Pivotal Data Showing the Effectiveness of Klario® for People with Type 1 Diabetes Published in Leading Therapy Area Journal
Pivotal Data Showing the Effectiveness of Klario® for People with Type 1 Diabetes Published in Leading Therapy Area Journal
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- Demonstrated clinical advancement in hypoglycaemia recovery: Klario® enabled a faster, more stable return to normal glucose levels compared with standard treatment, supporting its potential as a new benchmark in post‑hypoglycaemia care for adults with type 1 diabetes.
- Meaningful reduction in recurrence and fatigue burden: Participants treated with Klario experienced fewer repeat hypoglycaemic episodes and reported less fatigue and “brain fog,” reflecting a more complete and sustained recovery experience.
- Strong alignment with patient needs and quality‑of‑life outcomes: By combining glucose with beta‑hydroxybutyrate (BHB), Klario addresses both the immediate and lingering effects of low blood sugar, helping people with diabetes regain confidence and reduce fear associated with hypoglycaemia.
Flow Health Science today announced the publication of positive clinical trial results 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.
“Hypoglycemia represents a critical therapeutic challenge in diabetes management. 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.”
— Professor David Russell-Jones, Head of the CEDAR Centre, UK & Principal Investigator
Summary of Results
The publication is based on two clinical studies comparing Klario with standard of care (SoC). Study A was a pharmacokinetic investigation in six healthy adults; Study B was 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.
The randomized crossover study successfully demonstrated statistically significant and clinically meaningful results for Klario across 1,032 evaluated episodes of hypoglycaemia. Positive outcomes included 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. Overall, 75% of participants reported a faster return to daily activities and superior sense of control.
“Klario represents a major shift in hypoglycaemia treatment. 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.”
— Georgia Myers, CEO, Flow Health Science
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.
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 BHB levels acutely. This combination formula improves glycemic control in the immediate post-treatment period and provides rapid, sustained neuroglycopenic recovery.
For more information about Klario, please visit myklario.com.
About Flow Health Science
Flow Health Science 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.
Media Contact: Tara Lumley, Chief Strategy & Business Officer — press@flowhealthscience.com
Source: Flow Health Science