Pilot Study Evaluating Safety of ExOlin® in Patients With Poorly Controlled Type 1 Diabetes
Researchers are conducting a pilot study to assess the safety of a new treatment called ExOlin® in adults with type 1 diabetes. This study focuses on individuals who struggle to keep their blood sugar stable, despite using insulin pumps and continuous glucose monitors. This includes people who frequently experience high blood sugar, significant drops in blood sugar (severe hypoglycemia), or have side effects from insulin injections like skin issues or resistance. The main goal is to find out if ExOlin® is safe for people to use. It's a 'first-in-human' study, meaning it's one of the first times this treatment is being tested in people. The study will look at how ExOlin® works alongside their current insulin treatment. This is an important step in exploring new ways to help people with type 1 diabetes manage their condition more effectively and reduce challenging symptoms.
At a glance
What is this study about?
This study is about a new treatment called ExOlin®. It's being tested in people who have type 1 diabetes and find it difficult to keep their blood sugar levels stable, even with their current treatment. You might be familiar with terms like 'poorly controlled' or 'high glucose fluctuations' – this simply means that your blood sugar can go very high or very low, which can be challenging to manage.
The main aim of this study is to check if ExOlin® is safe to use. Because it's a new treatment, it's really important to see how it affects people and if there are any side effects. This particular study is a 'pilot investigation' and 'first in human', which means it's one of the very first times this treatment is being tried in people. It will help researchers learn a lot about ExOlin® and decide if it's worth studying further in larger groups of people.
Type 1 diabetes can be a demanding condition, and finding new and safer ways to help people manage their blood sugar is always a priority. If proved safe and effective in future studies, treatments like ExOlin® could potentially offer new options for managing blood sugar levels, especially for those who struggle with severe low blood sugar episodes (hypoglycemia) or other issues related to their insulin therapy.
Key takeaways
- This study is testing a new treatment called ExOlin® for safety.
- It's for adults with type 1 diabetes that's hard to control, even with an insulin pump.
- Participants must use an insulin pump and continuous glucose monitor.
- The study focuses on those with frequent high or low blood sugar, or severe low blood sugar episodes.
- It's an early-stage study, so close monitoring will be involved.
Who may be eligible?
To be considered for this study, you need to be an adult (18 or older) who has had type 1 diabetes for at least two years. Your body mass index (BMI) should be between 16 and 35. You must also be managing your diabetes with an insulin pump and a Dexcom G6 continuous glucose monitor for at least three months, and your HbA1c level (a measure of average blood sugar) needs to be between 7.0% and 12.0%.
Importantly, this study is looking for people whose diabetes is particularly difficult to control. This might mean you've had a severe episode of low blood sugar in the last year where you needed help from someone else, or you frequently experience big swings in your blood sugar (very high or very low). It also includes people who have specific problems with their insulin injections, such as insulin resistance (where your body doesn't respond well to insulin) or skin issues like lipodystrophy.
There are also some reasons why you might not be able to join. These include having kidney problems, a weakened immune system, ongoing inflammation or infection, certain skin conditions that might react badly to the new treatment, or if you're taking strong blood thinners. If you have had severe wound healing problems or certain types of prostheses, or if you're allergic to components of medical devices like plasters, you would also not be able to participate.
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 an adult (18 years or older)?
- Have you had type 1 diabetes for more than two years?
- Do you use an insulin pump and Dexcom G6 continuous glucose monitor?
- Is your HbA1c between 7.0% and 12.0%?
- Do you often have very high or very low blood sugar levels, or have you had a severe low blood sugar episode in the last year?
- Do you have problems with your skin where you inject insulin?
What does participation involve?
This is a 'first-in-human' pilot study, which means it's a small, initial study to check safety. You would receive the investigational treatment, ExOlin®, alongside your usual insulin aspart. The exact number of visits and their frequency would be explained in detail by the study team, but typically, pilot studies involve several visits for close monitoring. During these visits, the study team would check your health, take blood and urine samples, and monitor your blood sugar levels closely. The total duration of your involvement in the study would be explained before you agree to take part.
Potential risks and benefits
Locations (1)
- Hôpitaux Universitaires de StrasbourgVerified postcodeStrasbourg, France· Recruiting
Common questions
What is ExOlin®?
ExOlin® is a new treatment being studied for people with type 1 diabetes that is difficult to control. This study is testing its safety.
What does 'poorly controlled' type 1 diabetes mean?
It means your blood sugar levels often go very high or very low, or you frequently experience severe low blood sugar episodes, even with your current treatment.
Will I stop taking my regular insulin?
No, you will continue your current insulin therapy, including your insulin pump, alongside the new ExOlin® treatment.
Is this a new medicine for everyone with type 1 diabetes?
No, this is a very early, small study aimed at checking the safety of ExOlin® in a specific group of adults with difficult-to-manage type 1 diabetes.
What is severe hypoglycemia?
Severe hypoglycemia is when your blood sugar drops so low that you need help from another person to recover.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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