Transforming outcome & experience for patients with hypoglycaemia
Hypoglycaemia, or a 'hypo', happens when blood sugar drops too low. While fast-acting glucose brings sugar levels back into a safe range, many people with type 1 diabetes still feel tired, foggy, and unable to concentrate for hours afterwards. This study compares standard glucose gel with a new recovery drink called FLO23011. Along with fast-acting sugar, FLO23011 contains beta-hydroxybutyrate (BHB), a natural compound the brain can use for fuel. The goal is to see whether this helps both the body and brain bounce back more quickly. Participants try both treatments at home, each for six weeks, in a randomly chosen order. The trial lasts 12 weeks and involves two hospital visits in Guildford and one telephone review. Researchers will check recovery using short surveys and data from your usual continuous glucose monitor.
At a glance
What is this study about?
Living with type 1 diabetes often means dealing with unpredictable low blood sugar episodes, commonly called hypos. While taking fast-acting sugar quickly brings blood glucose back to a safe level, recovery does not always end there. Many people experience lingering brain fog, exhaustion, and poor concentration for hours afterwards. This can disrupt work, driving, sleep, and everyday life.
This clinical study explores a new way to help people recover both physically and mentally. It tests a product called FLO23011, which combines fast-acting carbohydrates with beta-hydroxybutyrate (BHB). BHB is a natural nutrient that the brain can use directly as an alternative source of energy. Researchers want to find out if providing this extra brain fuel helps people bounce back faster than using standard glucose alone.
By comparing FLO23011 directly with standard glucose gel, this research aims to move beyond simply correcting blood test numbers. If successful, the study could lead to treatments that reduce post-hypo fatigue and significantly improve daily quality of life for adults managing type 1 diabetes.
Key takeaways
- Tests whether a new drink (FLO23011) reduces brain fog and fatigue after a hypo.
- Open to adults aged 18 to 75 with type 1 diabetes on insulin.
- Lasts 12 weeks, testing two different treatments at home for six weeks each.
- Requires two visits to Royal Surrey County Hospital and one phone call.
- Participation is voluntary and does not replace your routine NHS diabetes care.
Who may be eligible?
This study is open to adults aged 18 to 75 who have had type 1 diabetes for at least one year and use insulin. To take part, your most recent HbA1c test result should be between 40 and 86 mmol/mol. You must also be able to understand study information in English and be comfortable using your continuous glucose monitor.
You cannot take part if you do not have type 1 diabetes or if you fall outside the age range. For safety reasons, women who are pregnant, breastfeeding, or planning a pregnancy without using reliable contraception are also unable to join. Additionally, you must not have taken part in a trial testing an experimental drug within the last 30 days.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you aged between 18 and 75?
- Have you had type 1 diabetes for at least 12 months?
- Do you take insulin to treat your diabetes?
- Is your HbA1c between 40 and 86 mmol/mol?
- Are you able to attend two appointments in Guildford over 12 weeks?
- If female, are you not pregnant, breastfeeding, or planning a pregnancy?
What does participation involve?
Taking part lasts 12 weeks in total. You will have two in-person appointments at the CEDAR centre at Royal Surrey County Hospital in Guildford (at the start and at week 12), plus one phone call at week 6. During the trial, you will test two different hypo treatments at home: standard glucose gel for six weeks and FLO23011 for six weeks, in a random order. Whenever you have a hypo, you use your assigned product just as you normally would to raise your blood sugar. You will share data from your continuous glucose monitor, fill out short questionnaires about how you feel after each hypo, and complete a brief interview at your final hospital visit.
Potential risks and benefits
Locations (1)
- Royal Surrey County HospitalApproximateGuildford, England
Common questions
Do I have to change my usual insulin doses?
No. You continue taking your prescribed insulin therapy and managing your diabetes just as you normally would.
Is FLO23011 a medicine?
No, FLO23011 is a food product. It combines fast-acting sugars with BHB, a naturally occurring substance that the brain can use for energy.
Will I have to pay for the study treatments?
No. Both the standard glucose gel and FLO23011 are provided free of charge for the duration of the study.
Where do the clinic visits take place?
The two in-person appointments take place at the CEDAR centre within Royal Surrey County Hospital in Guildford, Surrey.
Can I still eat extra carbohydrates after a hypo?
Yes. You can follow your normal routine and clinical advice, including eating a longer-acting carbohydrate snack after treating the initial low.
How to find out more
David Russell-Jones
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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