We'd like your feedback
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Prof
Shareen
Forbes
+44 1312426736
Shareen.Forbes@ed.ac.uk
Dr
Nicola
Baillie
+44 1312426736
Nicola.Baillie@ed.ac.uk
Type 1 Diabetes
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Type 1 diabetes (T1D) requires lifelong insulin therapy. Hypoglycaemia (low blood sugar) is a common and potentially life-threatening complication of insulin treatment. Despite advances in insulin types and delivery methods, hypoglycaemia remains a significant side effect, contributing to impaired quality of life for patients and their loved ones, and increased healthcare costs.
Hypoglycaemia poses significant risks including confusion, seizures, and coma. Recurrent hypoglycaemia can lead to hypoglycaemia unawareness; usually people who are treated with insulin are aware that their blood sugar is low and can take action to treat this (by consuming fast acting sugar). People who have hypoglycaemia unawareness do not have symptoms or signs, therefore their diabetes management is more complicated and they are at a much higher risk of severe hypoglycaemic events, including seizures and coma.
By investigating a supplement that counteracts the underlying mechanisms of hypoglycaemia, we have the potential to improve hypoglycaemia management and the quality of life for individuals with type 1 diabetes. There is no current preventative treatment for insulin induced hypoglycaemia. Current treatment strategies for hypoglycemia in type 1 diabetes primarily involve glucose monitoring and administration of glucose or glucagon. However, these approaches may not always be effective in preventing or resolving hypoglycemic episodes, especially if there is hypoglycaemia unawareness.
There is a need for treatments that can complement existing treatments to provide more targeted management of hypoglycemia in individuals with type 1 diabetes, and a need for treatments that can prevent the disabling and dangerous side effect of hypoglycaemia.
This study is investigating the effects of the supplement aniracetam during hypoglycaemia in individuals with T1D. Scientific studies so far lead us to think that supplementation with aniracetam will lead to improved control, a reduction in hypoglycaemic episodes, and, in the future, enhanced overall well-being in participants with type 1 diabetes.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. Proliferative retinopathy2. History of Diabetic ketoacidosis in the preceding 6 months3. Severe hypoglycaemic episode requiring external assistance in the preceding 6 months4. History of Haemophilia, Cystic Fibrosis, pancreatic disease or complete pancreatectomy, ischaemic heart disease, cardiac arrhythmia, epilepsy or hypoglycaemia induced seizure5. History of severe reaction or allergy to adhesive necessary to this study6. Unable to adhere to study timetable7. Unable to give informed consent8. Pregnancy or planning pregnancy. We will perform a pregnancy test on all eligible participants at baseline9. Concurrent use of any non-insulin glucose-lowering agent (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas). These may lower insulin requirements and predispose to diabetic ketoacidosis10. Hypothyroidism11. Concurrent use of medication that may affect blood glucose such as SSRIs12. Inability to understand or speak English. Time is of the essence during the clamp procedure, there is no time for translation13. A condition, which in the opinion of the investigator, would put the patient or study at risk
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Prof
Shareen
Forbes
+44 1312426736
Shareen.Forbes@ed.ac.uk
Dr
Nicola
Baillie
+44 1312426736
Nicola.Baillie@ed.ac.uk
The study is sponsored by Leona M. and Harry B. Helmsley Charitable Trust and funded by Leona M. and Harry B. Helmsley Charitable Trust.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
