication that compromises long-term glycemic control.
Klario™, a novel multi-substrate energy formulation combining glucose with BHB, was designed to achieve more complete recovery from hypoglycemia. In line with medical guidelines, Klario™ delivers 15 grams of fast-acting carbs to raise blood glucose quickly, while also raising levels of BHB acutely. This combination formula improves glycemic control in the immediate post-treatment period, and provides rapid, sustained neuroglycopenic recovery, transforming hypoglycemia treatment outcomes and patient experience.
About Flow Health Science Inc.
Flow Health Science Inc. is dedicated to transforming health outcomes through trusted, clinically-proven functional foods. Grounded in advanced metabolic science, our research and pipeline targets diabetes management, fatigue, hormone imbalances, and broader metabolic dysfunction.
For more information about Flow Health Science Inc., please visit the company’s website at https://flowhealthscience.com/.
Tara Lumley, Chief Strategy & Business Officer
info@flowhealthscience.com
Source – Flow Health Science Inc.